diff --git "a/deduped/dedup_0000.jsonl" "b/deduped/dedup_0000.jsonl" deleted file mode 100644--- "a/deduped/dedup_0000.jsonl" +++ /dev/null @@ -1,109 +0,0 @@ -{"text": "Several previous epidemiological studies have shown a relation between drinking water quality and death in cardiovascular disease whereas others have not found such a relationship. An intervention study was undertaken to evaluate the effect of water with added magnesium and natural mineral water on blood pressure.A group of 70 subjects with borderline hypertension was recruited and consumed 1) a water low in minerals, 2) magnesium enriched water or 3) natural mineral water, in a random, double blind fashion during four weeks.Among persons with an initial low excretion of magnesium or calcium in the urine, the urinary excretion of magnesium was increased in the groups consuming the two waters containing magnesium after 4 weeks. A significant decrease in blood pressure was found in the group consuming mineral water at 2 and 4 weeks.The results suggest that minerals taken in water are significant for the body burden and that an intake of mineral water among persons with a low urinary excretion of magnesium or calcium may decrease the blood pressure. Further studies should investigate the extent of mineral deficiency in different populations and the efficiency of different vehicles for supplying minerals, particularly magnesium and calcium. A relation between mortality from ischaemic heart disease (IHD) and drinking water characteristics was first shown in Japan in 1957 and reviIn a case-control study, an inverse relation was found between the amount of magnesium in drinking water and death from acute myocardial infarction and for females also between the amount of calcium and death . Diets rRegarding individual minerals, several studies have been reported where hypertensive subjects were treated orally with nutritional doses of magnesium . The resEpidemiological studies on cardiovascular disease suggest that drinking water is an important vehicle for the supply of minerals . This isThe present intervention study was undertaken to determine the effect of minerals in water on one of the major risk factors for cardiovascular disease – blood pressure. Subjects with slightly elevated blood pressure consumed water with different levels of minerals. Serum and urinary levels of minerals were measured as a marker of intervention and blood pressure was measured before and after the intervention.Female and male subjects, aged 45 – 64 years (n = 70) were recruited by advertising in local newspapers. Inclusion criteria were living in an area with low magnesium content in the drinking water, systolic pressure 15 mm above normal values for their age, diastolic pressure above 90 mm Hg, and within 20% of ideal body weight. Exclusion criteria were hypertension target organ damage, chronic diseases , pregnancy, and taking oral contraceptives or regular intake of mineral supplements. Subjects with a diastolic pressure above 100 mm Hg were advised to consult a physician for treatment. A few persons decided not to seek a physician's advice and choose to participate anyway. The Ethical committee at the Medical faculty, University of Gothenburg, approved the study.Blood pressure was measured using standardized techniques before the intervention, at 2 weeks and at the end at 4 weeks. Two separate recordings were made (diastolic pressure as Korothoff phase 5) after 5 minutes of supine rest. The blood pressure is reported as the average of these recordings.idem). Magnesium and calcium levels in urine were expressed as the creatinine ratio.Blood samples were taken before and after the intervention to determine the serum concentration of magnesium, calcium, sodium, creatinine and potassium . Before and after the intervention period, 24 hours urine samples were collected and the amounts of magnesium, calcium, and creatinine were determined . Table Table In spite of the random allocation to the different waters, it was found that the group consuming water C comprised a larger number of persons with a high initial systolic pressure. In the groups receiving waters A and B, none of the subjects had systolic blood pressures above 170 before the intervention. The subjects drinking water C were divided into those with an initial systolic pressure above and below 170 mm. For the group with the higher pressure (n = 6), there was a decrease in the systolic pressure before and at 4 weeks p = 0.023) but no difference at 2 weeks or for diastolic pressure. The results from the remainder of the group are also shown in Table but no dThe study is of exploratory character, based on a relatively small number of subjects and should be interpreted with care. There is also a lack of some data that retrospectively would have been of interest such as sodium in the urine and the effect of water with only calcium added. We do not think, however, that this has any influence on the major conclusions from the study.The intervention with the two waters with added magnesium influenced the body burden in terms of an increased excretion of magnesium in urine. This is consistent with findings from previous intervention studies ,17 althoThe intervention with water containing high amounts of several minerals decreased the blood pressure significantly in contrast to water with magnesium only where no significant effect was detected. This does not exclude that an effect could have been found with the latter water, had the intervention time been longer. On the other hand, the finding supports the concept that interventions should be performed under conditions similar to the ones present in normal environments, rather than with one specific agent. This could also explain the lack of an effect in previous studies where single minerals have been given as reviewed in the introduction.In summary, the results suggest that waterborne minerals constitute a supply for the body burden, that the urinary excretion can be used as a physiologically relevant indicator of the body burden of magnesium and calcium, and that the supplementation of magnesium together with other minerals may reduce blood pressure among persons with a low body burden of magnesium and calcium, either due to an insufficient intake through food or water, or through some metabolic/clinical disturbance. Additional studies are needed to explore this further.The study was supported by an unconditional grant to Gothenburg University from the Nestlé Water Institute, Vittel, France. The authors had full freedom for data analysis, manuscript preparation and submittance to a journal. RR has not received any fees or salaries for this work, including article processing charges, nor does he own any shares or has any other financial interest in the company. MA was an employee at the Water Institute at the time of the study.RR and MA jointly developed the research plan. RR conducted the field study. RR and MA jointly analyzed the data and wrote the manuscript.The pre-publication history for this paper can be accessed here:"} -{"text": "This study was conceived to analyze how exercise and weight management psychosocial variables, derived from several health behavior change theories, predict weight change in a short-term intervention. The theories under analysis were the Social Cognitive Theory, the Transtheoretical Model, the Theory of Planned Behavior, and Self-Determination Theory.2; age = 38.3 ± 5.8y), participating in a 16-week University-based weight control program. Body weight and a comprehensive psychometric battery were assessed at baseline and at program's end.Subjects were 142 overweight and obese women but with great individual variability. Both exercise and weight management psychosocial variables improved during the intervention, with exercise-related variables showing the greatest effect sizes. Weight change was significantly predicted by each of the models under analysis, particularly those including self-efficacy. Bivariate and multivariate analyses results showed that change in variables related to weight management had a stronger predictive power than exercise-specific predictors and that change in weight management self-efficacy was the strongest individual correlate (p < .05). Among exercise predictors, with the exception of self-efficacy, importance/effort and intrinsic motivation towards exercise were the stronger predictors of weight reduction (p < .05).The present models were able to predict 20–30% of variance in short-term weight loss and changes in weight management self-efficacy accounted for a large share of the predictive power. As expected from previous studies, exercise variables were only moderately associated with short-term outcomes; they are expected to play a larger explanatory role in longer-term results. Obesity and excessive weight are common concerns among people in industrialized countries. Scientific literature consistently reports the epidemic status of obesity e.g., -3], howe, howe3]]Albeit reported inconsistently in the literature, psychosocial variables are accepted as playing a key role in explaining weight management ,5. TheseThe SCT is the most frequently used paradigm in weight management interventions and it iimplementation intentions) are also part of the behavior change intervention and exercise ,28], witstages of change (SOC), which reflect the temporal dimension of the behavior, divided in six consecutive stages; and ii) a set of constructs that explain how people evolve along the SOC. These are named processes of change, i.e. cognitive and behavioral activities that individuals use to modify their experiences and environments to obtain the desired behavior. Also included in this model are the decisional balance, representing the pros and cons of engaging in the behavior, and self-efficacy, reflecting the person's confidence in performing the health behavior change and exer change , e.g., [r change ], mainlyr change . Studiesr change . Weight r change . This str change . Suris ar change . In thisThe SDT is a motivation theory that highlights people's inherent need to evolve and to be integrated in a social scenario. Three primary needs that have been identified are competence, relatedness, and autonomy, which lead to different types of motivation to act, the most important and desirable being intrinsic motivation. This construct reflects our inherent tendency to seek out novelty and challenge, while feeling competent and autonomous in the process. Enjoyment, mastery, and positive feelings arise from this quest, reinforcing the continuation of the behavior. In opposition, extrinsic motivation is more externally driven, more controlled , and more disconnected from the behavior itself (more focused on its outcomes). Lastly, amotivation is a state where there is a lack of intention to act so that the outcome behavior has no personal value and feelings of competence are not present . The SDTThe previous theories constitute science' best effort to explain how peoples' decisions and choices toward exercise and healthy nutrition are built . They arBuilding on recent discussions on the usefulness of theory-based interventions in health behavior promotion -40 and f2, and be free from major disease to be eligible for the study. After the selection process 142 overweight and obese women started the program. For this study, only the first four months are being analyzed, a period during which all participants received the same intervention; they were later randomized to two different long-term programs or to controls. Attrition was 6.3% from baseline to 4 months (133 completers). However, some psychometric data were incomplete due to errors in the completion of some questionnaires either on baseline or after the intervention, leading to smaller sample sizes in some analyses.Participants were recruited from the community for a 2-year weight management program through newspaper ads, a website, email messages on listservs, and announcement flyers. Subjects were required to be older than 24 years, be premenopausal and not currently pregnant, have a BMI higher than 24.9 kg/mThe intervention was composed of fifteen weekly meetings, which lasted 120 minutes, and where both educational and practical components were scheduled. Attendance averaged 83% and groups were composed of 32–35 women, who entered the study in two cohorts. The intervention has been described before and was In short, content included exercise, nutrition, and behavior modification components. Exercise topics ranged from the caloric expenditure of some common physical activities to choosing the right apparel to exercise. Exercise behavioral contents involved a motivational setup to increase walking and lifestyle physical activity, in which a pedometer was distributed and planning and log techniques were taught. Nutrition topics dealt, for example, with macronutrient and micronutrient content of the most common foods, energy density, and meal frequency. Behavioral nutrition contents comprised planning for special occasions, using the hunger scale, emotional eating, and preventing lapses, among others.These contents were expected to have effects on several constructs of the health behavior theories studied in the present investigation. For example the planning techniques should have an effect on intentions, on expected outcomes and in behavioral POC, while the more instructional activities should have interfered with attitudes, perceived barriers and in cognitive POC. In the beginning of each session participants were asked to share with the group their program-related experiences in the previous week. This discussion should have impacted on social support, social norms and self-efficacy, by vicarious learning and also by verbal and social persuasion from both staff and group members. Lastly, the intervention had the underlying goals of improving autonomy and that the participants should choose the tasks that were more enjoyable to them. These are highly motivational factors that have an effect on SDT constructs, accounting specifically for intrinsic motivation.The sessions were conducted by a team composed by two Ph.D.- and six M.S.-level exercise physiologists, psychologists, or dietitians. Participants were provided with individualized dietary plan and specific physical activity goals, aiming to induce an energy deficit of 300–500 kcal/d, by comparison with baseline values. Participants were informed that weight loss should be understood as a long-term goal, and that 5% weight loss after six months was an appropriate goal.A large battery of psychometric instruments was used in this study and participants were requested to attend two sessions for their completion, in each evaluation period. The instruments were Portuguese validated versions of some of the most used instruments for the constructs under analysis. In this section and throughout the manuscript, variables were divided and are presented in two separate categories: \"weight management\" and \"exercise\".The SCT weight management-related variables included self-efficacy and outcome expectancy measures. The Weight Efficacy Lifestyle Questionnaire WEL – ,44] is a is a44]]The TTM weight management constructs were i) self-efficacy ,44, ii) The TPB weight management constructs were assessed by a set of 18 items ,48 measuSocial-cognitive theory exercise-related variables comprise self-efficacy, perceived barriers, and social support. Exercise self-efficacy was measured with the Self-Efficacy for Exercise Behaviors Scale SEEB – ,50], ass, ass50]]The TTM exercise related variables were self-efficacy ,50, SOC,The TPB exercise-related variables were assessed through 17 items ,56 measuWe used the Intrinsic Motivation Inventory IMI – ,58], to , to 58]]Weight was measured at baseline and four months. A standardized procedure was used where weight was measured twice, to the nearest 0.1 kg (average was used), using an electronic scale .For correlational analyses, all variables were expressed by the residuals of the 4-month variable value regressed on baseline data. This procedure is recommended by Cohen and Cohen as it crThe impact of the intervention on weight and psychosocial variables was assessed by paired t-test procedures. Effect size' were calculated, and the criteria to designate its magnitude was the following: < .30 small effect size; .30 to .80 medium effect size; >.80 large effect size .The linear bivariate association between changes in weight and psychosocial variables were assessed by Pearson correlations. Multiple regression models were created to evaluate the multivariate estimates for the associations between psychosocial variables and weight change. The health behavior models' variables were entered separately in seven regression designs (three for the weight management related models and four for the exercise related models). The squared semi-part correlation was calculated to reflect the unique contribution of each predictor to the variance in the outcome variables .Weight change (WC) showed a large individual variability , contemplation (35.5%) and preparation (37.5%). After the 4-month intervention, these numbers were inverted, as participants were mostly in the action (58.6%) or maintenance (18.0%) stages. Further analysis of the exercise-related psychosocial variables , while maintenance was reached by 11.7% of the women. Weight management psychosocial variables did not change as markedly as exercise constructs and different variables emerged as significant, with intentions, subjective norms and outcome expectancies showing no change, while behavioral POC , self-efficacy , cognitive POC , attitude , and PBC reflected the desired intervention changes.Pearson correlation was used to analyze associations between predictors and WC Table . The firTo look further at the predictive power of constructs from behavior change models on WC, we designed a set of multiple regressions, with separate models for the constructs within each theory Tables and 4. T2 = 26.8%, p < .001), mostly due to changes in self-efficacy, which independently explained 19.4% of WC variance, seconded by behavioral POC with 3.1%. The SCT represented the next strongest model , with changes in self-efficacy alone contributing 20.5% to the explained variance. The model for TPB explained 17.6% (p < .001) of the variance in weight change, with attitude and PBC showing similar semi-part correlation values . All other weight management psychosocial constructs did not contribute significantly to the models.Weight management variables presented the stronger models, particularly the TTM , seconded by TTM . Change in self-efficacy was the only variable that significantly added predictive power to these models . The other models did not account significantly to weight change, although the importance/effort dimension in the SDT model independently contributed with 4.8% of the explained variance (p = .015).Table 2) scores; c) Theories that included self-efficacy (TTM and SCT) presented the stronger regression models, and d) Change in variables and models related to weight management had higher predictive power than those from exercise-related models.This study was conceived to analyze how changes in key psychosocial exercise- and weight management-related variables, derived from four important health behavior theories, would predict weight change during a behavioral obesity treatment short-term intervention. Weight change was significantly predicted by several single variables and by health behavior change theories/models as a whole. The following were this study's primary findings: a) Change in eating/weight management self-efficacy was the single best correlate of weight reduction, though several other variables were also associated with weight outcomes ; b) About 20–30% of the variance in weight change was explained by the best prediction models and most showed statistically significant prediction [The stronger models, TTM and SCT, were weight management-related and both included self-efficacy. We found few studies that have analyzed losses) ,64. In t losses) . It coul losses) reviewed losses) ,66. Inte losses) , raisingExercise processes seemed to be substantially influenced by the intervention, which included information on how to cope with common barriers, recommended exercises , scheduling techniques, physiologic and psychological benefits of exercise, and how to use/find available resources. Nevertheless, exercise-related variables and models were only moderately associated with weight outcomes with self-efficacy again showing the highest bivariate and multivariate associations. It is interesting to note that despite its association with weight loss, mean exercise self-efficacy scores did not change significantly during the intervention. As pointed out before , it is pSelf-Determination Theory was only evaluated regarding exercise constructs and represented a stronger model than the TPB, with the importance/effort dimension emerging as a single predictor from SDT. The intervention sessions repeatedly reinforced the importance of exercise for the success in weight management, especially for long-term outcomes, for instance by citing results from the National Weight Control Registry results . As a coLimitations of this investigation include self-reported data, the absence of a control group, a relatively small sample, and the lack of complete evaluation for some models , mostly due to the absence of validated Portuguese questionnaires for these constructs. Also, some of the constructs were analyzed with less than ideal measures, such as outcome expectancies. Finally, multiple measures collected during the 4-month program, instead of only pre and post results, would have improved our assessment of the psychosocial variables by better describing changes in each construct throughout the program.In sum, we observed that theories that comprise self-efficacy are the most predictive of weight change and that weight management- and eating-related constructs and theories better explain the variance in short-term outcomes, compared to exercise models. To a lesser extent, exercise theories were also predictive. However, their predictive power is expected to increase in longer-term analyses, especially for variables related to intrinsic motivation and SDT. This is in line with recent results in a very similar intervention, where psychosocial eating variables better predicted 4-months results while exercise motivation constructs were superior correlates of 16-month weight loss . In the The author(s) declare that they have no competing interests.ALP and PJT conceived the study and drafted the manuscript. ALP performed the statistical analysis, was responsible for psychometric assessments and participated in the study's implementation. TLB, SSM, CSM, and JTB actively participated in the study implementation and in data collection. SOS participated in the study design and in the selection of psychosocial predictors. LBS is a principal investigator in the research trial. All authors read and approved the final manuscript."} -{"text": "The relationship between BMI and leptin has been studied extensively in the past, but previous reports in postmenopausal women have not been conducted under carefully controlled dietary conditions of weight maintenance using precise measures of body fat distribution. The aim of the present study was to examine the association between serum leptin concentration and adiposity as estimated by BMI and dual energy x-ray absorptiometry (DEXA) measures in postmenopausal women.This study was conducted as a cross-sectional analysis within the control segment of a randomized, crossover trial in which postmenopausal women (n = 51) consumed 0 (control), 15 (one drink), and 30 (two drinks) g alcohol (ethanol)/d for 8 weeks as part of a controlled diet. BMIs were determined and DEXA scans were administered to the women during the 0 g alcohol treatment, and a blood sample was collected at baseline and week 8 of each study period for leptin analysis.2) had a 2-fold increase, and obese women (BMI > 30 kg/m2) had more than a 3-fold increase in serum leptin concentrations compared to normal weight (BMI ≤25 kg/m2) women. When the models for the different measures of adiposity were assessed by multiple R2, models which included percent body fat explained the highest proportion (approximately 80%) of the serum leptin variance.In multivariate analysis, women who were overweight (BMI > 25 to ≤ 30 kg/mUnder carefully controlled dietary conditions, we confirm that higher levels of adiposity were associated with higher concentrations of serum leptin. It appears that percent body fat in postmenopausal women may be the best adiposity-related predictor of serum leptin. Natural menopause, a normal aspect of aging, may influence risk of breast cancer , the leain vitro models, leptin acts as a growth factor and stimulates cellular proliferation, angiogenesis, motility, and invasion [In various invasion -20. Leptinvasion ,20 and cinvasion . Leptin invasion . In thisstudy periods; each study period was separated by two-five week washout periods. Total and regional adiposity measurements were assessed during the fourth week of the control treatment . DEXA whole body scans were used for adiposity assessments; measures of BMI were taken on the same day.This study was part of a randomized, crossover, intervention trial of moderate alcohol supplementation in postmenopausal women (n = 51). Details of the study design and procedures have been published previously ,24. Brie(1) women ≥ 50 y of age, (2) postmenopausal , (3) not receiving hormone replacement therapy (HRT), (4) not taking prescription medications that might interfere with the study, (5) willing and able to consume the diet prepared or approved by the Center and no other foods or beverages, and (6) without personal or parental history of alcohol abuse. The subjects were evaluated by a physician and determined to be in good health with no signs or symptoms of any disease or endocrine disorders.Postmenopausal women were recruited by advertisement from the communities surrounding the Beltsville Human Nutrition Research Center, Beltsville, MD. The eligibility criteria were: This study was approved by the National Cancer Institute's Institutional Review Board and the Committee on Human Research of the Johns Hopkins University Bloomberg School of Hygiene and Public Health. All subjects were fully informed of the study requirements and were required to read and sign a consent form detailing the objectives, risks, and benefits of the study. The subjects were compensated for their participation.All meals were prepared at the Beltsville Human Nutrition Research Center from typical U.S. foods and served in a seven-day menu cycle. Each day's diet provided 15% energy as protein, 50% energy as carbohydrate, and 35% energy as fat, with a polyunsaturated/monounsaturated/saturated fat ratio of 0.6:1:1. Daily fiber intake was 10 g/1,000 kcal, and daily cholesterol intake was 150 mg/1,000 kcal. Diets provided 100% of the U.S. recommended dietary allowances for vitamins and minerals . The stuBody composition was determined by pencil beam dual energy x-ray absorptiometry . Subjects were placed in a supine position with arms and legs close to their body for a whole body scan following the manufacturer's recommended protocol. Whole body and regional lean mass (mass of bone and nonfat soft tissue) and fat mass were determined using the manufacturer's algorithm (software version 1.33).During the last week of the control treatment, blood samples for leptin analysis were collected from fasting (> 12 hours) subjects before breakfast (6:30 AM to 9:00 AM) on each of three non-consecutive days in each study period. An equal volume of serum from each day's blood draw was pooled for analysis. Serum was separated and aliquots were frozen at -70°C. The laboratory methods for the serum leptin measurements were described previously . BrieflySerum leptin concentrations were log transformed using the natural log. All estimates of means and the differences between means were made using the log transformed leptin values. In tables we report means and regression coefficients returned to the original (arithmetic) scale.2 calculated from measured weight and height) were determined. Mean serum leptin concentrations for BMI categories were estimated using linear regression models that included a series of indicator variables for three standard BMI categories . BMI categories were also modeled as ordinal variables with values 0, 1, and 2. Additional models estimated percent changes in serum leptin concentrations per one-unit change in BMI, one-percent change in total body fat (measured as percent body fat), and 1000 g change in central, peripheral, or lean mass modeled as continuous variables. All models included age (continuous), parity (continuous), race , age of menarche , and family history of breast cancer . One woman's breast cancer information was missing and she was excluded from models that included breast cancer history. Sensitivity models including her as having or not having a family history of breast cancer did not change analysis conclusions. In a second series of models (Model 2), we added BMI to Model 1 as a covariate The addition of alcohol group assignment order, study period, hysterectomy, duration of menses, years since last menses, nulliparity, and age at first birth (for those with children) did not improve the precision of the estimates and these terms were not included in the final models. There was no evidence of effect modification as assessed by likelihood ratio tests of model fit after the addition of cross-product terms to models that included main effects. Throughout the paper all P-values are two-sided nominal (unadjusted) P-values. P-values for BMI and DEXA measurements were determined using likelihood ratio tests comparing models with the BMI or DEXA term of interest to models without that term. Multiple R2 and F-tests were calculated from the linear regression models. Statistical analyses were performed using S-PLUS .Pearson and Spearman correlations between the different DEXA measurements and BMI (kg/m2 to 42.5 kg/m2 (median 26.9); and total body fat ranged from 7,942 g to 55,756 g , while trunk, leg, and arm fat were of progressively lesser magnitude. Descriptive statistics for serum leptin concentrations are also presented in Table Fifty-one women successfully completed the entire study and are included in the present analysis. The physical characteristics and reproductive history of the subjects at baseline are provided in Table P < 0.0001). Among obese subjects, serum leptin concentrations were more than three-fold those seen in the normal weight subjects.Table Table 2 was used to assess the strength of the linear associations of the overall models to leptin , all adjusted for the covariates, so that they can be compared. Looking at the multiple R2 values, we found the percent body fat model explains a largest proportion (more than 80%) of the variance associated with serum leptin concentrations, and thus appear to be very strongly associated with serum leptin concentrations. However, all of the R2 values in Table Our adiposity measures are on different scales and it is difficult for example, to compare changes of one percent in body fat versus one kg body fat versus one BMI unit, thus we also used multiple RIn addition to the previous studies which suffer from inadequate control of diet and energy balance (known confounders of leptin levels) -14, in pSince increased BMI and centAlthough our study is limited by its cross-sectional design and modest sample size, the strengths of this study include a homogeneous study population and measurement stability, which resulted from the use of a carefully controlled diet adjusted to maintain body weight. The DEXA scans employed are considered a reference method for body composition analysis . AlthougIn conclusion, our study demonstrated that serum leptin concentrations showed striking differences by adiposity levels. Increased exposure to leptin was observed for increased adiposity determined by BMI, percent body fat, central and peripheral fat as well as lean body mass. Although BMI and DEXA adiposity are highly correlated in this cross-sectional study, it remains for further studies to confirm and refine our observations regarding: (i) percent body fat as the best adiposity-related predictor of serum leptin, and (ii) the independent value of central body fat in this prediction even after adjustment for BMI. Because of the well-known arguments for limitations in the use of BMI , such asThe author(s) declare that they have no competing interests."} -{"text": "African American women exhibit a higher mortality rate from breast cancer than do white women. African American women are more likely to gain weight at diagnosis, which may increase their risk of cancer recurrence and comorbidities. Physical activity has been shown to decrease body mass index and improve quality of life in cancer survivors. This study was designed to evaluate the feasibility and impact of a community-based exercise intervention in African American breast cancer survivors.A theory-based eight-week community intervention using pedometers with scheduling, goal setting, and self-assessment was tested in a convenience sample of African American breast cancer survivors (n = 24). Data were collected at three time points to examine changes in steps walked per day, body mass index, and other anthropometric measures, attitudes, and demographic variables.Statistically significant increases in steps walked per day and attitude toward exercise as well as significant decreases in body mass index, body weight, percentage of body fat, and waist, hip, and forearm circumferences, as well as blood pressure, were reported from baseline to immediate post-intervention. Positive changes were retained or improved further at three-month follow-up except for attitude toward exercise. Participant retention rate during eight-week intervention was 92%.Increasing walking for exercise, without making other changes, can improve body mass index, anthropometric measures, and attitudes, which are associated with improved quality of life and reduced risk of cancer recurrence. The high participant retention rate, along with significant study outcomes, demonstrate that among this sample of African American breast cancer survivors, participants were motivated to improve their exercise habits. African American women exhibit a higher rate of breast cancer mortality when compared with white women ,2. BeingUntil recently, women who have completed cancer therapy have been offered little to improve survival or decrease risk of new disease. Yet studies show that as a group, breast cancer survivors are interested in improving their health behaviors and quality of life ,7. Two rTo address weight gain in African American breast cancer survivors, we designed a theory-based cognitive-behavioral walking program to test its feasibility and impact on steps per day and BMI. The study was pilot tested among African American breast cancer survivors, using a community education model in an urban inner-city setting.We pilot tested an eight-week community-based walking program in a convenience sample of African American breast cancer survivors (n = 24) to investigate feasibility and impact on outcome measures over three time points: 1) baseline, 2) immediate post-intervention, and 3) three-month follow-up. African American women who 1) had been diagnosed with breast cancer, 2) had completed treatment at least three months before recruitment, 3) were mobile, and 4) were less than 70 years of age were eligible for the study.Using a broad, organized effort, participants were recruited from Massey Cancer Center clinics, outreach sites, contacts with local churches, community leaders, and breast cancer organizations including breast cancer support groups. A city council member, along with other breast cancer survivors, was also instrumental in communicating study information throughout the community. Flyers, television announcements, and personal communication were used during the three-month recruitment effort. We contacted approximately 230 potentially eligible women. Recruitment rate was approximately 10%. Reasons for nonparticipation included having cancer treatment within the prior three months, not being able to attend community meetings because of work or family commitments, or having comorbid conditions that decreased mobility.The theory-driven intervention was designed with the primary study goal of integrating walking into one's daily routine. The Health Belief Model was used as the theoretical framework for the intervention . This weStudy variables were assessed at three time points: baseline, immediate post-intervention, and at three-month follow-up. The study goal was the integration of walking into the participant's daily routine. The primary study outcomes were changes in number of steps and BMI. Steps per day were measured using a steps-only pedometer. Participants were instructed to wear the pedometer upon rising in the morning until bedtime and to record the number of steps walked. BMI was calculated from weight and height using a calibrated scale. Waist, hip, and upper arm circumferences were measured using a tape measure, and blood pressure was measured with a standard blood pressure cuff. Body-fat percentage was measured using Futrex, a portable near-infrared sensor system . All cliParticipant demographic information, cancer history, and attitudinal measures were assessed using standardized survey items from other study instruments. The instrument was pilot tested in a comparable age group of African American women. Attitudes toward exercise were measured using the Exercise Decisional Balance instrument , a 16-itt tests were used to determine differences in mean anthropometric and attitudinal measures between the three time points. In addition, based on frequency distribution of time since diagnosis, all study variables were tested among those diagnosed three years or less prior to start of the intervention (1999–2002) (n = 10) and those diagnosed earlier (1978–1998) (n = 12), using independent samples t tests.Data were entered into a database using SPSS statistical software . Descriptive statistics were determined for all study variables. Analysis of variance was performed to test for differences in measures collected at baseline, immediately after intervention, and at three-month follow-up. Paired Twenty-four women were enrolled in the intervention study. One participant dropped out because of scheduling conflicts. One experienced a cancer recurrence, resulting in 22 eligible women completing the intervention.Feasibility was determined by examining attendance at weekly sessions, study retention, and receptivity to pedometer use. Attendance at weekly sessions was excellent, with 70% of the participants attending seven or more intervention sessions. Study retention to the eight-week study was also excellent, with 22 of 24 women completing the intervention and immediate post-assessment. Participants had positive experiences using the pedometers and recording steps per day. Broken or lost pedometers were reported by approximately 25% of the study sample, and they were replaced to ensure continuous data collection. Additional data showed that 95% responded \"about right\" to a survey item asking whether number of study sessions were too many, too few, or about right.P < .001), hip circumference (P = .009), forearm circumference (P < .001), systolic blood pressure (P = .002), diastolic blood pressure (P = .001), and attitude toward exercise (P = .005).Results of ANOVA analyses of repeated measures showed statistically significant differences in steps per day . Other significant decreases included the following: BMI (P = .004), body weight (P = .005), percentage body fat (P = .003), and forearm circumference (P = .007). Increased positive perception of exercise was also reported (P = .03).P = .04), forearm circumference (P = .04), and diastolic blood pressure (P = .02). Thus, all anthropometric measures either stayed the same or showed further improvement by further reduction in measures from immediate post-intervention to three-month follow-up. Of all study variables, only attitude toward exercise significantly changed direction (P < .001), with women showing a more negative opinion of exercise by three-month follow-up compared with immediate post-intervention. There were no differences in mean study outcomes in the participants who did not attend three-month follow-up assessment sessions (n = 5) compared with participants who did attend and had measurements (n = 17).P = .02) when compared to earlier diagnosed women. The same effect was true at immediate post-intervention for both diastolic blood pressure (P = .02) and systolic blood pressure (P = .003). At three-month follow-up, recently diagnosed women were significantly more likely to have higher waist measures (P = .048), with trends toward larger hip (P = .06) and body fat (P = .05) measures than earlier diagnosed women.More recently diagnosed women tended to have higher body measures at all three time points, but only diastolic blood pressure was significantly higher at baseline (We found statistically significant changes in the main study outcomes of steps per day, BMI, and virtually all of the anthropometric changes measured in the study population after an eight-week intervention, with most results remaining at three-month follow-up. The breast cancer survivor participants were motivated and compliant with the intervention, which likely enhanced their success. Having had cancer and understanding their risk of recurrence may account for the strong motivation we found in this population, as suggested by the constructs of the Health Belief Model. It is also important to note that the sample participants all had more than a high school education, which may also have contributed to their success.Although we found only a few statistically significant differences in mean body measures in relationship to time since diagnosis, we may have detected more evidence of this pattern had we had a larger study sample. While not significant, the more recently diagnosed women had larger body measures and lower mean steps per day than earlier diagnosed women at both immediately post and at three-month follow-up.The goal of the study was to have women integrate walking into their daily routines on their own. They attended sessions for education, motivation, and self-assessment; walking did not take place during the study sessions. This was an important feature of the study design because research shows that compliance is likely to decline significantly after an intervention is completed . Thus, oThe mean change in body weight was modest but significantly less than baseline. This level of weight loss supports what similar interventions have reported . We wereWomen in the study improved their attitude toward exercise from baseline to post-intervention by reporting fewer barriers to exercise over the study period. This was not surprising given the focus of the intervention sessions on overcoming personal obstacles to exercise. However, the attitudinal improvement did not hold at three-month follow-up. Although steps per day did not significantly change at three-month follow-up, one might wonder if the decline in exercise attitude might eventually negatively influence exercise behavior after a longer time interval. Cancer stress scores did not change significantly over the course of the intervention. However, scores for this variable were not particularly high even at the start of the intervention. This could be related to the fact that only 18% of participants were diagnosed during the 12 months prior to the start of the study. Cancer stress may subside as time passes after a woman's diagnosis. Had we studied a group of more recently diagnosed women, we may have found more evidence of cancer stress at baseline and potential for impact after the exercise intervention than we did the with this study population.and physical activity — are modified. Overall, the study objectives were realized, and the study provides interesting pilot data for testing a more comprehensive lifestyle intervention in a similar population. However, the sample does not constitute a representative sample, and the study findings may not be applicable to other breast cancer survivors.This study was limited by the study size and lack of control group. For a pilot study, however, the sample size was adequate to study feasibility and study outcomes. In addition, the study reflects the common limitations for relying on self-report data. Anthropometric variables were included in the study in addition to self-reported data to provide measured data for evaluating results. The intervention tested exercise only; thus, even more significant changes among this population are possible if both energy balance components — food intake Steps walked per day, BMI, body circumferences, blood pressure, and attitudinal variables all showed improved mean statistically significant changes in this population of African American breast cancer survivors after a theory-based cognitive-behavioral community intervention. The study showed strong feasibility measures in positive response to using pedometers, high participant retention, social support, and excellent compliance after eight weeks. Given data indicating obesity is associated with shorter breast cancer survival time, these study results may position breast cancer survivors to have both improved quality of life and reduced risk of cancer recurrence. Further study is needed to test a randomized comprehensive diet and exercise intervention in African American breast cancer survivors against controls in a longer, larger randomized trial with additional study variables."} -{"text": "Asthma and allergic diseases are becoming increasingly frequent in children in urban centres of Latin America although the prevalence of allergic disease is still low in rural areas. Understanding better why the prevalence of asthma is greater in urban migrant populations and the role of risk factors such as life style and environmental exposures, may be key to understand what is behind this trend.The Esmeraldas-SCAALA study consists of cross-sectional and nested case-control studies of school children in rural and urban areas of Esmeraldas Province in Ecuador. The cross-sectional study will investigate risk factors for atopy and allergic disease in rural and migrant urban Afro-Ecuadorian school children and the nested case-control study will examine environmental, biologic and social risk factors for asthma among asthma cases and non-asthmatic controls from the cross-sectional study. Data will be collected through standardised questionnaires, skin prick testing to relevant aeroallergen extracts, stool examinations for parasites, blood sampling , anthropometric measurements for assessment of nutritional status, exercise testing for assessment of exercise-induced bronchospasm and dust sampling for measurement of household endotoxin and allergen levels.The information will be used to identify the factors associated with an increased risk of asthma and allergies in migrant and urbanizing populations, to improve the understanding of the causes of the increase in asthma prevalence and to identify potentially modifiable factors to inform the design of prevention programmes to reduce the risk of allergy in urban populations in Latin America. Large increases in the prevalence of asthma and allergic diseases have been reported in industrialized countries during the last twenty to thirty years ,2, althoAllergic diseases are caused by a complex interaction between host genetics and environmental exposures. Temporal trends in allergy prevalence in developed countries , and theRural residence is consistently identified as the strongest protective factor against asthma in epidemiological studies ,9 and isChanges in exposures to many different environmental and life style factors are likely to occur in populations that migrate from rural to urban areas, and studies of migrants to urban areas and comparisons of environmental exposures with the original rural and with more established urban populations should allow the effects of environmental exposures in early life (e.g. causing immune programming) on allergy risk to be distinguished from the effects of current exposures. Clarification of the dynamics behind the causation of allergy and asthma in urban migrant populations will further improve our understanding of what is behind the increase of frequency of these diseases with urbanization and westernization. The identification of modifiable risk factors could lead to new public health initiatives to reduce the burden of allergic disease among urbanizing populations.Latin American countries are undergoing a rapid process of population change that includes urbanization, migration, economic development and adoption of a \"modern\" lifestyle. Among the burgeoning urban populations of Ecuador and other Latin American countries, asthma and allergic diseases are perceived to be an increasingly important public health problem of children , althougThe study described here is part of the Programme \"Social Change, Asthma and Allergy in Latin America\" (SCAALA), a research programme being conducted in Ecuador and Brazil , funded by The Wellcome Trust as part of the programme of Major Awards to Centres of Excellence in Latin America. The SCAALA collaboration aims to clarify the social and biological mechanisms that mediate the effect of population and lifestyle changes on the frequency of atopic diseases. This paper deals with the methodological aspects of the study being conducted in Ecuador.The study in Ecuador aims to study changes in the prevalence and risk factors for asthma and allergy in populations that migrate from rural to urban areas and examine how such changes may relate to changes in the risk of atopic disease. The study will measure the frequency of symptoms of asthma, allergic rhinitis and atopic dermatitis in school children in urban and rural areas, and will collect detailed information on life style factors and environmental exposures that may affect the frequency of atopic diseases in the urban and rural environments. The study will investigate also changes in key immunologic factors (i.e. cytokines) and environmental exposures that may be associated with altered asthma risk in the rural and urban study groups. On the other hand, the SCAALA study in Brazil aims to investigate the associations between the prevalence and incidence of allergic diseases, environmental exposures, particularly hygiene-related exposures, and immunological parameters in a cohort of children in the city of Salvador in the State of Bahia, and has been described elsewhere .Ecuador is among the poorest of South American countries, with an estimated per capita GDP of US$4,300 in 2005 and industrialization that is far less advanced compared to richer countries in the region, such as Chile . In Ecua2 and has a population of approximately 429,000. The main economic activities are oil industry, tourism, timber extraction, and African palm oil. The principal city in the Province is Esmeraldas, with a population of 250,566 that is home to approximately 80% of the Ecuador's Afro-Ecuadorian population [The study is based in Ecuador's northern coastal province, Esmeraldas Province. The Province covers an area of 15,237 kmpulation . Esmeralpulation . Over thThe study will be conducted among school children attending rural schools in Afro-Ecuadorian communities in the District of Eloy Alfaro, in a tropical coastal area of Esmeraldas Province, and in marginal Afro-Ecuadorian 'barrios' in an urban centre, where migrants from the rural area congregate.The study forms two parts: (i) a cross-sectional study of environmental factors associated with atopy and allergic symptoms in school-age children in the rural District of Eloy Alfaro in Esmeraldas Province and in 'barrios' of the city of Esmeraldas where rural migrants congregate; and (ii) a nested case-control study of environmental risk factors for asthma using asthma cases identified from the cross-sectional study in urban and rural school children and a random sample of non-asthmatic controls.A total of 4,000 school children, aged 7 to 15 years, living in the District of Eloy Alfaro and 2,500 children of the same age range, living in the city of Esmeraldas, will be assessed to estimate the frequency of atopy and allergic diseases, including asthma, rhinitis and eczema, and identify and compare risk factors associated with these outcomes in urban and rural study populations. School children in urban areas will be defined by place of birth, period of residence in urban area and at what age, and whether their parents are migrants or not. The cross-sectional study will examine the relationship between atopy and allergic symptoms in urban and rural school children and the environmental factors that modify this relationship.Asthma cases and non-asthmatic controls , respectively, will be identified from the results of an allergy symptom questionnaire performed in the cross-sectional study by the questions – \"Have you had wheezing or whistling in the chest in the last 12 months? \" and \"Have you ever had wheezing or whistling in the chest at any time in the past?\" Non-asthmatic controls will be randomly selected from all children in each of the urban and rural areas that respond negatively to the second question. Nested case-control studies in the urban and rural areas will identify risk factors associated with symptoms of recent wheeze using both quantitative and qualitative epidemiological methods, investigations of immunological function and measurements of allergens and endotoxin in the environment.Data are available for the prevalence of recent wheeze in urban and rural study areas, from pilot surveys of 245 and 536 school children, respectively. These surveys estimate the prevalence of recent wheeze to be greater in the urban area . The prevalence of atopy was similar in urban and rural school children . A sample of 4,000 children in the rural area and 2,500 children in the urban area will provide approximately 820 cases of atopy for the cross-sectional study, and 292 and 335 cases of asthma for the case-control study in the rural and urban areas, respectively. Two hundred asthma cases from each area will be recruited into case-control studies . The study will have a case-control ratio of 1:4 . With a study power of 80% and P < 0.05, the nested case-control studies combined will be able to detect significant effects on asthma of common exposures with OR<0.7 and rare exposures with OR<0.5. Likewise, the individual case-control studies with the same power and level of significance will be able to detect an effect of OR<0.6 for common exposures , and OR<0.4 for rare exposures (10%).Asthma, rhinitis and eczema will be defined according to the core allergy symptom questions of the International Study of Allergy and Asthma in Childhood (ISAAC) . Atopy wA. Cross-sectional study: The questionnaire has been modified from the ISAAC Phase II study questionnaire [ionnaire , and hasionnaire ,25). TheB. Case-control study: A questionnaire for a more detailed history of asthma, rhinitis and eczema symptoms, based on the ISAAC phase II supplementary questionnaires [onnaires , will beonnaires and of rThe presence of exercise-induced bronchospasm (EIB) will be assessed in all children in the case-control as described previously ,26. Briez-scores for weight-for-age, weight-for-height and height-for-age will be calculated using the EPINUT program .Finger prick blood samples will be collected from all subjects in the cross-sectional study to estimate hemoglobin level using standard procedures. Anthropometric measurements will be performed using standardised methodology and will include weight (kg), height (cm) and triceps skin fold thickness (mm). Entamoeba histolytica (with ingested red cells) and Giardia intestinalis will be offered appropriate doses of tinidazole.Single stool samples will be collected from all children and examined using the modified Kato-Katz and formol-ether concentration methods . IntestiDermatophagoides pteronyssinus mite and the American cockroach, Periplaneta americana. Dust samples will be analyzed for endotoxin and fungal β-glucans and allergens from D. pteronyssinus (Der p 1) and P. americana (Per a 1) .Dust samples will be collected from the homes of the children in the case-control study using a ~ 1200 W vacuum cleaner, weighed and stored as described previously . SurveysD. pteronyssinus, American cockroach, and Ascaris lumbricoides using the Pharmacia CAP system ; IgG antibodies specific for hepatitis A virus, Helicobacter pylori, herpes simplex virus, herpes zoster virus, Epstein-Barr virus, and Toxoplasma gondii using commercially available assays; and for whole blood cultures stimulated with mitogen and relevant allergens for the measurement of the regulatory cytokines, IFN-γ, IL-13, and IL-10, as described elsewhere [Blood samples (7 mL) will be collected by venipuncture from participants in the case-control study and will be used for obtaining serum for the measurement of: polyclonal IgE ; IgE antlsewhere . A wholelsewhere .D. pteronyssinus/D. farinae mix, American cockroach, Alternaria tenuis, cat, dog, '9 Southern grass mix', and 'New stock fungi mix' .All children in the cross-sectional study will be tested for immediate hypersensitivity responses to relevant aeroallergens as described previously ,28. A poThe analysis will be designed to address five principal study questions: 1) What is the frequency of atopy and asthma in school children from the rural and urban study areas? 2) What environmental exposures are associated with atopy and asthma and how do these interact with area of residence to affect the relationship between atopy and wheeze symptoms? 3) Do environmental exposures associated with wheeze differ between migrant and established urban populations and, if so, are they potentially modifiable through intervention programmes? 4) Are place of birth and/or period of residence in rural and urban areas associated with risk of allergy? 5) How do complex inter-relationships between factors at different levels interact to affect the risk of asthma in urban and rural populations? Statistical analysis will be conducted according to a conceptual framework that defines a proposed causal pathway and the complex analytic approach to be used has been described in detail in a companion paper . MethodsEthical approval for the study has been obtained from the Hospital Pedro Vicente Maldonado, Provincia de Pichincha, Ecuador. Written informed consent to participate in the study will be obtained from the parent of each child and signed minor assent will be obtained from each child. The parent or guardian of each child will be provided with a copy of all laboratory results and if, appropriate, treatment recommendations will be made by a trained clinician that will review each case.Atopic asthma and other allergic diseases are becoming increasingly important public health problems in Latin American cities and there is little published information on the causes of this disease epidemic. The SCAALA research initiative includes two epidemiological studies being conducted in urbanizing populations that are investigating the environmental causes of allergy in urban Latin America and the biological and social mechanisms that underlie these epidemiological trends. While the SCAALA-Salvador aims to investigate the associations between the prevalence of asthma and other allergic diseases and potential risk factors that includes living conditions and early life and current exposures to infections , the SCAThe Esmeraldas-SCAALA study in Ecuador includes cross-sectional and nested case-control studies conducted in rural and urban contexts. The studies are investigating the impact of urban migration on asthma risk and the environmental exposures that are associated with an increased risk of asthma in populations that migrate from rural to urban areas. The study will focus on a single ethnic cultural group, Afro-Ecuadorians, that traditionally has lived in the remote rural North Eastern region of Esmeraldas Province, but that has migrated in significant numbers over the past 30 years to cities such as the provincial capital, Esmeraldas. The study of a single and easily identifiable group that presumably shares the same genetic 'stock' and that has migrated locally (within the same Province) should allow important environmental risk factors to be identified more easily and should not suffer from the biases that limit the interpretation of studies that have investigated populations that have migrated between countries. Specifically, the study, by investigating a migrant population, will distinguish between the effects of early life exposures (inducing immune programming) and current exposures in determining allergy risk.The knowledge generated from this study will help to define the size of the public health problem of allergy in Ecuador and may identify possible environmental exposures that could be considered for primary prevention public health strategies. The study in Brazil is a prospective study investigating the effects of early life exposures to environmental factors, and the potential effects of these on the immune system and the risk of allergy and has been described in detail in a separate paper .The causes of the allergy epidemic in Latin America are assumed to be multifactorial and an important strength of the SCAALA studies is the use of similar causal frameworks and the sharing of methodology and expertise in a wide range of scientific disciplines . The two studies are complementary and are likely to yield important information on the underlying causes of the allergy epidemic in urban Latin America.st century, and allergic diseases are likely to emerge as the most prevalent of chronic diseases of childhood in Latin America during this century. Latin America urbanization has its roots on the intense process of displacement of the poor rural population that move to the urban centres looking for work and other improvements in their life conditions. It is expected that the knowledge generated from the SCAALA studies will help identify public health interventions that may ameliorate the adverse effects of urbanization on the prevalence and severity of asthma and allergic diseases.In summary, the aim of the proposed programme is to investigate the biological and social mechanisms that underlie the epidemic of allergic diseases in urban Latin America. Urbanization and the health problems associated with this phenomenon probably represent the single most important challenge for health researchers working in developing countries in the 21ISAAC: International Study of Asthma and Allergies in ChildhoodSCAALA: Social Change, Asthma and Allergy in Latin AmericaThe author(s) declare that they have no competing interests.PJC and LCR had the original idea for the study. PJC designed the study and drafted the manuscript. MC, MV were involved in study design and co-ordination. NAN and LPC were responsible for the immunological methods. BG was responsible for the statistical analysis plan. LR, AR, AC, RS and MB were involved in study design. All authors helped draft the manuscript, and read and approved the final version of the manuscript.The pre-publication history for this paper can be accessed here:"} -{"text": "Evaluation of an Internet-based smoking cessation program: lessons learned from a pilot study [http://www.qsn.ori.org/), and the efforts to recruit participants and conduct a study through the Internet.It is estimated that more than 4 million people die annually from tobacco-related illnesses globally . Well-deot study represenThe authors of this paper have considerable experience in medical computing and in the burgeoning area of behavioural eHealth, having published several recent papers on Internet-based interventions for diabetes -6. AlthoThe aim of the study is to evaluate a strategy for online study recruitment and retention, to evaluate the influence of incentives on follow-up response, and to assess the impact of the Quit Smoking Network site on smoking behaviour.Feil and colleagues describea structured intervention that guides development of a cessation quit plan, interpersonal support , and a library of a wide variety of cessation resources .The intervention was also described as \"based on theoretically grounded and empirically validated intervention approaches\" citing an earlier paper by Lichenstein and Glasgow . DespiteThe research design is a single-condition study with a randomized follow-up component. Participants were recruited largely through magazine ads, local media coverage of the study and through the website itself . All participants were exposed to the website intervention and then randomly assigned to 1 of 4 follow-up conditions afterwards. Participants completed a pretest survey online prior to the intervention and were contacted at 3 months postintervention to complete the follow-up online. Participants who did not complete the 3-month follow-up were randomly assigned to receive further follow-up notifications by email or regular US mail after 3 weeks. No description of the randomization process was provided.Two hundred and nine participants (56%) completed the 3-month follow-up, mostly through the Internet . Both the mode of communication and incentive amount provided similar rates of follow-up. With regard to the impact of the intervention, 38% (67) of participants reported abstinence at 3-month follow-up . Such results are comparable to many other non-Internet smoking cessation trials .Although there was a reported cessation rate of 18% at 3 months, it is unclear whether this effect can be attributed to the intervention as no method of accounting for alternative explanations was provided. Since participants were self-selected based on an expressed interest in smoking cessation it seems reasonable that participants also sought other treatment options at the time of their participation. Another limitation of the study is the absence of the reported mean time to response after the second 3-month reminder was sent to participants.From a tobacco control perspective, there are additional concerns. An absence of a detailed description of instruments used to assess smoking variables is unfortunate. With a large body of literature in tobacco control, a number of acceptable measures or items have emerged to assess smoking behaviours and tobacco use. However no details of the items, item source, or scale reliability were provided and, in the case of cessation self-efficacy, were not even defined. Outside the effect on cigarette abstinence, the study's effects on outcome variables such as cessation self-efficacy were not reported.This study introduces a number of innovations for advancing knowledge of eHealth. The implementation and evaluation of an intervention completely at a distance represents a significant step forward in advancing eHealth research. Another innovation is the study of both incentive value and mode of contact on follow-up participation rates--issues that clearly require further study.Although the study design was innovative, the study as reported was problematic in a number of areas. With respect to eHealth issues, many of the evaluation reporting guidelines recommended by the Science Panel on Interactive Health Communication were notDespite its limitations, many of which could have been reduced by more complete reporting, this is an important study for eHealth and tobacco control. As with many pioneering studies, this work offers more questions for eHealth research than answers; but the answers it does provide are nonetheless important. Furthermore, the findings of the study have great clinical significance for tobacco control given that the intervention was delivered in absentia and the potential for widespread, population-based translation of the intervention is high. Building on the results of this pilot test it is hoped that the authors will soon offer a more extensive evaluation of the Quit Smoking Network, one that has addressed some of the concerns stated here and that furthers this study's unique contribution to the literature.What method or process was used to randomize participants into each condition?Among those participants who did not respond to the initial follow-up request, what was the mean time to follow-up?What are the theoretical model(s) guiding the Quit Smoking Network site and how are they applied?How was intervention exposure (dose) assessed or measured for each participant?What other smoking strategies did participants report engaging in? If not measured, why?How was cessation self-efficacy measured?What were the levels of reported social support at baseline and how were such measures correlated with smoking cessation at 3-month follow-up?How do you propose researchers address the issue of validating smoking self-report using remotely-delivered interventions?"} -{"text": "RESPIRE, a randomized trial of an improved cookstove, was conducted in Guatemala to assess health effects of long-term reductions in wood smoke exposure. Given the evidence that ambient particles increase blood pressure, we hypothesized that the intervention would lower blood pressure.a) between-group comparisons based on randomized stove assignment, and b) before-and-after comparisons within subjects before and after they received improved stoves. From 2003 to 2005, we measured personal fine particle exposures and systolic (SBP) and diastolic blood pressure (DBP) among women > 38 years of age from the chimney woodstove intervention group (49 subjects) and traditional open wood fire control group (71 subjects). Measures were repeated up to three occasions.Two study designs were used: 2.5 exposures were 264 and 102 μg/m3 in the control and intervention groups, respectively. After adjusting for age, body mass index, an asset index, smoking, secondhand tobacco smoke, apparent temperature, season, day of week, time of day, and a random subject intercept, the improved stove intervention was associated with 3.7 mm Hg lower SBP and 3.0 mm Hg lower DBP compared with controls. In the second study design, among 55 control subjects measured both before and after receiving chimney stoves, similar associations were observed.Daily average PMThe between-group comparisons provide evidence, particularly for DBP, that the chimney stove reduces blood pressure, and the before-and-after comparisons are consistent with this evidence. Approximately half of the world’s households depend on biomass and coal for cooking and heating . Most ofAlthough numerous epidemiologic investigations have concluded that fine ambient particles and secondhand tobacco smoke (SHS) are associated with cardiovascular morbidity and mortality , the WHO3 in homes where open fires were used for cooking < 3.5 μm in aerodynamic diameter] were 1,930 μg/m cooking . Howeverxposures .plancha to conduct the first randomized intervention to reduce long-term air pollution exposures (We participated in RESPIRE (Randomized Exposure Study of Pollution Indoors and Respiratory Effects), which used the xposures . This trElevated blood pressure (BP) predicts cardiovascular morbidity and mortality, and reductions in BP have been shown to reduce risk , 2003. Splancha improved woodstove would be associated with long-term reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) among healthy adults. As supporting evidence, we also aimed to determine whether the stove intervention was associated with reduced personal exposures to fine particulate air pollution.We hypothesized that the The protocols for the stove intervention trial were approved by the human subjects committees at the University of California-Berkeley, the U.S. Centers for Disease Control and Prevention, Liverpool University (UK), and the Universidad del Valle in Guatemala. The cardiovascular substudy was approved by the human subjects committees of the Harvard School of Public Health and Universidad del Valle, and all participants gave informed consent before data collection.San Marcos, Guatemala, borders the Pacific Ocean to the west and Chiapas, Mexico, to the north. From the rural area within this district, near the towns of San Lorenzo and Comitancillo, 23 villages were chosen based on a rapid assessment showing high prevalence (> 90%) of cooking with open wood fires. The study villages lie at 2,200–3,000 m elevation, creating a cool climate that necessitates enclosed homes, leading to high indoor air pollution concentrations.n = 537) were recruited and randomized from October 2002 through May 2003.Household eligibility criteria for the randomized trial, which focused on acute lower respiratory infections in infants, included exclusive use of an open biomass fire for cooking and having a pregnant woman or infant < 4 months of age. Households , among whom 208 were living and found at home during the substudy recruitment visit. The additional eligibility criteria, which were met by 185 of these women, were that they cooked daily and resided in a study house at the time of recruitment. Among the 185 eligible women invited to participate, the response rates were 75% among the control households and 54% among the intervention households, resulting in 120 participants overall. None of these women were pregnant, had given birth during the previous three months, nor were breast-feeding at the time of the study. Most were grandmothers of a child in the main study.2.5 (suspended PM < 2.5 μm in diameter) with gravimetric samplers during the 24 hr before blood pressure measurements. Each air sampler setup included an Apex pump , a Triplex Sharp-Cut Cyclone , and a 37-mm Teflon filter placed on top of a drain disc and inside a metal filter holder. The flow rate was set to 1.5 L/min and measured at the start and end of sampling with a soap bubble flow meter . The air sampler, weighing about 0.5 kg, was carried in a shoulder bag with the inlet clipped to the strap above waist height. The participants were instructed to carry the bags everywhere they went and place them near their bed when sleeping. The filters were weighed with a micro-balance under atmosphere-controlled conditions before and after sampling.We measured average personal PMParticipants were transported in project vehicles from their homes to the San Lorenzo Health Center, where all BP measures were taken between 1400 and 1800 hr. An automatic blood pressure monitor was used to measure SBP and DBP in the supported right arm of the seated subject after 10-min rest. Three repeat measures were taken within a 10-min period of continued rest.plancha for 293 days . After control households received the echo-intervention, an additional 65 measures were taken among 55 control subjects from March 2004 through March 2005. On average, the post–echo-intervention measures were taken 63 days after control households started using the improved stoves.Although 10 control subjects and 7 intervention subjects dropped out of the study or moved away from the study site after one measurement round, the protocol was repeated on two or three occasions for most participants. The trial period, from July 2003 through December 2005, included 111 measures among 71 women in the control group cooking over open fires and 115 measures among 49 women in the intervention group using the improved stoves. On average, the intervention participants had been cooking with the t-tests for continuous variables and chi-square tests for binary variables in SAS version 9.1 .We tested the baseline characteristics of the BP study intervention and control groups for comparability using We used the average of the second and third of three consecutive BP measures taken during each visit as the estimate for that day. SBP and DBP were the dependent variables in separate regression analyses. We estimated the intervention effects using two different study designs: between-group comparisons based on randomized stove assignment, and before-and-after echo-intervention comparisons among the control group.2.5 exposure and BP by study group, we plotted smoothed probability densities with spans determined by the default rule of thumb (nrd0) using R 2.4.0 software .The between-group study design compares BP between control and intervention groups during the trial period, when control homes had open fires for cooking and intervention homes had improved stoves. To illustrate the distributions of personal PMMixed models were run using the linear mixed effects (lme) function in R software. The model for the between-group estimates of the effect of improved stoves on BP isi denotes subject and j denotes the repeated measures within subjects. BMI is body mass index. β̂1 is the effect estimate for the randomly assigned improved stove (Group), which has only the subscript i because it varies between people but not temporally. β̂2, β̂3, and so on represent the effects of covariates, the boi term is a random intercept for the ith subject, and ɛij are the residuals. The random intercept accounts for correlation among repeated measures and therefore provides appropriate weighting of information from each subject, even though the number of measures per subject may vary.where temascal (wood-heated sauna), having household electricity, and an asset index as a measure of socioeconomic status. Age and BMI were fit as linear terms. We used binary indicator variables for smoking, SHS exposure, temascal use, and household electricity. The asset index is the sum of binary indicators for having a bicycle, a radio, and a television, and was entered as categorical variable. To increase precision, we also considered time-varying covariates, such as apparent temperature, season, day of the week, and time of day. We used linear terms to control for daily average apparent temperature and time of day and dummy variables for each day of the week and for rainy (1 May–31 October) versus dry season (1 November –30 April).Although randomization made the two groups similar according to all baseline covariates measured, because of the small sample size and potential for differential selection by intervention status and predictors of BP, we adjusted for covariates that may predict BP between subjects, such as age, BMI, ever smoking, SHS exposure, use of a 2.5 and BP among the control group during the trial and echo-intervention periods were illustrated using smoothed probability densities as described above. Only control subjects who had echo-intervention measures are included in these analyses, which were based on the following mixed model:The before-and-after study design estimates the within-subject effect of the stove intervention on BP by comparing the same people before and after adoption of the chimney stove. Distributions of personal PMPeriod), an indicator for the echo-intervention period, now also has a subscript j to denote that it varies across measurements within subjects. Temp refers to daily average apparent temperature. Again, a random intercept for subject is included.where the stove variable , −8.1 to 0.6] and 3.0 mm Hg lower DBP , both similar to the unadjusted associations. Excluding smokers did not alter the results, and there was no significant interaction between intervention and ever smoking nor intervention and SHS exposure for either BP measure .The crude and adjusted mixed-model estimates of between-group differences in mean SBP and DBP are shown in p < 0.001), and the association of SBP with the chimney stove in the between-group model increased in magnitude and precision to a reduction of 4.0 mm Hg . DBP did not have a significant nonlinear relationship with age (p = 0.62), and the estimate of the stove effect on DBP was unchanged by adjustment for age using the penalized spline model.Using penalized splines to adjust for age, we found a significant nonlinear relationship between SBP and age .The crude and adjusted mixed-model estimates of before-and-after differences in mean SBP and DBP are shown in In the before-and-after study design, adjustment for nonlinear associations between BP and age using penalized splines did not alter the associations of stove with either BP measure.plancha improved stove instead of the traditional open fire. After adjustment, the 95% CI for the mean difference in DBP did not overlap zero, and the 95% CI for the mean difference in SBP only barely overlapped zero. A few subjects from both groups were measured each week during the trial period, making any unmeasured time-varying covariates unlikely to be strong confounders. Adjustment for predictors of BP in the between-group model moved the effect estimates further away from the null. Similar estimates from the between-group and before-and-after analyses greatly strengthen the evidence because these are not susceptible to the same sources of bias. That participants and research assistants were not blinded to exposure status is unlikely to induce bias, because automatic blood pressure monitors were used. BP differences associated with stove type were estimated with greater precision in the before-and-after than in the between-group analyses, despite the larger sample size in the latter. This is attributed to lower random variability in BP within-subjects than in between-subjects.SBP and DBP were lower among women randomly assigned to cook with the 2.5 exposure associated with plancha compared with open fire use strengthens the evidence that the observed BP differences may have been caused by reduced wood smoke exposure. These personal exposures among both open fire and plancha users were much lower than average kitchen levels found in similar populations with the same stove types . If participation was also associated with BP, selection bias may have produced study groups that were not comparable. Although the original study design included baseline BP measures, ethical approval was given after the intervention group received improved stoves. Adjustment for age, socioeconomic indicators, and BMI is likely to have at least partially attenuated the potential selection bias. Furthermore, we did not find any meaningful difference between the groups out of all available baseline covariates. n = 23) were higher than the trial period BP among the 55 subjects measured both before and after . Thus, there is no evidence of spurious findings due to selection of subjects for the echo-intervention follow-up who happened to have higher blood pressure when measured during the trial period.The before-and-after comparisons rely on the assumption that BP would not have changed in the control group in the absence of the echo-intervention. There may be unmeasured time-varying covariates that influence BP and were associated with the echo-intervention. In addition, because not all control subjects measured during the trial period were also measured during the echo-intervention period, it is possible that we unintentionally selected people for the before-and-after comparisons who happened to have higher than usual BP before the echo-intervention. The trial period BP among the 16 control subjects excluded from the before-and-after comparisons due to missing post-echo-intervention measures for cooking and heating , but woo"} -{"text": "Whether lower frequency, moderate intensity exercise alters cardiovascular disease (CVD) risk has received little attention. This study examined the effects of 45 minutes self-paced walking, 2 d· wk37 subjects (24 women) aged 41.5 ± 9.3 years were randomly assigned to either two 45 minute walks per week or no training (control group). Aerobic fitness, body composition, blood pressure (BP), CRP and lipoprotein variables were measured at baseline and following 8 weeks. Steps counts were measured at baseline and during weeks 4 and 8 of the intervention.P < 0.05). There were no changes other risk factors. Subjects took significantly more steps on the days when prescribed walking was performed (9303 ± 2665) compared to rest days .Compared to the control group, the walking group showed a significant reduction in systolic BP and maintained body fat levels (max, improves activity levels, reduces systolic BP and prevents an increase in body fat in previously sedentary adults. This walking prescription, however, failed to induce significant improvements in other markers of cardiovascular disease risk following eight weeks of training.These findings suggest that walking twice per week for 45 minutes at ~ 62% HR It has become increasingly clear that many of the chronic diseases we face today are associated fundamentally with the pervasive sedentariness of modern lifestyle. In Northern Ireland at least 2000 people die each year due to an inactive lifestyle and the avoidable cost of inactivity to the health service is estimated at £0.62 million each year . DespiteIn the past decade, physical activity research has been characterised by the development of exercise prescriptions that are palatable to sedentary populations in the western world. First advocated by the American College of Sports Medicine and subs-1 for six months, improved fitness in 79–91 year old females [Walking is eminently suited to population exercise prescription as it is easy to do, requires no special skills or facilities, and is achievable by virtually all age groups with little risk of injury . There i females . However females . Recentl-1 on fitness, BP, body composition, lipids and CRP.The present study evaluates the efficacy of a workplace walking intervention on physical activity levels and cardiovascular risk factors. An examination of the effects of self-paced walking twice per week will reveal whether individuals can achieve health benefits from outdoor walking performed with minimal investment in time. The purpose of the present study was to examine the effects of 45 minutes walking, 2 d· wkThis study was a randomised controlled trial, with subjects assigned to a walking or control group. The Research Ethics Committee at Queen's University, Belfast approved the study. Measurements were made at baseline (pre-intervention) and following eight weeks (post-intervention).-1, fasting blood glucose > 7.0 mmol· L-1, body mass index (BMI) > 34.9 kg· m-2, current cigarette smokers, individuals with cardiovascular, pulmonary or metabolic disease, pain or discomfort in the chest, dizziness or heart murmur. In addition, individuals taking medication known to interfere with lipid metabolism, and females who were pregnant or planning to become pregnant in the following five months were excluded from taking part in the study. Thirty seven subjects (24 women) aged 41.5 ± 9.3 years were randomised to either a walking or control group on a 3 to 2 basis . All subjects gave their written informed consent.Subjects were recruited from staff at the Northern Ireland Civil Service via internal email. All subjects completed a Health History questionnaire. Exclusionary criteria were a physically active lifestyle , age > 65 years, resting BP > 159/99 mm Hg, total cholesterol > 6.2 mmol· L2). Waist measurements were made at the level of the trunk where the girth is minimal, i.e. the location where there was a noticeable indentation of the trunk. If there was no noticeable indentation the tape was located at the umbilicus. Hip girth was the horizontal circumference at the broadest part of the lower body, usually at the level of the trochanters [Height and body mass were recorded using a stadiometer and scales respectively. BMI was calculated by dividing body mass (kg) by height after the subject had rested in a seated position for five minutes. The average of the readings was used. If the first two readings differed by more than 5 mm Hg, an additional reading was obtained and all three readings averaged.max). They were encouraged to complete all four stages, but the test was terminated if heart rate (HR) reached 85% HRmax. HR was measured continually by short-range telemetry. During the last 30 seconds of each test stage, a capillary sample of blood was obtained and immediately analysed for lactate using a Lactate Pro Test Meter . Ratings of perceived exertion (RPE) using the Borg 15-grade scale were obtained during the last minute of each test stage, in accordance with scripted instructions [To monitor cardiovascular adaptations to training, a submaximal, graded exercise test was conducted pre- and post-intervention. In the week prior to the treadmill test, subjects were familiarised with walking on the treadmill at various speeds and slopes. Following a three minute warm-up, subjects were instructed to walk on the treadmill for four minutes at each of four gradients selected to elicit 40, 50, 60, and 70% of age-predicted (220 – age) maximum heart rate (HRructions -1) a value of 0.5 mg.L-1 was recorded. All samples for each given assay were analysed on the same day in a single batch at the Institute of Clinical Science at Queen's University, Belfast.Whole blood glucose and total cholesterol were determined from a fresh sample of capillary blood using dry chemistry methods for the purpose of initial screening criteria. Blood samples were obtained by venepuncture after a 10 hour fast and with subjects in a seated position. Subjects were instructed to refrain from physical activity on the previous day. Samples were separated, frozen at -20°C, and analysed within 8 months. Total cholesterol, HDL and triglycerides were determined by automated enzyme assay using a Cobas FARA bioanalyser . Commercial enzyme assay kits were purchased from Randox Laboratories Ltd. . The concentration of LDL cholesterol was calculated using the Friedewald formula . CRP wasA sample of whole blood was analysed within 12 hours for haematocrit and haemoglobin. Haematocrit was corrected by 1.5% to account for plasma trapped between erythrocytes. Haematocrit and haemoglobin values were subsequently used to correct for changes in plasma volume . As femaIt has previously been reported that adults intuitively self-select a pace concordant with cardiorespiratory benefits when walking for exercise . TherefoTwelve walkers and all of the controls wore a pedometer during weeks 0, 4 and 8 of the intervention . They were instructed to wear the pedometer during all waking hours and record the number of steps taken at the end of each day. In addition, during weeks 4 and 8, those assigned to the walking group recorded their step count before and after each walking session in their training diary. Each subject was trained in the correct use of the pedometer and given written guidelines to follow.t-tests. Non-parametric Kruskall-Wallis tests were used to compare the step counts of groups at baseline. Non-parametric Wilcoxon tests were used to compare paired step count data of the walking group . Physiological data were analysed using a 2-way ANOVA with repeated measures, with one factor between subjects and one factor within subjects (pre- vs. post-intervention).Physiological differences between groups at baseline were compared using independent -1, was excluded from the analysis as CRP values of this order may be indicative of infection or trauma . CRP data is therefore presented for 11 walkers and 8 controls. For all other parameters measured data are presented for the 21 walkers and 12 controls who completed the study. Physiological characteristics of the participants at baseline are shown in Table P > 0.05).Four individuals dropped out of the study due to: illness 1 control), moving job (1 control), family circumstances and lack of interest . Due to equipment error at the end of the walking intervention, body fat measurement was only possible in 12 walkers and 12 controls. Due to problems in blood sampling we were only able to determine blood lipids in 11 walkers and 9 controls. In addition one control subject, who had CRP values > 10 mg· L control,P > 0.05). Daily step counts for the walking group on days when prescribed walking was performed , on days when no prescribed walking was performed (Rest-days) and all days during the programme are shown in Table P < 0.001). Walkers undertook more voluntary steps on Rest-days (5803 ± 2749) than on Walk-days (4567 ± 2639) (P < 0.05). During the intervention, mean step counts for the control group averaged 6470 ± 1709.During week 0 (i.e. the week prior to commencing the intervention) daily step counts for the walking and control groups averaged 6437 ± 2285 and 6831 ± 2727 respectively. There was no significant difference in the week 0 step counts between groups . Systolic BP for the walking group decreased from 120.4 ± 19.7 mm Hg at baseline to 115.4 ± 17.7 mm Hg at post intervention. Body fat percentage of the walking group was 28.0 ± 5.8 and 27.9 ± 5.6 at pre- and post-intervention respectively. No significant changes were observed in body mass, waist and hip circumference, diastolic BP or lipid variables.Table -1 respectively (n = 11). Corresponding values for controls were 1.5 ± 1.5 and 1.5 ± 1.3 mg· L-1 at pre- and post-intervention respectively (n = 8). There were no significant effects observed. One subject, who had CRP values > 10 mg· L-1, was excluded from the analysis as CRP values of this order may be indicative of infection or trauma .Mean values for CRP in the walking group at pre- and post-intervention were 1.9 ± 1.7 and 1.6 ± 1.5 mg· L-1 and 112.0 ± 9.3 beats· min-1 at pre- and post-intervention respectively. Corresponding values for the control group were 121.2 ± 14.7 and 118.1 ± 13.0 beats· min-1 at pre- and post-intervention respectively. Blood lactate values for walkers at pre-and post-intervention were 1.6 ± 0.5 and 1.5 ± 0.5 mmol· L-1 respectively. Pre- and post-intervention values for the control group were 1.5 ± 0.5 and 1.7 ± 0.5 mmol· L-1. Following training RPE during the treadmill test reduced from 11.2 ± 1.4 to 10.8 ± 1.4 in the walking group. A similar reduction was observed in controls, who demonstrated RPE values of 11.3 ± 2.1 and 10.8 ± 1.8 at pre- and post-intervention respectively. No significant differences were observed between groups in HR, blood lactate or RPE.Mean HR for the walking group during the treadmill test was 116.5 ± 8.5 beats· minThe main finding of the present study is that 45 minutes self-paced walking, two days per week, decreases systolic BP, but has no discernable effects on fitness, body mass, waist/hip circumferences, diastolic BP, CRP or lipoproteins, in previously sedentary employees. The novel aspect of this investigation is that it is the first to use a low frequency walking programme with adults < 60 years of age, and the first to examine the effects of walking, without dietary intervention, on CRP levels. The study augments the limited body of evidence on the efficacy of worksite physical activity interventions.A significant effect was observed between groups for the change in systolic BP from pre- to post-intervention. Systolic BP was reduced by 5.0 ± 7.9 mm Hg in the walking group following eight weeks of training. A reduction of this magnitude is in general agreement with the findings of a meta-analysis on the effect of aerobic exercise on BP in normotensive adults . In suchFew other studies ,26 have A significant effect was observed between groups for change in body fat percentage from pre- to post-intervention. Relative to an increase in controls, the body fat percentage of walkers remained stable. The increases in body fat percentage of the control group may, however, be the result of over-cautious control subjects. It is possible that a desire 'not to be active' may have resulted in marginally lower than normal physical activity levels thus contributing to worsened adiposity.-1 vs. 150–420 min· wk-1). Given the varied training regimes in the aforementioned studies, and the paucity of data in the area, comparisons are difficult to draw. Further research is required to elucidate the relationship between exercise levels and changes in CRP, and the effects of training in various population groups. The present study augments the very limited body of evidence on the effects of training on resting CRP concentrations.Participants in the present study are classified as being at moderate risk of future cardiovascular events according to their baseline CRP levels . In the -1 [max, heart rate during a submaximal exercise test was reduced. Failure to evoke changes in aerobic fitness in the present study, despite the same volume of exercise, may be due to differences in training intensity (67–78% HRmax vs. ~ 62% HRmax) or differences in the length of the intervention (26 weeks vs. 8 weeks) [max for lower-fit subjects [Heart rate and blood lactate responses to submaximal workloads were used in the present study to monitor changes in aerobic fitness. No significant effects were observed for changes in heart rate or lactate response to submaximal workloads. The authors know of one other study in the published literature that has used the same walking prescription as the present investigation. Eighty women, aged 60–70 years progressed to walking 45 minutes 2 d· wk-1 . Followi8 weeks) . It has subjects . The facA systematic review of 32 cross-sectional, prospective observational and intervention studies, suggested that for adults, 7000 – 13,000 steps per day can be expected . BaselinThe walking intervention was well tolerated by the employees in the present study. No injuries were reported during the programme, most likely due to the mode of exercise and that fact that low injury rates are associated with moderate intensity activity . This fi-1. However, apart from one subject, the same individuals were below detectable limits at both sampling times, thus limiting the resulting effect on observed changes over time.The limitations of this study need to be considered when interpreting findings. The CRP assay used in the present study did not detect CRP in the blood samples of 6 subject as they were below the detectable level of < 0.5 mg· L-1 for eight weeks at ~ 62% HRmax, reduces systolic BP and prevents an increase in body fat, in previously sedentary employees. This walking prescription, however, failed to induce significant improvements in fitness, diastolic BP, body mass, serum lipids and CRP levels. The walking programme was associated with high adherence. These findings support the use of a twice-weekly, self-paced, worksite based, walking programme, to improve activity levels and systolic BP in previously sedentary employees. There is little evidence however to support the use of this exercise prescription for improvements in other markers of CVD risk. This walking prescription may therefore be useful as a stepping-stone to further increase levels of exercise, which may then provide greater benefits.In summary, the findings of the present study suggest that self-paced walking 45 min, 2 d· wkThe author(s) declare that they have no competing interests.MHM, EMM and CAGB were responsible for the design of the studyEMM was responsible for data collectionLGH was responsible for blood profilingAMN was responsible for statistical analysisMHM and EMM were responsible for preparing the manuscriptAll authors read and approved the final manuscriptThe pre-publication history for this paper can be accessed here:"} -{"text": "We previously reported widespread insecticide exposure during pregnancy among inner-city women from New York City. Here we report on a pilot intervention using integrated pest management (IPM) to reduce pest infestations and residential insecticide exposures among pregnant New York City African-American and Latina women (25 intervention and 27 control homes).The IPM consisted of professional cleaning, sealing of pest entry points, application of low-toxicity pesticides, and education. Cockroach infestation levels and 2-week integrated indoor air samples were collected at baseline and one month postintervention. The insecticides detected in the indoor air samples were also measured in maternal and umbilical cord blood collected at delivery.p = 0.016) after the intervention among intervention cases but not control households. Among the intervention group, levels of piperonyl butoxide (a pyrethroid synergist) were significantly lower in indoor air samples after the intervention (p = 0.016). Insecticides were detected in maternal blood samples collected at delivery from controls but not from the intervention group. The difference was significant for trans-permethrin (p = 0.008) and of borderline significance (p = 0.1) for cis-permethrin and 2-isopropoxyphenol (a propoxur metabolite).Cockroach infestations decreased significantly (To our knowledge, this is the first study to use biologic dosimeters of prenatal pesticide exposure for assessing effectiveness of IPM. These pilot data suggest that IPM is an effective strategy for reducing pest infestation levels and the internal dose of insecticides during pregnancy. TherefoIntegrated pest management (IPM) is considered an environmentally sustainable pest control strategy. It aims to reduce pest populations by identifying and understanding the biology and behavior of the insects and rodents; selecting and implementing a set of environmentally safe and effective control strategies; and monitoring the effectiveness of the strategies . TechniqThe current study is the first to use bio-markers and air monitoring to document changes in insecticide exposure after an IPM intervention. The IPM strategy used here was adapted from the Columbia Intervention to Reduce Indoor Allergens Study . The aimRecruitment and enrollment efforts for the intervention study occurred from August 2002 through April 2004. Thirty women were recruited from obstetrics and gynecology (OB/GYN) clinics located in New York Presbyterian and Harlem Hospitals. Eligibility was restricted to women 18–35 years of age who self-identified as either African American or Latina (Dominican or Puerto Rican) and reported using high-toxicity insecticides during pregnancy. Further, eligible subjects must have resided in northern Manhattan (north of 110th Street) or the South Bronx (south of Fordham Road) for at least 1 year before pregnancy and must not be planning to move from the community before delivery. From the 30 subjects who completed the screening and consent forms, 5 women dropped from the study between enrollment and monitoring . Samples collected from the subjects before the intervention will be referred to as preintervention, and samples collected after the intervention will be referred to as postintervention. From the remaining 25 women, 25 (100%) completed the prenatal questionnaire, 25 (100%) participated in pre- and postintervention indoor air monitoring, and biologic samples were collected from 21 (84%) subjects. Nineteen (76%) completed pre- and postintervention assessment of pest infestation.The control group was selected from participants in an ongoing prospective cohort study designed to validate biomarkers of prenatal insecticide exposure. As part of this study, insecticide levels were measured in 2-week integrated indoor air samples collected continuously over the last 2 months of pregnancy. Blood samples were collected from the mother and newborn at delivery. Enrollment for this study occurred in the OB/GYN clinics located in New York Presbyterian Hospital and Harlem Hospital from October 2001 through July 2004. The recruitment strategy and eligibility criteria for the controls were identical to those for the cases. From the total of 110 women fully enrolled in the biomarker validation study, 27 were selected as controls for the intervention study. Control selection aimed to match case subjects on year of enrollment (2002–2004) and self-reported use of high-toxicity insecticides during pregnancy. Baseline and follow-up integrated air samples were selected to match the pre- and postintervention samples in the cases. Questionnaire data were available for 100% of subjects. Baseline and follow-up indoor air data were available for 24 (88%) subjects; blood samples were collected from 17 (63%) subjects. Fourteen (52%) subjects completed the initial pest infestation levels. Follow-up samples were available for only six (22%) subjects.The institutional review board of the Columbia Presbyterian Medical Center approved the study, and we obtained written informed consent from all study subjects.The intervention commenced at the conclusion of the 2-week preintervention monitoring period. This IPM consisted of three main components: an extensive cleaning with minor building repairs, a low-toxicity insecticide application, and behavioral/health education. The kitchen, bathroom, and living room areas of the intervention apartments were professionally cleaned using low-toxicity, citrus-based cleaning products. Pest entry points were sealed with caulking compounds and/or metal screens. A professional insecticide placement company injected low-toxicity insecticides, 2.15% hydramethylnon , or small amounts of boric acid directly into the cracks and holes before sealing and placed glue traps for cockroaches throughout the kitchen, bathroom, and problem areas. Hydramethylnon has low toxicity and low vapor pressure and has been shown previously to be effective for long-term cockroach control . Using aA 45-minute questionnaire was administered to the intervention and control groups in each woman’s home by a trained bilingual interviewer during the third trimester of pregnancy. The questionnaire included information on demographics, home characteristics including housing disrepair and pest infestation levels, lifetime residential history, history of active and passive smoking, occupational history, maternal education and income level, alcohol and drug use during pregnancy, and history of residential insecticide use. Information about insecticide use included whether or not any pest control measures were used by an exterminator or by others during pregnancy and, if so, what types of measures were used and at what frequency , 2003.Before the intervention, a baseline 2-week integrated indoor air sample was collected from the homes of subjects in the intervention and control groups. Monitoring commenced in each home at the end of the second or beginning of the third trimester of pregnancy using a BGI pump with a 0.5-L/min flow-rate . The pump was attached to a URG polyurethrane foam (PUF) sampler with a 2.5-μm inlet cut fitted with a 30-mm quartz fiber filter and a foam cartridge backup to capture semivolatile vapors and aerosols. The pumps were attached to a battery and operated continuously over the 2 weeks. The monitoring equipment was placed in the main living area of the apartment, with the pump in a secure box and the sampler (located inside a protective wire cage) placed at least 60 cm from wall surfaces at a height of 135 cm. The sampler height was chosen to represent the average between the woman’s sitting and standing heights, because residential insecticide air concentrations have been shown to vary with height, being greatest near the floor . Study sApproximately 4 weeks after the intervention, a follow-up 2-week integrated indoor air sample was collected from intervention and control homes. Protocols for the follow-up air monitoring were identical to those for the baseline sample. The monitoring was targeted to occur during the 38th to 40th week of pregnancy; however, because of premature births or postponements, some subject’s homes were monitored immediately after delivery.To monitor cockroach infestation levels, six pheromone glue traps were placed in standardized locations throughout the kitchens of each subject during the 2-week baseline and follow-up indoor air monitorings. After 2 weeks, traps were collected and the number of adult and nymph cockroaches caught in each trap was counted.We used blood collection procedures validated in our prior research studies to ensure that blood samples were collected from women in the intervention and control groups at delivery . A sampl14 as a recovery surrogate, extracted with 6% diethyl ether in hexane for 16 hr and concentrated to 1.0 mL in 10% ether in hexanes. Extracts were stored frozen below −4°C. Insecticides are stable in the extract under these conditions. We determined the amounts of the target insecticides in samples using Agilent 6890/5973 gas chromatography/mass spectrometry in selected ion mode. Paired pre- and postintervention air samples were available on 25 cases and 39 controls. The target insecticides that were measured in the indoor air samples were bendiocarb, carbaryl, carbofuran, cis- and trans-permethrin, malathion, methyl parathion and propoxur. In addition, piperonyl butoxide, a synergist added to natural and synthetic pyrethroid insecticides, was measured as an indicator of pyrethroid insecticides. Chlorpyrifos and diazinon were not assessed because most of the women were enrolled in the study after the federal ban on their residential use and our prior data indicate that the ban was effective at reducing use and exposures to these insecticides among inner-city women in New York City a value of 0.5 × LOD. For hypothesis testing, variables were treated as continuous or categorical depending on their distributional properties. Continuous variables were initially log-transformed as appropriate to normalize the distribution. However, in almost all cases, the data could not be normally distributed after log-transformation, so nonparametric statistics were used. The differences in pest infestation levels and air insecticide levels between pre- and postintervention in both cases and controls were normally distributed, so we used parametric statistics to evaluate whether these differences varied significantly between the intervention and control group. Analyses were also undertaken to determine whether the intervention and control groups differed in terms of demographic characteristics or season and year of delivery. No significant differences were seen.t-test to determine whether the differences in pest infestation levels between pre- and postintervention observed in the intervention group were significantly different from the differences in pest infestation levels observed in the control group.For pest infestation levels, we used the Wilcoxon signed-rank test to assess the differences between pre- and postintervention pest infestation levels in both intervention and control groups. Because the differences in pest infestation levels were normally distributed, we used the independent sample t-tests and regression analyses controlling for race/ethnicity, season, and year of delivery to compare whether the change in air insecticide levels between pre- and postintervention differed significantly between the intervention and control groups. For insecticide levels in maternal and cord blood samples, we compared differences in detection frequencies between intervention and control subjects using chi-square analyses (Fisher’s exact test). Results were considered significant at p < 0.05 (two-tailed).For 2-week integrated air insecticide levels, we compared detection frequencies as well as detection levels. We used McNemar’s test to examine the change in detection frequency of insecticide levels in air between pre- and postintervention in both the intervention and control groups. We used the Wilcoxon signed-rank test to examine the change in insecticide levels between pre- and postintervention for both groups. Finally, we used the independent sample p = 0.008, 0.05, and 0.012, respectively). Participants included 25 intervention cases and 27 nonintervention controls. Demographic characteristics were compared between cases and controls and were generally comparable between the two groups . Discrepp = 0.016) (p = 0.006) and nymph cockroaches decreased by 44% (p = 0.033). By contrast, control households showed no significant reduction of adult or nymph cockroaches between baseline and follow-up . Adult cw-up see . Howeverw-up see .cis- and trans-permethrin in approximately 30% of pre- and 15% of postintervention samples and 24 and 16% of baseline control samples and 17 and 13% of follow-up control samples, respectively. In addition, piperonyl butoxide was detected in 71% of pre- and postintervention samples and 72 and 57% of baseline and follow-up control samples, respectively. The mean levels for these compounds in pre- and postintervention 2-week integrated indoor air samples are presented in Of the nine insecticides measured in 2-week integrated indoor air samples, five insecticides were not detected or were found in < 10% of either intervention or control samples. Of the remaining insecticides, propoxur was detected in 92% of pre- and postintervention case samples and 100% of baseline and follow-up control samples; and p = 0.016). Of the 23 intervention homes with available air sampling, a decrease in piperonyl butoxide was seen in 74% (17/23) of homes, whereas an increase was seen in 26% (6/23) of homes. Piperonyl butoxide levels also decreased in control homes, but not significantly (p = 0.08). The difference between pre- and postintervention levels of piperonyl butoxide in the intervention group was not significantly different from the difference between baseline to follow-up levels in the controls .Among the intervention group, only piper-onyl butoxide decreased significantly after the intervention . The meacis- and trans-permethrin (two isomers of the pyrethroid insecticide permethrin). These insecticides were detected in plasma samples from the control group but not from the intervention group. Specifically, 2-isopropoxy-phenol was detected in 0% of maternal blood samples from the intervention group and in 12% of maternal blood samples from controls . Cis- and trans-permethrin were detected in 0% of maternal blood samples from intervention group and 12 and 29% of maternal blood samples from controls, differences that were significant for trans-permethrin (= 0.008) . None ofThis pilot intervention study demonstrates that IPM can have a significant effect on pest infestation levels and appears to reduce residential insecticide exposures during pregnancy. Our findings showing significant reductions in cockroach populations are consistent with those of other intervention studies that focused on reducing either pest infestations or allergen levels related to pest infestation . To our Success of IPM interventions has been attributed to simultaneous application of multiple nonchemical approaches to pest control, including education, repair, least-toxic exterminations, reinforcement, and repetition . In our Despite the dual goal of IPM to reduce cockroach and insecticide exposures, most IPM evaluations have focused on the reduction of pests. Data on the effectiveness of reducing insecticide exposure are limited, and documented in only two studies. A building-wide intervention in New York City public housing found resident’s use of spray insecticides and Chinese Chalk, an illegal insecticide, dropped to zero after a building-wide IPM intervention that included education about the safe use of insecticides . An IPM intervention in Canada found decreases in both personal use of spray insecticides and resident requests for exterminators to use spray insecticides in their apartment, requesting instead lower-toxicity pastes or gels . Althougcis-permethrin and trans-permethrin, and the pyrethroid synergist piperonyl butoxide. Selection of these insecticides was based on evidence that they were widely used for residential pest control (trans-isomer of permethrin were lower in maternal plasma samples collected from the intervention group than in controls.In the present study, target insecticides in indoor air samples included the carbamate, propoxur, the pyrethroids control . Detecti control , 2004. T control . In our However, these findings should be interpreted with caution, particularly because results for propoxur do not mirror those seen for piperonyl butoxide. Specifically, propoxur levels in indoor air samples decreased in follow-up compared with baseline air samples among control households, but not among intervention households. Propoxur is a carbamate licensed for residential pest control and has not been subject to regulatory restrictions, as have the organophosphates, chlorpyrifos, and diazinon. However, our prior data suggest that propoxur use in inner-city communities in New York City may be decreasing. Specifically, we found a highly significant decrease in propoxur levels between 1999 and 2001 in personal air samples collected from African-American and Dominican women in New York City during pregnancy and in the corresponding blood samples collected from the mothers and newborns at delivery , 2004. UAlthough this pilot intervention indicated that IPM is effective at reducing pest infestation and the internal dose of the insecticides during pregnancy, limitations in the study design should be noted. The primary limitation of the study is the small sample size and the short time elapsed between pre- and postintervention monitoring. Many intervention studies allow 6 months to 1 year between samplings to determine if the intervention is both successful and sustainable. However, the current intervention was conducted during pregnancy and was thus limited in follow-up time. Further, the controls were selected from an ongoing biomarker validation study that followed women only during pregnancy. Thus we were not able to evaluate the sustainability of the intervention over an extended period. In addition, the optimal design for an intervention study is to match the intervention subjects to control subjects and have all data collected and analyzed simultaneously. This was not possible here because the controls were selected from ongoing research. However, the intervention and control groups were comparable in terms of years of enrollment and self-reported pesticide use.A principal goal of the pilot study was to assess whether environmental and biologic measures can be used in evaluating the efficacy of IPM interventions in reducing residential pesticide exposures. These initial results are promising, although additional research is warranted given the small sample size and inconsistency in some of the findings. Environmental measures for the targeted pesticides are not necessarily associated with the biologic measures. Therefore, a lack of meaningfully different results in air levels of pesticides between the intervention and control groups does not influence the expected results in maternal plasma between the two groups. Subsequent research could also draw on our study design to devise an IPM intervention that can be conducted by household members themselves and that is both feasible and affordable. Such an intervention could be applied to entire apartment buildings or complexes to determine the effects of larger-scale interventions, as opposed to individual units. In the current study, cleaning and home repairs were completed by a professional cleaning crew to allow comparability and consistency. However, the supplies and techniques are similar to those available in the community. In conclusion, we believe that this intervention protocol using IPM can be successfully adapted for use by individuals within households in this community to reduce pest infestation levels and residential pesticide exposure."} -{"text": "The prevalence of asthma and allergic diseases has increased in industrialised countries, and it is known that rates vary according whether the area is urban or rural and to socio-economic status. Surveys conducted in some urban settings in Latin America found high prevalence rates, only exceeded by the rates observed in industrialised English-speaking countries. It is likely that the marked changes in the environment, life style and living conditions in Latin America are responsible for these observations. The understanding of the epidemiological and immunological changes that underlie the increase in asthma and allergic diseases in Latin America aimed by SCAALA studies in Brazil and Ecuador will be crucial for the identification of novel preventive interventions.The Salvador-SCAALA project described here is a longitudinal study involving children aged 4–11 years living in the city of Salvador, Northeastern Brazil. Data on asthma and allergic diseases (rhinitis and eczema) and potential risk factors will be collected in successive surveys using standardised questionnaire. This will be completed with data on dust collection (to dust mite and endotoxin), skin test to most common allergens, stool examinations to helminth and parasites, blood samples , formaldehyde, physical inspection to diagnoses of eczema, and anthropometric measures. Data on earlier exposures when these children were 0–3 years old are available from a different project.It is expected that knowledge generated may help identify public health interventions that may enable countries in LA to enjoy the benefits of a \"modern\" lifestyle while avoiding – or minimising – increases in morbidity caused by asthma and allergies. The prevalence of asthma and allergic diseases (rhinitis and eczema) has increased in industrialised countries in the last 2 decades -3; in thAmong environmental exposures that may have contributed to the trends in allergy prevalence, those that have attracted most interest are the fall in exposures to infectious diseases. The so-called \"hygiene hypothesis\" proposed that increases in the prevalence of allergic diseases were explained by improvements in living conditions, use of antibiotics and childhood vaccinations leading to a reduction in exposure to infections in early life . DiffereWhatever the mechanisms involved the strong evidence that the temporal allergy trends are related to changes in lifestyle and living conditions raises the possibility that preventive interventions against allergic diseases can be identified. The understanding of the epidemiological and immunological changes that underlie the increase in asthma and allergic diseases will be crucial for the identification of novel preventive interventions.International studies of the asthma prevalence have been conducted with the International Study of Asthma and Allergies in Childhood (ISAAC) study group using a standardised written questionnaire for self-reported asthma and respiratory symptoms. In these surveys, some Latin American settings had very high prevalence rates, that were exceeded only by industrialised English-speaking countries . These rThe study described here is part of a larger ongoing research programme being conducted in Brazil and Ecuador. Populations in both countries have experienced recent changes in living conditions and life style . This research programme is funded by The Wellcome Trust through the programme of Major Awards to Centres of Excellence in Latin America and has adopted the name SCAALA . This paper specifically deals with the methodological aspects of the cohort study being conducted in Salvador, Brazil.The Salvador cohort study has two main objectives. Firstly, to investigate the associations between the prevalence of asthma and other allergic diseases and potential risk factors that includes living conditions and early life and current exposures to infections, and secondly, to investigate how the association between environment factors, allergic diseases and markers of atopy are mediated by serum interleukins. In contrast, the study in Ecuador aims to study frequency of atopy and allergic diseases and exposure to potential risk factor in rural populations and in migrants from rural to urban areas; and examine how these may explain the risk of atopic diseases in migrants from rural to urban areas. This study will be described in a separate paper.Salvador, the capital of the State of Bahia, in the Northeast Brazil has approximately 2.5 million inhabitants, and is located in the poorest region in the country. Over 80% of the population is black or mixed-race (mulatto). There is a high degree of social inequality: GINI coefficient was 0.66 in 2000 . The citChildren in this research project have been part of a study conducted earlier to evaluate the impact of the sanitation programme on the occurrence of childhood diarrhoea. This first study was originally designed to enrol three separate cohorts of children aged 0–3 years recruited from 24 small geographical areas selected to represent the population without sanitation in Salvador, called sentinel-areas ,17 TheseTo take advantage of these three cohorts , the children who were aged 4–11 years and had complete follow-up information (e.g. stool examination conducted at 3 different time points) were selected for the present study.Follow-up during the current study on asthma and allergic diseases consists of two additional surveys to be conducted between 2005 and 2006, and again in 2008. The two surveys will assess children from the three previous cohort studies and will: (i) update information collected in the baseline surveys (ii) collect information on additional risk factors, (iii) collect stool samples for diagnosis of intestinal parasitic infections, (iv) collect blood samples for immunological analysis, (v) collect dust to measure allergen exposure, (vi) collect data on formaldehyde and particulate levels indoors and outdoors and (vii) collect data on asthma and allergic diseases . The information collected during previous surveys and follow-up will be used in the present study to investigate early risk factors relating to infectious disease exposures and living conditions of the children from birth. All children from the previous 3 cohort studies were eligible to enter the present study.The total number of children recruited in the first resurvey with questionnaires completed was 1,445. Given this total number of children recruited, the magnitude of the prevalence rate ratio to be estimated with at least 80% of study power and 95% precision for selected characteristics were calculated by comparing proportions in STATA (command \"sampsi\"). This was done assuming an estimate of asthma prevalence of 10% , signifiAsthma, rhinitis and eczema will be defined according to the International Study of Allergy and Asthma in Childhood (ISAAC) . Atopy wThe field work of the surveys in 2005 and 2008 involves 7 different activities, each conducted by different field teams and supervised by at least one of the co-investigators. Application of the main questionnaire, anthropometric survey, and stool and dust sample collection were completed in 2005. The activities were:1. Questionnaire: mostly based on the ISAAC Phase II questionnaire , transla2. An anthropometric survey with two independent measures of height and weight collected in a standardised way conducted by trained nutritionists, taking the mean value as the final measure, as recommended by WHO: z-scores for weight-for-age, weight-for-height and height-for-age were calculated using the EPINUT program (details published elsewhere ).3. Stool samples collected for helminths and parasites with two different samples for each child, 2 days apart. Stools were analysed using the gravitational sedimentation technique of Hoffman, Pons & Janner to detect helminth eggs, protozoan cysts and oocysts. Two slides were examined for each stool sample. Quantification of helminth eggs was performed using the Kato-Katz technique . All chi2 area, adjacent to the head side. The filters were weighed before and after collection of the dust samples. Fibres and large particles were removed from the dust with forceps and the fine particulated dust samples were weighed, aliquotted as 100 mg samples and cryo-preserved at -20°C. Temperature and air humidity were recorded at the bedroom with a thermohygrometer .4. Dust samples collected using a residential vacuum cleaner containing a nylon 25 um micromesh sock filter . The chiA. lumbricoides, T. trichura, Toxoplasma gondii and Toxocara canis, and (iii) cytokines IFN-gamma, IL-13 and IL-10 and TGF-β in supernatant fluids collected from antigen-stimulated whole blood cultures.5. Blood samples: An aliquot of 10 mL collected to measure (i) total and allergen specific IgE , (ii) IgG antibodies to Hepatitis A virus, Herpes simplex, Herpes zoster, and Epstein-Barr viruses, Dermatophagoides pteronyssinus, Blomia tropicalis, Blattella germanica, Periplaneta americana, fungi, dog and cat epithelia. Saline and histamine was used as negative and positive controls, respectively. Wheal sizes will be read after 15 minutes and reactions will be considered positive if the mean of the two larger perpendicular diameters of the reaction is at least three millimeters superior to the mean of the two larger perpendicular diameters of the negative control reaction area.6. Skin prick test (SPT) carried out by allergen skin prick testing of the right forearm of each children using extracts of 7. Skin inspection for flexural dermatitis performed by trained observers using the ISAAC phase II protocol will comBlomia tropicalis Blo t 5, Dermatophagoides pteronyssinus Der p 1, Blatella germanica Bla g 2, Cat Fel d1, Dog Can f1Bacterial endotoxin and fungal b-glucan will be measured using the Limulus Amebocyte Lysate (LAL) assay (Cambrex Bio-Ciência do Brasil Ltda) following the manufacturers' instructions.Aeroallergens will be quantified from dust samples by capture ELISA using commercially available kits for the following aeroallergens: Ascaris lumbricoides (10 μg/ml); Blomia tropicalis (40 μg/ml); Dermatophagoides pteronyssinus (5 μg/ml). Pookweed mitogen diluted at 1/1000 will be used as a positive control and media alone as negative control. House dust mites cultivated in fish food will be purified, lysed in pH 7.4 phosphate saline (PBS) with the use of a blender . The A. lumbricoides antigen will be obtained by trituration of liquid nitrogen frozen adult worms obtained from a child treated with albendazole, in a blender as stated above in the presence of PBS. After centrifugation, the supernatants will be cryopreserved for storage before use. All antigens will be depleted of endotoxin by treatment with triton-114 and the protein contents will be determined by the Lowry method. Whole blood cultures will be cultivated at 5% CO2, for 24 hours for detection of IL-10 and for 5 days for the detection of IL-13, TGF-β and IFN-gamma. Cytokines in supernatant fluids will be measured using Pharmigen BD antibody pairs and recombinant standards by capture ELISA following the manufacturer's instructions. Cytokines will be estimated by interpolation of standard curves of recombinant standards.Heparinised whole blood will be cultivated at a dilution at 1:4 in RPMI containing 10 mM glutamine , 100 μg/ml of gentamicyn , and stimulated with the following antigens: Total IgE will be measured as follows: COSTAR high binding microassay plates will be coated with 4 μg/ml of an anti- human -IgE antibody overnight at 4C. Plates will be blocked with 0.15 M phosphate-buffered saline, pH 7.2 (PBS), containing 20% of dried skimmed milk (DSM) and 0.05% of Tween 20 overnight, at 4°C. Sera to be tested and IgE antibody standards . will be diluted 1:10 in PBS containing 10% of DSM and 0.05% of Tween 20 and incubated overnight at 4°C. A goat anti-human IgE-peroxidase conjugate , and an anti-goat immunoglobulin-peroxidase conjugate , will be diluted at 1:2000 and 1:10.000, respectively, and incubated for 60 minutes at room temperature. The results will be expressed in International Units (IU). A pool of parasite infected patients' sera will be used as positive control. Umbilical cord serum from a non-atopic and non-parasited mother will be used as negative control.Dermatophagoides pteronyssinus, Blomia tropicalis, Blatella germanica, dog and cat epithelia main allergens using the RAST system .Determination of specific IgE serum concentration will be done for A. lumbricoides IgG4 will be detected by an indirect ELISA using wells of high binding microassay plates , sensitized with 20 μg/ml, of the parasite antigen as stated above, diluted in carbonate-bicarbonate pH 9,6 buffer. The sera will be diluted at 1:50 in PBS containing 10% skimmed milk and 0,1 % tween 20 (PBS/SM/T). The reaction will be detected using a biotinylated anti-human-IgG4/, streptoavidin/peroxidase and H2O2 e OPD . The assay cut-off will be the mean plus 3 SD of negative controls . Anti-Toxocara IgG antibodies will be detected using 20 μg/ml of larvae excretorial-secretorial antigen obtained by cultivation of the larva as described by De Savigny et al. [A. lumbricoides; the development of the reaction will be done as described for A. lumbricoides IgG4 except for the conjugate that will be a biotinylated anti-human IgG. The assay cut of will be the mean plus 3 SD of negative controls . Anti-Toxoplama gondii IgG and IgM will be detected using commercially available ELISA kits , following the manufacturer's instructions. IgG antibody against the following virus will measured: Herpes simplex, Herpes zoster, Epstein-Bahr and Hepatitis A virus. Detection will be done using commercially available ELISA kits , following the manufacturers' instructions.Detection of anti-parasite antibodies. Anti-y et al. (The serData for study variables were collected either (i) during the 3 previous baseline surveys and that will be updated in the 2 forthcoming surveys (2005 and 2008), or (ii) are new data to be collected in these 2 forthcoming surveys. Table In the earlier cohorts no data was collected regarding asthma and hence incidence cannot be estimated in the first survey (2005). In the second survey (2008) a measure of incidence will be estimated reflecting new cases arising between 2005 and 2008. However, establishing asthma diagnosis in infancy is difficult. Additional information on occurrence of episodes of shortness of breath, fever and cough that are available for a year following the baseline surveys will also be used. This information may be more accurate than prevalence estimates estimated from data collected using a later questionnaire for asthma symptoms in infancy.Statistical analysis will be conducted according to a conceptual framework defining a proposed causal pathway. Bivariate association analysis will be carried out by calculating prevalence ratios and 95% confidence intervals to measure the strength of the association between each potential risk factor and the outcomes of interest. At his stage, the main outcomes of interest are atopy , asthma and allergy). Multivariate analysis will be taken out in several steps. First, within each level, multivariate data reduction techniques will be applied to summarise highly correlated variables to index variables . Secondly, for each level, multivariate regression models will be fitted to estimate association parameters adjusted for confounding factors of the same level. In addition, multi-level modelling and robust variance estimation techniques will be used to adjust for intra-subject correlation due to repeated measures on the same individual and/or geographical areas. Finally, to address the complex inter-relationships between risk factors of different levels and outcomes according to our pre-defined conceptual framework, we will apply the following analysis strategies: i) A hierarchical effect decomposition strategy fitting a sequence of regression models each including different blocks of covariates, similar to an approach suggested by other authors ; ii) LogEthical approval was obtained from the Brazilian National Ethical Committee in 2004. Written informed consent was obtained from the legal guardian of each subject. It details all the procedures in the course of the project. All the clinical relevant results will be sent to the subjects parents, and specific recommendations will be done by a trained clinician after reviewing each case.The SCAALA programme that includes the Salvador and the Ecuador project, is expected to provide important new information and contribute to our understanding of why the prevalence of asthma and allergies appear to be so high in urban settings in LA. The two studies have different objectives and designs, but they have similar conceptual frameworks and share expertise and operational resources. These projects require extensive co-ordination, involve expertise from several different disciplines and complex logistics . Study designs used include surveys and case-control studies making possible the comparison of prevalence and risk factors for asthma and other allergic diseases between urban and rural environments (the Ecuador study) and a longitudinal study of the effects of early life exposures of an urban population on asthma and other allergic diseases . The laboratory component will explore the relative importance of different immunological mechanisms in mediating the effects of environment exposures (with emphasis on helminths and other infectious diseases of childhood) on the risk of asthma and allergic diseases. Statistical analysis will involve the use of strategies that link data from different levels and will use advanced statistical techniques to deal with this complex frameworkThe Salvador study is the continuation of three different cohorts initiated several years ago with objective of studying the effects in changes in sanitation on the risk of infectious diseases The earlier data collected for these cohort studies, therefore, will provide important information that will allow the study to examine the importance of the 'hygiene hypothesis' in determining allergy risk in an poor urban centre of LA Theses cohorts provide prospective data over a period of 12 months from between birth and 3 years of age. Data was collected through home visits every 2 on diarrhoea, reported fever, cough and shortness of breath. Demographic, socio-economic, sanitation-related environmental data was collected also. Each child was weighed, height was measured, and a stool sample was collected for parasitologic assessment. Second, although data was collected at the individual level, the use of \"sentinel areas\" throughout Salvador made possible the collection of community level aggregate data and or census dataIn summary, the proposed programme aims to clarify the social and biological mechanisms mediating the effect of population changes on the frequency of atopic disease in LA. Latin America is undergoing a rapid process of population change, including urbanization, migration, economic development and adoption of a \"modern\" lifestyle. Efforts to improve water supply, sanitation, rubbish collection and other hygienic measures are common to the different LA countries. It is expected that knowledge generated may thus help identify public health interventions that may enable countries In LA to enjoy the benefits of a \"modern\" lifestyle while avoiding – or minimising – increases in morbidity caused by asthma and allergies.ISAAC: International Study of Asthma and Allergies in ChildhoodSCAALA: Social Change, Allergy and Asthma in Latin AmericaThe author(s) declare that they have no competing interests.MLB conceived of the study, and participated in its design and coordination and lead the drafting of the manuscript, SSC participated in the design, coordinated the study, participate on the plan of analysis and helped draft this manuscript; NAN carried out the stool sample studies and the allergens studies; LPC carried out the immunological studies; AAC carried out all clinical investiagtion, RTS participated inthe drafting on the manuscript; BG lead the development of plan of analysis, PJC participated in the conception of the study design and plan of analysis, LCR conceived of the study, participated in its design and plan of analysis and helped to draft the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"} -{"text": "Eating patterns in Western industrialized countries are characterized by a high energy intake and an overconsumption of (saturated) fat, cholesterol, sugar and salt. Many chronic diseases are associated with unhealthy eating patterns. On the other hand, a healthy diet (low saturated fat intake and high fruit and vegetable intake) has been found important in the prevention of health problems, such as cancer and cardio-vascular disease (CVD). The worksite seems an ideal intervention setting to influence dietary behavior. The purpose of this study is to present the effects of a worksite environmental intervention on fruit, vegetable and fat intake and determinants of behavior.A controlled trial that included two different governmental companies (n = 515): one intervention and one control company. Outcome measurements (short-fat list and fruit and vegetable questionnaire) took place at baseline and 3 and 12 months after baseline. The relatively modest environmental intervention consisted of product information to facilitate healthier food choices value of foods in groups of products was translated into the number of minutes to perform a certain activity to burn these calories).Significant changes in psychosocial determinants of dietary behavior were found; subjects at the intervention worksite perceived more social support from their colleagues in eating less fat. But also counter intuitive effects were found: at 12 months the attitude and self-efficacy towards eating less fat became less positive in the intervention group. No effects were found on self-reported fat, fruit and vegetable intake.This environmental intervention was modestly effective in changing behavioral determinant towards eating less fat , but ineffective in positively changing actual fat, fruit and vegetable intake of office workers. Lifestyles in Western industrialized countries are characterized by a decreasing level of physical activity -3, a higA healthy diet has also been found important in the prevention of health problems, such as some types of cancer and cardiovascular disease (CVD) -8. MoreoWorksites are an effective channel to promote healthy food habits among employees by means of comprehensive worksite health promotion programs (WHPP's), because they provide access to a large proportion of the adult population and people spend a great deal of their time at the worksite. In many WHPP's, traditional methods to increase knowledge and skills are used to stimulate healthy behavior -13. HoweTherefore, a worksite intervention (i.e. FoodSteps) solely consisting of relatively modest environmental changes was developed to stimulate physical activity, but also healthy food habits of office-workers. The purpose of this study is to present the effects of this intervention on determinants of dietary behavior and on self-reported fat, fruit and vegetable intake.2) in women and a BMI ≤ 23 (kg/m2) in men. In order to select a population at higher risk for disease associated with overweight, the inclusion criterion of a BMI ≤ 23 was applied in our study. Subjects who were pregnant or became pregnant during intervention year, or had severe cardiovascular/musculoskeletal disorders were excluded. Employees received a leaflet by company internal mail system in which they were asked to participate in the study and they had to return a written reply form to be included in the study. On the reply form a number of screening questions (including self-reported body weight and body height) had to be filled out. A written informed consent was obtained from the subjects and this study had the approval from the medical ethics committee of the VU University Medical Center.In this controlled longitudinal trial, two different government companies in The Hague (the Netherlands) were used: one intervention and one control company. These worksites were chosen because of the similar job-descriptions of the employees. The inclusion criteria for participating in the study were; (1) office worker, (2) the ability to climb the stairs, (3) a body mass index (BMI) ≤ 23 and (4) a contract for at least the duration of the intervention. In a review on the public health burden of obesity of Visscher et al , a numbeThe questionnaires were distributed among subjects at both worksites at baseline (October 2003), at three months (April 2004) and 12 months (November 2004).The FoodSteps intervention consisted of two parts, one part focusing on food and one on physical activity . The food-intervention took place over 12 months (January 2004–December 2004) in the company canteen of the intervention company and mostly consisted of placing informational sheets near food products, to stimulate healthier food choices. Every four weeks one group out of six groups of products was chosen to be highlighted. Each group was repeated once during the year. On the informational sheets the caloric value of a product was translated into the number of minutes to perform a certain activity . The product-groups were: (1) dairy products (2) warm snacks, (3) fruit-vegetables-salads, (4) cold ready-to-eat sandwiches (including fillings) (5) sandwich fillings and (6) pastry. On three vending machines similar information sheets were placed, on which the snacks offered in the machines were highlighted. The sheets on the vending machines were not changed during the intervention year. Additionally, an information stand was placed in the canteen with brochures and leaflets on healthy food, blood pressure and cholesterol. Finally, every two months during one day a week a buffet with healthy products was offered to the customers of the company canteen.Psychosocial determinants of eating more fruit, vegetables and less fat were measured applying the 'attitude-social influence- (self-)efficacy model' (ASE model) ,22. All The validated Short Fruit and Vegetable questionnaire was used to measure fruit and vegetable consumption. This questionnaire consists of 10 questions: 6 about fruit consumption and 4 about vegetable consumption . SubjectIn this study the validated Fat list was used2).The following data were collected by questionnaire: the highest achieved level of education, age, smoking (yes/no), number of alcoholic units per week, hours per week at the office, whether or not following a diet, whether or not being a regular visitor of the company canteen (at least once week purchasing food in the canteen) and whether or not taking lunch to work every day of the week. Additionally, as a part of the study, subjects were invited to attend a physical examination at all follow-ups where among other variables, body height (cm) and body weight (kg) were measured with subjects in underwear. The Body Mass Index (BMI) as measured at baseline was also used as a covariate in this study. BMI was calculated by dividing body weight (kg) by body height (m) squared (= kg/mBoth the short-term (3 months) and the long-term (12 months) effect of the intervention were analyzed by multivariate linear regression analysis. In this analysis the outcome at respectively 3 and 12 months was corrected for the baseline value. The regression-coefficient of the group allocation variable reflects, the difference in change over time between worksites in the outcome variable. Linear regression analysis excludes subjects with missing data. Only subjects with baseline data and data on at least one follow-up were included in the analysis. Baseline values that differed (according to independent t-test) between intervention and control subjects at baseline, as well as a set of predefined variables were checked as possible confounders. As possible effect modifiers were considered baseline data on: gender, BMI, whether or not taking lunch to work, being a regular visitor of the company canteen, smoking and alcoholic intake. Effect modification was defined as a significant (p < 0.10) interaction term between the group allocation variable and the variable of interest.In figure Although, a higher number of included subjects (about 900) was intended, with a power of 0,8 en alpha of 0,05, a difference of about a half (0.42) piece of fruit and 20.7 grams of vegetables can still be demonstrated with a total number of 515 participants.Questionnaire return-rates in the intervention site were 88.9% and 78.3% and in the control site 90.4% and 88.9%, at 3 and 12 months respectively. The baseline demographics of the total population are described in Table Table In addition, a significant negative interaction was found with BMI at baseline. This can be interpreted as an increasing intervention effect regarding the attitude to eat less fat at work for subjects with a higher BMI at baseline. No significant effects on any of the other psychosocial determinants were found.Table In Table The purpose of this study was to analyze the effects of a worksite environmental intervention on determinants of dietary behavior regarding eating more fruit and vegetables and eating less fat and on actual (self-reported) fat, fruit and vegetable intake.The results of this controlled trial showed that this environmental intervention only had a modest effect on determinants of dietary behavior. A significant effect was found on the perceived social support from colleagues regarding eating less fat. This determinant significantly increased at the short-term and borderline significant at long-term. However, also counterintuitive effects were found. First, at 12 months the attitude toward eating less fat decreased in the intervention group and decreased even more for subjects with a higher BMI at baseline. Second, self-efficacy towards eating less fat at work decreased significantly in the intervention group. The intervention was ineffective in significantly increasing fruit, vegetable intake and decreasing fat intake of the intervention group. An interesting finding was, however, that in the intervention group at short term the subgroup of workers who did not take their lunch to work every day significantly increased their fat intake compared to those in the control group.Just as in our study, in a controlled trial of Steenhuis et al a similaOther worksite health promotion programs (WHPP's) did show positive results on self-reported fruit-vegetable and fat intake. These trials -29 were This difference in study population is an important point that might explain our poor results. In our study a primarily white-collar and highly educated population participated. White-collar populations are known to have in general more favorable food patterns (i.e. they eat more fruit-vegetables and less fat) ThereforAnother explanation for the lack of positive results could be that in our study the same questionnaires as in the study of Steenhuis et al were useA weak point in this study was that a relatively large proportion of the study population was not a regular visitor to the company canteen (about 40%). Because of this, the food intervention did not have the full impact it could have had. However, at follow-up no interaction was found between whether or not being a regular visitor to the canteen, and fruit-vegetable and fat intake. Also, the food intervention might have been too modest to sort any effect. As mentioned in the method section, only one product group at the time was highlighted by means of larger information sheets near the products included in the selected group. No information was put directly on the products and no clear-cut distinction between healthy or unhealthy products was made (for instance labeling products with either red or green colors), like in a study of Larsson et al . LarssonA limitation of this study might be the fact that no randomization was performed. Bias introduced by possible differences between worksites, might have been prevented if a randomization at the level of the individual could have been performed. However, due to the nature of the intervention this kind of randomization was not possible. Moreover, the main reason for not performing randomization at the level of the worksite was that, at the moment that the FoodSteps research proposal was approved, one worksite had already agreed to participate. In order to speed up the preparations of the intervention, this worksite was chosen as the intervention worksite. During this preparation period the control worksite still had to be found.In conclusion, this relatively modest environmental intervention was effective in significantly changing behavioral determinants towards eating less fat , but ineffective in significantly changing actual fat, fruit and vegetable intake of office workers. Negative changes in attitude and self-efficacy towards eating less fat at work were found. In future research it needs to be investigated if the food habits of employees can be changed by a more intensive environmental intervention.The author(s) declare that they have no competing interests.WVM is primary responsible for the study as presented in this paper. He made a significant intellectual contribution to the manuscript and has been involved in drafting and revising the manuscript critically.LE is the executive researcher of the FoodSteps project as presented in this article. He was responsible for preparing and implementing the intervention, collecting and analysing the data and writing of the manuscript.MVP made substantial contribution to the conception and the design of the study. In addition, MVP has been involved in drafting and revising the manuscript critically.MCAP made a substantial contribution to the conception and the design of the study, analysing the data, drafting and revising the manuscript critically.All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"} -{"text": "The four ligating atoms comprise the hydoxylate and carboxyl­ate O atoms from two independent benzilate ligands, each of which forms a five-membered chelating ring, spanning an axial and an equatorial site about the Sb atom. The hydroxy­late atoms occupy the two equatorial sites, and the carboxyl­ate atoms are in the pseudo-axial sites; the O—Sb—O angle is 147.72 (5)°. One carboxyl­ate group shows quite different bond lengths from those of the other group; one O atom is clearly the carbonyl atom and the other O atom the hydroxy­late atom. In the other ligand, there is less distinction in the C—O bonds. This is presumably related to the carbonyl O atom being the acceptor atom of a strong N—H⋯O hydrogen bond, which links the ammonium cation to the Sb complex anion.The coordination around the Sb atom in the title compound, (C DOI: 10.1107/S1600536809054853/pb2016Isup2.hkl Structure factors: contains datablocks I. DOI: crystallographic information; 3D view; checkCIF report Additional supplementary materials:"} -{"text": "The increased prevalence of overweight and obesity warrants preventive actions, particularly among people in transitional stages associated with lifestyle changes, such as occupational retirement. The purpose is to investigate the effect of a one year low-intensity computer-tailored energy balance programme among recent retirees on waist circumference, body weight and body composition, blood pressure, physical activity and dietary intake.A randomised controlled trial was conducted among recent retirees . Outcome measures were assessed using anthropometry, bio-impedance, blood pressure measurement and questionnaires.Waist circumference, body weight and blood pressure decreased significantly in men of the intervention and control group, but no significant between-group-differences were observed at 12 or at 24-months follow-up. A significant effect of the programme was only observed on waist circumference (-1.56 cm (95%CI: -2.91 to -0.21)) at 12 month follow up among men with low education (n = 85). Physical activity and dietary behaviours improved in both the intervention and control group during the intervention period. Although, these behaviours changed more favourably in the intervention group, these between-group-differences were not statistically significant.The multifaceted computer-tailored programme for recent retirees did not appear to be effective. Apparently the transition to occupational retirement and/or participation in the study had a greater impact than the intervention programme.Clinical Trials NCT00122213. The increasing prevalence of overweight and obesity also affects the older population and prevIdeally, a behavioural intervention for this purpose should aim for small though sustainable changes to prevent gradual weight gain . PreferaWe developed and evaluated a one-year multifaceted programme including these factors using computer tailored feedback on physical activity and diet . The proSubjects were eligible for participation in the WAAG-Study (Wageningen Approach against fat Accumulation and weight Gain) if they were recent retirees (date of retirement maximum six months before or after baseline measurement), aged 55-65 years, and not undergoing any medical treatment that might affect body composition. Participants were recruited from pre-retirement workshops as offered by employers to approximately 10% of the Dutch retiring population. During such a five-day workshop several topics are discussed in order to prepare retirees for the new phase in life, e.g. changes in the household after retirement, health and vitality. Workshops were held all across The Netherlands. Approximately 1,100 workshop attendees were invited to participate in the WAAG-Study from September 2003 to mid March 2004. First follow-up measurements were conducted from September 2004 to the end of February 2005, and final follow-up measurements were conducted from September 2005 to the end of February 2006. The Medical Ethics Committee of Wageningen University approved the study protocol and all participants gave written informed consent upon enrolment after they received written and verbal information about the trial . In totaAll persons attending one single workshop (cluster) who were willing to participate were physically examined at the location of the workshop. Furthermore, questionnaires on demographics, physical activity, dietary intake and psychosocial determinants were handed out. Within one week after the workshop the clusters were randomly allocated to either the intervention or the control group. Cluster randomisation was performed in order to avoid induction of favourable behaviour change of individuals in the control group through their contacts with fellow participants in the intervention group. A randomisation list was generated beforehand by an independent person and took into account the number participants per workshop and the number of included clusters per week. Due to the nature of the study it was not blinded.Follow-up physical examinations were scheduled 12 ± 0.5 months (on average 11.9 ± 0.5 (mean ± SD); range 10.0-14.8 months) and 24 ± 1.0 months after the baseline examinations. At 12 months follow-up 94% and at 24 months follow-up 84% of the participants returned for re-examination. Drop out was mostly due to planning problems, since not all participants could be scheduled for an appointment within the set limits. There were no differences between those who dropped out and those who remained.The intervention programme was deveFive programme modules were provided to participants of the intervention group during the one year intervention period as shown in Figure During the total study period of two years, the control group was provided with newsletters with general information about the study, such as study progress, and information about art exhibitions and city trips for instance. They could not login to the website and had access to the general information about the study design only .Baseline physical examinations were performed at the site of the pre-retirement workshop, between 11 am and 2 pm. Follow-up examinations were conducted at various community health centres across the Netherlands at the same time of day. Examinations were carried out by the same two trained researchers over the total study period. Most participants (76%) were examined by the same researcher at baseline and 12 months follow-up and at the 24 months follow-up one researcher performed all examinations. Physical activity, diet, demographic and utilisation information were assessed by questionnaire. Questionnaires were handed out (baseline) and sent by mail (follow-up measurements) and were either returned in pre-paid envelopes (baseline) or handed in at follow-up physical examinations (12 and 24 months).Date of birth, date of retirement, physical activity level of their last job, and educational level were assessed by questionnaire. Activity level of the former job was based on four types of activities and ranged from non-active, e.g. administrative job, to very active, e.g. postmen. Highest attained education was categorised as 'low' , 'medium' or 'high' .We also collected information on the use of the different modules of the intervention. Participants self-reported at all follow-up measurements whether or not they have used the modules once, twice or more. This is stated as utilisation per module and presented as a proportion of participants that returned the questionnaire.All anthropometrical measurements were performed while participants wore underwear only. Body weight was measured to the nearest 0.2 kg after regular calibration and height to the nearest 0.1 cm . Circumferences of the upper-arm, waist, hip, thigh, and calf were measured twice to the nearest 0.1 cm with a non-stretchable plastic measuring tape on the non-dominant side of the body, according to standard protocol ,18. AbdoTBW (kg) = 2.896 + 0.366*HEIGHT2(cm)/RESISTANCE100 kHz + 0.137*WEIGHT(KG) + 2.485*SEX [WEIGHT -TBW)/0.732)/WEIGHT[A single frequency (100 kHz), tetra polar, body impedance analyser was used to estimate total body water according to = women) . From to2)/WEIGHT.Blood pressure was assessed with participants in supine position using the average of two standard automatic blood pressure measurements .Changes in physical activity were assessed with the validated Dutch version of the Physical Activity Scale for the Elderly (PASE) . This brTotal PASE score was computed by multiplying the amount of time spent per activity (hours/day) and participation in the household activities by the item weights and then summing these products. The item weights indicate the contribution of each item to the overall PASE score; highest weights were assigned to the more strenuous types of activities . Six queFurther, we derived total time (min/week) spent on bicycling and walking as an indicator for routine daily activities and total time (min/week) spent on moderate and high intensity and muscle strengthening activities as an indicator of recreational and sports activities.Changes in the diet were assessed with a validated, semi-quantitative food frequency questionnaire (FFQ). The FFQ has been developed to estimate intake of fat, fatty acids, cholesterol and energy in adults using a reference period of four weeks . All FFQFruit intake (g) was calculated by summing the amounts of fresh fruits. Vegetable intake (g) was calculated by summing the amounts of cooked, fried and raw vegetables. The sum of fruit and vegetable intake (g) was adjusted for energy intake (MJ). Furthermore, total fat intake (en%) and total energy intake (MJ/day) were derived for the FFQ.To estimate portion size, we used the total number of servings (of standard portion sizes) per month of certain energy dense products that are frequently consumed in the Netherlands: sliced meat, meat, beer and wine. To illustrate small adaptations, the number of sugar cubes in cups of coffee and tea, and milk added to a cup of coffee were evaluated.Subjects reporting extreme differences between baseline and 12 months follow-up (60% increase or decrease in energy intake (MJ/day)) were excluded from the analyses (n = 6).We hypothesised that waist circumference in the control group would increase by 0.5 cm (standard deviation of difference = 1.3 cm) per year and that it would remain stable in the intervention group . Based oproc mixed; SAS for Windows, SAS Institute Inc. Cary, NC, USA; version 9.1). Models were constructed with the follow-up measurements as dependent variable and the baseline measurement as covariate. The estimate for treatment effect reflects the between-group-difference at follow-up, corrected for the value at baseline.The effect estimates of the intervention included all participants who had provided at least one follow-up measurement. Data were analysed using mixed models with a random cluster effect allowing each cluster to have its own intercept. Analyses were performed using SAS (d) were interpreted according to the Cohen's guidelines and indicate the size of the effect of the programme. Cut off points for small effects are d < 0.32, medium effects as 0.33 0.56 [Additionally, we calculated effect sizes, a frequently used measure to demonstrate the magnitude of the effect of an intervention programme. The standardised effect size is calculated as the difference between the mean changes between the intervention and control group divided by the pooled standard deviation . Effect d > 0.56 . We also2 and a waist circumference ≥ 102 cm [Secondary analyses were performed for waist circumference and body weight and fat intake and energy intake at 12 months follow-up in pre-defined subgroups of participants having low educational level , physically active former job, a BMI ≥ 30 kg/m≥ 102 cm . Also anAll statistical analyses were performed for men only, because age related changes in body composition differ between sexes and the number of women was too small to have sufficient power to draw conclusions. Statistical significance was set at p < 0.05 for all tests performed.2 and body weight . Although the declines were greater in the intervention group, the between-group-differences were not significant .At 12-months follow-up, there was a significant decline (mean change) in waist circumference , sum of household activities , and total physical activity ((PASE) INT: 22.9; CON: 17.6) increased significantly. However, the between-group-differences were not significant (Table Among men in both groups daily activities (y) Table . Men in y) Table .Waist circumference in men in the intervention and control group remained lower compared to baseline, though during the second year of follow-up an increase was observed. Body weight stabilised in both groups. Again the between-group-differences for waist circumference and body weight were not statistically significant Table .INT: 0.9; CON: 1.2; p = 0.03) in favour of the control group. For other lifestyle behaviours mentioned in Table Change in sport and recreational activities was higher after two year in the intervention group (74.5 min/week) compared to the control group . The sum of household activities increased in both groups revealed a significant between-group-difference in waist circumference of -1.56 cm at 12 month follow-up in favour of the intervention group. In this subgroup the reduction in body weight was also larger in the intervention group compared to the control group. However, the between-group-difference of -0.96 kg (95%CI: -2.40 to 0.47) was not significant. There were no significant differences in changes in waist circumference and body weight between the intervention and control group observed in any other predefined subgroup.Secondary analyses among men with low educational level in the intervention group, while an increase was observed in the control group . The between-group-difference was -3.2 en% (p = 0.01).The per protocol analyses to test the influence of utilisation of the key modules did not reveal any differences between those that had actually utilised the modules once or more versus the randomly selected sex-matched control group at 12 and 24-months follow-up (data not shown).Retired subjects participating in a one- year low intensity energy balance programme decreased their waist circumference, body weight, BMI, blood pressure and most other body composition indices and improved their physical activity and dietary behaviour. Although the changes were more consistent and more pronounced among subjects of the intervention group, the between-group-differences were small and mostly not statistically significant. Additional analyses among low educated men indicate that the programme may be effective in men with a low educational level: for waist circumference and fat intake the between-group-differences were significantly different. After the follow-up period the between-group-differences more or less remained the same, though the magnitude of the differences diminished.We hypothesised that the intervention group would maintain their waist circumference and body weight in the two years following transition to retirement as opposed to the control group. Within the control group, the waist circumference would on average increase by 0.5 cm per year. Remarkably, in men, both groups reduced their body weight and weight circumference. And although the difference in change was -0.48, we could not demonstrate a significant effect. Possibly our study lacked statistical power. The sample size was calculated based on observational data on change in waist circumference in a middle-aged population. Such data were not available for the specific group of retirees we studied. Apparently, the variance that was used for the power calculation was too low. Further, despite the randomisation, the control group had on average higher, though non significant, scores for the outcome measurements at baseline, which may have caused regression to the mean. However, we included baseline values in the models and thus have allowed for these apparent differences.The lack of effect may also be due to our recruitment strategy resulting in a relatively healthy and health conscious group of subjects. The study participants were selected from pre-retirement workshops, often attended by higher socio-economic groups, who in general are more motivated to change physical activity and diet, which might have reduced the added value of the prevention programme. Earlier studies have described that individuals willing to participate in health promoting intervention studies are already interested in diet and physical activity and are health conscious ,31.Further, study participation itself may have led to increased awareness and motivation to change physical activity and/or diet in the control group and intervention group (Hawthorne effect), which also reduced the added value of the programme. The influence of the researchers or others involved in measurements is supposed to be very low, since information associated with the content of the intervention was not discussed at the physical examinations or during other contacts.et al, showed that in transition to retirement subjects decrease work-related activity and increase household activities as well as doing odd jobs [And last but not least, transition to occupational retirement per se may have induced the changes in (lifestyle) behaviours. The study by Nooyens odd jobs . Maybe tA limitation of the study is the small number of females. Although the percentage of women that participated is representative for the percentage of women that worked in this age group, the number was too small to draw conclusions on the effectiveness of the intervention. And although the PASE questionnaire was originally designed for older adults (65+ years) it was chosen because it distinguishes activities (household -and leisure activities) that are relevant for retired people. Moreover, the recall period was only one week which also enabled us to pick up changes over a short period of time.et al showed that determinants of weight gain among older populations do not really differ from determinants in adult populations [The programme of our study was developed according to the Intervention Mapping Protocol . This syulations .Our programme aimed to induce relatively small and possibly sustainable changes in physical activity and diet to prevent weight gain ,10.Moreover, the programme was developed in a way that it could be implemented nationwide, thus it was of low intensity, easily accessible and home-based. As a result, participants could voluntarily use the modules of the programme in accordance with their personal preferences. As a consequence commitment and adherence of the target group may have been too weak to result in a behaviour change.Although the use of personal computers and internet in the middle-aged has increased rapidly in recent years , it is uThe results of this study can by used by the Netherlands Heart Foundation and others to further improve the intervention modules. At present it is not clear if or how the results of this study will lead to further development or implementation of this intervention.The individually tailored one year energy balance programme did not have a significant effect on any of the outcomes in recent retirees though it showed a pattern of small, non- significant effects on changes in body composition, physical activity and dietary behaviour. Lack of power may partly account for these findings. Apparently transition to occupational retirement and/or participation in research had a greater impact than the intervention programme itself.The authors declare that they have no competing interests.AW, AJS, FJK and EGS were the principal investigators of the study and developed the concept and the design of the study. PJMH contributed to the body composition assessment, AS and SK contributed to the behavioural parts of the intervention and to the assessment of behaviour. AW performed the analyses and AW and JS drafted the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/110/prepub"} -{"text": "Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women.A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline) and 36-37 (end of intervention). The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method.The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml and 1.4 ng/mg higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations.The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women.http://www.isrctn.orgISRCTN21512277, During pregnancy, the fetus is exposed to multiple biologically active compounds that originate from the maternal diet. Some of these may affect offspring's later health. Dietary phytoestrogens are examples of such compounds, as they are found in the amniotic fluid and the umbilical cord blood . In the Dietary lignans have been portrayed as health-promoting agents in many epidemiological studies, which show an inverse association between plant lignan intake or serum/urine enterolignan concentrations and chronic Western life-style diseases, including breast and colon cancer, and cardiovascular diseases . FurtherSeveral studies indicate that supplementation of a habitual diet with lignan-rich foods can affect circulating enterolignan concentrations in women . HoweverEach municipality in Finland is responsible for arranging maternity health-care services for its residents, and these are covered by public tax revenue. Almost all (99.7%) pregnant women attend public maternity clinics . The preIn the Finnish maternity health-care system, pregnant women are recommended to visit 11-15 times a nurse and three times to a physician. This study was implemented during two of these routine visits to nurses at gestation weeks 8-9 (baseline) and 36-37 (end of intervention).The participants were pregnant women with no earlier deliveries. Women who were younger than 18 years of age, or suffered from type I or type II diabetes mellitus, twin pregnancy, physical disability that prevented exercising or had otherwise problematic pregnancy, substance abuse, treatment or clinical history of any psychiatric illness, were unable to speak Finnish, or intended to change residence within three months, were excluded from the study. The nurses recruited the participants when they enrolled for their first clinic visit at the beginning of their pregnancy, usually by phone. Forty-nine women in the intervention clinics and 56 women in the control clinics gave informed consent for participation. Recruitment took place between August 2004 and January 2005.The participants visiting the control clinics received the standard maternity care. The intervention group received recommendations for gestational weight gain and physical activity counseling, the details of which are presented elsewhere ,13.For the dietary counseling, the following dietary objectives were set for each participant to achieve or maintain: 1) to follow a regular meal pattern, emphasizing the importance of breakfast and > = 1 hot meal every day, 2) to eat at least five portions (400 g) per day, in total, of different kinds of vegetables, fruits and berries, 3) to consume preferentially high-fibre bread (> = 5 g fibre/100 g), and 4) to restrict the intake of high-sugar snacks to < = 1 portion per day . The dietary counselling consisted of one primary counselling session at the visit during gestation weeks 16-18, and three booster sessions until gestation week 37.The pre-pregnancy weight and height were self-reported, whereas weight development during the pregnancy was based on measurement by nurses in maternity centers. The baseline questionnaire, including questions on background, lifestyle and dietary intake (a 57-item food frequency questionnaire), was completed before the first visit (at gestation week 8 or 9). The second follow-up questionnaire was completed at the end of the study, on gestation week 37. Similar FFQ was filled by both groups. The baseline dietary information was based on the diet during the month before the pregnancy and the follow-up information on the diet during the month before the 26 to 28 pregnancy week's visit.m/z 151, and deuterated matairesinol was used as internal standard.The plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone were quantified in the serum using a previously developed and validated high-performance liquid chromatography-tandem mass spectrometric (HPLC-MS/MS) method . BrieflyBaseline information on age, pre-pregnancy BMI, weight gain during pregnancy, education level and smoking status before and during pregnancy were reported by both in the intervention and the control groups. Education was self-reported and categorized as basic or secondary education, polytechnic or university training. Smoking was inquired both before and during pregnancy . These variables were later included, when necessary, as confounding factors in the multivariable analyses. In all statistical analyses, p < 0.05 was used as the level of statistical significance.The group differences of lignans at the end point of both follow-ups adjusted for the baseline level of lignans and other possible confounders were examined by the linear regression model. The original lignan values were skewed, and were transformed by using the logarithm to enable statistical analysis requiring normally distributed variables. The results at the end point of each follow-up are illustrated as a group difference calculated using antilogs of mean differences of log-transformed variables, and presented with 95% CI.In the regression model, the analyses included baseline level of lignans, age, BMI, education, smoking and change in consumption of vegetables and fruits. Further adjustment was performed for dietary components that affect lignan intake or are thought to intervene with lignan metabolism. These were coffee, tea, other drinks, butter, potato, peas, milk products, pork, beef, and sugar. Since these dietary variables were not significant, they were dropped out from the backward stepwise regression model.Women in the intervention group were younger, less educated, and were more often smokers, and they had a higher pre-pregnancy weight and BMI on average than the women in the control group Table .Enterolactone was detectable in almost all the samples Table . Other lGroup differences were analyzed taking into account baseline lignans, age, BMI, education and smoking. The adjusted mean difference for enterolactone at the end of the intervention when compared to the baseline was 1.6 ng/ml higher in the intervention group than in the controls . Similar results were found for enterolignan . The mean adjusted difference between baseline and end for the sum of lignans was 1.4 ng/ml higher in intervention group than in the controls .The intervention group was less educated than the control group. Education is widely known to be associated with diet and BMI and may The small sample size was also a limitation of this study. Due to the small number of clinics, the clinic-level variation could not be taken into account by using multilevel analysis. Furthermore, there were more drop-outs in the intervention group than in the control group. Although the drop-out reasons were only partly related to the study, the drop-outs might have been less motivated to change their health behavior. In this pilot study, information on diet was obtained by questionnaires, which have not been validated for pregnant women. Additionally, use of food frequency questionnaire may be a limitation since the groups are not directly comparable. Weight before the pregnancy was self-reported, which may induce some bias. However, weight development during the pregnancy was measured by the nurses, and thus more reliably collected.The pregnant women in this study were healthy primiparas, who had relatively healthy dietary and physical activity habits. Therefore, there may not have been much room to further improve their diet. However, changes were noticed on diet and serum lignan levels among the women in the intervention group, indicating that the dietary intervention was successful.It is essential to determine whether this pregnancy intervention has any impact on the offspring's health. In our previous study, none of the newborns in the intervention group had a high birthweight - an indWe have shown earlier by using animal models that changes in maternal diet during pregnancy alter mammary cancer risk among female offspring ,21. OtheThe authors declare that they have no competing interests.RL is principal investigator in the clinical trial study. EK, JR and NS were responsible for data management. AIS is responsible for all chemical analyses. EK, MF and JR conducted statistical analyses. LHC contributed to the article on expertise on nutrition and animal models, and all authors contributed in writing of the paper.Flow chart of the trial. Flow chart of the cluster-randomized trial showing participating clinics, number of women eligible, randomized and drop-outs.Click here for file"} -{"text": "A collection of primitive operations for molecular diagram sketching has been developed. These primitives compose a concise set of operations which can be used to construct publication-quality 2 D coordinates for molecular structures using a bare minimum of input bandwidth. The input requirements for each primitive consist of a small number of discrete choices, which means that these primitives can be used to form the basis of a user interface which does not require an accurate pointing device. This is particularly relevant to software designed for contemporary mobile platforms. The reduction of input bandwidth is accomplished by using algorithmic methods for anticipating probable geometries during the sketching process, and by intelligent use of template grafting. The algorithms and their uses are described in detail. Molecular structure diagrams have been the mainstay of chemical communication since molecules began to be rationalised as Lewis structures. The basic ideas involved in representing structures have proven to be remarkably resilient -3. WhileIn recent decades, the process of creating molecular structure diagrams has steadily shifted towards use of computer software, which is now used exclusively for publications, and is in the process of replacing hand-drawings by way of electronic lab notebooks . There iThe subject of this work is a slightly different perspective on the drawing of a 2 D molecular structure diagram. Assuming that the composition of the molecule is known, and the desired output is an arrangement of atoms and bonds onto a flat surface, the process of building up the diagram can be described as a series of primitive unit steps, leading to a molecular connection table, with 2 D coordinates for each atom .In this work, we will explore an alphabet of primitives which has been chosen for the following properties:- small number of operation types- minimal degrees of freedom for input- opportunities for automated inferenceThe primary motivation for abstracting the sketching process in such a way is the emergence of new hardware devices which are highly constrained in terms of user input, such as smartphones, tablets and netbooks. These devices often lack an accurate pointing device. Mobile devices with touch screens, for example, are effective for selecting objects, but they are much less effective for the precise positioning operations upon which conventional molecule drawing software relies. Mobile devices which lack a touch screen offer merely a keypad and directional cursor keys.By describing all of the unit primitives needed to produce a molecular structure diagram in such a way that none of them requires precise user-supplied position information, structure sketching becomes possible for environments in which the user input is limited to little more than a series of menu choices.The objective of this work is to describe a collection of primitive drawing operations which provides a comprehensive set of editing capabilities. These can be used to compose complex diagrams with minimal effort on behalf of the operator.Ideally, each primitive would be able to examine the molecule diagram thus far, determine what it is the user wants changed, and execute the change. In practice, several additional fields are required for most operations. The unit primitives which are described in this work operate as sequences of:subject- select action- select result- select subject is an annotation to the existing structure, which consists of:The - current atom or current bond- a set of selected atomssubject atoms is defined as a set of:At any time there may be a current atom or a current bond, but not both. Each atom of the existing structure is either selected or unselected. In the text that follows, the term - all selected atoms, if there are any;or: the current atom, if there is one;- or: the two atoms of the current bond, if there is one;- else: an empty set.- action is the choice of primitive to apply to the current subject.The results. The list of results should be sorted so that the most plausible result is first, and the remaining possibilities in order of decreasing relevance.For many primitives, there is just one possible outcome when applied to a particular subject, e.g. changing atoms to a specific element, for which it is appropriate to design the primitive to have an unambiguous effect. For some of the more complicated primitives, there could be more than one possible outcome, e.g. attaching a template with multiple possible geometries. In these cases, the primitive may choose to generate a number of When this scheme is mapped to a practical implementation of a user interface, the sequence can be described as:- select the atoms or bonds of interest- pick the action from a menu- if there is more than one result, and the best suggestion is not the desired one, pick from the list of possibilitiesThe remainder of this section describes a minimal set of primitive classes which provide enough functionality to assemble a fully-featured molecular drawing package.Atom modification primitives are mostly straightforward and unambiguous, such as changing an element label, or altering atom-centred properties such as charge or radical count. The number of primitives required depends on the number of editable atom properties used to describe the molecular structure. The following primitive classes are representative.A new atom is created. Its position is determined automatically. If the structure already contains one or more atoms, it is along the top and to the right of the existing atoms.One primitive is required for each element of the periodic table. The new atom will have the corresponding label, with default values for all other properties, and no bonds.Add Atom primitive.The subject atoms have their atomic symbol changed. One primitive is required for each element of the periodic table. If there is no subject, then this primitive should be mapped to the corresponding Variations on this primitive should allow arbitrary values to be entered via an input dialog, for symbols which are not atomic elements, such as abbreviations or Markush structures.The subject atoms have their ionic charge set to a specific value, such as 0, -1, +1, etc. The primitives in this class can either specify exact values for the charge, or they can be increment/decrement operations.radical count) set to a specific value, where 0 is for diamagnetic atoms, 1 is for radicals, 2 is for carbene-like species, etc. One primitive is needed for each available value.The subject atoms have the number of unpaired electrons .New Bond with Order, in the Geometry section, which creates a new atom and a new bond.If the subject contains a single atom, this primitive is mapped to If the subject contains two atoms, and they are not currently bonded to each other, a new bond with the requested order is added between them.Otherwise, all bonds between any two atoms within the subject set are set to the indicated bond order. Any of these bonds which previously had a specific stereo style is reset to the default non-stereochemical bond type.This class contains one primitive for each explicit bond stereo-style supported by the molecular datastructure, which includes: inclined bonds (upward wedge); declined bonds (hashed wedge); and unknown stereochemistry (often drawn as a wavy line). When used correctly, these types are sufficient to unambiguously resolve most kinds of stereoisomerism.Set Bond Order class, if the subject contains a single atom, this primitive is mapped to New Bond with Stereo Style, in the Geometry section.Similarly to the If the subject contains two atoms which are not currently bonded to each other, a new bond of order 1 and the indicated stereo style is created. In the case of inclined or declined wedge bonds, the direction is arbitrary, and is defined by the current atom order.Otherwise, all bonds between any two atoms within the subject set become the focus of the operation: the bond stereo style is set to the indicated type. If the indicated type is inclined or declined, then any of the affected bonds which are already of this type have their order reversed, which inverts the meaning of the wedge, potentially altering the stereochemistry.Of all the subject atoms, any pairwise combination of two atoms which are not already bonded is considered. If there are any such atom pairs whose bond distances are approximately within the default bond distance (see Appendix 1) then all of these pairs are joined by adding a single bond between each pair.If there are unbonded pairs, but none of them are close enough to the default bond distance, then only the closest pair of atoms is connected.Any bond for which both the participating atoms are a part of the subject is deleted. The atoms themselves are not otherwise modified.Removal of atoms and bonds is straightforward, and requires only a small amount of logic to interpret the subject and apply the action to the molecule connection table.All of the atoms in the subject set are deleted, as are any bonds which are connected to them.Any bond which is between two atoms within the subject set is deleted. The atoms themselves are not modified.All atoms and bonds are deleted.Each atom in the subject set is examined to see if it is particularly close to any other atom in the structure, typically set to a tolerance level which is significantly shorter than the default bond distance (see Appendix 1). For each of the subject atoms, a list is made of all other atoms to which the distance falls within the tolerance. From this list, one atom is selected to be retained, using the merging rules described in Appendix 2. The coordinates of the retained atom are set to the average position of the atoms in the list.While the unit primitives for grafting new fragments onto an existing molecular sketch are entirely sufficient for building up many complex molecules, there will always be structures which need to be fine tuned, or drawn with nonstandard parameters. This is often the case around heavily congested atoms for which there is no non-overlapping planar layout that adheres to common conventions.Detailed control over individual atom positions is straightforward to implement, but care is needed to ensure that the primitives accomplish common tasks with a minimal number of invocations.The subject atoms are moved in a specific direction. There are twelve primitives in this class: four directions by three extents .The small and large nudges offset the X or Y coordinates of the subject atoms in the given direction by an offset, such as 0.1 or 0.5 Å.When moving to the furthest extent, the distance needed to move the subject atoms 1 Å beyond any of the other atoms in the molecule is calculated, and used as the offset.Two primitives are defined for this class: grow and shrink, which correspond to scaling factors of 1.25 and 0.8, respectively.If the subject contains any selected atoms, then a central point is determined from the average positions of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead. Each of the subject atoms has its position recalculated by scaling its distance from the central point by the scaling factor associated with the primitive.Scale Bond primitive.If there are no selected atoms, but there is a current bond, then this primitive is mapped to the corresponding Scale Atoms class, two primitives are defined: grow and shrink, which correspond to scaling factors of 1.25 and 0.8, respectively.As for the The subject must include two atoms which are bonded to each other. Each side of the bond is assigned a weighting of 0, 0.5 or 1.If the bond is acyclic, then the atoms of the connected components on either side of the bond are counted. If one side forms a component with more atoms than the other, then the smaller side is assigned a weighting of 1 and the larger side a weighting of 0. If both sides have the same size, or the bond is cyclic, then both sides are assigned a weighting of 0.5.The bond length is scaled according to the scaling factor assigned to the primitive, and the weights that are assigned to both sides, i.e. if a side has a weighting of 0 it does not move. For acyclic bonds, when moving one side of the bond, all other atoms associated with that side are moved as well. For cyclic bonds, only the two atoms that make up the bond are extended.Figure Two primitives are defined for this class: horizontal and vertical flip.If the subject contains some number of selected atoms, then these atoms are flipped about the indicated axis. The origin of the axis is calculated as the average position of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead.If the subject only contains a current atom or bond, then the whole connected component is used as the subject. If the subject is empty, then all atoms are used as the subject.Primitives in this class are defined to be common rotation increments, such as ± 1°, ± 5°, ± 15° and ± 30°.The position of the rotation centre is determined by the average position of the selected atoms, unless there is also a current atom or bond, in which case its central position is used instead. A further special case is defined: if there are no selected atoms, but there is a current bond, and one end of the bond is terminal, then the terminal atom is rotated about the position defined by the non-terminal end of the bond.Because the information provided to the unit primitives cannot include spatial information such as bond direction, a crucial part of the design of the primitives is based on perception of atom geometry.One of the most important sketching primitives is the ability to create a new atom which is bonded to an existing atom. With a traditional user interface this is done by using the mouse to drag a bond line in a particular direction, thus specifying bond angle and distance. Lacking such input, it is necessary for algorithms to be able to estimate the geometry of the atom, and from it, the most likely directions for a new bond.Fortunately there are only a handful of geometry templates which are commonly observed in molecular diagrams, for atoms in environments which are not constrained by rings or heavy congestion. In this work, seven geometry templates are used. These are shown in Figure Most atom environments, when unconstrained, are drawn with complete or partial occupancy of one of these geometries. By examining the immediate bonding environment of an atom, it is often possible to make a reasonable estimate as to which of these geometry templates is most appropriate - and more importantly, which would be most appropriate in the context of adding an additional bond to a new atom. The process of assigning probable geometry based on topology and partial geometry is explained in Appendix 3.When creating a new bond with a known bond order, the first step is to consider the subject atom with an additional bond with the requested order, connected to a newly created neutral carbon atom. In its new circumstances, the subject atom may have some number of preferred geometries. Consider the following cases shown in Figure In the examples shown in Figure Appendix 3 describes in detail the process of determining potential new bond angles. Once the list of angles has been generated, it is necessary to select one. For each of the angles, a point position is calculated by extending to the default bond length. The molecular congestion at each of these points is calculated (see Appendix 4), and the point which has the lowest congestion is used. A new carbon atom is created at this position, and a bond is created between the subject atom and the new atom.New Bond with Order, given that the bond order is 1. The newly created bond has the indicated stereochemical style, e.g. inclined, declined or unknown. For wedge bonds, the atom direction emanates from the subject atom.The new atom position is determined using the same method as for This class has one primitive for each of the 7 available geometries, which are shown in Figure New Bond with Order, but more specific: if the current geometry about the subject atom does not match the indicated geometry with one angle missing, then the operation will instead be mapped to the corresponding Set Geometry primitive. If it does match, then all of the angles which are implied by matching the partial geometry are scored by calculating the congestion at the point of the implied new atom (see Appendix 4). The angle which corresponds to an atom with the least congestion is used to create the new atom and bond.The implementation is related to that of This class has one primitive for each of the 7 available geometries, as shown in Figure Each of the subject atoms is examined in the context of the requested geometry type. If the current geometry about the atom matches the requested geometry, with some number of missing bonds, then this primitive has no effect. If a partial match is not possible, the geometry about the atom will be refitted, if possible, in order to make it compliant with the requested geometry.New Bond with Geometry. In Figure This primitive class is complementary with For each pairwise combination of an existing bond and a bond from the geometry template, the template is rotated so that the two angles match. Of the remaining existing bonds, the angles are rotated so that they align with the closest angle from the rotated geometry template.Cases which require moving of a bond which is part of a ring system are disallowed. If there are multiple ways to refit the geometry, that with the smallest overall angular displacement is chosen. If the geometry template is asymmetric, the process is repeated with its mirror image.One of the caveats of the methods by which the primitives select a new bond geometry is that there are often multiple choices which are quite similarly valid. Selecting the least congested position is the desired result more often than chance, but it is not uncommon for a more congested position to be preferred.For this primitive, the subject must indicate a bond, and only one side of the bond must be terminal. The non-terminal end of the bond is examined, and its most likely bond geometry is estimated, as if the selected bond were not present (see Appendix 3). If no compatible geometry is found, or the only compatible geometry contains no available positions, this operation is not carried out.Any missing angles, which are non-degenerate and differ from the original bond angle, are considered to be viable new angles for the selected bond. Two examples are shown in Figure The grafting of predefined template fragments onto an existing molecular structure is a vital part of the sketching process. Chemical structures include a number of diagram motifs which occur throughout the field, e.g. small rings of sizes 3 through 6 are all but ubiquitous, and rings which are neither square nor hexagonal are difficult to draw precisely. Besides rings and fused ring systems, there are a number of chains, branched chains, larger rings and functional groups which are particularly common. Almost all molecule structure drawing software has some number of predrawn templates, which can be added to the structure as a separate component, or attached to an existing component. Suggested default templates can be found in the Supplementary Information.With a few exceptions, the algorithms needed for fusing an arbitrary structure with an arbitrary template fragment are non-trivial. Given the information allocated to the unit primitives described in this work, it is possible to specify information about the attachment site on the current structure, but not any information about which part of the template itself should be involved in the joining process.Because practicing chemists often work on a series of projects for which particular structural motifs are frequently encountered, but not all of them are common throughout chemistry as a whole, it is also important to ensure that the list of available templates can be extended easily.copy and cut actions that have become a standard part of the desktop metaphor place a single template onto the clipboard, and paste reads the template back out and applies it, using the same algorithm as is used for grafting predefined templates. The clipboard therefore shares the same primitive classes as the template functionality.A standard convenience feature made available by almost all molecular drawing programs is the ability to copy portions of the current molecule onto a temporary container, often referred to as the clipboard, then paste them back later. For the purposes of this work, the clipboard should be considered as a single temporary template, i.e. the This primitive class describes two operations: copying a molecular fragment to a temporary container, such as the system clipboard, and copying a molecular fragment to a persistent collection of fragments, such as a group of templates.The template fragment itself is generated by considering the subject atoms to define a substructure, which is excised from the current structure.If the subject atoms make up whole connected components, i.e. they are not bonded to any atoms which are not part of the subject, then the template fragment is taken to be the substructure in its entirety.guide atoms for the primitive classes which make use of them, which is described below.Otherwise, all atoms which are immediately connected to one or more of the subject atoms are also included in the template fragment, but have their atom type converted into a placeholder atom label. In the examples shown in Figure A logical primitive is defined for each template that is available to the user, including the clipboard, if it contains a suitable molecular structure. The template fragment is an implicit parameter of the primitive. When the operation is instigated, several classes of behaviour will be investigated, depending on the nature of the template fragment and the subject.The objective of the grafting procedure is to produce a list of putative new structures, each of which is a plausible way in which the template might be appended to the existing structure. Each of the following primitive classes is given an opportunity to generate some number of potential new structures, if appropriate.guide atoms. The presence of these atoms introduces opportunities for special behaviour. Using guide atoms is a way to reduce the degrees of freedom when it comes to the possible types of outcomes, which is useful when a template was designed with the intention of using a specific attachment mode. It is also necessary when the attachment modes favour nonstandard bond distances or angles, which would not ordinarily be generated by the geometry perception algorithms.As described previously, templates may have special When there are no subject atoms, adding a template to the current structure is straightforward. It needs to be placed in an area where its atoms and bonds do not interfere with any that already exist, e.g. to the right and centre of the current structure.All possible rotations of increments of 30° and 45° are included in the list of output structures. If the template contains guide atoms, they are stripped out.If there is one subject atom, this primitive applies. If the template contains guide atoms, they are stripped out.New structures are generated using the following overall sequence:Mirror to be the mirror image equivalent of the Template.1. Define N, in the template fragment.2. Loop over each atom, Template, N}.3. Direct Connect {Mirror, N}.4. Direct Connect {Template, N}.5. Bridge Connect {Mirror, N}.6. Bridge Connect {let x = -x. If there are any bonds with inclined or declined stereochemistry, these are interchanged.The connections are repeated with the mirror image of the template structure, in case it is not symmetrical. Generation of the mirror image is done by inverting one of the axes, e.g. N) of the template fragment, and finding suitable angles by which to rotate the fragment. Bridge connection involves creating a new bond between the two atoms, rather than mapping them onto each other.There are two main methods used for grafting templates using a single atom as the frame of reference. Direct connection involves overlaying the subject atom of the initial structure with the iterated atom . The template fragment is translated so that atom N is superimposed on top of the subject atom from the starting structure. The template fragment is rotated by θ1-θ2+180°, about the atom N. The two fragments are then combined, and the result recorded.Both sets of angles are iterated over .3. Loop over each atom, 1 Nso that the direction of the 1N2 Nvector matches that of the first two subject atoms.4. Rotate the template fragment about 5. Match all remaining atoms.In step 4, the position of the first subject atom is used as the axis of rotation, so that the directions of the first two atoms are aligned. In the example shown in Figure 2 Nfrom the template fragment does not now overlap the position of the second subject atom, then the graft is rejected. Once the first two atoms are aligned and matched, the remaining subject atoms are each required to overlap with one of the template atoms. If any of them do not, the graft is rejected.If the position of the atom Once all of the atoms are matched, the fragments are merged, as described in Appendix 2, and a new structure is added to the list.If there is one subject atom, and the template contains one guide atom, and the guide atom has one adjacent neighbour, this primitive applies.bridge connect variant of the Graft with Atom Connection primitive, except with less degrees of freedom, because there is only one applicable template atom, and the projection direction and magnitude is defined by the guide atom.Grafting a template containing a single guide atom to a single subject atom has a similar effect to the The list of projection angles emerging from the subject atom is calculated. These angles are matched against the angle formed from the guide to its neighbour. In the example shown in Figure The bond distance is taken from the distance between the guide atom and its neighbour, rather than using the default bond distance. As with the other grafting primitives, the process is repeated with the mirror image of the template fragment. Once the grafting is complete, the bond connecting the guide atom to the rest of the template fragment is attached to the subject atom, and the guide atom is deleted. The remaining atoms are merged together if there is any overlap.The main benefit of this primitive arises when a template is to be affixed using an irregular or non-obvious geometry, but it is also a way to ensure that a specific template connection point is used preferentially.If there are two subject atoms, and they are bonded to each other, and the template contains one guide atom, and the guide atom has one adjacent neighbour, this primitive applies.The template grafting is done by mapping the subject bond and the template fragment bond to each other. There are 4 base permutations, obtained by using the template fragment vs. its mirror image, and aligning the matched bonds in both parallel and anti-parallel fashion.There is a further bifurcation if the two bonds differ in length: in one case the guide atom is mapped onto the first subject atom, and in the other case the atom adjacent to the guide atom is mapped onto the second subject atom, which is illustrated in Figure Graft with One Guide Atom primitive, because both of the connection angles and the bond distance can be defined prior to the grafting process, which is particularly useful if the subject contains an irregular geometry or nondefault bond distance.This primitive is useful as a constrained case of the If there is at least one subject atom, and the template contains at least one guide atom, this primitive applies in the following cases:1. There is one subject atom and one guide atom, and the guide atom has more than one neighbour.2. There are 2 or more subject atoms, and the number of guide atoms is equal to the number of subject atoms.Graft with One Guide Atom primitive. Bond angle projections are generated from the source atom. For the template fragment, a median angle is generated, by considering the angles between the guide atom and the atoms adjacent to it. In the example shown in Figure The first case is dealt with in a similar way to the Graft with Multiple Connections, except that the guide atoms are used to map the template fragment. As shown in Figure The second case is handled using the same technique as for When any successful matches are found, in which all of the guide atoms can be mapped onto a subject atom, the structures are merged together and the guide atoms are deleted.After each of the primitives described above has had its chance to generate some number of putative new structures, the result list is processed. First, the list is trimmed such that whenever any two structures are found to be equivalent, one of the structures is removed from the list. The method used to decide whether two structures are equivalent is described in Appendix 5.Once the unique set of structures is obtained, they must then be scored. The objective of scoring is to present the most feasible fused structures first, such that the user is most likely to see the desired result presented first and foremost. In cases where it is clear that some structures are significantly more reasonable than others , then some of the results can be omitted.The score for each grafted template result is computed by adding the following terms, where lower is better:1. The total congestion of the molecule (see Appendix 4).2. +1 for each atom that was merged with another atom due to positional overlap.3, sp2 or sp hybridised, and received a new bond which was not positioned at an angle 120° (sp3 and sp2) or 180° (sp) from its neighbours, with a tolerance of 5°.3. +50 for each atom of element type C, N, O, P or S which is clearly sp4. +1000 for every carbon or nitrogen atom with a total bond order of 5 or more.5. -1 for every guide atom involved in the grafting process.The scoring system heavily favours regular bond angles, prefers to add new atoms in less congested orientations, and encourages avoidance of certain types of impossible structures.If the best available structure has a score of less than 1000, then all structures with a score of 1000 or more are excluded.Once the scoring is complete, the structures are ordered so that the results with the lowest scores are shown first. For user interface purposes, it is appropriate to allow the user to traverse the list of potential structures, and select the desired result, if there is more than one. The best scoring result is frequently the intended result of the operation.The unit primitives which have been described thus far provide a way to draw or modify structure diagrams with a small number of steps and a much lower input bandwidth than would be required from a conventional software package which relies on a pixel-perfect pointing device, such as a mouse or trackpad. The following examples illustrate the steps required in order to draw three molecules from scratch, using the primitives described in this work.The first example, shown in Figure Graft with No Connections: benzenea. New Bond with Order: 1b. New Bond with Order: 2c. Switch Geometryd. New Bond with Order: 1e. Set Element Label: Of. New Bond with Order: 1g. Set Element Label: Oh. Graft with Atom Connection: acetyli. ingenol [The natural product ingenol can be dGraft with No Connections: cycloheptanea. Graft with Multiple Connections: cycloheptaneb. Delete Atomsc. Graft with Bond Connection: cyclopentaned. Graft with Bond Connection: cyclopropanee. New Bond with Order: 2f. Flip Atoms: vertical. Note that the two atoms making up the double bond are selected, while the source of the terminal bond is the current atom.g. Set Stereo Style: inclinedh. Set Stereo Style: inclined. Note that this reverses the direction of the already extant wedge.i. Set Bond Order: 2j. New Bond with Order: 1k. New Bond with Stereo Style: inclinedl. New Bond with Stereo Style: declinedm. New Bond with Geometry: tetrahedral (variant #1). Note this primitive is issued twice, in order to create two new bonds.n. New Bond with Order: 1o. Set Element Label: Op. Set Element Label: Hq. The gold-based catalytic intermediate for a carboxylation reaction is drawnGraft with Atom Connection: cyclopropanea. Set Bond Order: 2b. Set Element Label: Nc. New Bond with Order: 1d. Graft with Atom Connection: benzenee. New Bond with Stereo Style: declinedf. New Bond with Stereo Style: inclinedg. New Bond with Order: 1. Note this primitive is issued twice, in order to create two new bonds for each of the selected atoms.h. Create Template: copy to clipboard.i. Graft with One Guide Atom: paste from clipboard.j. Scale Atoms: growk. New Bond with Geometry: linearl. Set Element Label: Om. New Bond with Geometry: linearn. Graft with Bond Connection: acetylo. Graft with Atom Connection: cyclopentadienep. Set Element Label: Nq. Set Element Label: Or. A collection of unit primitives for sketching molecular diagrams has been described. It is complete, such that complex molecules can be drawn by stringing together a series of these primitives. It is efficient, insofar as the more regular components of a chemical structure can be drawn using a small number of primitives, since only a very small amount of information must be transmitted from the user in order for the algorithms to infer the intent. Less regular features can be created by manipulating atom positions or angles using a variety of low level primitives, but a number of implicit shortcuts can be exploited to keep repetitive actions to a minimum.Several representative examples have been shown, which illustrate the relatively small number of steps and low information content necessary to draw complex molecular geometries, and obtain publication-quality depiction layout coordinates.The primitives described in this work provide the tools needed to build a user interface in which input is limited to selecting atoms and picking from menu choices. The interface can expose the primitives by several means, such as menu bars, icon toolbars, keyboard shortcuts, etc. As long as all of the primitives are conveniently available, the user interface will provide a complete and efficient molecule drawing tool.These primitives have been implemented in a commercial software product called the Mobile Molecular DataSheet (MMDS), which is available for BlackBerry smartphones and iPhone/iPod/iPad devices . Both veWhile the motivation for this work arose from the need to provide molecular sketching capabilities on mobile devices with tiny screens and lack of accurate pointing devices, the set of primitives has applicability outside of this niche.One analogous situation is found in web-based applications where the capabilities of the browser must be assumed to be a lowest common denominator, which requires that the web server do most of the work . Under tde novo series [The primitives described in this work were designed for the purpose of using them to compose a user interface, but they may find applicability as part of scripted processes. For example, when producing a series of chemical structures as part of a combinatorial library ,21 or soo series -24, it mBecause a molecular sketch does not correspond to a physical model, the 2 D coordinates of the atoms are chosen so that they can be presented on a screen or a piece of paper, in such a way that chemists can quickly perceive the structural features and be able to ascertain stereochemistry from the layout and additional annotations.The choice of units for the coordinates is arbitrary, but in this work, Angstroms are used. The default unit of distance between any two atoms is 1.5 Å, which applies regardless of atom and bond type.overlapping. Some of the algorithms described in this work consider overlapping atoms as a cue to merge two atoms together. Otherwise, the presence of overlapping atoms is generally considered to be an error state, since this makes visual perception of a diagram difficult.Any two atoms that are closer than 0.2 Å are considered to be The template grafting algorithms described in this work mostly operate by joining specific atoms together. While these atoms are merged, bonded or deleted according to the algorithm, there is also the possibility for additional atoms to overlap. This situation is dealt with according to the following steps.The composite structure is partitioned into its two sources, i.e. atoms that originated from the starting structure, and atoms that originated from the grafted fragment. Pairwise combinations of these atoms are examined to see if they overlap. When an overlap is found, one atom must be retained, and the other atom deleted. Before the other atom is deleted, its bonds must be reassigned to the retained atom.exotic each atom is, which is calculated by assigning one point for each condition that applies:The decision as to which atom to retain is made based on how - Having an element label other than carbon- Non-zero charge- Any unpaired electrons- Non-default isotope abundance- Specific non-automatic hydrogen countThe most exotic atom is retained, or the first one, if they are equally so.exoticness of a bond is assigned by one point for each of:During the merging process, it is possible to create duplicate bonds. A similar process is used to decide which bond to keep. The - Bond order other than 1- Any stereochemical assignmentAs for atoms, the first bond is retained in the event of a draw.Other primitives besides template grafting also have need to merge together atoms which happen to overlap. In these cases the same procedure is used, but without the partitioning.For many of the primitives described in this work, it is necessary to produce a list of potential angles for a new bond that will be created with a particular source atom and bond order in mind. When the list of angles produced contains the result which is desired by the user, the amount of effort required to draw the structure is considerably reduced.The following sequence is used to obtain a list of potential new bond angles:1. If the atom is isolated, return four angles, aligned on the X and Y axes.2. Match the atom's bond topology to likely geometry templates , classify as either s-block atoms, classify as either trigonal, square planar or either of the octahedral geometries.b. For trigonal, square planar or either of the tetrahedral geometries.c. If the atom is carbon, and the bonds are all single, classify as either trigonal.d. If the atom is carbon, and the bonds are not all single, classify as p-block, and in the first 3 rows, classify as being trigonal, either of the tetrahedral geometries, or square planar.d. If the atom is in the p-block, but not in the first 3 rows, classify as being any of the available geometries.f. If the atom is in the octahedral geometries.g. Otherwise, classify as either of the two Once the possible classifications have been enumerated, each of them is checked to see if there is any way the current geometry can match it, within a tolerance of 2°. The first postulated geometry to achieve a match is given precedence. All of the nondegenerate vacant bond directions implied by the ways in which it can match the input structure are returned as the resulting list of possible new bond geometries.If no matches were found, the list of current bond angles are sorted by bond angle. For each bond, the angle directly in between itself and the next angle in the list is calculated and added to the result list.congestion to make decisions about where to place a new atom, bond or fragment, when an otherwise degenerate choice is available. The position which places new atoms as far away as possible from existing atoms is frequently preferable to the alternatives.A number of the primitives use The congestion at a specific point is calculated by:i iterates over each atom in the structure, and x and y denote the atomic position, where the subscripted variables are the positions of existing atoms.where The total congestion of a molecule is calculated by:i and j iterate over all unique pairs of atoms.where Two structures A and B are considered equivalent or not according to the following algorithm:1. If the number of atoms or bonds is different, the structures are different.2. The structures are translated so that their centre positions are the same. Each atom in structure A is mapped uniquely to the closest atom in structure B, which must be within 0.2 Å.3. If any atoms are not successfully mapped, the structures are different.4. Every atom in structure A must be mapped to an atom in structure B which has the same element label, charge, unpaired electron count, etc. If any mapped pair of atoms are not the same, the structures are different.a1 and a2, there must be a corresponding bond in structure B, between atoms b1 and b2, where a1:b1 and a2:b2 are mapped to each other. If the bond stereochemistry type is not a wedge bond (inclined or declined), the inverse mapping, a1:b2 and a2:b1, is also permitted. If no such pair can be found, the structures are different. The matched bonds must have the same order and stereochemistry type. If not, the structures are different.5. For every bond in structure A, between atoms 6. If no differences were found, the two structures are equivalent.This comparison considers alternate tautomers and Kekulé resonance forms to be different species, which is desirable for sketching purposes. The determination of the equivalence of two sketches, as described above, should not be confused with methods used to determine whether two connection tables represent the same molecule, such as unique SMILES or InChIA list of template fragments grouped into categories is provided [Additional file Additional examples of diagram drawing using the primitives described in this work can be found online .The author is the founder and president of Molecular Materials Informatics, Inc., which produces the Mobile Molecular DataSheet, a working implementation of the primitives described in this manuscript. This publication is a disclosure of the algorithms that form the basis of a commercial product.Suggested default template fragments. A printable document containing diagrams of template fragments.Click here for fileSuggested default template fragments (SD files). A collection of MDL SD files, one per group, containing machine-readable data for each of the template fragments.Click here for file"} -{"text": "Cardiovascular diseases (CVD) are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors as well as behavioural risk factors . The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors.In a randomized controlled trial, one group will receive a maximal intervention (= intervention group). The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team . The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback.This trial incorporates interventions by GPs and other health professionals aiming at a reduction of medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed.ISRCTN23940498 In Europe, cardiovascular disease (CVD) is the leading cause of death (1.5 million deaths per year) and is an important source of disability . The incPreCardio is a randomized controlled trial. Approval was obtained from the ethics committee of the University Hasselt. A total of 350 subjects will be included in the study with a follow-up of 3 years. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. All study participants need to sign an informed consent and have access to the internet. Other eligitability criteria are not included.study participants will be recruited through various channels. Firstly, all potential participants are insured by \"De Onderlinge Ziekenkas\". This membership gives the study secretariat access to necessary contact information. Secondly, all of the insured are self-employed, most of them lawyers. This provides the study office with two advantages: (1) communication is possible at the worksite and (2) the prevention programme is even more tailored to the uniform target group. The announcement of the study was already made through mass-media announcement but will be intensified at the worksites of the potential participants. Together with the involved Bars (of the province of Limburg in the East of Belgium) mass mailings and promotional activities at the worksite will be organized. Thirdly, a large event will be organised for the participants of the intervention group and control group. Before joining these events a written informed consent, downloadable on a website with brief information, should be signed and mailed back to the study secretariat. At this large event general information about PreCardio will be given, a first screening and the ability to purchase health-related products.The general practitioners (GP) that will participate in the study are GPs of the province of Limburg, situated in the East of Belgium. They will be recruited with involvement of their own provincial general GP platform \"Limburgs Huisartsenplatform\" and provincial institutions involved in health \"LOGOs\". Together with the GP platform and the LOGOs mass mailings to GPs of Limburg will be organised. Moreover, minimal two information sessions for GPs will be organised in the university building with information about the study and education about a new type of cardiovascular risk calculator will be offered. All participating GPs need to sign an informed consent and have access to the internet for downloading an electronic cardiovascular risk screenings programme based on the European Guidelines for CVprevention. Th. Th15]. For physical activity assessment it is important that each study participant gives an estimate of the intensity, duration and frequency of the physical activity he has in daily life. For this purpose a Dutch translation and computerized version of the International Physical Activity Questionnaire (IPAQ) was chosen. This cor from 0.45 to 0.77), and adequate validity comparing the food-frequency questions with 7-day food records (Spearman r from 0.38 to 0.53)[To stimulate rapid assessment only data collection will be limited to fat intake and fruit and vegetable intake. For fat intake assessment a computerized fat intake questionnaire with a good reliability and adequate validity was chosen. For fru to 0.53).To obtain data about smoking behaviour, a short questionnaire regarding smoking from a national health questionnaire used by the federal government was selected. This quThe Dutch translation of the Short Form 36 (SF-36) will be used to measure Health Related Quality of Life (HRQoL). This version was successfully tested in a Belgian and Dutch population with a Chronbach's alpha coefficient ranging from 0.81 to 0.91,22.Stages of change is a construct from the TransTheoretical Model. The staAttitudes are an important element in the Theory of Planned Behaviour. As recoSelf-identity is seen as the extent to which people see them fulfilling different societal roles. In thisPerceived control over behaviour is related to self-efficacy, the two variables are significantly and highly correlated . HoweverSelf-efficacy is usually measured in terms of individuals' confidence in their ability to perform the behaviour . Self-efPeople are autonomously motivated if they experience a true sense of volition and choice and act because of the personal importance of the behaviour ,31. If pIntention to engage in a behaviour is a direct precursor to engaging in the behaviour itself . BehavioSocial support is an important variable influencing behaviour change. ConsequA step test will be used for assessment of physical fitness. The step test procedure used was modified from earlier procedures. The steThe interventions targeted on medical parameters include a first medical prevention consultation with the GP. In this medical prevention consultation the cardiovascular risk (risk on having a heart attack in the next 10 years) will be calculated using a new computer programme. This computer programme is called \"Electronic Prevention Record\" (EPR). Innovative about the EPR is its connection to \"Electronic Medical Record\" (EMR). The EMR is also a computer programme, a record about the medical history and treatment provided to the patient. In the province of Limburg, the setting for the PreCardio-study, 75% of the GPs use an EMR. In BelgAll data collected at the medical prevention consultation are stored in the EPR that is connected to the EMR Fig . Therapewithout tailored feedback and without reminder from study office). It is also used as a means for study measurements at certain times during the 3-year follow up is about physical activity, fat intake and smoking and is modified for different measurements in time to avoid drop-out. However, the advice will always be formulated very abstract to avoid 'contamination' of the control group as was the case in another multiple risk factor cardiovascular intervention study[The website available for the control group is limited and contains information about the minimal intervention walking aiming at a health benefit. The programme most in line with the PreCardio mission, namely CVD prevention, is the \"Reduce my risk\" programme. This programme is a fitness programme aimed at improving physical fitness through more intensive PA. The basis for the fitness programme is a specially developed algorithm linked to the step test used in the study Fig . Three dNext to the personalised website with tailored feedback, study participants of the intervention group are entitled to support from a multidisciplinary team. This multidisciplinary team includes: a cardiologist, a general practitioner, a psychologist, a physiotherapist and a dietician. Different media will be available for this personal contact: personal messages on the website, the forum on the website, e-mail, telephone and group sessions. The first types of media will be more frequently used than the latter, dependent on the stage of behaviour change patients are in. Moreover, the cost-effectiveness of the prevention programme must be guarded. The psychologist (= behaviour coach) can aid people more thoroughly with behaviour change, using the different manuals and behavioural (cognitive) therapy.At GP-level a tool for computer-assisted cardiovascular risk screening (EPR) will be implemented. Minimal two information sessions for GPs will be organised in a university building with information about the study and education about the EPR. GPs will have access to an informational website. This informational website contains information about CVD prevention in general with a summary of the latest guidelines . . Furthermore, it contains information about the PreCardio-study and the role of the GP in the study. On this website information about the EPR will be available . GPs are provided with information on behaviour change, including video registrations of motivational interviewing adaptations for PreCardio. In the section on behaviour change more information will be given about the stages of change and type D-personality as a risk factor for CVD. The website for GPs also contains an overview of the personalised website for patients from the intervention group. GPs have access to a forum where they can post messages to open a debate with their participating colleagues about CVD prevention or the PreCardio-study or messages with a question for the PreCardio-team. In other sections contact information and links to relevant websites can be found.et al found a mean systolic blood pressure of 125 mm/Hg (SD 14 mm/Hg)[®. A two group t-test with a 0,05 two-sided significance level will have 82% power to detect the difference between a Group 1 mean of 120 mm/Hg and a Group 2 mean of 125 mm/Hg, a difference in means of -5 mm/Hg, assuming that the common standard deviation is 14 mm/Hg, when the sample sizes in the two groups are 200 and 100, respectively . Other outcome measures were also used to determine the necessary sample size. A recent study about the effect of a computer-tailored intervention to reduce fat intake included at post-test a mean fat intake of 85 grams/day (SD 34.5 grams/day) [A power calculation was performed to determine the number of study participants needed to detect a significant effect of the PreCardio prevention programme. A t-test will be used to compare the means of the outcome measures from the intervention and the control group. The sample size calculation is based on the population standard deviation of the primary outcome measure. For PreCardio, this is, for instance, systolic blood pressure. Kelley 14 mm/Hg). The samams/day) . A two gams/day) . In thisams/day) . A two gA linear regression model will be employed to assess the effects of the prevention programme on change in overall cardiovascular risk from baseline to 3 year follow-up.Next to an effect evaluation a cost analysis will be performed. There are different costs that will be measured in the PreCardio-study: (1) One-time costs, this is the total cost for the implementation of the prevention programme ; (2) Costs for medical resource use ; (3) Continuous costs: (acute care) costs for CVD, costs for CVD morbidity and mortality, hospitalization costs (4) Administration costs; (5) Personnel costs ; (6) Travelling and time costs (e.g. study participant's time and GP time); (7) Indirect costs due to productivity loss; (8) Material costs and overhead. This study will be performed from a health service perspective.et al., SF-36 data were converted using a specific algorithm into health state utility values for the determination of incremental QALYs[In cost effectiveness analysis incremental cost-effectiveness ratios (ICER) are used as an economic outcome measure. An ICER can be calculated as incremental cost divided by incremental effectiveness . Incremetal QALYs,48.The PreCardio-study is a randomized controlled trial. However, the shared worksite setting could lead to an intervention contamination. In this regard, the failure to find significant effects from the Heartbeat Wales programme due to contamination of the reference area is relevant. PartialSeveral aspects of the PreCardio-study are noteworthy. Firstly, all interventions are based on recent guidelines and knowledge on CVD prevention. Moreover, this knowledge was taken as a basis to develop a new computer programme for GPs. After limited input, this programme automatically determines CVD risk and generates therapeutic goals according to this risk. Furthermore, tailored advice is provided to the study participant. The involvement of GPs in the PreCardio-study is paramount. Secondly, study participants are provided with a number of aids to support them with behaviour change. These include a personalised website with tailored feedback and personal support from a multidisciplinary team. Consequently, a reduction in medical and behavioural risk factors resulting in a reduction in overall CVD risk is expected.BMI, body mass index; BREQ-II, Behavioural Regulation Exercise Questionnaire II; CVD, cardiovascular diseases; EMR, electronic medical record; EPR, electronic prevention record; GP(s), general practitioner(s); HRQoL, Health Related Quality of Life; ICER, cost-effectiveness ratio; ICT, information and communication technology; IPAQ, International Physical Activity Questionnaire; MI, motivational interviewing; PA, physical activity; QALY, Quality Adjusted Life Year; SDT, Self-Determination Theory; SF-36, Short Form 36 TBP, Theory of Planned Behaviour.The author(s) declare that they have no competing interests.The PreCardio-study Protocol was written by prof dr Neree Claes (NC) and psychologist Nele Jacobs (NJ). Both authors have made substantial contributions to this protocol and performed a feasibility study prior to the development of this study protocol. NC, project manager, has elaborated the study design and co-authorised the manuscript. NJ drafted the manuscript and participated in the study design. Both authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"} -{"text": "Sex Hormones and Physical Exercise (SHAPE) study. Purpose of SHAPE study is to examine the effects of a 1-year moderate-to-vigorous intensity exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether the amount of total body fat or abdominal fat mediates the effects.Physical activity has been associated with a decreased risk for breast cancer. The biological mechanismn(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones either direct, or indirect by preventing overweight and abdominal adiposity. In order to get more insight in the causal pathway between physical activity and breast cancer risk, we designed the In the SHAPE study, 189 sedentary postmenopausal women, aged 50–69 years, are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strenght training exercise programme. Partcipants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globuline and insuline. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.NCT00359060 Most of the established risk factors for breast cancer, such as family history of the disease, early age at menarche, late age at menopause, late age at first childbirth or nulliparity are not, or not easily, amenable to intervention. Physical activity is a modifiable lifestyle characteristic that has been associated with breast cancer risk in various studies -22 and aFurthermore, both an early menarche and a late menopause increase risk, probably by increasing lifetime exposure to ovarian hormones ,34. SeveSo far, one study has reported on the effects of an exercise intervention on sex steroid concentration among postmenopausal women. This study observed that a 12-month moderate-intensity exercise intervention in sedentary, overweight women resulted in small but significant decreases in serum estrogens and androgens. These results were restricted to women who lost a certain amount of body fat.Sex Hormones and Physical Exercise (SHAPE) study. This study examines the effect of an exercise intervention on sex steroid hormones and insulin in sedentary postmenopausal women and investigates if the amount of total body fat or abdominal fat mediates the effect. If increase in physical activity has a beneficial effect on the sex hormone and metabolic profile of postmenopausal women, it will offer opportunities for breast cancer prevention programs. This paper presents the design and evaluation plan of the SHAPE study.In order to get more insight in the causal pathway between physical activity and breast cancer risk, we designed the The SHAPE study examines the effects of a 1-year moderate intensity exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women. The study is designed as a single blind, randomised, controlled trial with two study arms.We chose to include only postmenopausal women because (a) there is more evidence for an inverse association between physical activity and breast cancer risk in postmenopausal women (b) the incidence of breast cancer is greatest in postmenopausal years (c) the major conversion locus of androgens into estrogens in postmenopausal women is fat tissue – a reduction in fat mass through exercise may be more likely to affect the relative concentrations of estrogens on postmenopausal women than in premenopausal women (d) there are no problems associated with measurements of hormones with timing of the menstrual cycle.The SHAPE study includes 189 healthy postmenopausal women aged 50 tot 69 year, who are sedentary and not currently using postmenopausal hormone replacement therapy. Postmenopausal status is defined as not having menstrual periods for at least 12 months. Being sedentary is defined as less than 2 hours per week of moderate sport activity and not adherent to the international physical activity recommendation. The international physical activity recommendation states that every adult should accumulate 30 minutes or more of at least moderately intense physical activity for at least five days per week ,47. The Participants are recruited through a random selection out of the female inhabitants aging 50–69 years of the following middle sized municipalities in the centre of The Netherlands: Utrecht, Zeist, Bilthoven, Houten, Soest en IJsselstein. Potential candidates receive an invitation letter explaining the goal of the study and a short eligibility questionnaire. Next, the potential candidates are contacted by phone to explain further details and the inclusion criteria list is completed to screen eligibility. Additionally, interested and eligible women receive written study information and are asked to complete and sign an informed consent form. With the women who return their informed consent form an appointment for the baseline visit at our research unit is made. See Figure Eligible women are randomised into an intervention group or a control group. Randomisation is blocked on two categories of waist circumference: < 92 cm and ≥ 92 cm .Women in the intervention group participate in a combined endurance and strength training programme over a period of 12 months. The programme is organised in a way to optimise fat loss. The goal of the intervention programme is to have participants exercise at least 3 times per week and to reach a training stimulus in each person. In general, implementation of the exercise goals is done slowly, to reduce chance of injury and to increase participants' adherence and sense of accomplishments.Twice a week the participants of the intervention group meet for an exercise session of one hour. Each group includes about 15–20 women. A qualified sports instructor facilitates the standardised group sessions according to a protocol. Group exercise takes place in six fitness centres located in the subjects' home town. Classes start with a 10-minute warming up: e.g. exercise to music routines and walking. Then the training is continued with moderate-to-vigorous level of aerobic exercise on 60 – 85% of the age-predicted maximum heart rate. The maximum heart rate is established as 220 minus the person's age in years. The participants receive heart rate monitors to control their training intensity. The training session ends with 25 minutes strength exercises and 5 minutes cooling down. The sport instructor registers the attendance of the subjects. Since it is important that the group exercise sessions are conducted uniformly in all centres, all instructors who participate in the SHAPE study are instructed extensively. In addition, the study coordinator (EM) performs several monitor visits per exercise group to control adherence to the protocol.Previous experience showed that group exercises are preferred by Dutch women of this age and are better adhered to in the short and long term . HoweverOnce a week the participants are asked to perform an individual home-based exercise session. They receive instructions during the group sessions. The home-based exercise programme consists of 30 minutes brisk walking or cycling with an intensity of moderate-to-vigorous intensity . Afterwards, the women record the type and duration of their activity in an exercise log, together with the mean heart rate during the training and the BORG-score (6–20) for exertion .Participants in the control group are requested to retain their habitual exercise pattern. They also receive newsletters. Although some control subjects may decide to increase their level of physical activity, we believe that it is unlikely that they will sustain in a similar level as the intervention group. Level of physical activity is measured frequently to monitor changes in physical activity (PASE questionnaire) during the course of the intervention.The study participants visit the research unit of the Julius Center at baseline, after 4 months and at the end of the study (See table Blood samples (30 ml per visit) are drawn between 9.00 and 11.00 AM after an overnight fast in order to determine serum concentrations of estradiol , estrone, estrone sulfate testosterone, androstenedione, insuline, glucose and sex hormone binding globulin. Blood samples are stored at -70°C. All samples from an individual subject are analysed in the same batch since the batch-to-batch variation can be higher than any woman's likely change in hormones over the year . Serum eThe laboratory \"Stichting Huisartsenlaboratorium Oost\" in Velp performsBody weight and height (to the nearest 0.5 kg and 0.5 cm respectively) are measured while the subjects wear light clothes and no shoes using an analogue balance (SECA) and wall-mounted tape measure.Body fat distribution is measured by the waist- and hip circumference. Waist circumference (to the nearest 0.1 cm) was measured standing at the midway between lower ribs and iliac crest. Hip circumference (to the nearest 0.1 cm) was measured standing over the buttocks. All measurements were taken in duplicate and averaged. Total body fat and body fat percentage are determined by using a whole-body DEXA scan . A whole body scan analyses body composition according to a three-compartment model: fat mass, lean tissue, and bone mineral content. The standard soft tissue analysis is performed using software supplied by the manufacturer. Total body fat is estimated for each subject in kilograms.Intra-abdominal fat is measured by abdominal ultrasound assessment . The ultrasound measure comprises the distance between the peritoneum and the lumbar spine at three predefined places. All measurements are performed longitudinally from one line over the abdomen halfway between the lower rib and iliac crest.Blood pressure is measured with an automatically tonometer (OMRON M4) after participants have been sitting quietly for at least five minutes.2 max). VO2 max is determined by a submaximal cycle test: the Fit Test programme on a Life Fitness cycle ergometer. The theory of the test is based on the Ästrand Rhyming Protocol [2 max estimate based on the subject's weight, age, gender, selected resistance, and steady-state heart rate. After the test, the subject pedals without resistance for 2 minutes to cool down.Fitness is measured by the maximal oxygen uptake was 0.993 (P < 0.001). Other reliability indexes were respectively 0.993, 0.532 ml/kg/min and 1.475 ml/kg/min. This reproducibility study showed that the Fit Test is a reproducible measure of submaximal work capacity.To assess reproducibility of the Fit Test, we tested 25 volunteers twice with an average period of 2.0 ± 1.5 days between the tests. Group means and standard deviations of the first and second VOA self-constructed questionnaire is used to assess level of physical activity, diet, socio-demographic variables, smoking history, medical history and reproductive factors.The general physical activity questionnaire includes the Voorrips questionnaire measuring habitual activity in elderly subjects and quesThe PASE questionnaire measuresDaily caloric intake, percent daily calories from fat, percent daily calories from carbohydrates and proteins is determined by a food frequency questionnaire ,58. The Medication use is asked each visit and registered by use of an internet database. This database is based on the current available medications and uses ATC codes.All randomised subjects will be analysed according to the intent-to-treat principle. The intention-to-treat principle will assess the intervention effect based on assigned treatment at the time of randomisation regardless of adherence. Demographics and baseline characteristics will be reported descriptively. We will assess whether life style factors that are potentially related to hormone levels might have changed differentially between exercisers and controls, including alcohol use and caloric intake. Differences between the treatment groups in primary and secondary efficacy parameters will be analysed by repeated measurement analyses in SAS and 95% confidence intervals will be calculated. We will also assess effect modification by change in intra-abdominal and, among exercisers only, by adherence levels.In this paper, we present the rationale and design of the SHAPE trial which aims to get more insight in the biological mechanism underlying the observed effect between physical activity and breast cancer risk.The success of the study will depend to a large extent on adherence to the exercise protocol. Factors that enhance adherence to exercise programmes in The Netherlands are group exercise , a varied programme and a regular instructor . We incoIt is also of utmost importance that the control group is compliant with the study protocol, e.g., retaining their habitual lifestyle pattern. Women who are randomised to the control group might be disappointed about the assignment and may take up exercise or change their diet. We monitor the level of physical activity of all participants with questionnaires in order to get insight in the actual amount of physical activity and potential cross-over between both treatment arms. Changes in diet are monitored by a food frequency questionnaire.Six fitness centres and fourteen instructors participate in the SHAPE study. Although the exercise protocol is standardised as much as possible, the attitude and experience of the instructor might influence the actual performance of the participants. In the analysis, we will explore whether outcomes of participants within the same sporting centre are correlated (intracluster correlation). If there is evidence for intracluster correlation, we will account for this in the analysis.Because of the stringent in and exclusion criteria, the participants of the SHAPE study comprise a selected group of postmenopausal women. This type of preselection will not affect the validity of the study (no selection bias) because randomisation is aimed to ensure comparability of intervention and control group but it may limit the generalisability. For example, since we exclude lean women and women not using hormone replacement therapy, the results might not be generalised to these groups of women.So far, one study (PATH study) has been published on the effects of exercise interventions on sex steroid concentration in women . The PATIn summary, this paper shows the rationale and design of the SHAPE study. The SHAPE study aims to unravel the mechanisms underlying the association physical activity and breast cancer risk. Furthermore, this study evaluates the feasibility of delivering an exercise programme for postmenopausal women.2max, Maximum Oxygen Uptake; ATC, Anatomical Therapeutic Chemical Classification SystemBMI, Body Mass Index; DEXA, Dual-Energy X-ray Absorptiometry; SHBG, Sex Hormone Binding Globulin; VOThe author(s) declare that they have no competing interests.EMM, PHMP and AJS designed the study, participated in the coordination of the study and writing of the article. All authors provided comments on the draft and have read the paper.The pre-publication history for this paper can be accessed here:"} -{"text": "Physical activity participation is low among blacks, and strategies are needed to successfully create immediate and sustained behavior change related to physical activity. Churches can play an important role in health promotion efforts among blacks because of their central role in spiritual guidance, communication, social support, and networking. This pilot study evaluated the feasibility and acceptability of implementing a physical activity program for sedentary black adults in churches.We used a preintervention/postintervention single-group design to evaluate the effect of a 3-month faith-based physical activity intervention on daily walking and moderate- and vigorous-intensity physical activity among sedentary blacks. Eighty-seven black adults participated in eight group sessions that included discussion of physical activity-related topics, an instructor-led physical activity session, and weekly incentives to promote physical activity. We used a questionnaire to assess moderate and vigorous physical activity in minutes per week at baseline and after 3 months. Walking was assessed weekly in steps per day by using a pedometer.2) reported 27 ± 54 and 10 ± 25 minutes per week in moderate-intensity and vigorous-intensity physical activity, respectively, and walked 4822 ± 2351 steps per day at baseline. After 12 weeks, moderate- and vigorous-intensity physical activity increased by 67 ± 78 and 44 ± 66 minutes per week, respectively (P ≤ .01), and daily walking increased by 1373 ± 728 steps per day (P < .001).Participants (mean age, 52 yrs; mean body mass index, 35 kg/mThese data suggest that a faith-based physical activity intervention may be an appropriate strategy for increasing physical activity among sedentary black adults. Future research will determine the impact of this program in a randomized, controlled design. The benefits of increased physical activity (PA) have been well documented -4, yet nThe purpose of this study was to develop and test a faith-based PA program to increase participation in daily walking and moderate- and vigorous-intensity physical activity , particularly in bouts lasting 10 minutes or longer, among sedentary black adults. This study was funded as a part of a career development grant. Data collected during this study were intended to serve as pilot data for a proposal for a larger randomized, controlled trial to test the faith-based PA program compared with a control group.We conducted this study in a suburban community in North Carolina from March through October 2005. In September and October 2004, nine local church pastors participated in in-depth interviews and provided input on the design, development, and implementation strategies for health promotion programs in churches in general and a faith-based PA program specifically. Pastors were recruited from a list of pastors who attended (or sent a representative to) at least one of two luncheons held for ministers in the local community to determine potential strategies for health promotion and disease prevention among blacks.Data from in-depth interviews suggested that, in general, health was viewed as a concept that encompassed spiritual, physical, mental, and emotional health. Pastors indicated that they play a role in the health of their church congregants by setting an example for healthy living, imparting the knowledge that wholeness and health are essential parts of Christian character that enable one to do God's bidding and that the body is God's temple. They advocate, encourage, and support efforts to engage in healthy behaviors and to implement health-related programming within the church. Pastors provided suggestions for why their congregants were not physically active as well as feedback on ways to successfully implement a faith-based intervention .We used information from the in-depth interviews to shape the study design and session content of the faith-based PA intervention. Because the pilot study was designed to determine the feasibility and acceptability of the intervention strategy, a preintervention and postintervention study design with no control group was used. This design was deemed the most acceptable for church pastors and is in line with previous research suggesting that a no- or low-attention control would not be well received by this population . The intParticipants maintained weekly logs of pedometer step counts, which were used to self-monitor walking, and received a weekly summary to track walking progress throughout the study. We used incentives to encourage participants to increase their daily MPA to at least 30 minutes by engaging in moderate-intensity walking. Although participants were not given specific targets to increase their steps per day, they were advised of the 10,000 steps recommendation for daily walking and wereWe hired group leaders to lead the weekly intervention sessions at churches. The following characteristics were considered desirable for group leaders: 1) having a working knowledge of general health and wellness but not being currently employed as a health educator, 2) being physically active but not exceptionally athletic, 3) having previous experience working with blacks and other groups in faith-based settings, 4) being comfortable speaking in group settings; and 5) not being a member of a church involved in the intervention. These criteria were selected to avoid hiring highly trained individuals, which might hamper the ability to disseminate this type of intervention to a larger audience, and to avoid potential biases by hiring church members because all four churches could not be represented in group leadership. Two black females were recruited as group leaders. Each group leader was assigned to lead sessions at two churches, depending on the time the church selected to hold the sessions and the availability of the group leader.Each church pastor also selected one church member to serve as a liaison between the church and the study staff and to attend to any church-related logistical issues. We paid church liaisons a modest honorarium for their participation in the study. In addition, church liaisons received a group leader training manual and session materials to facilitate continued implementation of the PA program after completion of the study. No additional incentives or compensation were provided to churches or pastors.or obtaining recommended MPA and VPA, but in bouts lasting less than 10 minutes, as assessed using a modified version of the International Physical Activity Questionnaire); 4) responding “no” to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or having obtained medical clearance; 5) having no other physical illnesses or disabilities limiting PA; and 6) being willing to commit to participating in weekly intervention sessions and all data collection visits. All individuals who attended an interest session received a pedometer, regardless of their eligibility for study participation. Eighty-seven participants met the eligibility criteria and were enrolled in the study.We selected a convenience sample of four churches that identified themselves as predominantly serving blacks and whose pastors participated in one of the previously mentioned ministers’ luncheons. Recruitment for study participants was at the churches’ discretion; it primarily consisted of making announcements during Sunday morning worship services and weekly activities and placing flyers throughout the church and in the Sunday bulletin. Interested individuals were invited to attend a general-interest session held at each church and led by the study’s principal investigator (MCW). Interest sessions were held during the time the church had selected for the weekly intervention sessions. This limited the number of individuals who would be unable to attend the sessions regularly. During the interest session, the principal investigator explained the study procedures and eligibility criteria and answered participant questions. At the end of the interest session, participants were screened for study eligibility using the following criteria: 1) being self-identified as black; 2) being 18 years of age or older; 3) not currently meeting recommendations for MPA or VPA ; thus, to maximize the sample size available for data analysis, we used the average number of steps per day across weeks. In addition, we analyzed steps per day categorically: less than 5000 steps per day (sedentary); 5000 to 7499 (low active); 7500 to 9999 (somewhat active), 10,000 to 12,499 (active), and 12,500 or more (highly active) .Moderate- and vigorous-intensity physical activity. Self-reported participation by minutes per week in MPA, VPA, and walking was assessed using a modified version of the International Physical Activity Questionnaire (IPAQ) (e (IPAQ) . The IPAParticipant characteristics and anthropometrics. At the baseline visit, we used a questionnaire to measure self-perceived general health and well-being and presence of chronic diseases. Using a digital scale, we weighed each participant twice and measured a third time if the two measures differed by more than 0.2 kg. Height was also measured twice to the nearest 0.5 cm using a height stadiometer and measured a third time if the two measures differed by more than 0.5 cm. The average of the two closest measures was used for height and weight. Body mass index (BMI) was calculated as weight (kg) divided by height (m2). Seated resting blood pressure was measured, in duplicate, using a digital Omron monitor after participants had been seated with legs uncrossed for at least 5 minutes. Blood pressure was measured a third time if the two measures differed by more than 4 mm Hg. The two closest measures were averaged and used for analyses.Statistical analysis. Statistical analyses were performed using SAS version 8.2 and SAS-callable SUDAAN software . We examined the magnitude of the intra-class correlation coefficient (ICC) among subjects from the same church, which was estimated to be 0.06. We used a SUDAAN modeling procedure with two levels of clustering to account for the ICC among church members and temporal dependence in repeated observations obtained on the same individual. Working independence between participants from the same church was assumed, along with an exchangeable covariance structure for repeated measurements on the same individual. Least square means were obtained from the models along with standard errors, which were then converted into standard deviations for the adjusted mean changes.2; range, 16.1 to 63.3 kg/m2; 69% of participants had BMIs ≥30 kg/m2). All participants were black, most were female (89%), almost half (49%) were married, and most (96%) had a high school-level education or higher. Eighty-five percent of study participants reported at least one chronic health condition. Almost half (43%) of study participants reported using antihypertensive agents, and the mean systolic/diastolic blood pressure levels of study participants were in the borderline hypertension range (137 ± 23 mm Hg systolic and 84 ± 14 mm Hg diastolic). The four churches included in the intervention were similar across all baseline characteristics with the exception of education (P < .01).At baseline, participants (n = 87) were 52 ± 14 years of age with an average BMI in the obese category . Most pP = .04). The increase in steps per day was 1373 ± 728 steps (a 28% increase) after 12 weeks to an average of 6148 ± 2534 steps per day (P < .01). Although our sample size was not large enough to detect statistically significant differences, we observed a decrease in the proportion of participants who were categorized as sedentary , and an increase in the proportion of participants who were classified as somewhat active . There was an increase from baseline to 4 weeks in the proportion of participants who were classified as active (from 1% to 4%), but no additional change was observed after 12 weeks (4% classified as active). Participants also reported increases in self-reported minutes per week in MPA and VPA . Weight and BMI remained stable over the 12-week intervention (data not shown). Changes in systolic and diastolic blood pressure after 3 months were in the expected direction but were not statistically significant (data not shown).Data on mean changes in study outcome variables are presented in We observed statistically significant increases in number of steps per day after 4 weeks and after 12 weeks, and significant changes in MPA and VPA after 12 weeks. We were encouraged to see that the proportion of participants who were classified as sedentary on the basis of previously published criteria for evaluating steps per day decreaseFindings from our study regarding changes in PA among blacks are in line with, and in some cases show better results than, studies with similar time frames and study designs. An uncontrolled community-based walking program among 24 black breast-cancer survivors (aged 47 to 66 years) included eight 75-minute weekly sessions held at either a community center or a local church . The stuNot surprisingly, we did not observe significant changes in blood pressure in our study. The pilot study had a large enough sample to test meaningful differences in daily walking as assessed by a pedometer but was not large enough to be able to detect small changes in blood pressure. We were encouraged, however, to see trends in the appropriate direction for these variables. We were also not surprised that weight did not change in the current study. Hill et al suggest that small changes in behavior, such as adding an extra 2000 to 2500 steps per day, may prevent excess weight gain . ChangesOur study had a number of limitations. First, because we were unclear about the feasibility of the proposed study design and because of the reluctance in some faith-based communities to be part of a randomized study, particularly to a no-attention control group, we did not use a randomized, controlled design. We recognize the lack of a control group as a major limitation of the study. Second, this study's sample group was small; additional participants may have improved our ability to detect differences in clinical variables. Third, we did not have objective data for participation in MPA and VPA. We attempted to collect these data using accelerometers but encountered several issues related to adherence to the accelerometer data collection protocol and, thus, were not able to use these data for analyses. Finally, we are aware that participants who enrolled in our study might differ from the general population, from individuals who do not attend church, and from individuals who chose not to volunteer for the study.The study also had several strengths. Although we were unable to obtain an objective measure of MPA and VPA, we were able to collect this information using a self-reported questionnaire. Although self-reported PA data tend to be overestimated, increases in MPA and VPA in our study were in line with increases in objectively measured PA. We addressed some limitations of previous studies by incorporating tenets of the church and by involving the church in intervention development. Participants reported high satisfaction with the intervention, suggesting that this strategy might be successful in other black churches. At least one church used the materials to conduct a second set of intervention classes with new participants. Although we did not collect outcome data on the new participants, anecdotal evidence suggests that the program was well accepted in the second set of classes. Group leaders were able to implement the program on their own, suggesting that the program strategy may be sustainable. Finally, the current pilot study found that participants increased their number of steps per day and approached the level suggested to prevent weight gain .These data suggest that a faith-based PA intervention may be an appropriate strategy for increasing PA among sedentary black adults. Future research will determine the impact of this program compared with a control group. We plan to conduct a randomized, controlled trial to compare the faith-based PA intervention with a control condition."} -{"text": "Concentrations of plasma β-carotene and lutein declined in both the groups during the postpartum period but the decline was significantly less in the supplemented than in the control women at one month ; lutein -0.26 vs -0.49 μmol/L, p<0.05) and three months . Concentration of breastmilk retinol was also significantly greater in the supplemented group at three months postpartum than in the controls . Concentrations of infants’ plasma retinol, β-carotene, and lutein, measured at six months of age, did not differ between the groups. Fat supplementation during pregnancy and lactation in women with a very low intake of dietary fat has beneficial effects on maternal postpartum vitamin A status.Dietary fat intake is extremely low in most communities with vitamin A deficiency. However, its role in vitamin A status of pregnant and lactating women is poorly understood. The aim of the study was to examine the effect of supplementing women with fat from mid-/late pregnancy until six months postpartum on their vitamin A status and that of their infants. Women recruited at 5-7 months of gestation were supplemented daily with 20 mL of soybean-oil (n=248) until six months postpartum or received no supplement (n=251). Dietary fat intake was assessed by 24-hour dietary recall at enrollment and at 1, 3 and 6 months postpartum. Concentrations of maternal plasma retinol, β-carotene, and lutein were measured at enrollment and at 1, 3 and 6 months postpartum, and those of infants at six months postpartum. Concentration of breastmilk retinol was measured at 1, 3 and 6 months postpartum. The change in concentration of plasma retinol at three months postpartum compared to pregnancy was significantly higher in the supplemented compared to the control women Vitamin A deficiency among pregnant and lactating women is widely prevalent in many developing countries –3 and poConventional approaches to combat vitamin A deficiency include periodic supplementation with vitamin A, fortification of foods, and a food-based approach with increased consumption of dark green-leafy vegetables. Among the intervention strategies, the dietary approach with an emphasis on increased consumption of provitamin A carotenoid-containing foods has been advocated as a preferable and sustainable strategy to eliminate vitamin A deficiency ,7. HowevStudies to date investigating the relationship between dietary fat and vitamin A status have been limited to investigations of efficacy in highly-controlled settings with a relatively-small number of subjects. Studies in children have shown that fat supplementation enhances the absorption of β-carotene and improves the vitamin A status . A studyThis community-based controlled trial was conducted from November 1995 to October 1997 in 16 villages in Matlab upazila (subdistrict) of Chandpur district, Bangladesh. The area, located approximately 55 km southeast of the capital city of Bangladesh—Dhaka, considered to be typical of rural and riverine delta areas . The usuSixteen socioeconomically-similar villages were grouped into two sets of eight each, separated by a distance of about 2 km. One set of villages was randomly selected for dietary intervention. It was felt that randomization of half of each selected area will have the same effect as would individual randomization in that both intervention and control groups will come from the same geographical area and community as each other. Therefore, any area-level effects are accounted for by the research design. The study participants were healthy pregnant women in their early or mid-pregnancy identified through menstrual history. A survey was conducted in the study villages to identify all currently-eligible women and also to list all married women of childbearing age, who could potentially become pregnant. A field team consisting of a health assistant, a community health worker (CHW), a dietary interviewer , and a porter visited each eligible subject at home and explained the study and meaning of their voluntary participation. A detailed interview on socioeconomic, demographic and household characteristics was conducted. Trained and experienced field workers measured body-weight, height, mid-upper arm circumference (MUAC) following standard procedures . Data onDuring the study period, 341 and 335 women were recruited from the intervention and control villages respectively . From thThe intervention consisted of unfortified soybean-oil supplied to the women in the intervention villages. The women in the control villages were not given any other dietary supplement or advice and maintained their usual diet. Each woman in the intervention villages was supplied with a weekly ration of 140 mL of soybean-oil and was asked to consume 10 mL of oil twice a day with their main meals as supplement. The community health worker (CHW) delivered the oil in a plastic bottle and a clearly-marked (at 10 mL) plastic dispenser to ensure the dose to each study woman in the home. Women were given several options to consume the supplement that included mixing of the oil with their foods, drinking during the meal, or frying their portion of the meal with the oil. However, pre-testing revealed that drinking during the meal was the most preferred choice of supplement intake, followed by mixing the oil directly with their meal portion. The study was, therefore, designed to supplement the diet in this way rather than instructing women to add oil during preparation of household food to ensure a measured ‘dose’ of oil for more accurate quantification of supplement intake. The total period of oil supplementation in an individual woman ranged from 8 to 10 months depending on the gestational ages of women at enrollment. The participants in the control group were not given any extra food to balance energy between the groups.Motivational efforts were continued throughout the study period to maximize high compliance to the intervention and to avoid any replacement of the usual diet by the supplement. Each subject was trained to maintain the daily record of oil intake using an easily-understandable record-keeping sheet supplied each time the oil was delivered. The CHWs collected the records of oil intake during their next weekly home-visits, and they supplied the participant with another bottle of oil for the ensuing week. They also interviewed the subject and obtained information about her attitudes towards and compliance to the oil during the previous one week.Fat intake from all sources was estimated by 24-hour dietary recall administered four times during the study period following standard guidelines . A surveData on nutrient intake were calculated using a computerized food-composition table for Bangladeshi foods, which used nutrient data from regional food-composition databases ,25. The Blood samples each of 0.5 mL were collected in lithium heparinized microtainers either by finger-prick or ante-cubital venipuncture, immediately put on ice, shielded from light in a cold carrier, and transported to the field laboratory within 3-6 hours of collection. Plasma was then separated by centrifugation and transferred to labelled screw-top, amber-coloured cryovials and stored at -20 °C for 2-4 weeks in the field laboratory before being transferred to the central laboratory in Dhaka for storage at -7 °C until analysis 2-3 months later. Simultaneous determination of concentrations of serum retinol, lutein, and β-carotene was done by high-performance liquid chromatography (HPLC) in the Nutritional Biochemistry Laboratory of ICDDR,B . RetinolA nurse or a trained interviewer collected a casual breastmilk sample according to the method previously used in this population . Breastmt-test for statistical significance. Changes in each of the outcome variables from baseline (pregnancy) to different follow-up periods were calculated for each subject by subtraction. Paired t-test was used for comparing within-group differences from baseline to the respective time periods. Independent sample t-tests were used for comparing changes at respective study periods between the groups. Concentrations of breastmilk retinol were compared between the intervention group and the control group by independent sample t-test of means. In this case, the change was not examined or tested as the intervention had been continuing for a certain period before the first sample of breastmilk was collected. The mean concentrations of infants’ plasma retinol, β-carotene, and lutein were compared between the groups by the independent sample t-test. The p value of <0.05 was considered statistically significant.Numeric variables were examined for their distribution outliers, and extreme values were identified and excluded from the analyses. Such values did not exceed 3-4% of the observations. Results are presented as mean±standard deviation for the normally-distributed variables or median and interquartile range for the variables not normally distributed. The differences between the groups were examined by Student's The Ethical Review Committee of ICDDR,B approved the study. An informed written consent was obtained from each woman before enrollment into the study.The baseline characteristics of 248 supplemented and 251 control women are presented in As expected, the mean fat intake from all the sources (including supplement) was significantly higher in the intervention group at 1, 3 and 6 months postpartum than that of the control group . Fat intCompared to the pregnancy (baseline) level, concentrations of plasma retinol increased in the intervention women in all the three measurement periods during the postpartum period ; however, the change at one month postpartum reached statistical significance . In the During the postpartum months, the concentration of plasma β-carotene declined compared to the pregnancy level in both intervention and control groups . The decThe concentration of plasma lutein also declined during the postpartum measurements and followed the same trend as that observed in β-carotene . HoweverThe mean concentrations of breastmilk retinol were higher in the intervention group than those in the control group at one month and three months postpartum (0.06 and 0.13 μmol/L respectively), and the difference was significant at three months postpartum but not at six months postpartum . No signThe aim of this study was to examine the effect of supplementation of dietary fat on the vitamin A status of pregnant and lactating women and their infants in a population where vitamin A deficiency is prevalent and dietary fat intake is low. As indicated by the improvement in concentrations of blood retinol and carotenoids and the improvement in concentrations of breastmilk retinol in the supplemented group, these findings suggest that increasing the dietary fat intake may have beneficial effect on the vitamin A status of women during early lactation.In this study, we aimed at increasing the fat intake by 18 g per day in the intervention group but the actual increase was less in many individual women. This was not unexpected since administration of the supplement was ultimately controlled by the study subjects themselves and not by the study team. Further, consumption of oil in this way, i.e. in a medicinal dosing, is not a normal dietary practice. Nonetheless, supplementation resulted in a doubling or greater fat intake in the intervention group.The supplemented group increased concentrations of plasma retinol at 1, 3 and 6 months postpartum measurements while an increase in the control group was observed only at one month postpartum measurement (5%) and a slightly declining tendency was noted at three and six months postpartum (-8 and -1%). The change compared to the baseline level at one month postpartum in the intervention was statistically significant, suggesting that dietary fat had a positive effect on plasma retinol concentration of the supplemented women. Both the groups showed lower concentrations of plasma β-carotene and lutein during postpartum; however, relatively less so in the supplemented group, indicating higher provitamin A bioavailability in the oil-supplemented women. These findings are consistent with earlier reports that fat supplementation in deficient population has beneficial effects on concentrations of retinol and carotenoids ,30,31.In the study population, dietary vitamin A is derived almost entirely from plant sources ,32. TherThe women in the supplemented group of our study had relatively higher concentrations of breastmilk retinol at one month and three months postpartum than those in the control group. The increase in concentration of breastmilk retinol in the supplemented group translates into 8-18 μg of daily additional preformed retinol delivery in their infants (assuming a breastmilk intake of 700 mL per day), an amount equivalent to 4-10% of the basal requirements for infants up to the age of six months ,36,37. AOur findings are consistent with those of other studies in developing countries where the breastmilk retinol level is either deficient or at the marginal range ,38. Of iWe have observed a substantial fluctuation in concentrations of breastmilk retinol. Such fluctuations in concentrations of breastmilk retinol have also been reported by others . It is aNo difference was observed in concentrations of the infants’ plasma retinol, β-carotene, or lutein. Possible reason might be that vitamin A status of the infants was measured at the end of six months of age when the difference in maternal vitamin A status between the supplemented and the control mothers did not exist. It might also be possible that the benefit to the infants of the intervention mothers, if it had occurred in early infancy, might not have been large enough to maintain a sustained higher concentration up to six months of age. Although the intervention mothers had a better concentration of breastmilk retinol during early lactation, it is notable that retinol concentration in most women of both the groups was always less than 1.05 μmol/L, the concentration considered to be just enough to meet the basal requirement of the infant but not enough to build good vitamin A stores . ICDDR,B acknowledges with gratitude the commitment of USAID/OMNI to the Centre's research efforts. Financial support from the Division of Human Nutrition and Epidemiology, Wageningen, is gratefully acknowledged. The authors thank all the mother-infant pairs for their valuable participation in the study."} -{"text": "Refugee women have a high risk of coronary heart disease with low physical activity as one possible mediator. Furthermore, cultural and environmental barriers to increasing physical activity have been demonstrated. The aim of the study was to evaluate the combined effect of an approximate 6-month primary health care- and community-based exercise intervention versus an individual written prescription for exercise on objectively assessed cardiorespiratory fitness in low-active refugee women.Relative aerobic capacity and fitness level were assessed as the two main outcome measures.A controlled clinical trial, named \"Support for Increased Physical Activity\", was executed among 243 refugee women recruited between November 2006 and April 2008 from two deprived geographic areas in southern Stockholm, Sweden. One geographic area provided the intervention group and the other area the control group. The control group was on a higher activity level at both baseline and follow-up, which was taken into consideration in the analysis by applying statistical models that accounted for this. relative aerobic capacity and the percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml·kg·min-1) to a greater extent than the control group between baseline and the 6-month follow-up, after adjusting for possible confounders (P = 0.020).The intervention group increased their A combined primary health-care and community-based exercise programme (involving non-profit organizations) can be an effective strategy to increase cardiorespiratory fitness among low-active refugee women.ClinicalTrials.gov ID: NCT00747942 Demographic and economic changes have resulted in a more diverse population with greater social disparities in Sweden during the last few decades because of the large influx of refugees mainly from Latin America in the 1970 s, Iran in the 1980 s, Bosnia and the Balkans in the 1990 s, and Iraq and the Middle East in the 2000 s. Refugee status has previously been defined by the United Nations as a person who is outside the protection of his or hers country owing to a well-founded fear of being persecuted for reasons of race, religion, nationality, membership of a particular social group, or political opinion [New York Times Magazine provided data documenting the growing ethnic minority and socioeconomic segregation in urban and suburban Sweden [The large influx of refugees has changed Swedish society. A 2005 article in the Many of these refugees have an increased risk of coronary heart disease (CHD) in both men and women. Female refugees born in Turkey, Iran, and Iraq and settled in Sweden had an age-adjusted excess risk of CHD compared with Swedish-born controls ranging from 110% to 130% -7. Femal2max below the 50th percentile and were also obese [Although it is convenient to assess changes in physical activity with questionnaires, cardiovascular fitness is a more reliable and objective measure. For example, data from the longitudinal CARDIA study showed that a change in individual cardiorespiratory fitness is strongly associated with a corresponding change in habitual energy expenditure and leisure time physical activity . Furtherso obese .largest increase in physical activity levels can be found among the least active at baseline; minority groups were, however, not included in that study [Physical inactivity and obesity are potential mediators of accelerating arteriosclerosis and the development of CHD seen among refugee women. According to the World Health Organization (WHO), it is important to target these risk factors in order to decrease the global burden of CHD. In addition, previous research has shown that the at study . Therefoat study . The finBoth individual and environmental factors are associated with physical activity in minority women. For example, a qualitative study from the United States showed that a lack of time due to caregiving duties, health worries, and lack of motivation were important barriers to women from ethnic minorities and refugee women becoming more physically active . The womThe real life situation of many refugee women in Sweden, such as low socioeconomic status, low educational status, and residing in a deprived and unsafe neighbourhood, has been associated with low levels of physical activity and exercise . In thisThe purpose of the present study was to investigate whether appropriate physical activities and social support can increase cardiorespiratory fitness in refugee women in Sweden. This purpose was implemented by evaluating the effect of an approximate 6-month primary health-care- and community-based exercise intervention versus an individual written prescription for exercise on objectively assessed cardiorespiratory fitness in low-active and overweight refugee women.Stöd till Aktivare Motion or STAM in Swedish).This controlled clinical trial was named Support for Increased Physical Activity , to identify the two deprived and immigrant-dense geographic areas (including large populations of Middle East refugees). The CNI scores ranged from-76.4 (most affluent neighbourhood) to 53.5 (most deprived neighbourhood) . The CNIEligible for inclusion were women aged 25 through 64 who were first-generation refugees in Sweden from either the Middle East or Latin America, were overweight and reported low levels of physical activity during their leisure time ,23. We eWe appealed to the community to obtain access to physical activity facilities for the intervention. Nine primary health care centres located in the two immigrant-dense areas were partly used in the recruitment processes. This process included information brochures in the waiting room but the women were also informed about the study by the personnel at the primary health care centres. We also recruited women through local advertising and via community organizations such as women's associations, child welfare centres, pre-schools, churches/mosques and courses in Swedish for immigrants.The women who were willing to participate filled in a first screening protocol. All women who filled in the screening protocol were contacted by research staff who could speak their native language. The participants were further informed about the study and those who agreed to participate and were eligible for inclusion were enrolled for a baseline assessment. Eligible for inclusion included 131 women in the intervention group and 112 women in the control group. All written material was translated to Spanish or Arabic by two independent professional translators and backwards translated by two other professional translators.2(m) (according to WHO's recommendations) and comprised three categories: (1) normal weight (BMI < 25.0), (2) overweight (BMI 25.0-29.9) and (3) obesity (BMI ≥ 30).In total three questions were included in the screening protocol to assess physical activity, overweight/obesity, and pre-existing ill health. Physical activity was assessed by asking the participants how often they exercise during their leisure-time. The response alternatives were the following: (1) I get practically no exercise at all, (2) I exercise occasionally, (3) I exercise regularly, about once a week, (4) I exercise regularly, about twice a week and (5) I exercise regularly, quite vigorously at least twice a week. Overweight and obesity were assessed on the basis of self-reported data on weight and height. Body mass index (BMI) was calculated as weight(kg)/heightOur intention was to include only those who were inactive and overweight/obese. However, around 10% in the intervention group and 50% in the control group were found to have a normal weight at the baseline measurements. They were not excluded from the study but we took BMI into account in the analyses.n = 114 women in the intervention group and 98 women in the control group) were assessed at baseline. Most women came from the Middle East: 96% and 80% in the intervention and control group, respectively. The women mainly came from the following countries: Iraq, Syria, Turkey, Lebanon and Chile. The largest groups in the intervention group came from Syria (26%) and Lebanon (10%) and the largest groups in the control group came from Turkey (26%) and Iraq (24%).Background information was assessed at baseline. Height, weight and cardiorespiratory fitness were assessed at baseline and at 6 months. In total, 212 women was given during the summer break. The women attended 16 sessions in average (range 1-32). An initial session of individual counselling with the purpose to strengthen self-efficacy, empowerment and personal motivation was given by a female physiotherapist who guided the women concerning how to start doing regular physical activities at a health-enhancing level and informed them about the benefits associated with physical activity. This initial session also addressed possible barriers to physical activity based on findings of a previous qualitative study, e.g. worries about palpitations, tiredness and sweating (15). The women received information about different levels of health-enhancing physical activity, such as moderate and vigorous physical activity and how they are related to perceived exertion . The womThe participants in the control group received an individual written prescription for exercise that was partly based on the results from the cardiorespiratory fitness together with an initial session of individual counselling. In general, the written prescription was based on the recommendation of regular health-enhancing physical activity, i.e. 30 minutes per day at a moderate intensity level ,30. The 2 l·min-1) were calculated by the bicycle computer, using the Åstrand-Rhyming nomogram (24). The data collectors in the present study were not blinded because we recruited the intervention and control groups from two different geographic areas.The Åstrand-Rhyming submaximal bicycle ergometer test was used to assess cardiorespiratory fitness . The MonOut of the 212 women who were assessed at baseline, 179 (84%) had at least one measurement either at baseline or at the six-month follow-up and they were included in the analysis (n = 91 in the intervention group and n = 88 in the control group). Most of the 33 excluded women were either not able to perform the test due to poor bicycling skills, or not able to bike at the correct speed, or had inadequate muscular strength to perform the test. A standardized walking test might have been an option; still, we believe that many of the women had too low a capacity to fit within any standardized protocol. The 33 excluded women did not differ with regard to age or BMI from those included.To sum up, 243 women (131 women in the intervention group and 112 women in the control group) showed an initial interest to take part in the study and were considered eligible. Of these women, 212 came to the baseline assessments (114 women in the intervention group and 98 women in the control group) and 179 had at least one measurement either at baseline or at the six-month follow-up (91 women in the intervention group and 88 women in the control group). All women in the intervention group took part in at least one session with a leader/instructor.relative aerobic capacity, defined as oxygen uptake per kilo body weight (O2ml·kg·min-1). The second outcome variable, fitness level, was dichotomized at a relative aerobic capacity larger than or equal to 23 O2ml·kg·min-1 (1) and (0) otherwise. According to Blair, a relative aerobic capacity below 23 O2ml·kg·min-1 is regarded as a high risk value for cardiovascular disease in women [Two outcome variables were used. The first was in women .age was categorized into 3 groups based upon tertiles of the data, 24-39, 40-44, and 45-64 years.Self-reported BMI (kg·m-2) was calculated from the objectively measured height and weight. BMI is categorized into 3 groups by the WHO and otherwise as (0).Height was measured to the nearest 0.5 cm using a stadiometer (Seca 214), and weight was measured using a bioimpedance analysis to the nearest 0.1 kg, subtracting 2.0 kg for clothes. obesity . In the Educational status was classified into three categories: less than 10 years, 10-12 years, and more than 12 years.Employment status was dichotomized as being employed or unemployed. Unemployed also included those on sick- or parental leave, retirees, students, and housewives.Acculturation was assessed on the basis of language skills. The acculturation variable has been used previously by the Swedish government-owned statistics bureau to study integration and health in a random sample of Swedish immigrants from Chile, Iran, Poland and Turkey.The participants in the present study answered to the following questions concerning: (1) knowledge of how to appeal against authorities, (2) ability to understand news reports, (3) speaking Swedish at meetings, (4) communicating with authorities over the telephone, (5) reading books in Swedish, and (6) being able to complete a written application for employment. The 1st question had two response alternatives (yes or no). The other five questions had four possible response alternatives, with 1 characterizing the highest degree and 4 the lowest degree of knowledge in Swedish. The answers to each question were dichotomized as one point for alternatives 1 and 2 (or 1 for question 1) and with zero points for alternatives 3 and 4 (or 2 for question 1). The dichotomy variables were summed up and categorized at two levels, with a low level of knowledge of Swedish/acculturation if the score was less than 4 and a high level of knowledge of Swedish/acculturation for a score of 4 or more.Years in Sweden was assessed as a continuous variable.n) and percentage (%) for categorical data (Table Baseline characteristics are shown as the median and interquartile range (IQR) for continuous data and number × 2 (time: baseline and 6-month follow-up) design, we analysed the treatment effect in relative aerobic capacity by applying a mixed linear model with random intercepts and slopes. Mixed model analyses allowed inclusion of subjects with missing data and differences between groups at baseline . The resWe used a generalized estimating equations (GEE) model (with an exchangeable correlation matrix and robust standard errors) when analysing the dichotomized outcome, fitness level . The resThe statistical package used was STATA Release 10 .2ml·kg·min-1) between groups with a power of 90% and a significance level α = 0.05 (based upon data from a pilot study with a mean of 24 O2ml·kg·min-1 and a standard deviation of 7 and a correlation of 0.7 between occasions), 69 individuals per group were needed. An increase of 3 units for a person with very low aerobic capacity is important from a cardiovascular health perspective [To find a difference of 3 units in Δ for relative aerobic capacity .P < 0.05). The control group had a significantly better relative aerobic capacity and a higher percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml·kg·min-1) at baseline than the intervention group.The characteristics of the study population are shown by group in Table relative aerobic capacity as outcome, while educational level, employment status, and acculturation did not. Table P = 0.02). This indicates that there is a treatment effect, i.e. the intervention group improved their relative aerobic capacity significantly more than the control group.We found that age and BMI significantly influenced the mixed model for P = 0.00001) larger increase over the 6-month follow-up in relative aerobic capacity than the control group (P = 0.02). However, the control group had a higher relative aerobic capacity than the intervention group at both baseline (P = 0.0001) and the 6-month follow-up (P = 0.01).The β-coefficients with 95% confidence intervals are shown in Table P = 0.02), also including age and BMI, when analysing the dichotomized outcome fitness level (relative aerobic capacity > 23 O2ml·kg·min-1). Table The GEE model showed results similar to those of the mixed model with a significant interaction between treatment and time (relative aerobic capacity and the percentage with an acceptable fitness level (relative aerobic capacity > 23 O2ml·kg·min-1) to a greater extent than the control group from baseline to the 6-month follow-up, after adjustments for age and BMI. However, the control group was on a higher level at both baseline and follow-up, which was taken into consideration by employing a mixed linear model with random intercepts and slopes and, for fitness level, a GEE model.The main finding of this controlled clinical trial was that the intervention group increased their 2max), determined during submaximal exercise testing, has been shown to provide a good estimate of cardiorespiratory capacity, which is an independent marker of the early atherosclerotic cardiovascular diseases [The finding that a combined primary health care- and community-based exercise intervention increased the relative aerobic capacity and the percentage with an acceptable fitness level is important because such an intervention may have the potential to decrease lifestyle-related disease risks such as coronary heart disease, cancer, and diabetes mellitus in low-active refugee women. Cardiorespiratory fitness, which we measured as maximum oxygen consumption in comparison with standard care in a primary care setting of sedentary ethnic minority and low-income women . Their rA protocol for an ongoing randomized controlled trial in primary health care recently reported on the effectiveness of an exercise referral scheme in the short and long term among women from ethnic minority groups . SeveralOne limitation in the design of the study is the use of a controlled clinical trial instead of a randomized controlled trial (RCT). Conducting a study in a real-life setting that can be implemented in the society at large is difficult. Although an RCT would have been optimal from a study design perspective, bias may be present in an RCT . For exaThis study also has several strengths. One is that it was conducted using existing community institutions, such as primary health care centres, which means that the model can be readily implemented. There are challenges in recruiting minority groups to prevention programmes with the aim to reduce cardiovascular risk factors ,52.A recent systematic review was able to identify only 13 intervention studies among immigrants of which three focused on cardiovascular risk factors . Most ofAnother strength is the use of a group-based intervention to be used in a country with a large and diverse immigrant population, particularly from the Middle Eastern countries. Besides the fact that the women can support one another, it is also cost-effective for the community compared to programmes for individuals or single immigrant groups. Finally, this study was evaluated using an objective measure of fitness, not just the self-reported level of physical activity, which is subject to measuring errors .This controlled clinical trial showed that a combined primary-health-care and community-based exercise programme can constitute an effective strategy to increase fitness among low-active overweight refugee women who are at risk of future coronary heart disease.The authors declare that they have no competing interests.JS, KS and SEJ contributed to the design of the study. All authors contributed to the analysis and interpretation of data. MH drafted the first manuscript. All authors revised the manuscript for important intellectual content and gave their final approval of the version to be submitted.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/11/55/prepub"} -{"text": "Physicians are often unable to eat and drink properly during their work day. Nutrition has been linked to cognition. We aimed to examine the effect of a nutrition based intervention, that of scheduled nutrition breaks during the work day, upon physician cognition, glucose, and hypoglycemic symptoms.A volunteer sample of twenty staff physicians from a large urban teaching hospital were recruited from the doctors' lounge. During both the baseline and the intervention day, we measured subjects' cognitive function, capillary blood glucose, \"hypoglycemic\" nutrition-related symptoms, fluid and nutrient intake, level of physical activity, weight, and urinary output.Cognition scores as measured by a composite score of speed and accuracy (Tput statistic) were superior on the intervention day on simple and complex reaction time tests. Group mean glucose was 0.3 mmol/L lower (p = 0.03) and less variable (coefficient of variation 12.2% vs. 18.0%) on the intervention day. Although not statistically significant, there was also a trend toward the reporting of fewer hypoglycemic type symptoms. There was higher nutrient intake on intervention versus baseline days as measured by mean caloric intake , and improved hydration as measured by mean change in body mass .Our study provides evidence in support of adequate workplace nutrition as a contributor to improved physician cognition, adding to the body of research suggesting that physician wellness may ultimately benefit not only the physicians themselves but also their patients and the health care systems in which they work. The typical work day of a hospital based physician is not only cognitively demanding, requiring complex decision-making in a fast-paced environment, it is also physically demanding, with extended hours and frequent on call periods. During their work time, physicians may be far removed from areas that provide access to nutrition (fluids and nutrients). As a result, physicians are often unable to eat and drink properly or at all during their work day -4.Previous studies have demonstrated that the impairment of neurological functions such as fine motor skills, information processing, and memory, is linked to hypoglycemia and under-nutrition and may contribute to motor vehicle collisions and air crashes -9. ConvePhysician performance has been increasingly linked to lifestyle and wellness factors such as sleep deprivation and stress and, in turn, to the quality of patient care -18. HoweTwenty consecutive staff physician volunteers were recruited from the doctors' lounge of a large urban teaching hospital during the first week of May 2008 following a hospital wide poster campaign advertising study recruitment location and timing. The physicians selected two typical, similar work days to be scheduled as the baseline and intervention study periods during May and/or June 2008. All data were collected on site at the hospital. Ethics approval was obtained from the Conjoint Ethics Review Board of the University of Calgary. Written consent was obtained from participants.This prospective study compared physicians' nutritional intake and cognitive function during work hours on two separate work days, a baseline day and an intervention day. A before and after study design was chosen rather than assigning participants to intervention or control days in random order, given the possibility that physicians assigned to first receive the intervention may be influenced to alter their typical nutritional habits. On the baseline day, the physicians followed their usual eating and drinking habits. On the intervention day, they were fed nutritious meals, snacks and fluids at scheduled intervals. Participants chose two typical and similar work days within a two week period to serve as baseline and intervention days. Most physicians chose daytime work hours as the study period (17/20) while three chose evening and overnight work hours.The intervention, that of ensuring that physicians consumed nutrients and fluids at regular intervals throughout their work day, was designed based on previous research where physicians and other health care professionals described barriers to achieving adequate nutritional intake during work hours -4, unpub, unpub4,The primary outcome was cognition. Secondary outcomes were blood glucose levels and \"hypoglycemic\" nutrition-related symptoms. Baseline demographic characteristics were recorded at study enrolment. Fluid and nutrient intake and physical activity were measured on both days. At the beginning of each day, participants were weighed and fitted with an activity and heart rate monitor. At that time and at approximately two hour intervals on both days, measures of cognitive function, capillary blood glucose, \"hypoglycemic\" nutrition-related symptoms, food and fluid intake, and volume of urine excreted over the previous two hours were captured. Participants were weighed again at the end of each day. On the baseline day, the physicians maintained their usual eating and drinking habits. On the intervention day, the physicians reported to the study center fasting, and all nutrition for the day was delivered to the physician and recorded. The participants were blinded to their glucose and cognitive function test results at the time of testing.Cognition was measured using Brain Checkers software, Version 3.01 run on Palm Tungsten E2, . Two software programs were used. The simple reaction test was designed to measure the speed of motor response to a visual cue with repeated testing over thirty seconds. The complex reaction test, a choice reaction time and continuous performance task, was designed to measure running memory, attention and visual information processing with repeated testing over two minutes. This task requires the subject to indicate whether the current number (1 through 9 appearing randomly on a screen) matches the previously displayed number (with random time delay between the two) by tapping on the appropriate text box (labelled \"same\" or \"different\") located below the number. For both tests, the reaction times of each unique response as well as the mean reaction time for the session were recorded for each participant. Accuracy was documented in terms of percent correct responses, lapses (the subject did not respond to the stimulus) and impulses (the subject anticipated and acted before the prompt). A Tput statistic was calculated that captures the correct responses per minute of time available to respond. It represents a combination of speed and accuracy with a higher Tput statistic indicating a superior performance. Based on the manufacturer's recommendation, subjects completed three practice tests prior to baseline data collection. This approach eliminates any learning effect during the study period and prevents learning effects from confounding actual study measurements -22.Capillary blood glucose samples were collected from participants' fingertip and analyzed immediately using the Precision Xtra Blood Glucose Monitoring System (glucose measured in millimoles per liter). Participants were asked to report from a checklist of \"hypoglycemic\" nutrition-related symptoms, including those produced by falling glucose and counterregulatory hormones and by reduced brain glucose. The seventeen symptoms covered manifestations of adrenergic responses , glucagon responses , and neuroglycopenic responses ,24. The Body mass was measured using SR Model SR241 scales . The measure of weight, performed by either of the two research assistants at the beginning and end of each study period, was standardized by using a single digital scale at the same location and ensuring participants' equivalent post urinary void state and clothing status . Volume of fluid consumed and urine voided were quantified. Dietary analyses were performed using individual physicians' recorded diet history . Two-hour diet recall was also taken at each blood glucose sampling in order to enhance the validity of the dietary record. Only nutritional intake during the study period was analyzed using Diet Analysis+, Canadian version 4.0 . Nutritional requirements were based upon the Dietary Reference Intakes (DRI 2002) , which rA triaxial accelerometer that records acceleration in three planes recorded activity level and heart rate simultaneously every fifteen seconds. Physicians were asked to rate both days on scales of 0 (low) to 10 (high) for workload, stress and general well being.After determining the appropriateness of parametric analytical methods, the statistical significance of mean differences in blood glucose levels and cognitive test scores were calculated using a generalized estimating equation to take into account the repeated measurements taken during each study day; change in body mass, and fluid and nutrient intake on baseline and intervention days were assessed for normalcy and means were compared using paired two sided t-tests; where the assumption of normalcy was not met, results were presented as medians plus interquartile range, and compared using a Wilcoxon signed rank test. Variability in glucose values was calculated using the coefficient of variation (CV), which describes variability relative to the mean [CV = (standard deviation/mean)*100%]. Analysis of variance (ANOVA) was used to assess within-day differences in mean cognitive test scores across the sampling times. A Fisher's exact test was used to compare proportion of physicians reporting \"hypoglycemic\" nutrition-related symptoms on baseline and intervention days.This study was originally conceived as a pilot study for preliminary testing of a nutrition based intervention, and for determination of multiple physiological and nutritional measurements in twenty working physicians. Given this, there were no a priori sample size considerations. However, based on mean glucose and cognition (Tput) values obtained, and corresponding standard deviations, we determined post-hoc that we had 96% power to detect a difference of 0.28 mmol/L in glucose values, and 97% power to detect a difference of 5 in Tput scores from the complex cognition test for the intervention day versus the baseline day.All statistical analyses were performed using Stata 10 .2 and ranged from 20.3 to 38.3 kg/m2. All participants were non-smokers and 15/20 (75%) reported exercising at moderate or high intensity for 30 minutes or longer at least 2-4 days per week. All twenty subjects completed both days with full data and follow-up for all study measures. No adverse effects of the intervention were reported.Twenty physicians from various medical specialties participated, with 10/20 participants (50%) from a medical specialty , 8/20 (40%) from a surgical specialty , and the remaining two (10%) from a primary care specialty . The mean duration of medical practice was 16.5 years, ranging from 5 to 36 years. The mean age was 46.8 years, and ranged from 36 to 64 years, and 85% were male. The mean Body Mass Index was 25.5 kg/mGroup mean glucose was slightly lower and considerably less variable on the intervention day compared to the baseline day Figure . The groStudy participants often reported symptoms associated with \"hypoglycemia\" despite few glucose results in the hypoglycemic range. On the baseline day, the symptoms most commonly reported were hunger (15/20 participants), fatigue (9/20), sweating (6/20), sensation of warmth (6/20), and drowsiness (5/20). On the intervention day, the symptoms most commonly reported were hunger (12/20), fatigue (7/20), sweating (3/20), sensation of warmth (3/20), or inability to concentrate (3/20). Supplementary analysis of the number of individual symptoms reported by each participant was also undertaken. Although the results were not statistically significant (p = 0.36), there was a trend toward fewer symptoms during the intervention day relative to the baseline day participants showed a mean loss of body mass on the baseline day compared with a mean gain during the intervention day . Mean fluid intake was significantly greater on the intervention day . The group mean average heart rate and physical workload were also similar. Physicians' self reports on a scale of 0 (low) to 10 (high) comparing the baseline to the intervention day showed no difference for perceived workload , stress , or general well being .The scheduled healthy food and fluids consumed during the intervention day were associated with improved physician cognition and less glucose variability. Although not statistically significant, there was also a trend toward the reporting of fewer hypoglycemic type symptoms. The change in cognitive function associated with the intervention appears notable relative to both population norms and age-related differences. For the simple reaction time test, the expected normal performance for ages 34-49 is a Tput score of 207, and a mean reaction time of 294 msec, and for ages 50-59, scores of 197 and 309 msec respectively. For the complex reaction time test, the expected normal performance for ages 34-49 is a Tput score of 100, and a mean reaction time of 547 msec and for ages 50-59, scores of 80 and 618 msec respectively . Our stuThe intervention was well received by participating physicians and its success may have been due to a number of factors. Nutrition was enforced through a scheduled regimen of food and fluid intake, readily available either at the centrally located doctors' lounge or at the physician's practice location. Physicians have previously indicated that they are often too busy to stop and eat and that limited access to nutrition during the work day, due to factors such as location, hours of operation, and cafeteria line ups, is a significant barrier . They haOn a practical level, implementing a nutritional intervention in a health care system is feasible. Health care organizations are increasingly evaluating the quality of food and drink made available to patients and staff, recognizing the benefits of quality nutrition to overall health. Making time for nutrition can be encouraged by developing educational campaigns that promote the benefits of nutrition breaks, by carefully scheduling nutrition opportunities during work hours, and through peer support of nutrition as a necessary component of a physician's ability to deliver quality health care. While food and drink are already available at defined locations in most hospitals, improved access can be achieved through placement of nutrition stations in high workload areas. For example, healthy food stations may be set up near operating rooms and on acute care wards via mobile carts, or where physicians tend to gather most, such as in the doctors' lounge. Although the nutritional intervention in this study was cost free, qualitative interview data from the study participants (results available from authors) support that physicians are willing to pay for good quality food and drink, suggesting that most of these proposals would be cost neutral. Lastly, there may be a number of secondary benefits to health care systems that are staffed by physicians who are cognitively improved as a result of adequate nutrition.As noted above, the literature provides evidence of the negative consequences of suboptimal nutrition for workers in a variety of work settings, in particular as they relate to cognitive function. Studies have also shown an association between the personal dietary habits of physicians and medical students and their nutrition counseling behaviors and attitudes ,29. FurtThe main limitation of this study is the relatively small number of participants. However, our paired study design and richness of measures nonetheless permitted sufficient statistical power to detect several significant differences on key measures between the two study days. A second limitation is the predominantly male and hospital based physician study sample, with a potential lack of sampling across the different types of workdays physicians may experience. For further generalization of results, these variables, and others such as age and weight would also need to be taken into account in future research. A third potential limitation is the non-randomized study design. However, the study is not necessarily weakened by lack of randomization between the intervention and non-intervention control groups given we ensured comparability in our pair wise comparison within individuals. A fourth limitation is that the study was not designed to evaluate whether the differences found between the study days translate into improved patient care. Lastly, the manufacturers of the cognitive function tests cite research to support that the learner effect is attenuated after three practice trials. Although it is still possible that a learner effect influenced the study results, each participant did undergo three practice trials before starting the study, and the ANOVA analyses across sampling times within each study day did not suggest a learner effect for same days responses. Weighing against these limitations is the strength of the full participation of twenty physicians over both study days despite interruptions in their work day due to the extensive collection of physiological measures and the added time commitments.Future studies might consider the development and randomized evaluation of an intervention that is more feasible in the acute care setting and that is based on a sustainable business model . Our study provides evidence in support of adequate workplace nutrition as a contributor to improved physician cognition, adding to the body of research suggesting that physician wellness may ultimately benefit not only the physicians themselves but also their patients and the health care systems in which they work .The authors declare that they have no competing interests.All authors had access to the data, had a role in writing the manuscript, and approved the final manuscript. JL contributed to the study conception and design, acquisition of data, analysis and interpretation of data, drafting and critical revision of the manuscript, statistical analysis, obtaining funding, and administrative support. JW contributed to the study conception and design, analysis and interpretation of data, critical revision of the manuscript, statistical analysis, obtaining funding. KD contributed to the study design, acquisition of data, analysis and interpretation of data, critical revision of the manuscript and technical support. WG contributed to the analysis and interpretation of the data, critical revision of the manuscript, statistical analysis, and administrative and material support. AL contributed to statistical analysis and interpretation of data, drafting of the manuscript and critical revision of the manuscript. DR contributed to the conception and design of the study, acquisition of data, analysis and interpretation of data, critical revision of the manuscript, statistical analysis, and technical and material support. JL had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, and had final responsibility for the decision to submit the manuscript for publication.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/10/241/prepub"} -{"text": "Objective To determine whether integration of nutritional supplementation with other public health programmes in early life reduces the risk of cardiovascular disease in undernourished populations.Design Approximately 15 years’ follow-up of participants born within an earlier controlled, community trial of nutritional supplementation integrated with other public health programmes.Setting 29 villages near Hyderabad city, south India.Participants 1165 adolescents aged 13-18 years.Intervention Balanced protein-calorie supplementation offered daily to pregnant women and preschool children aged under 6 years, coupled with integrated delivery of vertical public health programmes.Main outcome measures Height, adiposity, blood pressures, lipids, insulin resistance (homoeostasis model assessment (HOMA) score), and arterial stiffness (augmentation index).Results The participants from the intervention villages were 14 mm taller than controls but had similar body composition. The participants from the intervention villages had more favourable measures of insulin resistance and arterial stiffness: 20% lower HOMA score and 3.3% lower augmentation index. No strong evidence existed for differences in blood pressures and serum lipids.Conclusions In this undernourished population, integrated delivery of supplemental nutrition with other public health programmes in pregnancy and early childhood was associated with a more favourable profile of cardiovascular disease risk factors in adolescence. This pragmatic study provides the most robust evidence to date on this important hypothesis for which classic trials are unlikely. Improved maternal and child nutrition may have a role in reducing the burden of cardiovascular disease in low income and middle income countries. Some authors have suggested that the risk of cardiovascular diseases can be “programmed” in early life through the persistence of endocrine, physiological, and metabolic adaptations made in the face of undernutrition.3The evidence in support of this hypothesis is largely circumstantial: animal experiments and observational studies in humans showing associations between anthropometric measures (as proxies for undernutrition) and risk of cardiovascular disease.10Integrated Child Development Services is a national community based programme aimed at improving the health, nutrition, and development of children in India.13Using the opportunity afforded by the stepwise expansion of this programme during the 1980s and 1990s, the National Institute of Nutrition in India ran a trial to assess (among other things) the impact of food supplementation in pregnancy on the birth weight of offspring. A cluster of villages with a total population of 30 000 was chosen from each of the two adjacent administrative areas , one of which already had the Integrated Child Development Services programme in place (intervention arm), whereas the other was awaiting implementation (control arm). As the 100 or more villages in each of the two blocks were spread over an unfeasibly large area, villages were chosen geographically for random selection: contiguous villages falling within a 10 km radius of a prominent central village in each block were selected. This process resulted in 15 villages from the intervention arm and 14 villages from the control arm being recruited to the study.A 12 member team of investigators resided full time in the field for the duration of the study. Following a lead-in period of six months , the trial included all births in the area between 1 January 1987 and 31 December 1990. The “at risk” (of pregnancy) women were monitored monthly to detect missing of menstruation, and those identified as pregnant were followed closely during pregnancy until delivery . The field team attempted to visit the home as soon as possible after delivery to collect data on the outcome of the pregnancy and to weigh the newborn within 48 hours. An infant beam balance with a 20 g accuracy was used to measure weight.The supplement given in this trial was “upma,” a local preparation made from corn-soya blend (120 g) and soybean oil (16 g), providing 2.51 MJ and 20 g protein to the women and half this amount to the children. No other nutrients were added to the supplement. The other universal programmes—immunisation, anaemia control in pregnancy through distribution of iron and folic acid (500 μg) tablets, and the provision of basic health care—existed to a similar extent in both the intervention and control areas, although their uptake may be presumed to have been higher in the intervention area. Crossover of supplements from intervention to control villages was not a problem because of their separation by a large number of villages not involved in the study; in addition, supplements were offered only to the named residents of the village. A preliminary abstract reported the ongoing study,We designed this follow-up study to establish the status of women and their offspring who took part in the trial and to clinically examine offspring who were still resident in the area. The parents and children gave written informed consent.We did two parallel surveys on a village to village basis—the first to identify the study participants and the second to do clinical examinations. The identification survey preceded the clinical survey by three months, and we interchanged the survey area between intervention and control villages every couple of months to even out any variations arising from seasons and experience of the study team. In the identification survey, we first identified women who took part in the baseline trial by using their own and their husband’s name. We interviewed each woman thus identified to collect details on children she had previously borne. All children born in these villages during the initial trial period (1987-90) were potential study participants. However, owing to limited resources and to make maximal use of the baseline data, we invited only those children who could be successfully matched to the previous records to have clinical examinations. We used date of birth and sex for matching, as infants’ names were not recorded in the baseline study . Where multiple children of the same woman were eligible, we invited them all and made appropriate adjustments in the analyses.We used a single clinic site at each village to reduce measurement error arising from differences in clinic conditions. We held clinics in the morning, and invited 10-15 children to come fasting each day. We completed a full interviewer administered questionnaire and clinical examination on the children and a brief questionnaire on the mothers (who were asked to accompany the child).We measured height with a portable stadiometer . The participant stood erect with his or her head in the Frankfort plane, and a gentle upward pressure was applied under the mastoid. We used a digital weighing machine to measure weight. We measured skinfold thickness at four sites in triplicate with the Holtain calliper . We used a validated oscillometric device to measure blood pressure in the supine position with appropriate cuff sizes; we took two measurements and averaged them for analyses. We measured ambient room temperature with a digital thermometer.We assessed the augmentation index, a measure of global arterial stiffness, by using an applanation tonometry technique with the Sphygmocor apparatus Medical, Sydney, Australia).We classified sexual maturation into four stages on the basis of time since the onset of menstruation (girls) and testicular volume (boys).We collected fasting blood samples (at least eight hours) in appropriate vacutainers, transferred them within one to two hours (in icebox at 4-8° C), and processed them within four hours. We did assays for glucose, triglycerides, total cholesterol, and high density lipoprotein cholesterol on the same day with an autoanalyser and the recommended kits . We estimated insulin concentrations by radioimmunoassay in batches within four to six weeks.18We produced detailed protocols and used them regularly to standardise the work of the fieldwork team. “Blinding” of the fieldworkers to the group assignment was not an option; however, all measurements except anthropometry were to a large extent automated , thus reducing the possibility of bias. Only one observer made each measurement , to eliminate interobserver bias. We assessed reproducibility of clinic measurements by repeating the measurements on a random subsample (5%) of participants after one to three weeks and found it to be consistently high (intraclass correlation coefficients of >0.98 for anthropometric measures and >0.85 for blood pressures and augmentation index). We put in place internal and external quality control arrangements for biochemical assays, and split assays were done on a 5% subsample (intraclass correlation coefficients >0.94). We validated testicular self assessment technique against a trained observer in a separate substudy and found it to be highly accurate (mean difference in model ranks (self reported minus directly observed)—0.07 —with no evidence of systematic bias on a Bland-Altman plot).We used the log of the sum of four skinfolds to calculate the percentage of body fat23We applied suitable transformations to outcome variables that deviated markedly from a normal distribution . We used linear regression models to investigate association of supplemental nutrition with cardiovascular disease risk factors. Analysis was on an intention to treat basis, using area of birth as proxy (irrespective of whether the participant took the supplement or not). We fitted four predefined models to adjust incrementally for the main domains of potential confounding or intermediary variables: model 1 ; model 2 ; model 3 (stature—height); and model 4 . We additionally adjusted blood pressure for ambient room temperature and augmentation index for heart rate, as these factors can artefactually affect their values.26Data could be clustered at the level of the village and the household (in case of multiple children). To take account of village level clustering, we used robust standard errors in all the models, with village as the level of cluster. This technique uses the cluster level residuals to derive the standard errors, so that the resulting standard errors are larger and valid in the presence of clustering but the parameter estimate remains unchanged. This technique was inappropriate for household level clustering, as very few households had multiple children taking part in the study. We therefore examined the impact of household level clustering on the results by excluding the second of the two children from the same household (no household contained more than two children). We similarly estimated the impact of a few migrant children on the results by excluding these children from the final models. We examined interaction between the intervention and the sex of the participant, as evidence exists of preferential feeding of male children in this setting,Sample size calculations done before the start of the study suggested that the anticipated sample was going to be adequate to detect important differences in most outcomes .Of the 4338 pregnancies recorded in the trial, birth weights (recorded within 48 hours) were available for 2964 (68%) children. The mean birth weight of children born in the intervention area (2655 (SD 424) g) was higher than that of controls (2594 (SD 430) g); the mean difference was 61 g . Adjustment for sex of the child made no difference to the results; however, we deemed data on gestational age to be of insufficient quality (strong digit preference) to be included in the analyses. Personal information (necessary to trace families) was available for 2756 women, of which 1963 (71%) could be contacted successfully children for at least one outcome, with slightly fewer for blood pressure , lipid profile , glucose-insulin , and arterial stiffness . The lower number with glucose-insulin data was due to a failure to obtain insulin assay reagent in time for the last batch of assays (n=48), and that for arterial stiffness data was due to an inability to complete all assessments during the course of a clinic day, as most villages lacked the continuous electricity supply needed to run the apparatus. Some, but not all, of the participants returned subsequently to have their assessments completed.Table 2Children in the intervention and control arms were not different in their sexual maturation (data not shown). Table 4The study included 36 sibling pairs, of which five pairs were twins; all other households contributed only one child to the study. Thirty two participants had migrated away from their place of birth, of which nine had migrated within the study area . Exclusion of the migrant children or the second child (in the case of sibling pairs) made no material difference to the results.This is the first intervention study to show that modest improvements in the protein-calorie intake of pregnant women and young children may result in a more favourable cardiovascular disease risk factor profile among populations with prevalent undernutrition. These findings may indicate potential life course pathways underlying the causes of cardiovascular diseases in general.The importance of balanced protein-calorie malnutrition in early life has been studied in two natural experiments based on the starvation experience of populations under siege in the second world war (Dutch and Leningrad studies) and one small randomised controlled trial of supplemental nutrition from Guatemala.The main strength of this study is its setting: a nutritional intervention in a population with high background levels of chronic undernutrition, so we could realistically expect to find programming effects of inadequate diet, if they exist. The controlled design of the original evaluation would have reduced the chances of confounding; furthermore, the crucial confounders were either completely absent or severely restricted .The study also has some important limitations that need to be acknowledged, chief among them the potential for bias owing to non-randomisation of villages in the baseline study, losses to follow-up, and lack of data on current diet and patterns of physical activity. In the baseline study, all villages within a radius of the central village were selected in both intervention and control areas, making selection bias unlikely. Bias could arise, however, if the intervention area urbanised at a different rate from the control area, thus influencing the prevalence of risk factors for cardiovascular disease. Data on urbanisation collected from the village heads showed little variation between the villages (data not shown), and adjustment for urbanisation (population size) did not materially alter any of the results. Areas considered deprived are prioritised for the introduction of the Integrated Child Development Services programme in phases; however, the staggered introduction of the programme in similarly deprived and adjacent areas (such as those in the study) is mainly due to financial and operational constraints associated with the introduction of a public programme in a large country .12The response rate among children invited to the clinic was high 78%), although it was somewhat lower in the control areas, which in all probability arose from lack of interest in participation in the study shown by heads of some of the control villages . Loss to follow-up resulting from this is likely to be non-systematic. The participating children represented 45% of all eligible births in the area from that time, which compares favourably with the overall follow-up rates in other relevant studies .8%, althoDifferences in current diet and patterns of physical activity could account for the differences seen in risk of cardiovascular disease. Although it is theoretically possible, we see no obvious reason to believe that children from these neighbouring villages had marked differences in lifestyle. The villages are still fairly homogeneous in their diet (limited range of foods eaten mostly at home) and activity patterns . Furthermore, no differences in body composition existed; as adiposity reflects the net energy balance between intake (diet) and expenditure , the low fat mass in this population and its narrow distribution range, argues against any important lifestyle differences between the two areas. Finally, despite the relative automation of most of the outcome measures used in this study , the possibility of bias arising from the lack of blinding of the fieldworkers cannot be ruled out completely.Insulin resistance is believed to be central to many of the changes attributed to the thrifty phenotype.42The relative importance of nutrition in various stages , sources of nutrition, or indeed the rate of growth in early versus late postnatal life cannot be delineated from this study, as the intervention was given throughout.45We need to contextualise our observations and consider what public health benefits may accrue if this intervention was translated into primary prevention of disease burden. The Anglo-Cardiff collaborative study suggested that a 3% lower augmentation index equates to a three year less aged vascular phenotype.34The intervention in this study was given within the framework of a public welfare programme.Observational studies suggest that early undernutrition predisposes to cardiovascular disease in later life, but robust evidence from intervention trials is lackingIntegration of supplemental nutrition with public health programmes in pregnancy and early childhood was associated with a reduction in cardiovascular riskImproved maternal and child nutrition may have a role in reducing the burden of cardiovascular disease in low income and middle income countries"} -{"text": "Ingestion of glucosinolates has previously been reported to improve endothelial function in spontaneously hypertensive rats, possibly because of an increase in NO availability in the endothelium due to an attenuation of oxidative stress; in our study we tried to see if this also would be the case in humans suffering from essential hypertension.in vitro antioxidative potential, for a 4 week period or to continue their ordinary diet and act as controls. Blood pressure, endothelial function measured by flow mediated dilation (FMD) and blood samples were obtained from the participants every other week and the content of glucosinolates was measured before and after the study. Measurements were blinded to treatment allocation.40 hypertensive individuals without diabetes and with normal levels of cholesterol were examined. The participants were randomized either to ingest 10 g dried broccoli sprouts, a natural donor of glucosinolates with high In the interventional group overall FMD increased from 4% to 5.8% in the interventional group whereas in the control group FMD was stable (4% at baseline and 3.9% at the end of the study). The change in FMD in the interventional group was mainly due to a marked change in FMD in two participants while the other participants did not have marked changes in FMD. The observed differences were not statistically significant. Likewise significant changes in blood pressure or blood samples were not detected between or within groups. Diastolic blood pressure stayed essentially unchanged in both groups, while the systolic blood pressure showed a small non significant decrease (9 mm Hg) in the interventional group from a value of 153 mm Hg at start.Daily ingestion of 10 g dried broccoli sprouts does not improve endothelial function in the presence of hypertension in humans.NCT00252018Clinicaltrials.gov Oxidative stress is considered to play a important role in the processes of cellular injury which ultimately leads to the development of atherosclerosis.A group of substances which might have this effect are the glucosinolates, substances naturally occurring in cruciferous plants; the glucosinolates are precursors to isothiocyanates, of which sulphoraphane is one of the most potent inducers of the expression of phase-2-enzymes, in mammalian cells.Among the enzymes induced in vitro the gluthation-S-reductase may be of particular interest since it is instrumental in recycling gluthathion to its reduced state in the cell. In broccoli sprouts younger than 4 days glucoraphaninWe therefore decided to study whether the administration of dried broccoli sprouts in patients with essential hypertension could decrease blood pressure and increase flow mediated vasodilation(FMD). We have focused on endothelial function since this parameter previously has been demonstrated to be influenced by the level of oxidative stress, and because it is a sensitive predictor for oxidative stress as well as for the future development of atherosclerosis.We hypothesized that an increase in flow mediated vasodilation shooud be detectable in the interventonal group after four weeks of treatment both if we used the participants as their own controls and if we compared them to a control group. This was our primary outcome.Secondary outcomes in our study were measurement of blood pressure and lipoproteins where we were interested in seeing if the blood pressure would decrease during treatment and if lipoproteins would show an increase in HDL as well as a decrease in LDL.The protocol for this trial and supporting CONSORT checklist are available as supporting information; see Volunteers were enrolled in the study after advertising in local newspapers for non smoking hypertensive individuals without known diabetes or hypercholesterolemia. In- and Exclusion criteria are listed in The study was approved of the ethics committee for Copenhagen and Frederiksberg municipalities (no 01-257/04). Written informed consent was obtained from all participants.Endothelial function was measured on each individual three times, at start of treatment and twice during the four weeks of treatment with an interval of two weeks. Blood samples for erythrocyte content and inflammation, samples for lipids, blood glucose and inflammation were taken at each visit. Furthermore samples were obtained for analyzing the blood content of glucosinolates and their metabolites. The purpose for measuring the erythrocyte content blood glucose and inflammatory status was to insure that the stimulus for measuring FMD was as uniform as possible for each visit since a change in blood viscosity could influence the shear stress of the vessel wall and therefore increase the measured FMD, likewise elevated blood glucose has been showed to decrease FMD response. Endothelial function was measured using Flow Mediated Dilation (FMD) using a protocol following current guidelines.The broccoli sprouts were obtained from a commercial grower and were sprouted for 3 days. Immediately after harvesting they were refrigerated and subsequently dried at 40°C.The dried sprouts were afterwards packaged in airtight plastic bags each containing 10 grams of dried sprouts, equivalent to 100 g fresh sprouts. The dried sprouts had the glucosinolate content measured using previously described methodsPatients were randomised to treatment with broccoli sprouts or control in a 1∶1 ratio. Treatment consisted in a daily ingestion of 10 g dried broccoli sprouts. The block size for randomization was 4. Randomization was performed by an assistant in sealed envelopes and group allocation was blinded to the investigator. The participants were thus unblinded with regards to their allocation but the investigator was blinded throughout the study to the status of the participants. Since broccoli sprouts are not commercially available and have a much larger content of glucoraphanin than mature broccoli, we were confident that the control group would not ingest glucoraphanin in substantial amounts during the study. Pre-study antihypertensive medications were maintained during the study for all participants. The participants were given a package containing 28 bags with 10 g dried broccoli sprouts in each, instructions were to eat the content with one of the meals of the day, they were also instructed to avoid eating or drinking for at least 8 hours prior to each day of study. As part of our efforts to determine compliance we took blood samples from the participants at each session and the participants were informed that this also was done in order to estimate the content of the active substances in their blood stream. The investigator was blinded during the study and the preliminary statistical analys, During the study the analysis of blood samples and measurement of FMD was done immediately after each session and the data were entered into the study database. The investigator was unaware of the allocation of the participants during the study. After conclusion of the study the allocation of each participant into two groups was given the investigator, but during this part it was still not revealed which group had been the control and which had been the interventional group.Following the hypothesis outlined in the introduction our primary outcome was if we would observe an increase in FMD in the interventional group during the intervention.Secondary outcomes were changes in blood pressure and changes in levels of blood cholesterol during the study in the interventional group.The results were analyzed using SAS software (version 9.10). Comparisons between intervention and control group were analysed by non-paired Student's t-test and comparison of changes over time for the intervention and the control group were performed using a paired students test. Results were presented with calculated mean values and confidence intervals for the measurements at the different session as well as for the differences between values in the two groups.It was assumed that a detectable effect would produce at least a 3% difference in FMD, on this assumption it was calculated that our study would have a power of 90% with 20 individuals in each group.The study enrolled 41 participants, 20 in the control group and 21 in the interventional group. In all 53 persons were screened prior to enrollment, of these10 did not meet the enrollment criteria and 2 decided not to participate. The reason for including one more in the interventional group was that one participant dropped out one day after receiving the sprouts owing to the disagreeable taste of the sprouts. One participant in the interventional group missed one visit because of hospitalization (leg fracture). All other participants received treatment as allocated and participated in examinations as planned. The baseline characteristics for the participants are listed in The FMD values with 95% confidence interval and p values calculated using students test for the intervention and control group are displayed in For the blood test taken simultaneously with the FMD measurements, we have not been able to detect any differences in these samples in the course of our study. The results for are shown in Systolic, diastolic as well as mean blood pressure did not change significantly during the study. Differences detected in the study were related to gender and age.Results are shown in The glucosinolate content of the sprouts was determined before and after the drying and packaging had taken place in order to ensure that the content of glucosinolates in the dried sprouts was known and to asses the possible deterioration of the glucosinolates due to the drying.Measurements of the concentration in the sprouts at the end of the study were similar to those prior to the study . The sprAs stated in the Apart from one participant leaving the study because of the taste of the sprouts which made her very uncomfortable, no adverse effects were observed during the study.In the current study we have tested whether dietary glucosinolates can improve endothelial function in patients with hypertension as it has been demonstrated in animal models.During this period, we have not been able to demonstrate any change in blood pressure, or blood samples reflecting blood lipids or inflammatory status. This finding is at odds with experiments carried out on spontaneously hypertensive stroke prone rats (SHSP), which may be due to a variety of factors. The animal study was designed to investigate if a daily dose of sprouts would protect against the development of hypertension, while we only studied endothelial function in patients with established hypertension. Furthermore, dosage as well as duration of treatment was also different, as the rats were given dried sprouts from weaning and until termination of the experiment after fourteen weeks, which translated to a human lifespan would imply treatment form early childhood into adolescence. Finally, hypertension is not a well described disease entity in humans whereas the SHSP are a distinct breed of rats characterized by their tendency to develop hypertension and stroke.Our study has some limitations that need to be addressed. The dose we gave was, if related to body mass, approximately 7 times smaller than the dosage given to the rats in the study discussed aboveThe fact that we were not able to detect glucosinolates in the blood of the participants raises the question if lack of compliance could be a reason for the lack of observed effect. Other studies does indicate that the glucosinolates in the precense of myrosinase will be transformed to isothocyanates at an early stage of digestionAs stated in the result section we did not find any changes in blood lipids measured during the intervention period. This is at odds with other experiments carried out in humans and with similar doses of sprouts, since Murashima et al demonstrated a decrease in total and LDL cholesterol in humans after one week of treatment with 50 g of fresh broccoli sprouts given daily, our daily dose had twice the glucosinolate content, comparable to 100 g fresh sprouts. We used dried broccoli sprouts as opposed to fresh sprouts, since other studies have shown a rather fast deterioration of the glucosinolate content in fresh broccoliChecklist S1CONSORT Checklist.(0.19 MB DOC)Click here for additional data file.Protocol S1Trial Protocol, in Danish.(0.10 MB DOC)Click here for additional data file."} -{"text": "Objective To assess whether non-polluting, more effective home heating has a positive effect on the health of children with asthma.Design Randomised controlled trial.Setting Households in five communities in New Zealand.Participants 409 children aged 6-12 years with doctor diagnosed asthma.Interventions Installation of a non-polluting, more effective home heater before winter. The control group received a replacement heater at the end of the trial.Main outcome measures The primary outcome was change in lung function . Secondary outcomes were child reported respiratory tract symptoms and daily use of preventer and reliever drugs. At the end of winter 2005 (baseline) and winter 2006 (follow-up) parents reported their child’s general health, use of health services, overall respiratory health, and housing conditions. Nitrogen dioxide levels were measured monthly for four months and temperatures in the living room and child’s bedroom were recorded hourly.Results Improvements in lung function were not significant . Compared with children in the control group, however, children in the intervention group had 1.80 fewer days off school , 0.40 fewer visits to a doctor for asthma (0.11 to 0.62), and 0.25 fewer visits to a pharmacist for asthma (0.09 to 0.32). Children in the intervention group also had fewer reports of poor health , less sleep disturbed by wheezing , less dry cough at night , and reduced scores for lower respiratory tract symptoms than children in the control group. The intervention was associated with a mean temperature rise in the living room of 1.10°C and in the child’s bedroom of 0.57°C (0.05°C to 1.08°C). Lower levels of nitrogen dioxide were measured in the living rooms of the intervention households than in those of the control households . A similar effect was found in the children’s bedrooms .Conclusion Installing non-polluting, more effective heating in the homes of children with asthma did not significantly improve lung function but did significantly reduce symptoms of asthma, days off school, healthcare utilisation, and visits to a pharmacist.Trial registration Clinical Trials NCT00489762. Asthma is one of the most prevalent chronic diseases in childhood. In New Zealand about 25% of children report symptoms of asthma, and asthma is the second most common reason for children being admitted to hospital.4Evidence is growing that symptoms of asthma can be aggravated or triggered by adverse aspects of the indoor environment.9As well as cold temperatures, factors such as damp, mould, and pollutants have been implicated in aggravating the symptoms of asthma.12Infants and elderly people spend proportionally more time indoors15Nitrogen dioxide has been widely used as a marker for outdoor air quality in studies of pollution related to vehicle emissions, but the most important source of personal exposure to nitrogen dioxide is unflued gas appliances.23Nitrogen dioxide is a proinflammatory gas and can exacerbate respiratory symptoms such as wheeze or cough. It can reduce immunity to lung infections and increase the severity and duration of an episode of flu.32Relatively few intervention studies have examined the effects of housing improvements on health and fewer still have shown an impact on symptoms of asthma.37We previously carried out a randomised controlled trial of the effects on respiratory health of insulating homes.We carried out a randomised controlled trial in which baseline measures were collected in winter (June to September) 2005. Households in the intervention group were allocated a non-polluting, more effective replacement heater before the follow-up winter of 2006. The control group received a similar heater in 2007, after the final data collection in 2006.The study was carried out in five areas in New Zealand—Porirua and the Hutt Valley in the North Island and Christchurch, Dunedin, and Bluff in the South Island. Households were recruited from December 2004 to May 2005. We identified community coordinators in nine local asthma societies and primary health organisations . The community coordinators invited families who had a child with asthma to participate in the study. The study was also publicised in radio interviews. Overall, 899 applications were received of which 422 (47%) met the inclusion criteria: the family lived in a study area and had a child aged between 6 and 12 years with doctor diagnosed asthma and symptoms in the past 12 months; the child slept at least four nights a week in the house; the house contained a less effective form of heating (unflued gas or plug-in electric heaters); the family intended to live in the house over the two winter periods; and the homeowner agreed that the household could take part in the study. If more than one child in a household met the study criteria then the child whose birthday occurred first after 1 June became the index child.After enrolment and before winter 2005 participating houses were insulated to the current New Zealand building code standard, as our previous study had shown positive effects from insulation alone.1), and correct placement of temperature loggers and nitrogen dioxide diffusion tubes. At the end of winter 2005 the community coordinators assisted households in completing the questionnaires. To check for reporting bias we included three outcomes for which we hypothesised no association with the intervention: diarrhoea, vomiting, and ear infections. The questionnaires are available at www.wnmeds.ac.nz/healthyhousing.html.The research team trained the community coordinators in the informed consent procedures, completion of questionnaires and symptom diaries, use of Piko meters for measuring peak expiratory flow rate and forced expiratory volume in one second were explained at community meetings and described on the research group’s website. The homeowners chose a replacement for their existing heaters. Landlords were encouraged to consider their tenants’ preferences. An independent statistician then randomised the households to intervention or control groups, stratified by area and heater choice. The heaters were installed in the intervention houses before winter 2006. The control group were told that they would receive a replacement heater at the end of the study.Baseline measures were repeated after the intervention at follow-up in winter 2006. In 2006 we changed the format of the questionnaire, eliminating the instruction that if people answered no to the question on wheeze they were to skip related questions, and we added a question on twisted ankles to check for reporting bias. We changed the method of recording the data from the Piko meter to recording readings in the symptom diary, as the downloaded data from 2005 were unsatisfactory. The temperature loggers were reprogrammed to record temperature every hour instead of every 20 minutes and to remain in place for the whole winter. We re-emphasised to the community coordinators the need for accuracy and timely retrieval of data.Participants signed informed consent forms. Parents signed on behalf of their children. Households were told that the heaters were the property of the homeowner.The primary outcome measure was changes to lung function. The study was powered to show a reduction in the amplitude of diurnal changes, expressed as a percentage of their mean peak expiratory flow rate over winter (amplitude % mean). A total of 430 children were required to detect a 15% reduction in the intervention group compared with the control group, assuming a correlation with the previous year’s measurement of 0.4, with 90% power, α at 0.05, and a 15% non-response rate. Secondary outcomes were reported asthma symptoms, scores for lower respiratory tract symptoms from the diaries, asthma drug use, healthcare utilisation, and days off school. Intermediate outcomes were temperature and nitrogen dioxide levels in the living room and child’s bedroom.www.r-project.org/). The binary information was analysed using both standard generalised linear models and analysis of covariance (adjusting for outcome at baseline) generalised linear models with the logistic link function. From these models we derived unadjusted odds ratios as measures of effect size and adjusted odds ratios as measures for precision of estimates. We similarly analysed the numerical counts but with a Poisson link function. For these models we present the change for the intervention group compared with the control group as mean number of events, with 95% confidence intervals.Epi-Info version 3.4.1 was used to double enter the responses to the questionnaire and data from the diaries. We cleaned and analysed the data using the statistical package R version 2.4.1 , we used the overall mean and validated the results using the complete data. Results for the interpolated data were predominantly within 5% of the results for the non-interpolated data.1 and peak expiratory flow rate from three good forced expiratory manoeuvres, measured each morning and evening. The three outcomes presented are the best blow in the morning, in the evening, and that day.In the daily diaries individual respiratory symptoms were recorded on a nominal scale (0 to 3) as used previously.1.For all daily records we used a linear mixed modelWe tested model distributions by examining the dispersion variable in the Poisson models and QQ plots for the normal models. Ethnicity was collected using the standardised self identity question of Statistics New Zealand. When multiple ethnicities were reported we used prioritised Māori and then Pacific ethnicities.41Overall, 409 households were randomised. After exclusions and withdrawals 349 (85%) households remained and daily peak expiratory flow rate .Table 2v good, very good, excellent) by their parents . Parental reports showed a reduction in sleep disturbed by wheeze and dry cough at night .The other three symptoms improved but not significantly. Of the four outcomes used to test for reporting bias only twisted ankles showed a significant effect.Table 3Results from the daily symptom diaries are presented as mean ratios—the average score for the intervention group divided by the average score for the control group , 0.4 fewer visits to the doctor for asthma , 0.25 fewer visits to a pharmacist for asthma , and 0.27 fewer visits to the doctor for non-asthma related conditions .After the intervention, during the winter of 2006, the average living room temperature of intervention households was 17.07°C compared with 15.97°C for control households: a difference of 1.10°C . Similarly, the average temperature in the child’s bedroom for intervention households was 14.84°C compared with 14.26°C for control households: a mean difference of 0.57°C .Exposure to low temperatures, measured as degree hours—that is, hours per day, multiplied by number of degrees less than 10°C—was over 50% less in the intervention group than control group. In the living room the exposure was 1.13 degree hours in the intervention group compared with 2.31 degree hours in the control group, a difference of 1.18 degree hours . Exposure in the child’s bedroom was 2.03 degree hours in the intervention group compared with 4.29 degree hours in the control group, a difference of 2.26 degree hours .3v 15.7 μg/m3, P<0.001). A similar significant effect was found in the child’s bedroom .42Ambient outdoor nitrogen dioxide levels were the same in both groups, but indoor levels were significantly reduced in the intervention group. In 2006 the intervention group had significantly (P<0.001) lower geometric mean nitrogen dioxide levels in the living room than the control group compared with the average cost of the unflued gas or portable electric heater ($NZ100 per house).The major limitation in randomised trials of this sort is the impossibility of implementing blinding of the participants or field workers, once they visited the home. This could have resulted in a reporting bias, although as all participants knew at the outset of the study that they would receive new heaters it is unclear in which direction this would be. However, the outcome measurements included both self report and blinded measures and when both were available, as with days off school, the blinded measures showed a greater effect, suggesting any reporting bias was in the direction of minimising the intervention effect. In addition, three of the four questions that tested for reporting bias were not significantly affected by the intervention. The other outcome (twisted ankles) showed increased reporting in the intervention group, also suggesting that any bias was in the direction of minimising the effect of the intervention.Another important issue is the choice of primary outcome measure; we chose lung function because it was more objective and because the study could not be double blinded. It may be that lung function is less important to the daily life of children with asthma than are the frequency and severity of symptoms. In addition symptoms may be more sensitive to change and more reliable than laboratory based measures carried out by children in a community setting.As highlighted by one study, managing a community trial with community organisations as partners is challenging for all parties.The results suggest that improving both the type and amount of heating in the homes of children with asthma does not significantly affect measured lung function but does have several beneficial effects. Houses in this study included all forms of tenure, and the households had a range of incomes, so apportioning the relative benefits to the participants and to the public good is an important policy issue. In the United Kingdom, Scotland has made the policy decision that installing central heating in all social and pensioner housing, regardless of tenure, is largely for the good of the public and will pay more health dividends than focusing on clinical waiting lists, as is done in England.47Although the improvement in lung function was not statistically significant, large improvements were found in the symptoms of asthma. These patient centred measures are arguably as important to the daily life of children with asthma as more objective measures, and adopting this environmental intervention is an effective adjunct to the pharmaceutical treatment of asthma symptoms.Observational, but few intervention, studies have shown associations between asthma symptoms and dampness and cold in poorly heated homesNon-polluting, effective heating did not significantly affect measured lung function of children with asthma but it improved wellbeing and reduced symptoms of asthma and days off school"} -{"text": "Hypertension is a major chronic lifestyle disease. Several non-pharmacological interventions are effective in bringing down the blood pressure (BP). This study focuses on the effectiveness of such interventions among young adults.To measure the efficacy of physical exercise, reduction in salt intake, and yoga, in lowering BP among young (20-25) pre-hypertensives and hypertensives, and to compare their relative efficacies.The study was done in the urban service area of JIPMER. Pre-hypertensives and hypertensives, identified from previous studies, constituted the universe. The participants were randomized into one control and three interventional groups.A total of 113 subjects: 30, 28, 28 and 27 in four groups respectively participated for eight weeks: control (I), physical exercise (II) - brisk walking for 50-60 minutes, four days/week, salt intake reduction (III) - to at least half of their previous intake, and practice of yoga (IV) - for 30-45 minutes/day on at least five days/week.Efficacy was assessed using paired t test and ANOVA with Games Howell post hoc test. An intention to treat analysis was also performed.A total of 102 participants completed the study. All three intervention groups showed a significant reduction in BP . There was no significant change (SBP/DBP: 0.2/0.5 mmHg) of BP in control group (I). Physical exercise was most effective ; salt intake reduction and yoga were also effective.Physical exercise, salt intake reduction, and yoga are effective non-pharmacological interventions in significantly reducing BP among young hypertensives and pre-hypertensives. These can therefore be positively recommended for hypertensives. There is also a case to deploy these interventions in the general population. Hypertension is a major chronic lifestyle disease and an important public health problem worldwide. A recent report indicates that nearly one billion adults had hypertension in 2000, and this is predicted to increase to 1.56 billion by 2025.There are several non-pharmacological methods of controlling blood pressure (BP). physical12young adults through non-pharmacological interventions at an early stage of the natural history of the disease, and compares their relative efficacies in reducing BP and hence the objectives,This study focuses on tackling these important risk factors of hypertension among To measure the efficacy of the following interventions in lowering BP among young (20-25) pre- hypertensives and hypertensives:Physical exerciseReduction in salt intake andPractice of yogaTo compare the relative efficacies of these three interventions.51 hypertensives and 173 pre-hypertensives, as per the JNC VII criteria for classification of pre-hypertension (120-139 mm Hg SBP and/or 80-89 mm Hg DBP).. Since itOf the 120, seven participants (three hypertensives plus four pre-hypertensives) did not consent to be part of the program, while 30, 28, 28 and 27 in the control, physical exercise, salt intake reduction and yoga groups respectively consented amounting to a total of 113 study subjects . The pathogenesis, risk factors, complications and therapy of hypertension was explained to the participants in the local language, Tamil, so as to motivate them for compliance. Their blood pressure was measured at the start of the study period using the mercury sphygmomanometer.Participants of this group were motivated to undergo physical exercise in the form of brisk walking for 50-60 minutes, four days per week.–17 As a These subjects were motivated to reduce their daily salt intake to at least half of their previous intake.1819 Data1812asanas proved to be effective in BP reduction(pranayama (breathing exercises); and asanas like savasana, ardha matsyendrasana, naadishudhi asana, single leg, and double leg raise.This group of participants was taught yoga reduction21) by a by a asareduction This incAll these interventions were carried out for eight weeks. Flexibility was allowed for those who took time for motivation and started the intervention at subsequent dates; however they were followed up for the corresponding eight-week period. At the end of the study period their BP values were measured.Out of the initial 113, 11 subjects (including 6 hypertensives) dropped out. At the end of the study 29, 27, 25 and 21 in the groups I, II, III and IV respectively were successfully followed through.The study was approved by the Institute Research Council and Institute Ethics Committee. Informed consent was obtained from all the participants.The pre-intervention and the post-intervention BP values were analyzed using the paired ‘t’ test. ‘Intention to treat’ analysis was carried out by including the attrition cohort. The inter-group comparisons were made using ANOVA with Games Howell post hoc test.Of the 102 participants who completed the study, 68 were males and 34 females. Age distribution concurred in all groups. The male-female distribution was similar in all groups except a slight over-representation in the salt intake reduction group. During course of the study one, one, three and five participants dropped out from groups I, II, III and IV respectively. The mean systolic BP in the four groups ranged between 123 and 128 mm Hg and the diastolic blood pressure between 82 and 87 mm Hg. Considering those who completed the study, the baseline mean SBP and DBP of the four groups differed significantly; this could be due to their differential attrition patterns. The distribution of hypertensives among the groups is also significantly different due to the effect of attrition .P less than 0.05 in each case) compared to the control group wherein the fall was not significant [P less than 0.05 in each case) whereas the change in the DBP values of the control group was not significant [As regards SBP in the pre and post intervention setting, in the physical exercise group there was a reduction from 128.6 to 123.3 (5.3), in the salt intake reduction group from 124.0 to 121.4 (2.6), in the yoga group from 126.8 to 124.8 (2.0), and in the control group from 123.1 to 122.9 (0.2). This fall in SBP in each of the interventional groups was statistically significant and physical exercise Vs practice of yoga . However, when the effectiveness of salt intake reduction and yoga were compared, there was no significant difference [P is equal to 0.002) and Physical exercise vs practice of yoga showed statistically significant differences. Here too, salt intake reduction Vs practice of yoga showed no significant difference [After checking for normality using Kolmogrov-Smirnov test, ANOVA was done with Games-Howell post hoc test as Levene's test for equal variance was significant. On analysis of the relative efficacies, considering SBP, there were statistically significant differences with Physical exercise Vs salt intake reduction was recorded. This study found physical exercise and salt restriction to be more acceptable than yoga at the community level.This study has highlighted the effectiveness of physical exercise, salt intake reduction and yoga in prevention and control of hypertension among young adults. A comparative discussion of these variables follows.et al. whereas both salt intake reduction and yoga were equally effective as non-pharmacological interventions for prevention and control of hypertension among young adults. In a recent meta-analysis, de Luis et al. demonstrComparable attrition rates (3%) in the physical exercise and the control groups highlight the high acceptability of physical exercise. Salt restriction group also registered a high acceptability of 90%. Even in the yoga group, the acceptability was as high as 78%.The WHO document on ‘Community Prevention and Control of Cardiovascular Diseases’ providesAn attrition rate of 9.7% was recorded during the course of this study.The study assumed that all participants underwent the same magnitude of intervention. There could have been variations in the extent of compliance among members of the same interventional group. The study did not have any mechanism to standardize or quantify the actual magnitude of intervention per individual."} -{"text": "Even though depression and anxiety are highly prevalent in adolescence, youngsters are not inclined to seek help in regular healthcare. Therapy through the Internet, however, has been found to appeal strongly to young people. The main aim of the present study is to examine the efficacy of preventive Internet-based guided self-help problem-solving therapy with adolescents reporting depressive and anxiety symptoms. A secondary objective is to test potential mediating and moderating variables in order to gain insight into how the intervention works and for whom it works best.This study is a randomized controlled trial with an intervention condition group and a wait-list control group. The intervention condition group receives Internet-based self-help problem-solving therapy. Support is provided by a professional and delivered through email. Participants in the wait-list control group receive the intervention four months later. The study population consists of adolescents (12-18-year-olds) from the general population who report mild to moderate depressive and/or anxiety symptoms and are willing to complete a self-help course. Primary outcomes are symptoms of depression and anxiety. Secondary outcomes are quality of life, social anxiety, and cost-effectiveness. The following variables are examined for their moderating role: demographics, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from parents and friends, substance use, the experience of important life events, physical activity, the quality of the therapeutic alliance, and satisfaction. Mediator variables include problem-solving skills, worrying, mastery, and self-esteem. Data are collected at baseline and at 3 weeks, 5 weeks, 4 months, 8 months, and 12 months after baseline. Both intention-to-treat and completer analyses will be conducted.This study evaluates the efficacy and mechanisms of Internet-based problem-solving therapy for adolescents. If Internet-based problem-solving therapy is shown to reduce depressive and anxiety symptoms in adolescents, the implication is to implement the intervention in clinical practice. Strengths and limitations of the study are discussed.Netherlands Trial Register NTR1322 Depression and anxiety disorders are the most prevalent mental disorders in adolescence, with lifetime prevalences between 17% and 28% by the age of 18 . FurtherDespite the high incidence of common mental health problems in adolescence, teenagers rarely seek professional help for their emotional problems through regular healthcare services. The Internet, however, offers the possibility to access this large group of untreated adolescents for adequate care: it has low threshold acceptability, is used frequently by young people, and reduces objections like lack of willingness to talk to a stranger about personal problems and fear of stigma . A recenFor adults, preventive self-help interventions have been offered through the Internet and proven to be effective in reducing symptoms of depression and anxiety e.g., -21). Sel. Sel21])Most web-based self-help interventions for psychological problems have been developed for treating (symptoms of) specific disorders like depression or a specific anxiety disorder. Face-to-face problem-solving therapy (PST), on the other hand, has been found to be effective in a variety of problem areas ,26. A neWhile Internet-based self-help is effective in adults, it is still unknown whether these interventions also work for adolescents. Also, little is known with regard to the mechanisms underlying change in this form of treatment and potential predictors of treatment effect. For the current study, the Dutch Internet-based PST intervention was adapIn the present study, we examine the effects of an Internet-based guided self-help intervention (PST) for adolescents reporting mild to moderate symptoms of depression and/or anxiety compared to a wait-list control group. Potential moderating and mediating variables are investigated in order to identify predictors of treatment effect and to evaluate potential underlying mechanisms of change. Moderating variables are explored, i.e., demographics, motivation, treatment credibility and expectancy, externalizing behaviour, peer and parental perceived social support, substance use, the experience of life events, physical activity, the working alliance between participant and coach, and satisfaction. Problem-solving abilities, mastery, self-esteem and ruminative responses are investigated for their possible mediating effect.This study is a randomized controlled trial with two groups: the Internet-based self-help intervention group (PST) and a wait-list control group (WL). The study protocol has been approved by the Medical Ethics Committee of the VU University Medical Center.Adolescents (12 to 18-year-olds) with mild to moderate depressive and/or anxiety symptoms who are willing to participate in a self-help course are eligible for this study. Inclusion criteria are: sufficient knowledge of the Dutch language, access to Internet, and having an email address. Exclusion criteria are: absence of parental permission, already receiving treatment for mental health problems, the presence of severe depressive symptoms , severe anxiety symptoms , and/or prominent suicide ideation .Participants are recruited through banners and advertisements on the Internet, advertisements in magazines, referral by school-doctors, through brochures and posters in schools, and through information to parents who are treated in mental health care institutions for anxiety and depression. When signing in on the website, subjects receive a brochure and an informed consent form by email. In the brochure, information about the study's procedure and intervention is provided, and requirements for participation and parental consent are carefully explained. After application by the adolescent via email, parents receive a brochure and informed consent form by post. After receiving signed informed consent from both child and parents, participants receive an email with a link to the baseline questionnaire. Subjects with a score of 41 or higher on the CES-D are excluded. They receive a telephone call in which they are advised to consult their general practitioner. Their parents are also informed by telephone. The same procedure is followed in cases of a score of 15 or higher on the anxiety subscale of the HADS and/or a score of 2 or higher on the BDI-II suicide item. Eligible adolescents are randomized to either the intervention or the wait-list control condition, and are informed about the randomization outcome by email. Their parents also receive this email. Depression and anxiety subscales of the National Institute of Mental Health Diagnostic Interview Schedule for Children (NIMH-DISC IV) are subsequently conducted by telephone. Within two weeks after the baseline measurements, the intervention starts. Assessments take place during the treatment period, at treatment termination, and 4, 8, and 12 months after the start of the intervention. Figure Participants are randomly assigned to either the intervention or a waiting list. Randomization will take place at an individual level after the baseline measurement and one week before the start of the intervention. An independent researcher will make the allocation schedule with a computerized random number generator. The random allocation list will be generated in random permuted blocks of variable size . The randomization outcome per participant will be revealed to the primary investigator after the baseline measurement. In this manner, the investigator can give some background information to the designated coach guiding the intervention participant through the course. Though the researcher has knowledge of participants' group assignment after the baseline measure, all other measures consist of automated online questionnaires and so there will be no contact here between participants and the primary researcher at all. Adolescents agree to participate before randomization and without knowing which group they will be allocated to. Received baseline questionnaires are numbered in order of arrival.The sample size is based on the expected difference (Cohen's d = .50) between the intervention group and the wait-list control group at post-test, on the primary outcome variables, i.e., depressive and anxiety symptoms. Based on an alpha of .05 and a power of .80 in a two-tailed test, we need 63 subjects in each condition. Because Internet interventions tend to result in relatively high dropout rates of up to 40%, we aim for 210 participants. The expected effect size and dropout rate are derived from our experiences with an earlier study on the proposed intervention in adults . High drThe PST intervention is a Dutch adaptation of SET . It has PST in this study consists of several steps and takes five weeks, with one lesson a week. In the first lesson, subjects make a list of what is most important in their lives and a list of their current worries and problems. Having listed their problems, participants subsequently divide these into three categories: (a) unimportant problems (problems unrelated to the things that matter to them), (b) important problems which can be solved, and (c) important problems which cannot be solved . In the following weeks, participants can adapt their \"important things\" and \"problem\" lists while they learn to deal with the three types of problem introduced in the first lesson.In lesson 2, subjects are taught the focal component of the intervention which is a specific six-step problem-solving procedure for structurally resolving important problems which can be solved. In the first step of this procedure, participants need to describe their problem. The next steps involve (2) writing down all possible solutions you can think of, (3) choosing the best solution, (4) describing how the solution will be carried out , (5) carrying out your plan of the solution, and (6) checking whether the problem is resolved. Participants practice with this six-step PST procedure from lesson 2 onwards; all other material and exercises only play a supporting role.Lesson 3 deals with problems unrelated to things which are important, by proposing different strategies to eliminate negative thoughts and enhance positive thoughts. Strategies to eliminate negative thoughts concern (a) establishing one or two 15-minutes sessions a day for thinking about a problem (b) forcing yourself to immediately stop negative thoughts when they pop up, and (c) distracting yourself when ruminating, e.g., by calling a friend or engaging in sports. Two exercises for positive thinking are proposed; these are (a) thinking about three things which gave you a good feeling that day, and doing this every night before going to sleep, and (b) writing as many positive thoughts as possible on small cards, and then pulling one of these out regularly.In lesson 4 - about important problems which cannot be solved -, participants are told that there are no rules for coping with a major event, but that it usually helps not to avoid negative emotions. Avoidance can be reduced by writing about your feelings, talking about your experiences with people that you feel close to, or by getting in touch with fellow-sufferers. Links to Dutch websites for specific types of problems are provided on the website.During the fifth and last lesson, subjects look at their \"problem list\" again and are encouraged to identify the most important problem area - the problem most closely related to their feelings of depression and/or anxiety. They subsequently write down their goals concerning this problem for the long term. What are your goals for the next four months, and what are you going to do when encountering difficulties? Subjects also look at their \"important things list\" and are encouraged to think about actions they can undertake in order to reach these important things. Other exercises include making plans of how to deal with upcoming important life events which might make you feel low, and making a plan of what to do when encountering signals of depression or anxiety again; i.e., what steps they can take in order to prevent a relapse.After the last lesson the website provides some general tips for counteracting depressed and anxious feelings, and phone numbers of professional mental health institutes are supplied. Figure Subjects in the intervention group receive email support from employees of the Prevention and Intervention group of a mental health care institute in Amsterdam and the first two authors of this paper. Support is directed at guiding the participant through the intervention. This is done by sending an email if the coach does not receive participants' exercises at the end of the lesson and by commenting on the exercises made by participants. Comments include thanking the participant for sending and completing the exercises, compliments about exercises done well, asking for clarification when necessary, answering questions participants might have about the exercises, and giving tips when finding that the participant did not fully understand the exercise . When participants send their assignments to their coach, they receive feedback within three working days. Support is not intended to give direct or individual advice on how to cope with depression, anxiety or other problems. Although performing the course with email support is strongly recommended, participants are permitted to complete the intervention without support.Participants on the waiting list receive no intervention or support, only a link to a website with general information about depression and anxiety. They can commence the intervention four months after the intervention group starts the course.Screening measures, primary outcome measures, secondary outcome measures, measures of clinical predictors, and measures of mediating variables can be distinguished in this study. The instruments include a diagnostic interview by phone and self-report questionnaires which are filled in by participants through the Internet.A structured diagnostic interview and self-report questionnaires including suicidal ideation, depression, and anxiety are administered as screening measures in this study.The Diagnostic Interview Schedule for Children (version NIMH DISC-4.0) is a reliable and valid structured diagnostic interview designed for lay interviewers, which includes algorithms to diagnose DSM-IV disorders in children and adolescents . ParticiThe Beck Depression Inventory II (BDI-II) measuresPrimary outcome measures include symptoms of depression as well as anxiety, because the intervention is intended to reduce symptoms of these two internalizing disorders. The questionnaires used for assessing these primary outcome measures, are also used as screening measures.The Centre for Epidemiological Studies Depression scale (CES-D) is a widThe Hospital Anxiety and Depression Scale (HADS) is an exSecondary outcome measures include quality of life, symptoms of social anxiety, and cost-effectiveness.The Pediatric Quality of Life Inventory 4.0 (PedsQL) is a self-administered paper-and-pencil questionnaire designed to assess quality of life in children and adolescents . It inclThe Social Anxiety Scale for Adolescents (SAS-A) is one oThe Trimbos and iMTA questionnaire on Costs associated with Psychiatric Illness (TiC-P) is used Predictors that might distinguish adolescents who benefit from the intervention, include demographic variables, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from significant others, substance use, the experience of life events, physical activity, the quality of the therapeutic alliance, and satisfaction.A self-designed demographic questionnaire is used to collect participants' demographic information. This instrument consists of 15 questions concerning nationality, ethnic origin, living situation, and education.A self-designed questionnaire is used to assess participants' willingness to spend time on the intervention. The instrument consists of 5 questions rated on a 5-point Likert scale ranging from \"I totally disagree\" to \"I totally agree\".The Credibility/Expectancy Questionnaire (CEQ) assessesα = .57, and 10 items on aggressive behaviour, α = .75. This short version of the YSR externalizing scale has an alpha of .79. Good reliability and validity estimates of the YSR have been documented [The Youth Self Report (YSR) is a 101The Social Support Scale for Adolescents (SSSA) is a 24-Adolescents are asked to respond to two questions about (1) how often they had consumed alcohol in the past 4 weeks, and (2) the number of occasions on which seven or more drinks in a row were consumed in the past 4 weeks. Answers are rated on a 6-point scale .Smoking behaviour is assessed with the question \"Have you ever smoked even part of a cigarette?\" Current smokers are those who mark the response \"yes, I now smoke cigarettes\". Non-smokers are those who mark any other response option, ranging from \"No, I've never smoked even part of a cigarette\" to \"Yes, I used to smoke at least once a week, but I quit\". Daily smoking is assessed with the question \"how much on average do you smoke per day?\" Response options range from 0 (less than one cigarette per day) to 6 (more than 30 cigarettes per day).Drug use is measured by asking participants to indicate how often, if ever, they have used soft drugs in the last twelve months. This question is also posed for using hard drugs. Responses range from 0 (never) to 13 (40 times or more).Adolescents complete a 12-item short form of the Life Event Questionnaire , which iPhysical activity is measured with the Godin-Shephard questionnaire . This quThe Working Alliance Inventory (WAI) is a measure of the quality of the therapeutic alliance between the client and therapist. The original 36 items of this self-report questionnaire are rated on a 7-point Likert scale and measure three distinct factors of the therapeutic relationship: the therapeutic bond, task agreement, and agreement on therapeutic goals. Good psychometric properties have been found . For thiThe 8-item Client Satisfaction Questionnaire (CSQ-8) is a one-dimensional instrument to assess global patient satisfaction . This shTo test whether the basic components of the intervention mediate the effects of the treatment on changes in depressive and anxiety symptoms, questionnaires including problem-solving skills, worrying, mastery, and self-esteem are administered.The Coping Inventory for Stressful Situations (CISS) is a 48-The tendency of adolescents to engage in excessive, generalized, and uncontrollable worry is assessed with the Penn State Worry Questionnaire for Children (PSWQ-C) . The PSWPerceived control is assessed with the Mastery Scale . The sevSelf-esteem is measured with the Rosenberg Self-Esteem Scale (RSES) , a widelplus. With this method, it is possible to identify distinct groups of individuals, differing in the initial level and course of a specific behaviour, through the empirical identification of developmental trajectories [Intention-to-treat and completer analyses will be performed. Overall, treatment efficacy will be assessed with linear mixed modelling analysis using SPSS. For analyzing mediating variables and for the identification of subgroups in the sample, general growth mixture modelling will be applied, using M-ectories . This teectories .This study compares a preventive problem-solving guided self-help intervention through the Internet with a wait-list control group and aims to provide insight into the efficacy of the Internet-based intervention for adolescents. A secondary objective is to examine how the intervention works and for whom. A discussion of specific strengths and limitations of this study follows below.First of all, a strength of this study is that it is a practice-based project and both research aims relate to important matters in the treatment of adolescents with symptoms of depression and anxiety. There is a lack of studies on the efficacy of preventive self-help interventions for adolescents with emotional problems, which limits the evidence base for this treatment method. Simultaneously, insight into the questions as to which subgroups respond differently to the intervention and why and how the intervention led to change is scarce. Mechanisms of change are rarely studied in child and adolescent therapy, though the study of mechanisms of treatment can serve as a basis for maximizing treatment effects and ensuring that critical features are generalized to clinical practice . ResultsA strength of our intervention in particular is that it is offered through the Internet; it constitutes a self-help format, and may be used in adolescents with different types of comorbid problems. This is especially salient since a large group of untreated adolescents can therefore be reached.A strong aspect of the design of this study is the number of measurements. Six measurements are used, making it possible to analyze the role of potential mediating variables in predicting intervention effects and the development of different kind of symptoms over time.Another advantage of this study concerns the possibility to compare results with studies using clinical samples. Though subjects are included on the basis of self-rating instruments - as the intervention is intended to be applicable and accessible for a broad population with self-reported mild to moderate depressive and anxiety symptoms - information about whether subjects meet criteria for Major Depression, Dysthymia, Panic, Agoraphobia, Social phobia, and Generalized Anxiety Disorder is assessed. The standardized diagnostic interview is not used at posttest, however, so this study does not examine whether the intervention is actually capable of reducing the incidence of cases of depression and anxiety as defined by diagnostic criteria. When using a diagnostic interview both at baseline and follow-up, large numbers of subjects are needed to yield sufficient statistical power to be able to show significant effects on incidence . MoreoveA limitation of this study includes the relatively small sample size, making it difficult to draw firm conclusions about the moderation and mediation research questions. As our trial is primarily focused on determining whether the Internet intervention is a feasible and effective preventive intervention for adolescents with subsyndromal anxiety and depression, power is only calculated for our primary outcome measures. With regard to moderating and mediating variables or the effectiveness of our intervention for specific subgroups, our study is of an explorative nature, which will permit us with enough power to detect rather robust effects, while other less prominent associations may be more difficult to discern.Another limitation and expected problem constitutes refusals to participate in this study. Due to ethical considerations, only adolescents who are willing to ask for their parents' consent to participate in the current trial can be included. However, adolescents would often prefer to participate without parental consent. Negative parent-child relationships were also found to be related to depression in adolescence , suggestIn conclusion, many adolescents report symptoms of depression and anxiety but do not seek help in regular healthcare. This study aims to contribute to the evidence-based preventive treatment of emotional problems in adolescents by investigating problem-solving self-help therapy via Internet.The authors declare that they have no competing interests.PC and HMK obtained funding for the study. All authors contributed to the design of the study and the adaptation of the Internet-based PST intervention. WH coordinates the recruitment of participants and data collection during the study. JS and WH supervise the Problem-Solving Therapy. WH wrote the manuscript. All authors contributed to the further writing of the manuscript. All authors read and approved the final manuscript."} -{"text": "Postpartum weight retention may contribute to the development of obesity. We studied whether individual counselling on diet and physical activity from 2 to 10 months postpartum has positive effects on diet and leisure time physical activity and increases the proportion of primiparas returning to their pre-pregnancy weight.A controlled trial including ninety-two postpartum primiparas was conducted in three intervention and three control child health clinics in primary health care in Finland. The intervention included individual counselling on diet and physical activity during five routine visits to a public health nurse; the controls received the usual care.In total, 50% of the intervention group and 30% of the control group returned to their pre-pregnancy weight (weight retention ≤ 0 kg) by 10 months postpartum (p = 0.06). The confounder-adjusted odds ratio for returning to pre-pregnancy weight was 3.89 for the intervention group compared with the controls. The mean proportion of high-fibre bread increased by 16.1% (95% CI 4.3–27.9) by 10 months postpartum in the intervention group compared with the controls when adjusted for confounders (p = 0.008). No significant differences were observed in changes in leisure time physical activity between the groups.The intervention increased the proportion of primiparas returning to pre-pregnancy weight and the proportion of high-fibre bread in their diet. Larger randomized controlled trials are needed to show whether counselling can improve dietary and leisure time physical activity habits in postpartum women and also to confirm the results concerning the effect on reducing postpartum weight retention.Current Controlled Trials ISRCTN21512277 In Finlormation . Postparormation . The aveormation .Excessive gestational weight gain is the primary risk factor for retaining weight in the postpartum period -6. OtherRelatively few weight loss interventions have been conducted among postpartum women. Only two of these studies aimed primarily to reduce postpartum weight retention ,13, whilThe aim of the study was to investigate whether individual counselling on diet and physical activity after pregnancy has positive effects on diet and leisure time physical activity (LTPA) and increases the proportion of primiparas who return to their pre-pregnancy weight by 10 months postpartum. This study is a part of a pilot study testing the feasibility of the study protocol for a larger study also including pregnant women .The postpartum women were recruited through the child health care system, which is available to all families with children in every municipality in Finland and is funded by public tax revenue. Almost all (98%) children attend these public child health clinics (CC) for regular check-ups, as concluded from the proportion of children who are immunized according to immunization schedules under the age of two . The stuAll PHNs from the intervention clinics and the control clinics participated in the study (n = 8 and n = 6 respectively). Before the intervention began, the PHNs of the intervention clinics were trained in applying the counselling procedures, data collection and other study arrangements by the research group . The PHNs were also asked to practise the counselling between the training sessions with at least one client not participating in the study. The experiences were shared in small group sessions. The PHNs of the control clinics were trained for data collection and other study arrangements . All PHNs received a handbook in which the tasks for each research visit were explained and summarized. The researchers visited the clinics monthly during the intervention.All participants were primiparas. The exclusion criteria were age under 18 years, type 1 or type 2 diabetes mellitus, twin pregnancy, physical disability that prevents exercising, otherwise problematic pregnancy, substance abuse, treatment or clinical history of any psychiatric illness, inadequate language skills in Finnish and intention to change residence within three months. Between August 2004 and January 2005, the PHNs approached all postpartum primiparas in these six CCs and assessed their eligibility for the study either on their visit to the participant's home after delivery or on the first visit to the CC. All eligible women were asked to participate in the study. In total, 53 women in the intervention clinics and 39 women in the control clinics gave informed consent to participation , suggesting that the PHNs merely gave general advice on diet and physical activity rather than implementing actual counselling. During this study, the PHNs of the control clinics continued their usual physical activity and dietary counselling practices.The PHNs had brief discussions with the participants about pre-pregnancy body weight at the child's 2-month visit to the CC. If the pre-pregnancy weight was lower than the current weight, the PHN encouraged the participant to try to return to that weight with the help of dietary and physical activity objectives (see below) during the study period. Extensive weight loss programmes, however, were not recommended.The physical activity counselling consisted of one primary counselling session at the 2-month visit and four booster sessions at the 3, 5, 6 and 10 month visits. The counselling was implemented using the model of Laitakari and Asikainen , which iAccording to the physical activity recommendations for health and fitnAs a part of the LTPA plan, the participant had an option to attend supervised group exercise sessions held once a week for 45–60 min at a location close to each intervention clinic. The group exercise included both endurance and muscular training and it was developed specifically for postpartum women.Based on dietary recommendations ,28, a suThe dietary counselling consisted of one primary counselling session at the 3-month visit and three booster sessions at the 5, 6 and 10 month visits. The model of Laitakari and Asikainen was alsoThe main outcome for postpartum weight retention was the proportion of women returning to their pre-pregnancy weight (weight retention ≤0 kg) by 10 months postpartum. The dietary outcomes were changes in meal pattern , overall intake of vegetables, fruit and berries (portions/d), use of high-fibre bread and intake of high-sugar snacks (portions/d). The physical activity outcome was the change in the weekly METmin of LTPA.Body weight was measured in light clothing and without shoes at every CC visit related to the study. The scales were calibrated to the reference scale within ± 0.5 kg at the beginning and at the end of the study. Additionally, waist circumference was measured at these visits. Data on gestational weight development was obtained from the maternity card. Pre-pregnancy weight and height were self-reported.The baseline questionnaire including questions on background , dietary intake and LTPA was completed before the child's 2-month visit. The first LTPA and the dietary follow-up questionnaires were completed at the 5-month visit and the second follow-up questionnaires at the 10-month visit. These questionnaires were returned to the PHN, who checked that they were properly filled in. Information on dietary intake was obtained using a 57-item food frequency questionnaire that was a simplified version of the food frequency questionnaire used in the Health 2000 study in Finland . The bas2-test for categorised variables. Differences in the duration of exclusive and partial breastfeeding were tested using non-parametric Mann-Whitney U test, since these variables were not normally distributed. As there were missing values in the duration of breastfeeding for 11 women, an indicator variable together with the continuous breastfeeding variables was used in the multivariable analyses to prevent the loss of data. These background variables were used, when necessary, as covariates in the multivariable analyses regardless the statistical significance of the baseline differences.To test the baseline differences in background characteristics Table , t-test 2-test. The confounder-adjusted analysis of the proportions of women returning to pre-pregnancy weight, and retaining a maximum of 2 or 5 kg were done by using a logistic regression model. Analysis of covariance (ANCOVA) with confounding variables as covariates was used to test the between-group differences in average weight retention and waist circumference at 10 months postpartum, also changes in the dietary outcomes from 2 to 5 and to 10 months postpartum. As the weekly METmin were not normally distributed, they were converted into logarithms. The between-group differences of the log-transformed METmin variable at 5 and 10 months postpartum were analysed using ANCOVA of repeated measures. All statistical tests were two-sided and p < 0.05 was used as the level of statistical significance.The unadjusted differences between the groups in the proportions of women who returned to their pre-pregnancy weight were tested by χFigure In the intervention group, 43 (90%) women participated in all physical activity counselling sessions and 45 (94%) women in all dietary counselling sessions. All 48 women participated in the primary physical activity and dietary counselling sessions. Five women missed one physical activity booster session, three women missed one dietary booster session and three women missed the discussion about returning to pre-pregnancy weight. On average, the women participated in 4.9 of the five physical activity counselling sessions and in 3.9 of the four dietary counselling sessions. The average participation rate in the group exercise sessions was 50.7 % (sd 28.5) of the sessions available for each woman.The differences in the background characteristics were not statistically significant between the groups Table . There wFigure The proportion of high-fibre bread of total weekly amount of bread increased in the intervention group compared to the control group when adjusted for confounders Table . The meaThe unadjusted mean weekly METmin during leisure time were 2 328 (SD 1 308) in the intervention group and 2 061 (SD 975) in the control group before pregnancy (the baseline). At 10 months postpartum the values were 1 906 (SD 970) and 2 051 (SD 1 249) respectively. There were no statistically significant differences between the groups in changes in the weekly METmin from baseline to 5 or 10 months postpartum when adjusted for baseline weekly METmin, age, education, gestational weight gain and BMI at 2 months postpartum.This study aimed at reducing postpartum weight retention in primiparas by counselling them on diet and physical activity during five of the child's routine visits to a CC. We observed that a higher proportion of the women in the intervention group than in the control group returned to their pre-pregnancy weight by 10 months postpartum, when adjusted for confounders. However, among those women who did not return to their pre-pregnancy weight, the intervention group retained more weight than the control group on average. Therefore, the average weight retention was not lower in the intervention group than in the control group.The changes in dietary habits were modest, since only the mean proportion of high-fibre bread of total weekly amount of bread increased by 15–16 %-unit in the intervention group compared to controls from baseline to 5 and 10 months postpartum. This change corresponds e.g. to replacing one slice of low-fibre bread by one slice of high-fibre bread for every sixth slice consumed. No between-group differences were found in the intake of vegetables, fruit and berries or high-sugar snacks in favour of the intervention group. As the proportion of women having breakfast and a hot meal every day was already high at baseline, there was little potential to promote these habits by counselling. The counselling did not have an effect on the total amount of LTPA, possibly at least partly due to the fairly high level of LTPA at baseline (before pregnancy) or difficulties in arranging more time for LTPA in the new life situation.The results of this study mostly concur with the two earlier interventions aimed at reducing postpartum weight retention ,13. In bHowever, this study primarily piloted the study protocol for a larger study, which contributes to some limitations of this study. Firstly, the CCs were not randomized, which may have increased the baseline differences between the groups. The intervention group had slightly higher mean gestational weight gain and BMI, which are risk factors for high postpartum weight retention -6. AlthoIt is not clear why a higher proportion in the intervention group than in the control group returned to their pre-pregnancy weight as the effects of the intervention on dietary and LTPA habits were so minor. This discrepancy could be related to difficulties in assessing one's diet and LTPA accurately or to the limitations of our questionnaires not validated among postpartum women. The LTPA questionnaire may not have been sensitive enough in measuring changes, particularly in everyday light-intensity LTPA, which contributes significantly to the total energy expenditure. In addition, the intervention group may have decreased their total energy intake as a result of the dietary counselling, but it could not be measured by the semi-quantitative food frequency questionnaire. On the other hand, neither Leermakers et al. nor O'ToTo our knowledge, this was the first study conducted in a primary healthy care setting aiming to reduce postpartum weight retention by dietary and physical activity counselling. The PHNs implemented the five counselling sessions on the child's routine visits to the CC and therefore the participation rate at the counselling sessions was very high. The counselling focused on promoting healthy dietary and physical activity habits. Individual recommendations for energy intake and expenditure, and thereby for energy deficit , were not applied, because it would have been too complicated, especially as the time allocated for the counselling was short. It is possible that the women would have needed even more counselling or support to improve their dietary or physical activity habits. The time span between the last two booster sessions (4 months) may have been too long to motivate the women to adhere to the dietary and LTPA plans without support from their PHN. On the other hand, increasing the number of counselling sessions may not be feasible, since the time resources of the PHNs are limited and the main focus on the visits is on the infant's health and growth. It is possible that the presence of infants interfered with the counselling.The need for postpartum counselling and support for healthy diet and weight management has been emphasised in several papers -36. In pIntegrating individual dietary and physical activity counselling for mothers into the routine visits to CCs increased the proportion of postpartum primiparas returning to their pre-pregnancy weight, although it did not have an effect on the average weight retention. Larger randomized controlled trials are needed to show whether counselling can improve dietary and physical activity habits in postpartum women and also to confirm the results concerning the effect of counselling on reducing postpartum weight retention.The author(s) declare that they have no competing interests.TIK: study design, intervention protocols , acquisition of data, analysis and interpretation of data, and preparation of manuscript.MP: study design, intervention protocols, statistical methodology, analysis and interpretation of data, and preparation of manuscript.MA: study design, intervention protocols , acquisition of data, interpretation of data, and preparation of manuscript.MF: study design, intervention protocols, interpretation of data and preparation of manuscript.EW: study design, interpretation of data, and preparation of manuscript.RL: principal researcher, obtained funding, study concept and design, intervention protocols, interpretation of data, and preparation of manuscript.All authors read and approved the final manuscript."} -{"text": "We have previously reported that a one-year school-based exercise intervention program influences the accrual of bone mineral in pre-pubertal girls. This report aims to evaluate if also hip structure is affected, as geometry independent of bone mineral influences fracture risk.t-test between means and analyses of covariance (ANCOVA). Pearson's correlation test was used to evaluate associations between activity level and annual changes in FN. All children remained at Tanner stage 1 throughout the study.Fifty-three girls aged 7 – 9 years were included in a curriculum-based exercise intervention program comprising 40 minutes of general physical activity per school day (200 minutes/week). Fifty healthy age-matched girls who participated in the general Swedish physical education curriculum (60 minutes/week) served as controls. The hip was scanned by dual X-ray absorptiometry (DXA) and the hip structural analysis (HSA) software was applied to evaluate bone mineral content (BMC), areal bone mineral density (aBMD), periosteal and endosteal diameter, cortical thickness, cross-sectional moment of inertia (CSMI), section modulus (Z) and cross-sectional area (CSA) of the femoral neck (FN). Annual changes were compared. Group comparisons were done by independent student's No between-group differences were found during the 12 months study period for changes in the FN variables. The total duration of exercise during the year was not correlated with the changes in the FN traits.Evaluated by the DXA technique and the HSA software, a general one-year school-based exercise program for 7–9-year-old pre-pubertal girls seems not to influence the structure of the hip. Physical activity during growth is associated with benefits in bone mineral accrual and possibly bone structure -4, a cliThe Malmö Pediatric Osteoporosis Prevention (POP) study was conducted as a prospective controlled investigation of the impact of an exercise intervention on skeletal development in children from school start and onwards. The baseline measurements in the school, that was allocated as intervention school, were made before the intervention was initiated and the follow-up measurements one year later. Three neighboring control schools, allocated within the same city suburb, were evaluated in the same way, but the follow-up measurements of the control group were done in the same months but two years later. Due to lack of resources in our research laboratory, controls were re-measured first after two years. However, we accepted a two-year follow-up for the controls, because data in the literature imply that skeletal growth and accrual of bone mineral is linear in Tanner stage 1 and before the age of ten ,18-26. TThe four schools that were contacted agreed to participate. All four were located in the same part of the city in areas that were socio-economically similar; they were government funded; and allocation of pupils to the schools was done according to residential address. Before the intervention, they all used the Swedish standard curriculum for physical education (PE) to the same extent. After the four schools accepted participation, one of them was asked to be the intervention school and agreed to that. The intervention school modified its curriculum by increasing the number of PE classes; in other words, we did not choose a school that already had a high level of physical activity (PA) for its pupils. The other three schools were included as a control cohort. Furthermore, in order to ascertain whether there was any selection bias at baseline, we compared the girls who took part in the study with those who refused to participate. This was done by considering data on height, weight, and body mass index (BMI) obtained from the initial standard compulsory school health evaluation of first grade pupils. The drop-out analyses revealed that, based on data from the school records, there were no significant differences at baseline in height, weight, or BMI between girls who participated in the study and those who refused to take part ,9.In the intervention school, all 61 girls in grades 1 and 2 were invited to attend, and 55 agreed to participate (attendance rate 90%). We excluded one girl at baseline, because she was 11 months younger than the second-youngest girl. At follow up, one girl declined further participation. Therefore, a total of 53 girls with a mean age of 7.7 ± 0.6 (mean ± SD), (range 6.5–8.7), years at baseline were included in the intervention group. Sixty-four volunteers participated at baseline as controls. At follow-up, 13 had moved out of the region or declined further participation, and we excluded one girl because she was being treated with growth hormone. Thus a total of 50 girls with a mean age of 7.9 ± 0.6 (range 6.8–8.9) at baseline were included in the control group. All participants were healthy Caucasians who had no diseases and were not taking medications known to influence bone metabolism.The exercise intervention was initiated at the beginning of the school term after the baseline measurement. The program consisted of both indoor and outdoor physical activities that are ordinarily included in the PE curriculum in Swedish schools, such as running, jumping, climbing ropes, and playing a variety of ball games. The curriculum was supervised by the usual class teacher and was increased from 60 minutes per week to 200 minutes per week (40 minutes/day), thus no specific osteogenic training program was added. Furthermore, the teachers were instructed to vary the activities and sports, so that the children would not get bored by repetition. The aim was to minimize the number of dropouts, which has been reported to be fairly high during and after exercise intervention programs . The con®, Madison, WI) measurements the children were dressed in light clothes and no shoes. Paediatric software was used in all scans with children below 35 kg in weight. That is, the software was changed in some children between the different measurements. All standard image files of the proximal femur were analyzed by one technician, by use of the hip strength analysis (HSA) software. The software is provided by Lunar Instruments Corporation . Using this software the X-ray absorption data of the proximal femur is extracted from the output image data file and the bone mineral content and areal bone mineral density and its distribution within the FN calculated. First the operator has to manually define the center of the femoral head and place the FN axis as accurately as possible along the FN. Thereafter, the region of interest in the FN is placed in the proximal part of the FN, and finally the femoral shaft axis is defined centrally along the shaft. The software will then iteratively assess all cross sections in the FN region of interest and identify the plane with the least cross-sectional moment of inertia . CSMI is an estimate of the ability of the FN to withstand bending forces, and that value was calculated using the mass distribution derived from the absorption curve [2 = 0.96) [3) and cross-sectional area . The section modulus is also an estimate of the ability of the FN to withstand bending forces, and it was computed as CSMI divided by half the width of the FN. CSA is a measure of the resistance of the bone to axial forces, and it represents the area of mineral packed together in the defined cross section of the FN and is essentially proportional to the bone mineral content (BMC). In addition, endosteal diameter was estimated using the algorithm described by Thomas J. Beck [2 × FN length), where r = FN mid-diameter/2, assuming the FN to be cylindrical [During the dual X-ray absorptiometry . Automat J. Beck . Mean coindrical ,31.® phantom. The technicians in our research group performed all the measurements, and one technician conducted all software analyses. Total lean mass and total fat mass were estimated from the DXA total body scan. Body weight was measured to the nearest 0.1 kg using an electric scale, and height was determined to the nearest 0.5 cm using a wall-mounted measuring rod.The coefficient of variation (CV) was evaluated by duplicate measurements in 13 healthy children ages seven to fifteen (mean 10) years was found to be 1.4% for BMC, 1.6% for aBMD, 3.7% for total body fat mass, and 1.5% for total body lean mass. The CV values for the HSA analyses were 1.5% for FN periosteal diameter, 2.2% for FN CSA, and 6.2% for FN CSMI. The machine was calibrated daily with the LunarA questionnaire previously used in several studies but modified for pre-pubertal children ,33 was eInformed written consent was obtained from parents or guardians of participants prior to the study start. The study was approved by the Ethics Committee of Lund University , Sweden, and conducted according to the Helsinki Declaration of 2000. The Swedish Data Inspection Board approved both the data collection and database.t-test between means was used for group comparisons. Analyses of covariance (ANCOVA) were used to adjust for chronological age at baseline and increment in height and weight in the follow up evaluations to adjust any difference in growth. Pearson's correlation test was applied to correlate the total mean duration of physical activity, calculated as the mean of the total physical activity at baseline and at follow-up, with changes in the bone parameters during the study period. Statistical calculations were performed using Statistica®, version 6.1 (StatWin®). A p-value < 0.05 was defined as a statistically significant difference. With known annual growth in the evaluated parameters in Swedish children aged 7 years and with a significance level of p < 0.05 this study was powered to detect an annual difference in gain in BMC of 0.102 g/yrs, BMD of 0.019 g/cm2/yrs, vBMD of 0.011 g/cm3/yrs, neck length of 0.6 mm/yrs, periosteal width of 0.5 mm/yrs, CSA of 0.05 cm2/yrs, Z of 0.19 cm3/yrs, CSMI of 0.029 cm4/yrs, endosteal width of 0.5 mm/yrs and cortical thickness of 0.3 mm/yrs.Research has shown the technical problems when scanning small children based on inconsistency in limb positioning and location of the region of interest , we advoAs previously reported, the intervention group and the control group did not at baseline differ with regard to registered lifestyle factors or anthropometric parameters . After oThe mean values for the FN at baseline were 6.0% higher for aBMD (p = 0.04) and 7.0% higher for cortical thickness p = 0.02) in the intervention group as compared to the control group and magnetic resonance imaging (MRI) ,42, as tThe technical limitations of the HSA technique must also be highlighted. Inconsistent positioning of the limb or placement of the region of interest results in errors ,13. A smIt is also well known that differences in fat in the marrow or the soft tissue above, below or around the bones may affect the DXA bone variables . HoweverA one-year moderately intense school based exercise intervention program in pre-pubertal girls seems not to influence the by the DXA technique and HSA software estimated FN structure. Further studies are required to determine if an exercise program exceeding one year, a program with a higher intensity of training and a program in early peri-pubertal girls could be beneficial for the FN structure.The author(s) declare that they have no competing interests.Study design: MK and PG; Data collection: CL, JB and SSL; Statistical analyses and hip strength analyses and writing of the paper: GA, HA and MK. All authors read and approved the final manuscriptThe pre-publication history for this paper can be accessed here:"} -{"text": "Persons with cerebral palsy (CP) are at risk for developing an inactive lifestyle and often have poor fitness levels, which may lead to secondary health complications and diminished participation and quality of life. However, persons with CP also tend not to receive structural treatment to improve physical activity and fitness in adolescence, which is precisely the period when adult physical activity patterns are established.We aim to include 60 adolescents and young adults (16-24 years) with spastic CP. Participants will be randomly assigned to an intervention group or a control group . The intervention will last 6 months and consist of three parts; 1) counselling on daily physical activity; 2) physical fitness training; and 3) sports advice. To evaluate the effectiveness of the intervention, all participants will be measured before, during, directly after, and at 6 months following the intervention period. Primary outcome measures will be: 1) physical activity level, which will be measured objectively with an accelerometry-based activity monitor during 72 h and subjectively with the Physical Activity Scale for Individuals with Physical Disabilities; 2) aerobic fitness, which will be measured with a maximal ramp test on a bicycle or armcrank ergometer and a 6-minute walking or wheelchair test; 3) neuromuscular fitness, which will be measured with handheld dynamometry; and 4 body composition, which will be determined by measuring body mass, height, waist circumference, fat mass and lipid profile.This paper outlines the design, methodology and intervention of a multicenter randomized controlled trial (LEARN 2 MOVE 16-24) aimed at examining the effectiveness of an intervention that is intended to permanently increase physical activity levels and improve fitness levels of adolescents and young adults with CP by achieving a behavioral change toward a more active lifestyle.Dutch Trial Register; NTR1785 Cerebral palsy (CP) occurs in 1.5 to 3.0 of 1000 live births and is the most common cause of physical disability in pediatric rehabilitation medicine which caParticipation in regular physical activity (PA) provides psychological and physiological benefits in adolescents . In addiPersons develop their adult PA lifestyle in adolescence ,16. TherThe LEARN 2 MOVE 16-24 research project aims to evaluate the effectiveness and underlying working mechanisms on the short and long term of an Active Lifestyle and Sports Participation (ALSP) intervention. It is hypothesized that persons following the ALSP intervention will experience increased PA and improved physical fitness in both the short term and the long term (maintenance of effects) as the primary goal of the intervention is to achieve a behavioral change toward a more active lifestyle. The present paper describes the research design, methodology and intervention of the LEARN 2 MOVE 16-24 research project -25.Multicenter approval was granted by the Erasmus MC Medical Ethics Committee, The Netherlands. Local approval was granted by all participating centers.The study has a multicenter randomized controlled design. The experimental group will receive the ALSP intervention. The control group will receive no intervention to improve PA and fitness, which is current policy. Erasmus MC (Rotterdam), Rijndam Rehabilitation Center (Rotterdam), VU Medical Center (Amsterdam), Rehabilitation Center Amsterdam (Amsterdam), Rehabilitation Center De Hoogstraat (Utrecht) and Sophia Rehabilitation (Den Haag/Delft) will participate in this study.This study has a single-blind research design; all measurements will be performed by assessors who are blind for group allocation and who have no involvement in the recruitment, randomization procedure or intervention.The ALSP intervention and the research measurements will be performed at each participant's house and at two university medical centers and four rehabilitation centers from which all participants will be recruited.At least 50 participants are required to detect a difference of 30 minutes a day in PA level between the control and experimental group, with a power of 0.8 and an alpha of 0.05. To allow for dropouts, we aim to recruit at least 60 participants. This calculation is based on data from previous research conducted by our research group ,14.Adolescents and young adults with spastic unilateral or bilateral CP are eligible for inclusion if they meet each of the following criteria• Age 16 - 24 years• Gross Motor Functioning Classification System (GMFCS ) level IIndividuals will be excluded if they meet any of the following criteria• Disabilities other than CP that affect PA or fitness level• Contraindication for exercise• Severe cognitive disorders and insufficient comprehension of the Dutch language that preclude understanding the purpose of the project and its testing methods• PA level at baseline exceeds the mean PA level + 2 SD of a CP populationEach participating center will compile a list of its patients aged 16 - 24 years and diagnosed with CP. All patients will be checked on inclusion and exclusion criteria by their rehabilitation physician. An information letter and invitation to participate was sent to eligible participants. A second letter was sent 3 weeks later to non-responders.After baseline measurement, participants will be stratified according to their GMFCS level to obtain an equal distribution of gross motor functioning between the two groups. Within each stratum and for each participating center, participants will be randomly allocated (1:1) to the experimental or control group.The ALSP intervention lasts 6 months and was developed for adolescents and young adults with physical disabilities . It aims1. Counselling on daily PA2. Physical fitness training3. Sports adviceCounselling on daily PA is the main component of the intervention and consists of six individual counselling sessions over a period of 6 months with a PA counsellor who serves as a 'personal coach'. During these counselling sessions, participants will receive individual PA advice which primarily focuses on PA in daily life, and not necessarily on sports. The counselling sessions on daily PA are based on Motivational Interviewing (MI) which is defined as a directive, client-centered counselling style for eliciting behavioral changes by helping clients to explore and resolve ambivalence . TechniqPhysical fitness training will consist of 12 weekly supervised sessions and 12 home sessions. These training sessions of approximately one hour consist of aerobic endurance, aerobic interval and strength training. Over these 12 weeks, aerobic exercise duration and aerobic intensity (as determined by the Karvonen formula ) are graSports advice includes sports counselling and sport-specific training. Sports counselling is based on the Rehabilitation & Sports Program ,22. DuriThe International Classification of Functioning, Disability and Health (ICF) model provides a unified language and framework for the description of health and health-related states . This moTo objectively measure the level of daily PA the VitaMove (VM) system will be applied. This system is based on long-term ambulatory monitoring of signals from body-fixed accelerometers. This system consists of 3 to 5 recorders duration of dynamic activities as a percentage of a 24-hour period; (2) number of transitions ; (3) intensity of activities: (3a) mean motility ); (3b) motility during walking; (3c) motility during wheelchair-driving; and (4) distribution of continuous dynamic activity periods .The following data will be analyzed from these measurements: will be 2peak in ml·min-1 and ml·kg-1·min-1). Subjective strain will be measured immediately after the final stage by the Borg Scale for Rating of Perceived Exertion [The aerobic capacity will be measured during a maximal ramp protocol. This test will be performed on an electronically braked cycle ergometer or electronically braked armcrank ergometer depending on the main mode of ambulation during daily life, as this elicits the highest oxygen uptake . The tesExertion . DetermiExertion .The 6 minute walking test will be Muscle strength will be measured with a hand-held dynamometer using the \"break\" testing method. The strength of the hip flexors, hip abductors and knee extensors will be measured in individuals whose main mode of ambulation is walking. The strength of shoulder abductors and elbow extensors will be measured in non-ambulant individuals. The applicator of the dynamometer is held against the distal part of the limb segment, and participants will be asked to build up their maximum force against it. When maximum is reached the examiner applies sufficient resistance to overcome the force exerted by the participant. Both the left and right side will be measured. The lever arm from the joint to the dynamometer will be kept constant by marking the position of the dynamometer on each participant's leg. Each trial lasts approximately 4 seconds, and three repetitions will be performed with 1 minute of rest in between. The average value of the three repetitions will be analyzed.-2) will be calculated from height and body mass. Waist circumference (cm) will be measured mid-way between the lowest rib and the iliac crest while standing. Waist circumference will be measured in a sitting position in persons using a wheelchair. Thickness of four skin folds will be measured twice on the left side of the body with a Harpenden calliper . The mean of the two measurements will be used as representative. Percentage body fat will be predicted from skin fold thickness according to the method of Durnin and Womersley [Height will be measured barefoot in a standing position. In case of joint contractures, measurements will be performed from joint to joint in a lying position. Body mass of ambulatory participants will be obtained while standing barefoot on a scale and of non-ambulatory participants while sitting on an electronic scale. Body mass index , selectTo evaluate the change in PA level and physical fitness, as well as the secondary outcome measures, multilevel regression analyses will be applied, because these analyses allow for missing values. Another advantage of these analyses is that patient data can be clustered within the participating centers. For all multilevel analyses, MLwiN software will be used.This paper outlines the design, methodology and intervention of a multicenter randomized controlled trial that examines the effectiveness of an intervention that aims to achieve a permanent increase in PA level and improve the fitness level of adolescents and young adults with CP by promoting a behavioral change toward a more active lifestyle. The results of this trial are expected to be presented in 2012.The authors declare that they have no competing interests.The work presented here was a collaboration between all the authors. JS and RB drafted the manuscript. JS, RB and MR have made substantial contributions to the conceptualization and the design of the study and defined the research theme. JM, WS, HR, EL and HS have made valuable contributions to the conceptualization and the design of the study and contributed to the manuscript by revising it critically for important intellectual content. All authors have seen and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2431/10/79/prepub"} -{"text": "In menopausal women, the term quality-of-life incorporates its physical symptoms such as hot flushes, night sweats and vaginal mucosa dryness. We set out this study in order to evaluate the effect of education on the quality-of-life and the improvement of health standards in menopausal women.Women are one of the most important parts of the family and society, and community health is dependent on provision of the needs of this group. Menopause is one of the most critical stages of life among women. One of the aims of health services for all of the people in the 21Sixty-two women aged 44–55 referring to and academic outpatient clinic in Shiraz were selected by simple random sampling, and allocated in two groups. Data was collected using a modified Hildich questionnaire on quality-of-life in menopause stage. Quality-of-life of the subjects were evaluated prior to and 3 months after educational intervention.P = 0.001). A significant difference was seen between groups in terms of changing quality-of-life after intervention (P = 0.001).Mean quality-of-life score in study and control groups, prior to education, was 81.7 and 74.8; changing to 75.3 and 75.8, respectively three months after intervention. The study group showed a significant improvement in their quality-of-life (Appropriate training to menopausal women improves their quality-of-life and promotes their health. Women are among the most important part of any society and family, and community health provision is dependent on the fulfillment of different health needs. On the other hand, menopause is one of the most critical stages of women health. Definingst century is to improve quality-of-life. in Shiraz was evaluated during 2007–2008. The Medical Research Ethics Committee of Shiraz University of Medical Sciences approved the study. All of participants signed informed consent and they were assured of guarantees of confidentiality and anonymity during and after the study.From power calculation, by means of a prior pilot study, 31 women in each treatment group with at least 25 completing the study were needed for 95% power to detect at least 5% difference in the quality-of-life.Patients considered for this study were healthy, premenopause or menopause women. InclusioScores for quality-of-life in the study and control groups were evaluated and compared in two stages both between and within the groups as changes before and after education.In order to collect data on quality-of-life, we used a questionnaire containing 29 questions about quality-of-life in menopause designed by Hilditch. The qualet al. study (13). Using Likert scoring method, each question could be scored by 6 points . Hereby, the total scores for vasomotor aspects were from 2 to 12, for psychosocial aspects were from 6 to 36, for physical aspects were from 16 to 96 and for sexual aspects were from 2 to 12. The total score of quality-of-life for each participant could be from 26 (the lowest level) to 156 (the highest level) points. The more the scores decreased, the better the quality-of-life became (13).Of all questions in the original Hilditch questionnaire, we selected and utilized 26 questions in this study . According to the scoring system of original version of Menopause Specific Quality of Life Questionnaire (MENQOL), each question should have been scored by 8 points. However, because of the similarities among some points, two points were omitted in Rotem Regarding the perception of our participants, their culture and the period of conducting the study, we had to modify the questionnaire in order to make time and cultural adaptation. We omitted three questions from the original MENQOL questionnaire: the item ‘sweating’ was omitted from vasomotor domain, because half of the study was carried out during the end of spring and beginning of summer and the weather was warm-to-hot during the study. If we had put the item ‘sweating’, participants might probably have misreported the daily sweating due to warm weather, not real flashes; because of the different perceptions that Iranian people have, the item ‘avoiding intimacy’ was omitted from sexual domain; it might have been misinterpreted by each of participants and they might have been confused between emotional intimacy, physical intimacy and sexual intimacy; the item ‘dissatisfaction with my personal life’ was skipped from psycho-social domain, because so many factors are influencing the personal life and these factors differ from person to person and community to community. Regarding these changes, we rechecked the validity and reliability of new modified questionnaire. We proceeded to evaluate our modified questionnaire and six-point scoring system. By recruiting a panel of experts to review the test specifications and the selection of items, the content validity of modified questionnaire was approved. The experts were able to review the items and comment on whether the items cover a representative sample of each domain. Moreover, using modified questionnaire, we did a pilot study on 25 menopausal women referring to an outpatient clinic and Cronbach α approved the reliability of questionnaire (0.85).Participants randomly allocated in two groups as control and study groups in the following way: we listed all of the eligible people and assigned each member of the population a numerical label. Then, using a random table, we pointed a finger on the table in order to choose an arbitrary and random starting point. The one, who possessed that number, was the first participant in study group. Next, we moved across the row of numbers to the very next number to select the first subject in control group. If the next number was less than 62, it was taken as a sample. We continued and assigned every other number to each of the groups until we had two groups that had 31 participants in each of them.After an initial evaluation and estimation of educational needs, educational intervention was performed weekly, for six consecutive weeks; each section lasted 45–60 min, sittings in the form of eight-person discussion groups. The content of the educational sessions were following: to give information about female genital organs, the definition of menopause and how it happens (the first session); to describe the symptoms and complications of menopause (the second session); to offer some approaches in order to diminish menopausal complications (the third and fourth session); to present training programs on exercise and its effect on the menopausal symptoms (the fifth session); and to describe muscle relaxation techniques and its effects on the severity of menopausal complications (the sixth session). At the end of each session, the summary of the instructed program was delivered to participants and at the end of the whole period of education, a booklet containing all of presented programs accompanied with the CD for relaxation techniques were given to the participants in the study group.The control group received no education and they had no contact with study personnel (or other participants) beyond recruitment and data collection.At third month after intervention, entire participants of two groups completed the MENQOL questionnaires.t-test in order to compare the mean scores for diverse criteria within groups before and after the study. Independent t-test was used in order to compare the mean scores between groups before and after the study. Chi-square test was used for determining the differences among demographic status between groups and the quality-of-life measures in relation to age, the mean age at menopause and level of education. A P value less than 0.05 was considered as statistically significant.Data was processed using SPSS version 11.5 for windows. We used paired P > 0.05) [Thirty-one women in each study group completed the study. The mean age of participants was 50.63 ± 2.7. The demographic status of both study groups were evaluated at the baseline and there were no statistically significant differences in all baseline parameters between groups ( > 0.05) .P = 0.004). In the control group, comparing the scores before study, after study showed a statistically significant drop (P = 0.004).After educational intervention, a salient improvement was seen in the mean score for vasomotor symptoms compared to the scores prior to intervention (P = 0.001). However, in the control group a significant deterioration was registered (P = 0.001).The score for psychosocial function in the study group improved after intervention (P = 0.001). In the control group, it showed a significant negative growth (P = 0.001).Three months after intervention, mean scores for physical wellbeing compared to base scores in the study group showed a significant improvement (P = 0.001). Whereas, control group showed a significant opposite movement (P = 0.001).In terms of sexual health, the study group showed a significant improvement (P = 0.001). Nevertheless, control group showed a significant deterioration in their sense of wellbeing (P = 0.001) [Three months after education, score for quality-of-life in the study group was improved significantly (= 0.001) .P = 0.001) [There was a statistically significant difference between study and control groups, three months after educational intervention, according to the mean score for vasomotor symptoms, psychosocial aspect, physical wellbeing, sexual health and quality-of-life (= 0.001) .The goal of the present intervention was improving quality-of-life. As a rule, simple but effective interventions would be beneficial for all kinds of diseases and discomforts.Setting a random sampling and using self-administered questionnaires that the researcher did not have any role in completing them, we aimed to conduct a bias-free study. Using discussion group and putting participants in touch with the others, women were able to talk with each other about their experiences.et al. study in Ecuador,. Many studies have shown that differences in demographic characteristics could affect the women's quality of lives. According to Peter Chedraui Ecuador, the qual Ecuador,Due to the finding in our study that the majority of subjects had a lower level of education and a lack of proper sources of information , the need for planning and implementation of an educational program becomes more apparent.P = 0.004) and the difference between post-intervention scores of the study group and those of the control group was significant (P = 0.001). Therefore, it can be said that the intervention led to an improvement in vasomotor symptoms of the study group. Our findings are similar to those of Booth-Laforce et al.,; while the control group had a significant deterioration. Likewise the comparison of mean score, in the same aspect, showed a significant difference between the study and control groups after intervention (0.001). Therefore, the applied intervention led to improvement of psychosocial status in participants. This finding is similar to the result of Elavsky et al.(et al.(Our finding showed a significant improvement in psychosocial wellbeing in the study group, three months after intervention (ky et al. study, wl.(et al. who repoet al.(Following betterment in hot flashes, the study group showed a significant improvement in sexual health, which their changes were significantly better than that of the control group. Lobo et al. pointed et al. in Nigeret al.(Quality-of-life improved significantly in the study group following intervention while the controls significantly regressed in the same. The mean scores in the study group, in addition, were significantly better following their education. This finding confirms that of Keefer et al. who repoThe finding of this study asserted that the four aspects of quality-of-life well improved after educational intervention, and the education can cause an improvement in the quality-of-life by decreasing the problems of menopause stage and lowering their intensity,. Therefore, the urgency of need to planning and implementing an appropriate educational program is emphasized in order to promote the quality-of-life in this group of people.This study was conducted to evaluate the effect of education on the quality-of-life and the improvement of health standards in menopausal women. Our findings showed that an appropriate training to menopausal women can improve their quality-of-life and promote their health."} -{"text": "Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings themselves perceive autonomy in daily life. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on residents' own wishes for daily activities.A total of 9 nursing homes and 55 participants aged 65 years or older were included in the study. All the participants were restricted in performing at least one P-ADL activity unassisted and had a Mini Mental State Examination-score above 16. Perceived autonomy was measured at baseline, after 12 weeks and after 24 weeks by The Autonomy Sub-dimension in the Measure of Actualisation of Potential test. Programmes were based on participants' individual assessment of their most important daily activities. Staff at all nursing homes who usually organize physical training, social or creative activities carried out individually tailored programmes using their usual methods and equipment. Participants in each nursing home were divided by lot into either a control group or an intervention group. The control groups received their usual care and treatment.This study is designed to assess the status of perceived autonomy at baseline and to provide information about the effectiveness of individually tailored programmes according to perceptions of autonomy registered in institutionalised physically frail older people. This will add knowledge to assist response to present and future challenges in relation to health promotion initiatives for this group.NCT00783055 The development of elderly care services is of prime concern across Europe due to demographic trends which show an increasing elderly population . The DanPerceived lack of control has been found to be injurious to older peoples' physical and mental health, and when despite their frailty older people experience autonomy they become more alert both mentally and physically and their self-rated well-being improves -8. Due tWhen older people are exposed to changes such as moving into a nursing home their physical and psychological problems ,9 and feThe concept of autonomy is often used interchangeably with the experience of having choices and being in control. Perceived lack of control has been found to be detrimental to physical and mental health , and, whIt is generally acknowledged that frail older people in nursing home settings to some degree are restricted in the execution of their choices and wishes. This calls for a more specified definition of the concept of autonomy that takes frailty and thereby dependency into consideration. According to Agich 'There is no opposition to dependency – not when one relies on others in a way that is consistent with one's sense of self-worth and identity' . A numbeThe sense of control over their activities exerts a positive influence on older adults' well-being ,30 even Research demonstrates that it is possible to experience autonomy while being dependent on assistance, and that older people's perception of independence changes with the process of functional decline. It is, therefore, not only their actual performance but also their ability to make meaningful choices and decisions that are of importance . HoweverThe aim of the present study is to assess the short-term (0–12 weeks) and long-term (12–24 weeks) changes of an individually tailored programme based on residents' own wishes for activity on their perceived autonomy.The study was approved by The Regional Scientific Ethical Committee in Denmark No. 2004-1-52 and The Danish Data Protection Agency.This study is the Danish part of a Nordic multi-centre study, where the aim is to describe the impact of individually tailored programmes in nursing home settings on residents' physical functioning, dependence in ADL and self-rated well-being. The multi-centre study includes three Nordic countries and is initiated and designed by a group of Swedish researchers.A number of physical and mental tests are carried out and information on age, diseases, medicine, aids and length of staying at the nursing home is registered. In the Danish part of the study, a test has been added in order to measure perceived autonomy before and after the intervention period. This paper concentrates only on the assessment of the status of perceived autonomy and the effect of individually tailored programmes on perceived autonomy among physically frail older people in nursing home settings. The individual programmes are based on the participants' individual wishes according to the specific daily activities they wish to improve, to preserve and/or to revive.The intervention group participated in a 12 – week programme, whereas the control group received their usual care and treatment. After a 6 month period they were offered an individual programme according to their wishes for activities received an invitation letter informing about the project. The nursing homes were situated in a large geographical area of Denmark including rural areas, larger cities and the capital of Denmark. Invitations were sent in four rounds during a one and a half-year period from February 2005 to June 2006. A total of 20 nursing homes responded and of these 9 wanted to participate. The 9 nursing homes represent both small and larger nursing homes and are geographically placed in both the countryside and in cities.Residents, relatives and staff from all involved nursing homes attended information meetings. Local politicians were also present at some of the meetings. Information about participation, duration of the study and clarification of the staff's roles were on the agenda and if necessary the meetings were repeated in order to ensure that everybody was informed.Physically frail elderly nursing home residents were recruited directly at the above mentioned information meetings or at a visit conducted by a well-known staff member in their home. The staff at each nursing home was responsible for informing participants face to face and for collecting the signed informed consent. Participants were informed about randomisation to either an intervention or a control group.Aged 65 years or older, participants with all kinds of diseases leading to physical frailty ensuring an unselected case-mix, dependence on daily assistance in minimum one P-ADL activity , able to understand verbal instructions, willing to participate, expected to live in the nursing home during the intervention period. Both men and women.Terminal stages of disease, MMSE-score below 16 .Participants were divided by lot into either a control group or an intervention group.The randomisation was stratified according to sex.The intervention groups participated in individually tailored 12 – week programmes, whereas the control groups received usual care and treatment.Participants' identity and group allocation were only identifiable for the researcher.Blinded research assistants did the testing. Previous training sessions for testers and the use of scripts during the testing had to ensure that all participants received the same instructions.A total of 55 older people were included according to the autonomy study of which 50 participated.A number of measures were collected for the purpose of characterising the total cohort at baseline, in terms of age, sex, length of stay in the nursing home, most frequent diseases, most frequent medicine prescribed and walking/mobility aids Table .Five participants dropped out: three from the control group and two from the intervention group. Typical reasons for drop – out were withdrawal due to either aggravation of disease or death.Descriptions of Danish nursing home residents are scarce and therefore the following characteristics are based on the one existing and recent study by Beck et al which chIn general, the staff comprises of nurses, auxiliary nurses, cleaning staff, occupational therapists, physiotherapists and volunteers.inside is that a reception area leads to corridors with front doors to residents' individual flats. Further, a corridor leads to common areas such as dining rooms, café, training facilities etc. Residents rent their own individual flat with a bathroom, a kitchen and a living room/bedroom. The outside environment usually has a common garden area with benches and flowers.Typical of the physical environment Daily life is characterised by schedules for most activities such as mealtimes, bedtimes, physical training, social or creative activities.preserving residents' autonomy.Nursing homes have to list their moral values – often on the nursing home's own website – and the list frequently includes Although there were some differences, all 9 nursing homes included in this study complied with the earlier mentioned regulations about housing for the frail and old. Among the differences was for example the fact that some only consisted of a ground level while others had more floors. Some were less accessible regarding distance, e.g. to the front door, garden, training facilities and dining room.In a few nursing homes occupational therapists and physiotherapists were employed by the local community council to serve more than one nursing home and therefore not able to be present in the nursing home on a daily basis.The Autonomy Sub-dimension in the MAP test [Perceived autonomy was measured at T1, T2 and T3 by using tential) -33. The tential) -33.With permission from the Canadian authors, The Autonomy Subscale was validated to be used in Denmark by the researcher under statistical supervision in 2005.The Autonomy Sub-dimension can be used separately and represents a subjective measure which elucidates perceived autonomy. Six items are scored on a 5 – point Likert type scale and the test is performed as a paper and pencil test where the tester and the participant are sitting at the same side of the table. The tester reads the text and the participant chooses the response. Each sentence is read out loud in order to avoid misunderstandings.low, average or high degree of autonomy.The mean of all six scores forms the result and is categorised as either: The testing procedure involved a training programme concerning testing procedures in order to assure a high inter-rater reliability. The training programme ran over a three – week period and involved a thorough verbal and written presentation of test material and a manual, exercises, feed-back and de-briefing.type, with whom, where, duration per time and frequency per day/week.Staff at each nursing home who usually organizes physical training, social or creative activities carried out the individual programmes for the intervention groups utilizing their usual methods and equipment. The individual programme was planned together with the participant. Furthermore, the staff registered the participant's activities in terms of: The statistical analytical program SPSS version 15.0 and 16.0 will be used for registration, analysis and presentation of data.The changes from 0–12 weeks and 12–24 weeks within the two groups separately will be assessed using paired t-test and/or Wilcoxon rank sum test for variables not fulfilling the normal distribution of residuals. Furthermore, bar charts will be made for delta values for the changes from 0–12 weeks and 12–24 weeks.The analyses will be performed according to the intention-to-treat principle, and carried out using a regression model incorporating difference in changes , and controlling for baseline values, e.g. age and gender.Furthermore, the content of the individual programmes and participants' activity wishes will be analysed using a thematic analysis.Participants of this study represent a group of people who might be in a deficit of stimulation due to being physically frail and institutionalised. Therefore, changes in the control groups are expected.Statistical significance is set at p < 0.05.The statistics will be performed in cooperation with The Research Unit for Statistics, Faculty of Health Sciences at The University of Southern Denmark.Sample size estimations were initially based on the calculations done for the Nordic multicenter study. These estimations show that to obtain a power of at least 80% and a significance level of 5%, 60 participants in each group are sufficient. No previous studies have investigated the effect of individually tailored programmes on perceived autonomy and thus it was difficult to determine an appropriate sample size. Therefore it was decided to recruit the largest possible number of subjects and aim for at least 60 in each group.Many studies concerning autonomy in nursing home settings focus either primarily on the staff perspective or evaluate how staff and residents perceive autonomy in pre-defined areas of daily life. A recent European study including five countries argues, in agreement with many other studies, that comparison of nurses' and residents' views on autonomy reflect different results . HoweverIf the results of this study are promising, future efforts might be directed at developing guidelines for more effective approaches to ensure frail older institutionalised peoples' autonomy in daily life. The hypothesis is that these efforts will lead not only to experiences of autonomy but also to enhanced mobility, independence, participation and well-being.The authors declare that they have no competing interests.Both authors contributed to the design of the study and wrote the paper together. MA administered the study, was responsible for collecting the data and for performing the statistical analyses. LP provided guidance and supervision during the whole process. Both authors contributed significantly to the preparation of the paper, and read and approved the final version.The pre-publication history for this paper can be accessed here:"} -{"text": "Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Māori.This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants.Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.Australian New Zealand Clinical Trials Registry (ACTRN12609000937213) Globally, acute respiratory infections (ARI) cause more deaths and hospitalisations among Indigenous children compared with their age-matched counterparts; the greatest impact is among young children aged 0-4 years . SpecifiWhile there are multiple socioeconomic determinants of ARIs among Indigenous children, environmental tobacco smoke (ETS) exposure is arguably the most readily amenable to modification. The adverse health effects of ETS are well documented, especially its association with respiratory illness. The association between parental smoking and childhood respiratory disease is strongest at younger ages . In chilIn recognition of the damaging health effects of ETS, the World Health Organization (WHO) has prioritised the need to reduce parental smoking as a core component of improving health and development in early childhood . This isDespite the recognition of the adverse child health effects of ETS and the scale of the problem among disadvantaged populations in particular, exposure reduction in homes is a relatively recent area of scientific study . A recenThis study aims to test the efficacy of a culturally appropriate, family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and NZ.Infants (<12 months) of Indigenous mothers/caregivers who receive an intensive family-centred tobacco control program about ETS, compared with 'usual care,' will have fewer health care presentations for respiratory illness.The primary objective of this study is to determine the efficacy of a family-centred tobacco control program about ETS, to reduce health care presentations for respiratory illness in Indigenous infants in the first year of life. Secondary objectives include assessment of the effect of such a program on a range of measures of infant ETS exposure, including mother/caregiver's self-report of infant exposure to ETS and implementation of smoking restrictions in the home and/or car, infant urinary cotinine, household smoking status, mother/caregiver's smoking cessation and quit attempts. A process evaluation of the family-centred tobacco control program will also be undertaken.This study will be a parallel, randomized controlled study with allocation concealed from the study researchers. Participants will be randomly allocated to one of two study arms: the 'intervention' group who will receive the tobacco control program about ETS exposure over three home visits in the first three months of the infant's life, or the control group who will receive 'usual care' (i.e. they will not receive the tobacco control program). IHWs will be trained to deliver the intervention program, the goal of which is to reduce or eliminate exposure of infants to ETS. Data collection will occur at baseline (shortly after birth), and when the infant is four months and one year of age. The primary outcome of interest is the rate of health care presentations for doctor-diagnosed respiratory illness. Figure This study will be conducted in Darwin City and the Greater Darwin area in the Northern Territory, Australia; and within the Counties Manukau District Health Board region, Manukau City, NZ. The target populations for this study are Indigenous families who reside in these two geographical areas. The sampling unit is Indigenous newborn infants and their mothers/primary caregivers (aged 16 years and over).Infants will be eligible for inclusion if:• They are aged between 0-5 weeks. • Their mother/caregiver is Indigenous .• Their mother/caregiver is aged 16 years or over.• Their mother/caregiver currently smokes or the infant lives in a household where there is at least one other person who smokes (defined as smoking at least weekly).• Their mother/caregiver plans to reside permanently with the infant in Darwin or Greater Darwin areas of Australia or within the Counties Manukau District Health Board region, Manukau, NZ.• Their mother/caregiver has given signed written consent to participate in this research study.• Their mother/caregiver has given signed written consent for study staff to access the infant's health records.• They are a singleton or the first born in a multiple pregnancy delivery.• Their mother/caregiver speaks English and/or Māori.Infants will be excluded from the trial if:• They have serious neonatal respiratory complications .• They have other serious neonatal complications .• They have major organ abnormalities .The above exclusion criteria are because these infants will be given intense interventions to reduce ETS exposure regardless. Infants will also be excluded if:• Their mother/caregiver has previously been recruited in this research study.• They live in the same household as a mother/caregiver who has previously been recruited in this study.Participants will be randomized by computer with stratification using permuted blocks by country and infant age . This will ensure a balance in these key prognostic indicators between the intervention and control groups. All participants (i.e. the infants) will be assigned a unique registration number allocated by a central computer following the submission of their details on a web-based form.This is an assessor blinded trial, with only the study researchers assigning the major primary and secondary outcome measures and trial statisticians blinded to group assignment. Research assistants, who will be responsible for collecting the minor outcome measures will accompany the health workers to the participants' homes for all visits and thus cannot be blinded. The primary outcome will however be a double-blinded measure.Globally, Indigenous notions of health and illness are generally defined more broadly than a Western biomedical definition that focuses more often on physical health or the absence of disease . In AustIn this study, the intervention program about ETS will be framed around an Indigenous model of health promotion, which attends to the psychological, physical, spiritual and cultural wellbeing of the individual and the family/community, as it relates to this project. In NZ, Te Whare Tapa Wha will be used. This model has been applied to understanding Māori smoking cessation behaviour and for Participants will be told that they will be randomly assigned to a group that receives 'usual care', or a group that receives extra home visits by an IHW, and that a variety of study measurements will be taken over a 12-month period.Treatment group: The intervention program will (i) provide information and education about the health effects of ETS exposure and use behavioural 'coaching' techniques to help mothers/caregivers and family members implement strategies to reduce the infant's ETS exposure, as well as (ii) identify the smokers among other household members and deliver culturally appropriate smoking cessation advice, counselling and treatment options as requested. An eight weeks supply of free nicotine replacement therapy (NRT) (patches or gum) will be available to participants and other household members for whom such drug therapy is indicated . NRT will be provided by the IHW with appropriate counselling and follow-up. Furthermore, for those that are interested a fax referral to Quitline will be offered, with proactive call back by Quitline.• The intervention program will be delivered during three face-to-face home visits (of approximately 45-60 minutes) conducted over the first three months of the infant's life. Culturally appropriate resources will be used to assist in both education and behavioural 'coaching'. These resources will be obtained from relevant health groups in each country who hold a repository of such resources . IHWs will deliver the program after appropriate training, and will complete standardised progress reports after each program session, which will be used at a weekly team meeting with the health workers and study personnel for discussion and ongoing training.Control group: The control group will receive 'usual' care through their community health provider. Usual care entails routine visits to maternal and child health providers at several defined time points during the first 12 months of the infant's life. At these postnatal visits, health providers check developmental milestones and general wellbeing. Additionally, mothers/caregivers routinely receive messages about smoking cessation and ETS exposure in their homes during these visits as part of general health promotion.• In addition to the above, the IHWs will briefly check that both groups have received the 'usual' care delivered to new mothers and their infants through routine 'well baby' visits in the first 12 months of life through their standard health provider . This will be undertaken at baseline, when the infant is four months and one year of age. The focus will be on key health promotion messages that should have been delivered at routine community health visits Mothers/caregivers will be given a few key messages if they have not received this information, e.g. clear face, sleep on back for SIDS prevention. If these visits have not been attended or if the key messages have not been received by the mothers/caregivers, they will be referred back to their usual maternal and child health provider.Rate of health provider presentations for new primary episodes of ARI in the first year of life.Primary Outcome: All participating infants will be evaluated at baseline and when the infant is four and 12 months old, for the occurrence of medically attended acute respiratory illnesses (MAARI). These are defined as new onset events, including a change from the child's baseline medical status, referable to the upper and/or lower respiratory tracts. To identify episodes of ARI mothers/caregivers will be asked at baseline, and when the infant is four and 12 months old, whether their child has had any presentation to the clinic or hospital and the names of the clinics attended. Research assistants will collect the source data relevant to the primary outcome measures, so will review the individual child's health provider and hospital clinic records . Source documents will be photocopied, de-identified, labeled with the participant registration, and stored with the trial records. Two clinicians at each study centre will review the records and confirm documented respiratory illnesses without knowing the group allocation of the individual children. MAARI events will be evaluated by these clinicians to determine whether they are medically-attended upper respiratory infection (URI), lower respiratory infection (LRI) and/or otitis media infection .▪ Mother/caregiver's self-report of smoking restrictions in the home and car.▪ Mother/caregiver's self-report of smoking cessation: defined as mother/caregiver not smoking a single cigarette (not even a puff), in the preceding seven days. We will also be assessing prolonged abstinence .▪ Mother/caregiver's self-report of number quit attempts: defined as not smoking a cigarette for at least 24 hours.▪ Process evaluation indicators: a mix of quantitative and qualitative measures to assess how well the intervention program was implemented according to protocol e.g. number of 'coaching' activities completed, obstacles and successes in delivering program, parent satisfaction with the program.▪ A total sample size of 190 provides 90% power (5% significance) to detect a 25% reduction of new episodes of respiratory illness (primary outcome) in the intervention group compared to the control group. This is based on a conservative estimate of an average of 3 health provider visits per year in the control group, compared to an average of 2.25 visits in the intervention group . There are few published data on the community burden of ARIs in Northern Territory Indigenous children or NZ Māori children. In a recent study of disease burden and clinic attendances for young Indigenous children in two remote Northern Territory communities, the median number of presentations for upper respiratory illness in the first year of life was 7.5 (interquartile range 4-11) and for lower respiratory illness, 2.5 (interquartile range 1-5) . The oveIn Australia and NZ, mothers/caregivers will be approached for recruitment into the study through a range of community, Indigenous-controlled health and government hospital services. We will approach both pregnant women and new mothers to ascertain their interest in participating in the trial. If pregnant women are interested in the study, we will re-approach them after they have given birth. Eligible and interested mothers will be asked for their consent for randomization. Documented written consent will be obtained from all participants prior to entering the study. A range of project-specific advertising material will be produced and local Indigenous media may be used to bolster recruitment.In 2006, there were approximately 240 Indigenous infants born to mothers who were resident in Darwin, Australia. We anticipate that 90% or 216 Indigenous infants/mothers will be eligible for recruitment annually into this study. In a separate study based in Darwin to improve ear health outcomes, 55% of Indigenous women approached in pregnancy have consented to participate in a randomized controlled vaccine study . Using these figures, we could confidently anticipate that approximately 108 eligible Indigenous mothers will agree to participate in our study each year, or 9 per month. This is likely to be an underestimation, as our proposed study is less invasive than the ongoing vaccine trial (which requires immunisation and repeated blood samples).It is anticipated that recruitment will be faster at the Auckland site owing to a larger eligible population. Approximately 580 babies are born each month at Middlemore Hospital, of which 21% are Māori . Data reported in 2003 showed that about 55% of Māori pregnant women in NZ were smoking at the time of conception, and 15% of these women quit smoking during their pregnancy From theFigure Participants may be withdrawn from the study if one or more of the following occurs:• Voluntary withdrawal: A parent or primary caregiver can voluntarily withdraw their infant from the project at any time without having to provide a reason for doing so.• Failure to meet eligibility criteria: An infant will be withdrawn from the project if their mother/caregiver has previously signed a consent form but they do not meet all the eligibility criteria at the baseline visit (when the infant is five weeks old +/- one week).• Failure to be located after multiple follow-up home visits• Death of infant• Significant illness requiring prolonged hospitalization• A serious and irreconcilable protocol violation (as determined by the Investigators)In the event that a study participant dies, their family contact will be asked if they require the information recorded to be disposed of as per other participants at the completion of the study, or whether they wish the information to be returned to the family.The design and management of all databases associated with this trial will be undertaken by the data management and information technology groups at the Clinical Trials Research Unit (CTRU), University of Auckland. The databases will be constructed in Oracle. Validation rules for each Case Report Form (CRF) will be specified by the site study managers, in association with the CTRU data manager. These rules will include range checks so that inaccuracies in data collection can be identified early. A query will be raised as soon as any values are entered that are outside the allowed range or if data are missing. The research assistants at each site will amend the CRF's as soon as a query is raised. All information collected from participants will be treated as strictly confidential. De-identified data will be stored in computers under a password secure file. Paper records will be stored under numerical code in a locked filing cabinet within a secure office area, and will only be accesses by approved study staff.An independent person will be appointed to monitor the study conduct. This monitor will audit both Australia and NZ study sites and the CTRU during the trial to ensure that the study protocol is being adhered to.At the study sites the monitor will audit every randomized participant's records to ensure their existence, that they meet the inclusion criteria and have provided written and signed informed consent, and that the NRT is been distributed within the limits of the protocol. The monitor will review the study documentation and records held at each site to ensure that (1) documentation is up-to-date [i.e. correct version of protocol and Manual of Procedures] and (2) record keeping meets the requirements specified in the protocol and complies with regulatory requirements. The monitor will visit each site early on during the study (after ten participants have been randomized), at study close-out and once during the course of the trial. At least 10% of paper copies of the CRF's will be checked for consistency with the electronic records by the monitor. 100% of electronic ARI endpoint data will be checked against source data.The monitor will audit the sites which hold the NRT to check that NRT supply records are in order and that there are sufficient supplies remaining, that the NRT are being stored appropriately and are not being used beyond expiry dates, and that the handling of unused NRT complies with study procedures.A Data Safety and Monitoring Committee will not be established as the trial does not meet any of the criteria stipulated by Ellenburg et al. (2002) for setting up such a Committee .a priori in a statistical analysis plan prepared by the study statistician . No planned interim analyses will be undertaken of the outcome data. A baseline data paper will be prepared after all baseline data for both countries has been collected. The number of episodes of ARI experienced after the intervention for each group will be analysed on an \"intention to treat\" basis. Each of the primary and secondary outcome variables will be examined separately. There are no plans to combine outcome variables into composite variables. Data will be analysed for each country separately and combined. All ETS exposure variables will be treated and examined as outcome variables, rather than as co-variates of the primary outcome variable. Intra-rater and inter-country agreement for grading of the primary outcome assessment will be assessed using the Kappa statistic (unweighted), with 95% confidence intervals for the kappa statistic calculated using the method described by Altman [Statistical analyses will be performed by statisticians at the CTRU. The statistical unit at Menzies School of Health Research (Menzies) will play an advisory role. Data from the trial will be entered into an Oracle database at the CTRU, and then extracted into SAS version 9.2 (SAS Institute Inc. Cary NC), and R version 2.8.1 for analysis. Data analyses will be specified y Altman .All known potential confounders will be measured at baseline, including mother/caregiver's smoking status (and stage of change), education level, marital status, breastfeeding status, smoking status of partner and other household members, crowding, and exposure of infant to other sources of environmental smoke . Thus, comparisons of the intervention and control groups will be performed both unadjusted and adjusted for these known confounders. This second adjusted analysis will control for any maldistribution after randomisation of the confounders between the two groups.Analysis of the primary outcome will involve comparing the rate of respiratory illness between the two groups. Simple unadjusted rates, relative risks and 95% confidence intervals will be obtained in the first instance, with subsequent multiple regression analysis adjusting for other variables. Two forms of regression analysis will be considered for the primary outcome: poisson regression analysis and negative binomial if there is evidence of overdispersion or underdispersion. Analysis of secondary outcomes will be conducted using standard statistical procedures applicable to categorical or continuous data. A per-protocol analysis will also be performed in order to check the robustness of the results. All tests of significance will be two-tailed.For treatment effects, sensitivity analyses will be carried out to determine the effect of missing data.The study will be conducted in accordance with the Australian National Health and Medical Research Council Guidelines on 'Ethical Matters in Aboriginal and Torres Strait Islander Health Research in Australia' . In AustProject Managers will be responsible for the day to day management of the trial, one in Darwin and the other in Auckland. The Project Managers' responsibilities include the development of Standard Operating Procedures, maintaining an up-to-date collection of essential documents (in line with GCP requirements), monitoring recruitment rates, attending to participant queries or concerns and managing the fieldwork staff.Two IHWs in each country will be responsible for recruiting participants into the study and for delivering the 'intervention' program, as well as collecting process evaluation data. The development of Indigenous research workforce capacity is a vital aspect of this trial. Research assistants will collect urine samples and administer the face-to-face questionnaire to participants. They will also be responsible for data entry and data cleaning, and together with the IHWs, ensure that participant follow-up appointments are completed during the scheduled window periods.Two clinical investigators in Darwin and Auckland will review participating infants' clinical notes and code the clinical outcome data.Exposure to ETS is a strong but potentially preventable contributor to respiratory illness among young Indigenous children, when household ETS exposure of children is at its peak. Interventions aimed at encouraging smoking cessation as well as reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. This community-based, international trial has been designed to provide high-quality evidence of the efficacy of a theoretically and culturally sound, intensive family-centred tobacco control program to reduce ETS exposure among Indigenous peoples and so reduce the burden of ARI. As such, it will make a valuable contribution to future updates of the Cochrane review of family and carer smoking control programmes for reducing children's exposure to environmental tobacco smoke. The inclusion of a process evaluation as part of the study will inform the progress and shed additional light on the outcomes of the trial. Finally, this study seeks to incorporate Indigenous models of health to inform the design of the intervention and recruitment methods, and emphasizes Indigenous capacity building at all levels.ARI: Acute respiratory illness; ETS: Environmental tobacco smoke; sometimes referred to as second hand smoke. Usually refers to cigarette smoke in the environment of people who do not smoke; CTRU: Clinical Trials Research Unit; Auckland, NZ; IHW: Indigenous health worker - either Aboriginal or Torres Strait Islander or Māori; Menzies: Menzies School of Health Research, Darwin, Australia; NRT: Nicotine replacement therapy, available in a range of forms such as patch, gum lozenges, tablets and nasal spray. In this research study, NRT will be dispensed in the form of nicotine patches and/or gum only.The authors declare that they have no competing interests.VJ is an Australian Investigator. She contributed to the study design and drafted the first version of the study protocol. She has led the development of the intervention program, the questionnaires and the study set-up in Australia. NW is the Principal Investigator for this trial in NZ. She contributed to developing and writing the final version of the study protocol. She has contributed to the development of the study questionnaires and has led the study set-up in NZ. DT is the Principal Investigator for the trial in Australia. He contributed to the study design and drafting of the study protocol. MG is a Māori health researcher in NZ, and a co-investigator on this study. She was instrumental in developing the culturally appropriate intervention program and contributed to the development of the final study protocol. She led the consultative process with Māori and assisted with the recruitment and training of the Māori IHWs and research assistants. AC is an Australian Investigator. She originally conceived of the study and contributed to the study design. CB is a NZ Investigator and contributed to developing and writing the final version of the study protocol, especially in relation to the definition of the primary outcome. PM is an Australia Investigator. He contributed to the conception and design of the study. NB is an Aboriginal health researcher and an Australian Co-investigator. She contributed to the study design, particularly in relation to developing a culturally appropriate intervention and in providing advice on recruitment and retention of Indigenous families in Darwin. SV is a NZ Investigator. He is the trial statistician, and contributed to the protocol in matters relating to randomisation, study power and statistical analyses. RB is an Australian Investigator and contributed to the development of the questionnaire to assess the secondary outcomes for the study. CS is an Australian Investigator and contributed to the conception of the study. She also provided expert input initially into the questionnaire design. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin. TM is an Australian Investigator and contributed to the development of the intervention program and training of the Australian IHWs. DF is a NZ Investigator. She contributed to the study protocol, the development of the intervention program, and advice on recruitment and retention of Indigenous families in South Auckland. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin. All authors have provided critical review of this manuscript and have approved the final protocol.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/114/prepubCase Definitions for Acute Respiratory Infection. A table providing full definitions of acute respiratory infection for this studyClick here for file"} -{"text": "Physical activity (PA) rates decline precipitously during the high school years and are consistently lower among adolescent girls than adolescent boys. Due to cultural barriers, this problem might be exacerbated in female Iranian adolescents. However, little intervention research has been conducted to try to increase PA participation rates with this population. Because PA interventions in schools have the potential to reach many children and adolescents, this study reports on PA intervention research conducted in all-female Iranian high schools.A randomized controlled trial was conducted to examine the effects of two six-month tailored interventions on potential determinants of PA and PA behavior. Students (N = 161) were randomly allocated to one of three conditions: an intervention based on Pender's Health Promotion model (HP), an intervention based on an integration of the health promotion model and selected constructs from the Transtheoretical model (THP), and a control group (CON). Measures were administered prior to the intervention, at post-intervention and at a six-month follow-up.Repeated measure ANOVAs showed a significant interaction between group and time for perceived benefits, self efficacy, interpersonal norms, social support, behavioral processes, and PA behavior, indicating that both intervention groups significantly improved across the 24-week intervention, whereas the control group did not. Participants in the THP group showed greater use of counter conditioning and stimulus control at post-intervention and at follow-up. While there were no significant differences in PA between the HP and CON groups at follow-up, a significant difference was still found between the THP and the CON group.This study provides the first evidence of the effectiveness of a PA intervention based on Pender's HP model combined with selected aspects of the TTM on potential determinants to increase PA among Iranian high school girls. Regular physical activity (PA) has a beneficial effect on overall health and is iThe physiological and psychosocial changes experienced during the high school years may make adolescence a particularly high-risk period for girls to adopt sedentary habits . HoweverTheory-based research is necessary to conduct school-based interventions and one potentially useful theory is Pender's Health Promotion Model (HPM). This model is derived from Bandura's Social Cognitive Theory (SCT) and inclOf particular interest to the current research, competing preferences are viewed as alternative behaviors with powerful reinforcing properties over which individuals exert a relatively high level of control. They are last-minute urges based on one's preference hierarchy that can derail a plan of action for positive health action. For example, \"giving in\" to a competing preference might include watching television or playing computer games rather than being physically active. Individuals vary in their ability to sustain attention and avoid disruption of health behaviors but in general, the inhibition of competing preferences requires the exercise of control capabilities. In the HPM, competing preferences are proposed to directly affect the probability of occurrence of behavior as well as moderating the effect of commitment .Another model that can be applied to this research area is the transtheoretical model of behavior change (TTM), which includes the stages of change that a person moves through when adopting a behavior and the processes of change used in the stages to help in the adoption of a new behavior. The framework proposes that individuals move through a temporal sequence of five stages: pre-contemplation , contemplation , preparation , action , and maintenance (active for more than 6 months) . Marcus As no single theory can account for all complexities associated with behavior change, integration across major theories is recommended in research . TherefoResearchers have identified the importance of designing targeted interventions that address the needs of specific populations. Due to cultural barriers that prevent Iranian women from exercising in public places and do not encourage PA in general, research is needed to establish ways to help adolescent Iranian females to develop and sustain active lifestyles. Therefore, the purpose of this study was to evaluate the post-intervention and six month follow-up effects of a tailored PA intervention for Iranian adolescent girls based on the Pender's health promotion model (HPM) and selected constructs from the transtheoretical model (TTM), using a randomized control trial within schools as the medium for the intervention. Three groups were included in the study: an HPM intervention group with HPM interventions addressing stages of behavior change, an HPM with two TTM processes added group (THP), and a control group who received their usual PE program. The main study hypothesis was that the integrated model would result in improved PA maintenance. It was further hypothesized that the THP group would result in greater increases in PA-related cognitions and PA participation compared to the HPM only group.All three groups completed questionnaires prior to the start of the interventions, immediately following the intervention, and six months after the end of the interventions. The research was approved by the Tarbiat Modares University ethics board and the appropriate educational authorities. Prior to participation, investigators sent a written information sheet and consent form for the parents and participants to sign.Participants came from three, all female, Iranian, public secondary schools that were randomly selected using a random number table from a possible 31 schools in the area. All selected schools chose to participate. The teachers were all female and all schools were from the same socioeconomic background. Participants within the schools were eligible for inclusion in this study if they were in the preparation stage of exercise behavior change at baseline and were in grades nine or ten . This inclusion criterion was used because it is participants in the preparation stage who are recommended for recruitment to exercise programs as they are most likely to benefit . FurtherAll the instruments were translated into Persian by a bilingual researcher and then validated using standard back translation technique by a natIntervention study questionnaires were administered by the researcher to students in their classrooms. The investigator remained in the room during questionnaire administration and answered any questions. For each of the next six consecutive days following questionnaire administration (Saturday through Thursday) each participant completed a child/adolescent/activity log (CAAL) .Stage of change was assessed using an adapted two question measure . In the Perceived self-efficacy was adapted from an existing exercise self-efficacy scale . This scPA was assessed using a modified child/adolescent activity log (CAAL) . The CAAs = .76 to .77, P < 0.001).The discriminant validity of the log in this study was supported by the stages of change. As expected, those adolescents who were in later stages reported more minutes of PA (M = 62.88 min ± 27.05 min) than those in earlier stages . Furthermore, stage of change and total number of minutes and mean of minutes activity per week on the CAAL were significantly correlated which included 18 items measuring both benefits and barriers . Each item was measured on a 4-point Likert scale ranging from 1 to 4 (very true) . The meaThree subscales developed by Garcia and colleagues were usePA preferences were measured by a scale based on Pender's instrument for measuring variables in the health promotion model . The 9-iCounter conditioning and stimulus control process of change questions were adapted from a questionnaire developed by Marcus and colleagues . IndividThe various components of the interventions, the timeline, constructs targeted and educational methods used are outlined in Table The THP group also received education on the two processes of change: counter conditioning and stimulus control. The counter conditioning education included information on walking or bicycling to school or the store instead of using the bus, getting on or off the bus several blocks away from the destination, taking the stairs instead of the elevator, and taking fitness break by walking or doing desk exercises instead of taking a sedentary coffee break. The stimulus control training included tips on how to change one's environment by posting motivating messages and by removing things in the environment that contribute to inactivity. The control group received no educational or counseling sessions but did receive the educational pamphlets after administration of the final follow-up questionnaires.In addition to the educational sessions, each participant from the two intervention groups received a 20 to 25 minute individual counseling session based on personal responses to the questionnaire at baseline, and at the fourth, tenth, and eighteenth weeks of the intervention. These counseling sessions helped the participants to set and review personal PA goals, to determine strategies to overcome barriers to PA, and to review her social network. Each participant was also provided with a reminder card of her goals and asked to display the card in a suitable place at home or in her school notebook.th week (68% participation) and one at the 18th week (71% participation) of the intervention were held with the participants' mothers to help the mothers understand the benefits of PA, to highlight the importance of social support, and to help them when they tried to help their daughters reach their PA goals. Further, during the 22nd week of the intervention, each participant was telephoned by the researcher to encourage the participant to maintain her PA and to further discuss her PA goals. During the last week of the intervention the participants went mountaineering with their mothers and teachers, a popular means to be active in Iran, to further encourage PA and social support in the participants.Teachers in the two intervention schools attended sessions aimed at educating them about the intervention models and the importance of social support and modeling. This was done so the teachers could provide role modeling by doing exercise in the schools and could also provide support to help the participants to reach their PA goals. Two 60 minute sessions, one at the 102. For all analyses alpha levels were set at p < 0.05.The analyses were conducted with the Statistical Package for the Social Sciences (SPSS), version 15.0. Variables were assessed for normality of distribution and logarithmic transformations were performed on self-efficacy, social support and mean PA whereas square root transformations were performed on perceived barriers, stimulus control and preferences. Where assumptions of homogeneity of variance and sphericity could not be satisfied, non-parametric tests were used. At post-test and follow-up, stages of readiness to change PA behavior were merged into two categories: pre-action and action (action and maintenance). This decision was made because at follow-up 40 percent of cells had an expected count of less than five. Although there was not a similar limitation at post-intervention, groups were also collapsed at that time so that equivalent analyses could be conducted. Chi-square tests were used to compare these categories between the three groups at post-intervention and follow-up. Progression in the stages through the time points for the three groups was compared using the Friedman test. Changes in outcome variables from baseline through post intervention and follow-up were assessed by a repeated measure ANOVA to determine differences between intervention groups. Where significant interactions were found, follow-up univariate analyses of covariance (ANCOVA) were conducted to reveal main effects. In these analyses the baseline measures were included as the covariate with the follow-up variable as the dependent variable. All post hoc tests were performed with adjustment for multiple comparisons and intervention effect sizes were calculated using Partial ηX2 (4) = 51.61, p = 0.001, and at follow-up, X2(4) = 20.2, p = 0.001. There was a statistically significant increase in the number of participants in both THP and HP groups who progressed through the stages from baseline to follow-up (Friedman X2 (2) = 49.6, 2 p < .001, and X2 (2) = 43.1, p = 0 .001), whereas limited progression occurred in the control group (X2 (2) = 1.90, p = .38). At the six-month follow-up the THP group had a larger percentage of participants in the action stages than the HP group. The percentage of participants in each stage at posttest and follow-up is summarized in Table Demographic characteristics at baseline are summarized in Table p = .000, η2 = .16, stimulus control, F = 14.82, p = .000, η2 = .15, overall minutes PA per week, F = 31.50, p = .000, η2 = .29 and mean minutes PA per day, F = 39.94, p = .000, η2 = .34. It was noted that the assumption of homogeneity of variance was not met for stimulus control, counter conditioning and mean PA per day. However, equivalent non-parametric analyses revealed similar significant results. Post hoc analyses showed that the differences for counter conditioning and stimulus control were not significant between the THP and HP groups but there were significant differences between the two intervention groups and the control group (p = .003 – .006).Table p = .001, stimulus control, F = 14.02, p = .04, overall minutes PA per week, F = 4.32, p = .01, and mean minutes PA per day, F = 5.0, p = .008. At follow-up, results showed no significant differences between the THP and HP groups for any of above outcomes except stimulus control p = .02, but the two intervention groups and the control group differed for both behavioral processes (p = .000 – .02). No significant differences were found between the HP and control group for overall minutes and mean of PA.There was no significant difference between the THP and HP groups for overall and mean PA minutes. However, students in both intervention groups reported significantly more PA than students in the control group. Main effects tests by group at follow-up, controlling for the differences in baseline values, found significant differences for counter conditioning, F = 7.83, p = .000) and a decrease between post-intervention and follow-up (p = .004). There was also an increase for stimulus control between baseline and follow-up for the THP and HP groups (p = .001 and .004 respectively). Using the same procedure for counter conditioning showed the THP group had a significant increase between baseline, post-intervention (p = .000) and follow-up (p = .04). However, there was a significant decrease in counter conditioning between post-intervention and follow-up (p = .001). Main effects tests for time showed that the two intervention groups had significantly increased their mean PA between baseline and post-intervention (p = .000) and also from baseline to follow-up (p = .000).Main effects for time showed that the THP group had a significant increase for stimulus control between baseline and post-intervention from the TTM in conjunction within the HPM would result in greater increases in PA related cognitions and PA behavior. This integration of models was hypothesized to address the lack of consideration of environmental influences within the HPM and acknowledges the substantial body of research showing that TTM tailored interventions can promote an individual's progression through stages -37. All As already mentioned, participants in the THP group also reported more PA at post intervention than the HP group, although these differences were not statistically significant. At the end of intervention period both the THP and HP groups reported spending about one hour more in activity per day compared to participants in the control group who increased their activity by only six minutes per day compared to baseline. This finding is likely related to the overall advancement into action stages by participants in both intervention groups because a number of other researchers have found that participants in the action stages reported more PA than those are in the pre-action stages -37. WhilSubstantial relapses in behavior are generally observed in many intervention studies \"when the intensive intervention ends and external supports are withdrawn\" . TherefoA unique aspect of this research was the involvement of the participants' teachers and mothers with the intention of changing cultural norms and providing vicarious learning for the participants through observing important others engaged in PA. As noted in the introduction, the cultural norms for Iranian females to be active are restrictive. Therefore, it may be that by asking the participants' teachers and mothers to encourage the participants to be more active and to express their expectations that the girls be more active, a shift occurred around social norms for the participants within this study. However, it also may be that changes occurred due to peer learning and further research is required to clarify this finding. In general however, this is an extremely encouraging finding that can be used when creating interventions with similar populations.Another important strength of the current study was the duration of the intervention (24 weeks) and the inclusion of follow-up assessments. To achieve significant changes in deeply entrenched behaviors, interventions among adolescents should last longer than one semester . While pThere were several limitations of the present study. First, the data were measured by self-report questionnaire which introduces the possibility of biased results. Another limitation is the assessment of the validity of the CAAL and it is recommended that the CAAL be further validated with an objective measure in Iranian adolescents. It should be noted however, that test-retest reliability of the CAAL in this study was .98. Another limitation is the restriction of these interventions to participants in the preparation stage at baseline. Future research should expand these interventions to include participants at other stages of change at baseline. Such research would also necessitate expanding to other processes of change such as consciousness raising for participants in precontemplation.Outcome evaluation showed a positive short-term effect for the intervention groups on stage of readiness, potential determinants of PA and on amount of PA, as both intervention groups increased their PA by approximately one hour per day. Although participants in the THP group reported using more behavioral processes than those in the HP group, no significant differences were found between the THP and HP groups for PA at the post intervention. However, the THP group recorded more PA and more positive results on most of the potential determinants compared to the control group and therefore appears to be the stronger intervention. At the six month follow-up, PA levels had decreased from posttest and fewer students in both intervention groups were in the action stages of behavior change. However, the significant differences between the HP and control groups for PA were not present at the six-month follow-up, but some differences between the THP and control groups were still present indicating that this was the stronger intervention.Iranian girls face many barriers to an active lifestyle, including lack of suitable places to be active, access to facilities and resources, cultural limitations, and the low importance placed on exercising over other activities such as doing homework or home responsibilities. Therefore, access to equipment and facilities and a supportive environment are important strategies for promoting PA among this group of adolescents . Indeed,The author(s) declare that they have no competing interests.PT participated in the design of the study, performed the statistical analysis and drafted the manuscript. TB participated in the statistical analysis, helped to draft the manuscript, and read the paper critically for theoretical content and interpretation of study findings. DL participated in the sequence alignment and helped to draft the manuscript. SN and FG conceived of the study and participated in its design and coordination. All authors read and approved the final manuscript."} -{"text": "The prevalence of overweight and obesity (OW/OB) among adolescents worldwide has increased since the 60 s. Spain has reached one of the highest OW/OB prevalence rates among adolescents from European countries. The aim of this methodological paper is to describe the design and evaluation in the EVASYON study .st to 9th visits), and extensive during the last 11 months (10th to 20th visits). In order to assess the efficacy of the treatment, 8 dimensions were measured: diet; physical activity and fitness; eating behaviour; body composition; haematological profile; metabolic profile; minerals and vitamins; immuno-inflammatory markers. Moreover, genetic polymorphisms were also determined.The EVASYON was planned by a multidisciplinary team to treat OW/OB in Spanish adolescents. The EVASYON is a multi-centre study conducted in 5 hospitals in 5 Spanish cities and two hundred and four OW/OB Spanish adolescents were recruited for this intervention. The treatment was implemented for approximately one-year follow-up. The adolescents were treated in groups of a maximum of 10 subjects; each group had 20 visits during the treatment period in two phases: intensive during the first 2 months (1The treatment programme developed in the EVASYON study was designed as a national pilot study to be implemented as an effective treatment for adolescents with OW/OB into the Spanish Health Care Service. Adolescence is characterized by important changes in body size and composition. Obesity started to appear as a public health problem in the last decades of the 20th century ; currentOverweight prevalence among adolescents around the world has increased since the 1960s. Approximately 14-15% of all 15-yr-old youngsters in the United States may be classified as obese . OverweiIt is widely accepted that treating childhood overweight is an important contribution to the multilevel response to the obesity epidemic . EffectiThe main aims of the EVASYON study were: 1) to develop a treatment programme including education on nutrition and physical activity, 2) to implement this programme for one year in Spanish adolescents with overweight and obesity and 3) to evaluate its efficacy.For comparative and popularization purposes with previous and future studies, the aim of this paper was to describe the design and evaluation methods during the EVASYON study.The design of the EVASYON Study is an interventional study in a cohort of overweight and obese adolescents aged 13 to 16 years. Despite the lack of control group, we aim to assess the determinants of the treatment effectiveness.In order to estimate the sample size, we considered the results obtained in the AVENA study, a multicenter evaluation of the nutritional status of Spanish adolescents , showed Before starting the EVASYON programme, a screening was performed of all candidates. Several inclusion criteria were defined to homogenize sample characteristics. Inclusion criteria in the EVASYON programme are shown in Table Nine measurement categories were assessed: 1) Diet; 2) Physical activity and health-related physical fitness; 3) Psychological profile; 4) Body composition; 5) Haematological profile; 6) Biochemistry and metabolic profiles; 7) Mineral and vitamin profile; 8) Immunological profile; 9) Genetic profile.All the parameters of each measurement category, excluding genetic profile were assessed at least at four points Figure : baselinA trained dietician conducted face-to-face interviews with participants and their parents at the beginning of the programme and visits 1, 9, and 20 . Nutrient intake scores were computed with and om Spain ,31.Physical activity was assessed applying a combination of methods. Participants in the EVASYON study wore the ActiGraph GT1M activity monitor . The ActiGraph GT1M is a small and lightweight uniaxial accelerometer validated widely in laboratory and free-living conditions with children and adolescents . AccordiIn the EVASYON study, health-related physical fitness was assessed using the validated and standardized tests included in the EUROFIT and FITN2max may be estimated with the Leger equation.The progressive 20-m shuttle-run test published by Leger and Lambert in 1982 and revised in 1988 is one o©; Takei, Tokyo, Japan). Dynamometer was adjusted by sex and hand size for each subject [Subjects perform the test in a standard bipedal position and with the arm in complete extension without touching any part of the body with the hand-dynamometer as fast as possible.Proposed in the FITNESSGRAM battery, this test measures the flexibility of the hamstring muscles. The test is performed with a standard and sturdy box with a scale on the top of the box. Back-saver sit and reach is similar to the traditional sit and reach except that the measurement is performed on one side at a time, so each side has its individual score.The questionnaires used during the EVASYON Study were the following:In order to assess self-esteem, the AF-5 multidimThe ABOS scale was developed to evaluate patient's symptoms based on the relatives' description of the subject's eating behaviour. This test is useful in a clinical setting for evaluation of patients with eating disorders. The original version evaluateEDI-2 is a self-report instrument that assesses the cognitive and behavioural characteristics commonly found in individuals with eating disorders . It is oThe anthropometry protocol used in the EVASYON study was identical to the standardized protocol used in the AVENA study with more than 2000 Spanish adolescents .2). Skinfold thickness were measured on the left side of the body [Each measurement was taken three times but not consecutively. A complete set of measurements was performed and then repeated twice more. Weight and height are obtained by standardized procedures. Body mass index is calculated as weigh/height squared the subject contracts muscle biceps as much as possible, and the tape is passed around the arm so that it touches the skin surrounding the maximum circumference. To measure the waist circumference, the tape is applied horizontally midway between the lowest rib margin and the iliac crest, at the end of gentle expiration. The hip circumference measurement is taken at the point yielding the maximum circumference over the buttocks, with the tape held in a horizontal plane. Proximal thigh circumference is measured just below the gluteal fold and perpendicular to its long axis; the subject stands erect with the feet slightly apart and the body mass evenly distributed between both legs. In addition to the anthropometry measurements, in Zaragoza and Granada, we used laboratory techniques. Participants in these cities (n≈80) were assessed by bioelectrical impedance (BIA), and dual energy X-ray absortiometry (DXA). BOD PODPubertal development was assessed according to the five established Tanner stages . Each stBlood pressure was measured using a validated digital automatic blood pressure monitor according to the International Protocol of the European Society of Hypertension .Blood collection was performed upon an empty stomach between 8 and 10 AM, after fasting for 10 h. Health state of human volunteers was optimal for blood sample collection.In all cases, blood was extracted from the antecubital vein 21.5 mL). Blood collection was carried out by experienced clinical staff. Blood samples were divided into aliquots as follows: 1.5 mL in EDTA tube , 10 mL in EDTA tube (for plasma extraction) and 10 mL in gel containing tube (for serum extraction). To avoid erroneous values due to sample deterioration, blood cell counts and differentials were analyzed in the laboratories of each hospital that participated in this study. Within 1-h of collection, blood was centrifuged and aliquots of plasma or serum were stored at -80°C. Serum samples were sent to each laboratory at convenient time intervals . Haematological, lipidic-metabolic, vitamins, immunological and genetic studies were centralized in each participating laboratory. The parameters included in each of these categories are presented in Tables 1.5 mL. B®, Bio Rad Diagnostics Group, Irvine, CA, USA) was used to assess precision. Na+, Cl- and K+ were measured with an electrolyte analyser . Urine samples were diluted 2:1 (urine: diluent) with diluent for urine S2490 . QualitycheckTM S2480 and S2470 were used as internal standards to assess precision. Urine total volume and pH were also monitored.48 h urine samples were collected coinciding with the two last days of 72 h dietary records. Subjects were given detailed verbal and written instructions about how to collect a complete 48 h urine sample and given 3 L sterile plastic bottles. Collection began with the second urine of the second day and ended with the first urine of the last day of 72 h dietary record. Urine creatinine concentration was determined by kinetic Jaffe reaction on a Cobas centrifugal analyser . Urinary Ca was determined by atomic absorption spectrometry . Phosphorous was analysed by photocolorimetry . Quantitative urine control and the EEC Good Clinical Practice recommendations , and current Spanish legislation regulating clinical research in humans . The study was approved by the Ethics Committee of each hospital that participated in this project and by the Ethics Committee of the Spanish Council for Scientific Research (CSIC). The study was explained to the participants before starting, and the volunteers, parents or tutors signed an informed consent.Access to the database was restricted to the researchers that participated in this study. Therefore, the information obtained in the study was considered as confidential, although the sanitary authorities have full access rights for inspection purposes.The studied parameters are treated considering some fixed variability factors: gender, age, tanner, BMI classification . AttendaFirstly, an assessment of missing data and the identification of potential outliers are carried out. The statistic processes is as follows:1) Univariate descriptive analysis, study of data distribution, basic statistics such as central and dispersion values. The interrelationship among variables is assessed by studying the correlation coefficients on the basis of their distribution and their association to those groups defined upon random and fixed factors. Pair comparison tests with previous analysis of the homogeneity of variance are used. Chi-Squared tests and exact probability calculations are also performed to study the relationship among qualitative variables.2) General lineal models for each point in time and as a function of time . Multivariate models are used from different perspectives: classical regression models and continuous or categorical principal component analysis are used to describe multivariate interrelationship among selected variables. Also, multivariate analyses are used to predict the intervention success at a selected period of time and at the end of the study by variables that measure the health improvement of the patients.The analysis of the data will be done using the statistical packages SPSS and SAS.The EVASYON study develops, for the first time in Spain, a multidisciplinary treatment programme for adolescents with overweight and obesity that is aimed at all possibly involved areas of the individual, such as dietary habits, physical activity and cognitive and psychological profiles, in order to prevent the development, in an immediate future and in the long term, of chronic diseases associated with obesity such as diabetes, hypertension, cardiovascular diseases, metabolic syndrome, etc. Health-related researchers who participate in this study expect that the programme, once its efficacy has been proved, may be applicable in any hospital or clinic from the Spanish System of Health with a multidisciplinary group consisting of paediatricians, endocrinologists, psychiatrists, psychologists, physical activity specialists and dieticians.The EVASYON study is essentially characterized for being a multidisciplinary and multicentre project. Thus, both the assessment of the efficacy and the protocols of the treatment have been developed by professionals in each of the specific fields: psychology, nutrition, physical activity, fitness, paediatrics, body composition, genetics, immunology and biochemistry. Moreover, the study has been conducted in 5 hospitals from 5 Spanish cities, respectively . Adaptation of the protocol for 5 different hospitals had as principal advantage that the treatment programme potentially will be easier to implement in any healthcare centre of the Spanish Health Care Service.Nonetheless, organizing a single educational treatment for all the centres and the assessment protocols was a complex process. Training workshops for all the EVASYON members, who were going to take part in the programme and in the assessment, were conducted to unify criteria and to test the methodologies presented in this article before beginning the study. One pilot group in each hospital served to solve starting-up problems in the treatment programme, doubts, human and technical resources and coordination with adolescents and their families. Some decisions were also made in the workshops on how to send blood samples, protocols of physical fitness test to carry out in hospitals, possible postbariatric surgery or follow-up of participants after the study ended.The EVASYON study has both strengths and weaknesses. Several strengths that the EVASYON study presents are as follows: 1) the sample size achieved of 204 adolescents with overweight and obesity provides an acceptable statistical power to conduct multivariable analysis . Few studies performed in clinical settings have recruited, to our knowledge, a greater number of participants than the EVASYON study -26 the dThe EVASYON study also involves weaknesses that must be taken into account: 1) the study does not include a control group of overweight or obese adolescents. This makes it difficult to understand the progress, maintenance or deterioration of the baseline health of participants. Strong weight loss studies with educational therapeutic programme based on physical activity and nutrition have included control groups or not ; 2) an iInitiatives as the EVASYON study contribute to the development of the Spanish Strategy for Nutrition, Physical Activity and the Prevention of Obesity (NAOS Strategy) initiated in 2005 by the Ministry of Health and Consumer Affairs . The NAOIn summary, the EVASYON study is an interventional study assessing the effectiveness of an educational therapeutic model in physical activity and nutrition in Spanish adolescents with overweight and obesity. The EVASYON programme attempts to be a national pilot study that may be implemented as a method of treatment of obesity in adolescents into the Spanish Health Care Service. This multidisciplinary and multicenter study assesses changes in participants for approximately 1-year follow-up over 8 dimensions: 1) diet, 2) physical activity and health-related physical fitness, 3) psychology, 4) body composition, 5) haematology, 6) biochemical and metabolic profiles, 7) mineral and vitamin profiles, and 8) immunology profile. Genetic profile was also assessed for examining the influence of gene-environmental interactions on obesity.The authors declare that they have no competing interests.DMG, SGM, and MAP contributed equally to this work. AM, CRF, CC, AM, JMG designed the study and obtained funding. DMG, SGM, MAP, EN, JW, OLV, CA, MPV, MD, JAM, MGF and LAM provided insight into the study design. All authors participated in the writing of the paper and provided comments on the drafts and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/9/414/prepub"} -{"text": "Maintaining a healthy weight and undertaking regular physical activity are important for the secondary prevention of cardiovascular disease (CVD). However, many people with CVD are overweight and insufficiently active. In addition, in Australia only 20-30% of people requiring cardiac rehabilitation (CR) for CVD actually attend. To improve outcomes of and access to CR the efficacy, effectiveness and cost-effectiveness of alternative approaches to CR need to be established.This research will determine the efficacy of a telephone-delivered lifestyle intervention, promoting healthy weight and physical activity, in people with CVD in urban and rural settings. The control group will also act as a replication study of a previously proven physical activity intervention, to establish whether those findings can be repeated in different urban and rural locations. The cost-effectiveness and acceptability of the intervention to CR staff and participants will also be determined.This study is a randomised controlled trial. People referred for CR at two urban and two rural Australian hospitals will be invited to participate. The intervention group will participate in four telephone delivered behavioural coaching and goal setting sessions over eight weeks. The coaching sessions will be on weight, nutrition and physical activity and will be supported by written materials, a pedometer and two follow-up booster telephone calls. The control group will participate in a six week intervention previously shown to increase physical activity, consisting of two telephone delivered behavioural coaching and goal setting sessions on physical activity, supported by written materials, a pedometer and two booster phone calls. Data will be collected at baseline, eight weeks and eight months for the intervention group . The primary outcome is weight change. Secondary outcomes include physical activity, sedentary time and nutrition habits. Costs will be compared with outcomes to determine the relative cost-effectiveness of the healthy weight and physical activity interventions.This study addresses a significant gap in public health practice by providing evidence for the efficacy and cost-effectiveness of a low cost, low contact, high reach intervention promoting healthy weight and physical activity among people with CVD in rural and urban areas in Australia. The replication arm of the study, undertaken by the control group, will demonstrate whether the findings of the previously proven physical activity intervention can be generalised to new settings. This population-based approach could potentially improve access to and outcomes of secondary prevention programs, particularly for rural or disadvantaged communities.ACTRN12610000102077 Cardiovascular disease (CVD) is the leading cause of death in Australia and contThus the challenge is to improve health outcomes for the majority of people with CVD who do not attend CR. In response to this challenge, investigating alternative service models for delivering CR programs shows promise . To deteDistance interventions, delivered remotely via print, telephone or internet, are likely to have improved population reach, accessibility, cost-effectiveness and maintenance of gains at follow-up compared to centre-based programs . SystemaReports of interventions promoting healthy weight and physical activity in people with CVD are scarce. A recent Australian study identified significant benefits of a telephone-delivered, pedometer-based intervention on physical activity levels among people with cardiac disease who attended outpatient CR . AnotherEven fewer interventions address the majority of cardiac patients who do not attend CR. The CHOICE program included a face-to-face consultation and four follow-up phone calls and was effective in improving cardiac risk factors for people with cardiac disease who had not attended CR . Furber Cost effectiveness analyses are rarely conducted on health care interventions and to oThe PANACHE randomised control trial will investigate if a home-based approach can decrease obesity and increase physical inactivity in people with CVD in urban and rural areas in Australia. It will also determine whether the outcomes of an intervention previously found to increase physical activity ,27 are rThis study is a randomised controlled trial comparing the efficacy of a healthy weight telephone coaching intervention (intervention group) with a physical activity telephone coaching intervention (control group). An outline is shown in Figure Approval to conduct this research has been granted by the Human Research Ethics Committees from University of Wollongong, South Eastern Sydney and Illawarra Area Health Service, Greater Southern Area Health Service and the University of New South Wales. All people referred to outpatient CR over a 12-18 month period at two Sydney and two NSW rural hospitals in Australia will be invited to participate in the study, whether or not they attend outpatient CR. Based on a previous Australian study , it is aParticipants will be recruited six-eight weeks after referral to CR by which time they would be likely to be clinically stable in their recovery process. Brief written information about the study will be included in the information packs distributed to people referred to CR. A personalised invitation letter will also be mailed, followed up with a telephone call.During the follow up telephone call participants will be randomised by the researcher into intervention and control groups when they agree to be enrolled in the study. Participants will be block randomized within site. Microsoft Excel will be used to generate random numbers and the Statistical Analysis System (SAS) will be used to randomise these numbers into sets of two letters by blocks of four to ensure a balanced sample size across both study groups . The ranThe intervention group will receive an eight week healthy weight intervention based on social cognitive theory ,34 which2 participants will be recommended to lose weight [2 the focus will be on weight maintenance [Goals will be individualized and if the participant's BMI is greater than 24.9 kg/me weight and to untenance and 30 mThe healthy weight intervention was piloted with nine rural participants. The findings were used to refine evaluation questions and procedures, modify the telephone coaching guide and improve the suitability of written support materials.The control group will receive the same six week physical activity intervention previously found to be efficacious ,27. AlsoQuestionnaires will be completed by telephone at baseline, eight weeks and eight months for the intervention group and at baseline, six weeks and six months for the control group. Researchers administering the questionnaires will be trained to follow written standard procedures. They will be supervised during the administration of the initial questionnaires and thereafter at random intervals. All objective measures will be obtained by the same researcher following a written standard protocol.Semi-structured interviews will be conducted with urban and rural CR staff to assess their views of the usefulness and acceptability of the program and its implementation in their setting. Focus groups will be held with rural and urban study participants regarding their experiences of the program and its delivery. Participants will also provide information on process measures when they complete the telephone questionnaires at week eight (intervention) and week six (control) on the acceptability of program activities and materials such as resources on weight control, nutritional and physical activity, and coaching advice. The weight, nutrition and physical activity goals set by participants during their telephone coaching sessions will also be recorded.The primary outcome is self-reported weight and BMI . SecondaTo validate self-reported changes in height, weight, food intake and physical activity, objective data will be collected at baseline and at eight months from a sub-group of 25% of the intervention group (a convenience sample of 45 participants). At baseline and at eight months the researcher will meet with this sub-group to measure their height, weight and waist circumference after they have self-reported these measures in the questionnaires administered via telephone at baseline and eight months. Participants will then be asked to record their intake of food and drink for three days (two weekdays and one weekend day) and to wear an MTI Actigraph accelerometer to record their physical activity for the next seven days. At the end of the week in which the accelerometer is worn the self-report questions on physical activity, sedentary activity and nutrition habits, which ask about these activities over the last seven days, will be completed. Thus the objective data obtained using a food diary and accelerometer will be collected over the same time period as the self-reported data. A three-day food diary collected over two week days and one weekend day has been found to be a reliable measure of usual energy intake . AccelerCosts calculated will include program costs , direct health care costs related to participants' cardiac conditions and other costs (for example participant's expenditure on exercise related products and services such as shoes and exercise classes). Information will be collected regarding the number of days absent from work or normal activities due to cardiac problems.2 BMI between the intervention and control group (based on the COACH study effects on weight loss [To detect a reduction of 1.3 kg in weight and 0.5 kg/mght loss ) with a The analyses of the trial will be based on (i) intention to treat and (ii) treatment received. Bivariate and multivariate analyses will assess the effects of the intervention (compared to controls) on weight loss, sedentary behaviour, nutrition and physical activity adjusted for residence , age and sex for all cases and then treatment received after initial intention to treat analysis. Continuous data will be analysed with paired t-tests and linear regression and categorical variables with chi square tests and logistic regression with p < 0.05 as the level of significance but adjusted appropriately when multiple testing is conducted. Analyses will be performed with PASW 18.0 . Food diaries will be analysed using FoodWorks 2007 (Xyris Software).The economic evaluation will be conducted using accepted guidelines . To deteThematic analysis will be used to examine transcripts of the interviews with CR staff and the focus groups with study participants. Two researchers will independently code the themes arising and then compare and discuss their coding. For the purpose of triangulation, these researchers will then discuss the themes with an additional researcher. The steps taken in the thematic analysis and the reasons for taking them will be documented to provide an audit trail.Despite the effectiveness of conventional centre-based CR programs, participation rates are low and the majority of people requiring CR are missing out on evidence-based health benefits of lifestyle interventions for cardiac patients. In addition, little research has been conducted on improving health outcomes for the majority of cardiac patients who do not attend CR. This study addresses these gaps in public health practice, firstly by testing an alternative delivery mode for CR, secondly by targeting the entire population of people referred for CR, irrespective of whether they attend a CR program or not, and thirdly by establishing the efficacy of a healthy weight intervention for people with cardiac disease. The economic impact of secondary prevention programs for CVD is an under-researched area. The economic analysis conducted alongside this study will provide important information on the relative costs and benefits of the intervention.This study will show whether the population-based, low contact, high reach intervention tested can promote healthy weight and physical activity among people with CVD in rural and urban settings and whether it can be delivered cost effectively. By replicating the previously proven physical activity only program ,27 in thThe findings of this study will have significant implications for the management of people with CVD. In addition to improving health outcomes for people with cardiac disease, these interventions have the potential to reduce costs and improve access to CR services, particularly for disadvantaged and rural people. They could be a feasible addition to existing services and could also be delivered to people with CVD who have already attended CR programs as a \"maintenance\" program.The authors declare that they have no competing interests.JS drafted the manuscript, contributed to the study design and is coordinating the study. SF, MA-F, MH, PP, AM and AB contributed to the study design, advised on coordination of the study and reviewed the manuscript. All authors read and agreed to the manuscript as written.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2261/10/17/prepub"} -{"text": "P < .001) and fat mass (P < .001) was greater in the exercise group. The one-year gain in body mass-adjusted knee extensor and flexor PT at 180 deg/sec was significantly greater in the intervention group compared with the control group . There was no group difference in VJH. In conclusion, the increase in school-based physical education from 60 to 200 minutes per week enhances the development of lean body mass and muscle strength in pre-pubertal boys.This prospective controlled intervention study over 12 months evaluated the effect of exercise on muscular function, physical ability, and body composition in pre-pubertal boys. Sixty-eight boys aged 6–8 years, involved in a general school-based exercise program of 40 min per school day (200 min/week), were compared with 46 age-matched boys who participated in the general Swedish physical education curriculum of mean 60 min/week. Baseline and annual changes of body composition were measured by dual energy X-ray absorptiometry (DXA), stature, and body mass by standard equipments, isokinetic peak torque (PT) of the knee extensors, and flexors at 60 and 180 deg/sec by computerized dynamometer (Biodex) and vertical jump height (VJH) by a computerized electronic mat. The annual gain in stature and body mass was similar between the groups whereas the increase in total body and regional lean mass ( Physical activity has been regarded as one of the most important life style factors that could improve a variety of health-related aspects, including musculoskeletal health. But studies have indicated that children and adults in the recent decades have become less physically active , and thePhysical activity includes a variety of activities as it is defined as any bodily movement produced by skeletal muscles that result in energy expenditure . PhysicaIn children and adolescents, it is well established that gains in strength and power are possible following prospective controlled short-term progressive resistance training programs two to three times per week. Reports show that muscle strength, muscle mass, and physical performance improved in both boys and girls –9. ThereTo our knowledge there is not an extant literature on general exercise training of longer duration and its effect on neuromuscular development in young children. However, reports show positive effects on fat mass, physical fitness, and performance. A school-based program with expanded physical education lessons (4 lessons/week) during three years was effective in increasing children's physical performance and preventing excessive weight gain . SimilarThese studies provide important information about the musculoskeletal effects of resistance training programs in volunteers or of exercise training programs of longer duration but with obesity or physical fitness as main outcome. However, it still remains unclear whether a long-term, general, and moderately intense exercise program on population level could improve muscle mass and performance in children 6–8 years old. We have previously reported that this goal could be reached in Prepubertal girls but therA population-based general exercise intervention program of moderate intensity was created by increasing the frequency of compulsory school physical education, and not the intensity, as to be able to include all children in the intervention, not only those who could stand a more high intense training. This study was designed to evaluate whether this intervention program could improve body composition, lower extremity muscle strength, and physical performance in Prepubertal boys. We hypothesized that the 12-month program would confer these benefits.The Malmö Pediatric Osteoporosis Prevention (POP) Study, is a prospective controlled exercise intervention study designed to annually assess skeletal and muscle development in children from school start onwards , 22. BasThe study design has previously been reported in detail when reporting changes in bone mass , but in In order to ascertain whether there was any selection bias at baseline, we have previously reported that there were no significant differences in the grade 1 examination regarding stature, body mass, and BMI of the boys, when a drop-out analysis compared the study participants and the nonparticipants . FurtherThe intervention program included the general exercise program used within the Swedish school physical education curriculum, supervised by the regular physical educational teachers but with the training increased to 40 minutes per day, corresponding to 200 minutes per week, but no specific registration was done as regard participation rate. Before the study the intervention school had had the same duration of physical education as the control schools. The duration was chosen in order to maximize a range of health-related benefits beyond just the gain in bone mass, which has been shown to respond to shorter bouts of body mass-bearing exercise –31. AlsoA questionnaire, previously used in several pediatric studies but slightly modified for the POP study , 22, 33,2 (kg/m2). A research nurse assessed the Tanner and expressed as the absolute or percentage change from baseline. Analyses of covariance (ANCOVA) were then used to compare the trait-specific annual changes in the groups, and baseline age and baseline peak torque values were included as covariates if there was a significant difference between the groups at baseline. Life style factors prior to and after study start were analysed with Fisher's exact test and Student Ex60) with 80% power and an alpha level of 0.05. The reason we chose PTEx60 as our primary muscle force outcome is that there is evidence in the literature for a greater absolute increase in knee extensor compared to flexor muscle strength from age 9 to 21 years [The study design would detect a minimal difference of 0.123 Nm/kg in the annual change in muscle strength (PT21 years . Trainin21 years .P = .05) (Fl60 and PTFl180 (body mass-adjusted both P < .001) were both higher in the control group . Furtherol group . Ex180 and PTFl180) were significantly greater in the intervention than in the control group and PTFl180 . Similar < .001) .This 12-month prospective, controlled, school-based exercise intervention study indicates that an increase in the duration of general moderately intense physical education in the school from 60 to 200 minutes per week is associated with an increased lower limb peak muscle strength gain in Prepubertal boys. A statistically significant difference between the groups can not automatically be transferred to a difference of biological and clinical significance; however, these findings still may have important public health implications as they provide evidence-based data to support the benefit of school-based physical education as an effective strategy to enhance muscular health in Prepubertal boys. There are several reasons why it is beneficial to enhance musculoskeletal health during growth. Bone density, muscle mass, and muscle strength are all traits that play an important role in reducing the risk of a number of chronic musculoskeletal diseases in adulthood , 39 and Several effects may explain the benefits seen in muscle strength from increased physical activity. Training may confer neuromuscular adaptations in conjunction with increases in muscle mass and muscle size, which all increase during puberty in association with the increased secretion of sex steroids , 44. Butin vivo techniques of measuring muscle mass [r2) indicates that the duration of physical activity during the study explained no more than 3.6%–14.4% of the variance in the reported traits and long jump [Despite reports that general physical training can improve muscle strength in children, there are conflicting reports as to whether these benefits translate into improvements in other physical performance estimates such as athletic performance, VJH, long jump, or sprint speed , 50, 51.P = .10) . The lacP = .10) , it coulAn unexpected finding in our study was the greater annual gain in arm fat mass in the intervention group compared with the controls . Howeverin vivo techniques [There are limitations to this study. This was not a randomized, controlled study, as randomization was refused by the principals, teachers, parents, and children since it was neither feasible nor practical for some children to be given additional exercise during compulsory school hours while others were not. But since all schools had a similar amount of regular school physical education before study start and since there were no differences in anthropometry between participants and nonparticipants or between participants and dropouts, the risk of selection bias seems minimal. Due to lack of resources in our research laboratory, the control group boys were not remeasured until after two years. However, as all the boys remained Prepubertal during the study, it was possible to compare the annual changes between the groups as the development of muscle strength is proportional to the gains in stature and body mass that occur linearly during this period , 55. Thichniques , 48, it chniques . Anotherchniques . FinallyIn conclusion, increasing the amount of moderately intense exercise within the school curriculum physical education to 40 minutes per day provides a feasible strategy to enhance muscle strength in Prepubertal boys. These findings have important clinical implications, as the first two decades in life may represent the most opportune time to reduce the risk of a number of chronic musculoskeletal health conditions . Thus, t"} -{"text": "Schools are the most frequent target for intervention programs aimed at preventing child obesity; however, the overall effectiveness of these programs has been limited. It has therefore been recommended that interventions target multiple ecological levels to have greater success in changing risk behaviors for obesity. This study examined the immediate and short-term, sustained effects of the Switch program, which targeted three behaviors at three ecological levels .Participants were 1,323 children and their parents from 10 schools in two states. Schools were matched and randomly assigned to treatment and control. Measures of the key behaviors and body mass index were collected at baseline, immediately post-intervention, and 6 months post-intervention.d = 0.15 for body mass index at 6 months post-intervention) to large , controlling for baseline levels. There was a significant difference in parent-reported screen time at post-intervention in the experimental group, and this effect was maintained at 6 months post-intervention (a difference of about 2 hours/week). The experimental group also showed a significant increase in parent-reported fruit and vegetable consumption while child-reported fruit and vegetable consumption was marginally significant. At the 6-month follow-up, parent-reported screen time was significantly lower, and parent and child-reported fruit and vegetable consumption was significantly increased. There were no significant effects on pedometer measures of physical activity or body mass index in the experimental group. The intervention effects were moderated by child sex , family involvement (for fruit and vegetable consumption), and child body mass index (for screen time). The perception of change among the experimental group was generally positive with 23% to 62% indicating positive changes in behaviors.The effect sizes of the differences between treatment and control groups ranged between small (Cohen's The results indicate that the Switch program yielded small-to-modest treatment effects for promoting children's fruit and vegetable consumption and minimizing screen time. The Switch program offers promise for use in youth obesity prevention. Pediatric obesity continues to be a serious public health issue with trends indicating that the prevalence of childhood obesity will reach 24% in the USA by 2015 -6. Many Family components are critical for youth obesity prevention programs because parents directly and indirectly influence children's PA and nutrition behaviors at home and also dictate the physical and social environments that are available to their children . SeveralSocial ecological models that target multiple levels of influence have been recommended to address the obesity epidemic ,17. AlthAn established social ecological framework was used to guide the development of the Switch intervention ,27. DetaAll 10 elementary schools in Lakeville, MN and Cedar Rapids, IA, USA, participated in the study. These two school districts were approached due to the requirements of funding agencies. Schools were matched within district by enrollment and percent free/reduced-cost lunch and then randomly assigned to the experimental (three in Cedar Rapids and two in Lakeville) or control (three in Cedar Rapids and two in Lakeville) condition. Prior to participation, parents provided active written consent, and children provided assent.N = 430), fourth (N = 446), and fifth (N = 423) grade children returned consent forms . Participation rates were similar between the experimental and control schools . Forty-seven percent were male and most (90%) were White, which is representative of their communities. Figure A sample of 1,323 third (Data were collected prior to implementation (baseline), immediately following the intervention (post-intervention), and 6 months post-intervention. Out of 1,323 consented families, 1,288 children (97%) provided data. Of those, 1,196 (93%) provided data at baseline, 1,156 (90%) at post-intervention, and 1,110 (86%) children at 6 months post-intervention. Data were provided by 1,076 children (84%) at both baseline and post-intervention, 1,029 (80%) at both baseline and 6-months post-intervention, and 992 (77%) at all three time points. A total of 1,150 (87%) parents provided data. Of those, 980 (74%) provided data at baseline, 916 (69%) at post-intervention, and 811 (61%) at 6 months post-intervention. Data were provided by 778 parents at both baseline and post-intervention, 694 (52%) at baseline and 6 months post-intervention, and 631 (48%) at all three time points. Although the percentages varied between waves of data collection, over 80% of parent surveys were completed by mothers, between 7% and 11% were completed by fathers, and the rest were completed by both parents together.The study was approved by the University of Minnesota Institutional Review Board in accordance with the Declaration of Helsinki and the 'Ethical Principles of Psychologists and Code of Conduct' . It is rThe Switch program promoted healthy active lifestyles by encouraging students to 'Switch what you Do, Chew, and View'. The specific DO, VIEW, and CHEW goals were to be active for 60 minutes or more per day, to limit total ST to 2 hours or fewer per day, and to eat five fruits/vegetables or more per day. The intervention utilized overlapping behavioral and environmental strategies employed at multiple ecological levels, and is described in detail elsewhere .The community component was designed to promote awareness of the importance of healthy lifestyles and the prevention of childhood obesity in the targeted communities, and included paid advertising and unpaid media emphasizing the key messages. Note that both experimental and control participants may have been exposed to the community component. The school component was designed to reinforce the Switch messages and facilitate the family component of the intervention. Teachers were provided with materials and ways to integrate key concepts into their existing curricula. Teachers were not required to participate, since the study was not designed as a school-based (curricular) intervention. Control schools did not receive any school materials. The family component was designed to provide parents (and children) with materials and resources to facilitate the adoption of the healthy target behaviors. Monthly packets containing behavioral tools were provided to assist parents and children in modifying their behaviors. Control families were recruited similarly to experimental families, but received no materials other than the surveys .Data were collected from multiple informants. Baseline assessments (October 2005) included children wearing pedometers for 1 week, completing surveys in classrooms, and having anthropometric measurements taken by school nurses. Parents and teachers also completed surveys. The same measures were conducted immediately post-intervention (May 2006). To measure the maintenance of effects, data were collected approximately 6 months after the end of the intervention (November 2006).Habitual PA was assessed by a pedometer . Accuracy was assessed by having participants walk 10 steps and pedometers that were off by more than 1 step were replaced. Children were instructed to wear the pedometer for 7 consecutive days and to record the time they put the monitor on and off as well as the number of steps accumulated each day. At least 4 days' of data (3 weekdays and 1 day at the weekend) with at least 10 hours/day were required to be considered compliant . The classification of meeting physical activity goals was determined using two published recommendations. The Vincent and Pangrazi recommenStanding height and weight were measured by trained school nurses using standardized procedures . Body maTime spent viewing TV and playing video games was assessed (independently) by both parents and children, using methods that have been used reliably with parents and chilParents and children reported on children's FV consumption with items adapted from the National Youth Risk Behavior Survey . The iteAt the conclusion of the program, children and parents in the experimental group were surveyed about noticeable effects of the program on ST, FV, and PA. For each behavior measured, participants reported on a five-point verbally anchored scale the degree to which they perceived their family changed behaviors (ranging from 'a lot more' to 'a lot less').r = 0.47); we therefore standardized scores on each measure and a family involvement score was calculated by averaging parent and child ratings. This composite measure of family involvement allowed for testing whether involvement modified the effect of the intervention, as it could be hypothesized that the effect of the program would be greatest for families who were most involved. High and low involvement groups were created by a median split.Parents and children also reported how much they had participated in the various aspects of the program at post-intervention . Reports of parents and children were found to be significantly correlated units. Cohen's d is computed by subtracting the average score for the control group (MC) from the average score for the treatment group (MT), and then dividing the difference by the SD on the outcome measure for the sample. We used the standard criteria for ES of small (d = 0.20), medium (d = 0.50), and large effects (d = 0.80) [The primary tests examining differences between baseline and post-intervention and baseline and 6 months post-intervention were conducted using hierarchical multilevel regression analyses to take into account the nested nature of the data (families are nested within schools). An analysis of variance was conducted to test for differences between the schools on the outcome measures at baseline. School had a significant effect for all six outcome variables, explaining from 1% to 11% of the variance in each. Because schools explained a significant amount of variance hierarchical analyses were required and, therefore, subsequent analyses of differences between the treatment and control groups employ variance due to school as the error term in the analyses. This adjustment reduces the degrees of freedom (df) from over 1,300 to 9, but is necessary due to the variability by school and the fact that participants were randomized at the school level. Baseline values were used as covariates to control for any differences between participants on these variables prior to the intervention. This also controls for the observed difference between groups for the child reporting of FV. Further analyses were conducted to provide a more comprehensive evaluation of the intervention. One set of analyses examined whether or not the child's sex moderated the effectiveness of the intervention. These analyses examined whether the intervention had a greater impact for boys or girls. Another set of analyses examined whether family involvement in the programming moderated treatment effects. These analyses specifically examined whether effects were stronger for participants that were highly involved in the program. A final set of analyses tested for moderation of treatment effects by weight status. These analyses specifically examined whether the effects were stronger for overweight or obese youth compared with normal weight youth. As we had directional hypotheses, all reported tests are one-tailed. Effect sizes (ES) were also calculated using Cohen's = 0.80) . We empl2 . Overall, 19% of children were classified as overweight and 8% were obese. There were significant differences between boys and girls on child-reported and parent-reported weekly ST = 6.35, P < 0.001, and t (976) = 5.69, P < 0.001, respectively). This was due primarily to video game play. By child report, boys and girls were not significantly different on the number of fruits and/or vegetables they had eaten the previous day. Based on national guidelines (five servings of fruits and vegetables per day) approximately 44% of the children met the recommended guidelines. By parent report, girls ate almost two more servings of fruits and vegetables per week compared with boys = 2.22, P < 0.05). Only 17% of children met the recommended guidelines of at least five servings a day. As expected, boys tended to have greater step counts than girls (t (823) = 9.01, P < 0.001). Depending on the recommendation used, between 28% and 43% of children achieved the recommended level of PA. Boys and girls were not significantly different on meeting the Vincent and Pangrazi recommendation , but were significantly different on meeting the stricter Tudor-Locke recommendation .Characteristics of the sample at baseline are shown in Table d = 0.15 for BMI at 6 months post-intervention) to large . There was a significant difference in parent-reported ST at post-intervention, and this effect was maintained at 6 months post-intervention (a difference of about 2 hours/week). Child-reported ST was also lower in treatment groups at 6 months post-intervention, but the effect was not significant . There were significant increases in parent-reported FV consumption at post-intervention and 6 months post-intervention. The increase for child-reported consumption was marginally significant at post-intervention and was significant at 6 months post-intervention. PA, as measured by pedometer, at post-intervention and 6 months post-intervention was not statistically significant, although the students in the treatment schools accumulated an average of about 350 more steps per day . Despite a lack of statistical significance, these differences are in the expected direction. At both post-intervention and 6 months post-intervention, the mean BMI values were not significantly different between the treatment and control groups.Tables t (961) = 2.84, P < 0.01) and 6 months post-intervention (t (907) = 1.99, P < 0.05). At both times, the interaction was due to girls in the treatment group reporting greater FV consumption than girls in the control group . For PA, boys had higher step counts than girls at both post-intervention and 6 months post-intervention, but the interaction with treatment was significant at post-intervention, t (717) = 2.48, P < 0.05, with the program having a significant effect on girls . For BMI, there was a significant sex by treatment interaction at 6 months post-intervention, t (1083) = 2.19, P < 0.05, with boys in the treatment group having a lower BMI (M = 19.1 kg/m2) than boys in the control program (M = 19.4 kg/m2).We examined whether the treatment effects were modified by child sex. These analyses examined the effect of treatment program, sex, and the program by sex interaction on the outcome measures, controlling for baseline values. Although boys had higher total ST than girls (due to more video game play), the interactions between sex and treatment were non-significant. In contrast, the sex by treatment interaction on child-reported FV was significant at post-intervention (t (460) = 4.61, P < 0.001) and at 6 months post-intervention (t (423) = 2.37, P < 0.05), and for parent-reported FV at post-intervention (t (340) = 3.05, P < 0.01), controlling for baseline values. Greater consumption of FV was reported by children who were highly involved (defined by median split) in the treatment program than for children who were less involved in the treatment program .We examined whether the treatment effects were modified by level of involvement, hypothesizing that the effects of the Switch program would be largest for families who were most highly involved. Significant interactions were found with child-reported FV consumption at post-intervention than overweight (M = 30.9) or normal weight (M = 29.6) participants, t (1005) = 2.54, P < 0.05. This relation was moderated by a statistically significant interaction, t (1003) = -2.47, P < 0.05, with obese children showing the largest difference in ST between the treatment (M = 30.2) and control (M = 40.8) groups. Thus, the positive effect on child-reported ST was greatest for obese children.We examined whether the treatment effects were modified by child weight, hypothesizing that children who were classified as obese might benefit more from the program. Obese children reported higher ST at post-intervention . Furthermore, these community-based messages were available to both experimental and control families and, therefore, may have minimized differences between the groups.Although over 1,300 families participated in the study, a major limitation of this study was the sample size. Statistical analysis of treatment effects was at the school level due to families being nested within schools and randomization at the school level, resulting in low power to detect differences. Future studies should randomize at the classroom or family level to have greater degrees of freedom . Another limitation is the potential for social desirability to influence the results. It seems unlikely, however, that only the experimental group would be subject to such desirability biases. To reduce the potential effects of bias and method variance, we used multiple informants. An additional limitation was reliance on pedometers to measure PA. Although it seems preferable to have an objective measure, compliance with the requirements was lower than anticipated. Furthermore, the pedometer captures the total amount of PA and does not provide information on the intensity of PA. It is unknown if the amount of time spent in moderate-to-vigorous PA was altered by the intervention. IHere, it is possible that the total number of steps/day was unchanged yet the time spent in moderate-to-vigorous PA increased. Future studies should use PA monitoring tools that capture both the volume and intensity of PA.In conclusion, the results indicate that the Switch program produced modest treatment effects for children's FV and ST. It is noteworthy that the effects remained significant in the 6-month follow-up evaluation as this indicates maintenance of these differences over time. Although levels of BMI were not statistically different between groups, the maintenance of behaviors over time may contribute to reduced risks for overweight in the future. The Switch program which targets multiple behaviors through multiple channels offers promise for use in youth obesity prevention.ADA: American Dietetics Association; BMI: body mass index; ES: effect sizes; FV: fruit and vegetable consumption; PA: physical activity; SD: standard deviation; ST: screen time.The authors declare that they have no competing interests.The Switch program is a program of the National Institute on Media and the Family, a non-profit organization. Several of the authors were employed by the Institute to create the program or to conduct the research , or consulted with the Institute on the design (JCE) or analysis (DWR and RAR).DAG, JCE, DAW, RC, MW, SS, and KF designed the study, established methods and questionnaires, and participated in the coordination of the study. GW provided insight into the conceptual framework of the study. DWR, DAG, and RAR conducted the statistical analyses. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"} -{"text": "Excessive gestational weight gain and postpartum weight retention may predispose women to long-term overweight and other health problems. Intervention studies aiming at preventing excessive pregnancy-related weight gain are needed. The feasibility of implementing such a study protocol in primary health care setting was evaluated in this pilot study.A non-randomized controlled trial was conducted in three intervention and three control maternity and child health clinics in primary health care in Finland. Altogether, 132 pregnant and 92 postpartum women and 23 public health nurses (PHN) participated in the study. The intervention consisted of individual counselling on physical activity and diet at five routine visits to a PHN and of an option for supervised group exercise until 37 weeks' gestation or ten months postpartum. The control clinics continued their usual care. The components of the feasibility evaluation were 1) recruitment and participation, 2) completion of data collection, 3) realization of the intervention and 4) the public health nurses' experiences.1) The recruitment rate was slower than expected and the recruitment period had to be prolonged from the initially planned three months to six months. The average participation rate of eligible women at study enrolment was 77% and the drop-out rate 15%. 2) In total, 99% of the data on weight, physical activity and diet and 96% of the blood samples were obtained. 3) In the intervention clinics, 98% of the counselling sessions were realized, their contents and average durations were as intended, 87% of participants regularly completed the weekly records for physical activity and diet, and the average participation percentage in the group exercise sessions was 45%. 4) The PHNs regarded the extra training as a major advantage and the high additional workload as a disadvantage of the study.The study protocol was mostly feasible to implement, which encourages conducting large trials in comparable settings.Current Controlled Trials ISRCTN21512277 Obesity has become an epidemic throughout the world and increases the risk of several diseases such as type 2 diabetes, cardiovascular disease and certain cancers . For womThe effect of dietary and physical activity habits on gestational weight gain and postpartum weight retention is still unclear . TherefoThe study was conducted in six MCs and CCs in the city of Tampere and the town of Hämeenlinna. The selection of the clinics was based on the clinics' administrative personnel's suggestion for suitable clinics. In the larger trial, a larger number of other clinics will be randomized to intervention and control clinics. The most important reason for randomizing the clinics instead of individuals – i.e. public health nurses (PHN) or pregnant and postpartum women – is the likelihood of contamination of the PHNs' counselling practices. In this pilot study, three MCs and CCs volunteered to be intervention clinics and the remaining clinics were treated as control clinics. Feasibility of the study protocol was evaluated separately in the MCs and the CCs, because the larger trial was meant to begin in early pregnancy and continue after delivery.In Finland, women with no earlier deliveries are recommended to make 11–15 visits to a PHN and three visits to a physician during pregnancy . In the Fourteen PHNs from the intervention clinics and nine PHNs from the control clinics participated in the study. The PHNs recruited pregnant and postpartum women with no previous deliveries for the study. The exclusion criteria were age under 18 years, type 1 or 2 diabetes mellitus, twin pregnancy, physical disability preventing exercise, substance abuse, treatment or clinical history of any psychiatric illness, otherwise problematic pregnancy (defined by a doctor), inadequate language skills in Finnish and intention to change residence within three months. The PHNs recruited the pregnant women by phone when making an appointment for the first MC visit. The postpartum women were recruited when the PHN visited the participant's home after delivery or on the participant's first visit to the CC. As this was a pilot study, the sample size was not based on power calculations. Instead, the aim was to recruit at least 40 pregnant and 40 postpartum women from the intervention and the control clinics . All participants provided written informed consent to participation. The study was approved by the Ethics Committee of the Pirkanmaa Hospital District.Data collection was similar in the intervention and the control clinics Table . The PHNIn the control clinics, the PHNs continued their usual physical activity and dietary counselling practices. In the intervention clinics, the intervention included individual counselling on physical activity and diet and an option to attend supervised group exercise sessions once a week at a location close to the clinic Figure . The conBefore the study began, the PHNs of the intervention clinics were trained in the counselling procedures and the study arrangements and the PHNs of the control clinics for the study arrangements by the research group. All PHNs received a handbook in which the tasks related to each visit were explained. One or two researchers visited each clinic monthly during the study. One supportive meeting was held for the PHNs of the intervention and the control clinics separately. The exercise instructors (n = 10) were trained for the group exercise sessions by the research group .The location of the clinics should not have any effect on the services the clinics provide, because all clinics are supposed to follow the national guidelines for maternity and child health care ,18. In tInformation on the background characteristics and the usual counselling practices of the PHNs was collected by a questionnaire (n = 21) before the PHNs were trained for the study. The responses varied between the six MCs and CCs, but the numbers of PHNs in each clinic were too small to test the statistical significance of the between-clinic differences. Concerning all clinics, 15 (71%) PHNs were aged 40 years or more. The PHNs had either the official degree of PHN (n = 15), midwife (n = 1) or both (n = 5). Of those PHNs who had worked in a MC, the median time of working in a MC was 3.5 (range 1 to 30) years. Likewise, of those PHNs who had worked in a CC, the median time of working in a CC was 13.0 (range 1 to 26) years. The counselling practices varied remarkably between the PHNs, but not between the PHNs of the intervention and the control clinics ,20.In Finland, the clinic attended by each pregnant and postpartum woman is determined by her place of residence. The socioeconomic background of the residents varies between these areas, which may also have affected the characteristics of the participants. There was some variation in the participants' mean age, mean pre-pregnancy BMI, education level, smoking status and the baseline dietary and physical activity habits between the six clinics (results not shown), but the statistical significance of the differences could not be tested due to the small number of participants in each clinic. Information on these variables has been reported earlier in the intervention and the control clinics ,20.The feasibility assessment of the study protocol comprises the following four components. The main indicators and data collection for each component are described below.Information on the achievement of the recruitment aim within three months, the participation rate of the eligible women and the drop-out rate of participants were obtained from the standardized recruitment forms used by each PHN.The proportion of data obtained on weight development, diet and physical activity was assessed from the number of completed and returned baseline and follow-up questionnaires, maternity cards and postpartum weight measurement forms. Information on the proportion of blood samples obtained was collected from the laboratory records.Concerning the intervention clinics, the realization rate, content and duration of counselling sessions was assessed from the PHNs' counselling cards. Each counselling session was regarded to have been implemented as intended if all essential parts of the counselling card were filled in for the session. The proportion of women completing ≥ 75% of the weekly records for physical activity and diet was obtained from the participants' follow-up notebooks. The mean participation percentage in the group exercise sessions was determined by calculating first the participation percentage of each woman separately from the number of sessions available for her and then averaging the individual participation percentages. Information on participation was obtained from the participant lists kept by the exercise instructors.Information on the PHNs' opinions of the appropriateness of the training for the study was collected using a questionnaire three months after the initiation of the study. The PHNs assessed the training on the Osgood scale (1 = very poor ... 5 = excellent). Additionally, the advantages and the disadvantages of the study for the PHNs were inquired from them by a semi-structured interview within two weeks each PHN's last participant had finished the study.As only 113 participants were enrolled within the three months allocated, the recruitment period was prolonged to six months Table . FinallyThe proportions of data obtained on weight, physical activity and diet were 96–100% and the proportions of blood samples obtained were 95–98% Table . The bloIn the intervention clinics, 98% of the counselling sessions were realized as intended and the mean durations of the sessions were as intended Table . All priUsing the 5-point scale, the PHNs of the intervention clinics scored the training for study arrangements 3.4 (sd 1.2), physical activity counselling 3.9 (sd 1.1) and dietary counselling 3.6 (sd 1.1) on average. The PHNs of the control clinics scored the training for study arrangements 3.9 (sd 0.7) on average. Nearly all PHNs regarded the training and the support during the study as sufficient and the researchers' visits to the clinics as useful.The PHNs of the intervention clinics considered the increased knowledge on physical activity and diet and the improved counselling skills to be the major advantages of the study for them. The PHNs of the control clinics appreciated the training they were promised after the study. The major disadvantage reported by the PHNs was that implementation of the study protocol took too much time. The extra time needed for the visits was 40–60 min/visit in the intervention clinics and 10–20 min/visit in the control clinics on average.We evaluated whether a study protocol aiming at preventing excessive gestational weight gain and postpartum weight retention could be feasibly implemented in the Finnish maternity and child health care system. Integrating a study protocol into the routine functions of primary health care is a demanding task, but we managed to implement the protocol mostly as intended.The overall participation rate was high (77%) and the drop-out rate low (15%). Data on weight development, diet and physical activity was collected very successfully. The proportion of blood samples obtained was extremely high, indicating that collection of this kind of material is possible in studies conducted in real health care settings. In the intervention clinics, almost all counselling sessions were realized as intended and most participants recorded their adherence to the physical activity and dietary plans regularly to their follow-up notebook. This success reflects the PHNs' and the participants' strong commitment to the study, possibly because they were able to see the importance of the study and to see some personal benefits compensating the burden.Although the main experiences were positive, some problems were encountered. The recruitment time needed to be prolonged because the recruitment of the participants was slower than expected. The experience helps in estimating the realistic time needed for recruitment in further studies. The participation rate was slightly lower in the intervention clinics than in the control clinics, which may be related to the participants' background characteristics, to their reluctance to improve or monitor their dietary and physical activity habits or to the PHNs' motivation to recruit participants. In further studies, the way in which study is introduced to the participants and how they are motivated to participate in it will be especially important.The drop-out rate was higher in the intervention MCs than in the other clinics, but the reasons for drop-out seemed quite plausible in all clinics. Pregnancy is often associated with changing residence and, consequently, clinics. For some women who changed residence, we managed to collect the follow-up questionnaires and the maternity cards by mail, thus preventing them dropping out of the study. Some women withdrew for reasons related their pregnancy (such as twin pregnancy or risk for premature delivery) or a stressful life situation. Additionally, as postpartum weight retention was the main outcome for postpartum participants in the effectiveness analyses, we had to exclude women who were pregnant again 10 months after their first delivery. On the other hand, the drop-outs related to the missing blood samples actually occurred due to misunderstanding because the participants would have been allowed to continue the study despite not giving the blood samples. Some participants in the intervention clinics withdrew because they found the data collection too burdensome. Therefore, the amount of data collection should be paid more attention in further studies. For this pilot study, we collected feasibility information, which may not be necessary in further studies.Although the other data collection was successful, NAF samples were obtained from only 41% of the postpartum participants. The sample could not be obtained from women who were still breastfeeding when the collection of the samples was finished. Further studies should allocate a longer time period for collection of NAF samples. As NAF samples are not routinely collected in health care, some women may have been suspicious or afraid of giving them. To minimize the number of women refusing to give the sample, the methods of collecting NAF sample should be described in detail to the participants beforehand. However, the most frequent reason for a missing NAF sample was that no NAF could be obtained from the breast despite attempts. Other studies have also reported difficulties in obtaining NAF . TherefoThe average participation percentage in the group exercise sessions was relatively low, especially among the pregnant participants. No information is available on the reasons why the women did not participate more often. The reasons have been discussed earlier and theyThe quality and adequacy of training of the PHNs will be of crucial importance in future studies, since the PHNs regarded the increased knowledge about physical activity and diet as well as improved counselling skills as the major advantage of participating in the study. However, as the PHNs found that the implementation of the study protocol was time-consuming, the time spent on study arrangements and all paper flow should be kept to a minimum in further studies. A risk group approach should also be considered to limit the PHNs' workload and to better target counselling at those in need. Allocating shorter times for counselling may impair the effectiveness of the intervention.A major strength of the study was that the counselling was implemented during routine visits to primary health care instead of using extra study personnel. Using this approach, we also aimed at developing counselling practices, which could be incorporated into real health care situations. Safety issues are especially important when implementing interventions among pregnant and postpartum women. Therefore, another major strength of the study was that no statistically significant differences were observed in the incidence of selected adverse events between the intervention and the control groups . Nor werOne limitation of the pilot study was that we were not able to randomize the clinics, which may have caused some baseline differences between the participants of the intervention and the control clinics ,20. HoweImplementation of the study protocol proved to be feasible in this setting, which encourages the undertaking of a large study in Finland and possibly also in other countries with maternity and child health care services funded by public taxation . Such beThe authors declare that they have no competing interests.TIK participated in the development of the study design and the intervention protocols and in the acquisition and analysis of the data. MA participated in the development of the study design and the intervention protocols and in the acquisition of data. PK and EW were involved in the development of the study design. KO participated in the development of the intervention protocols (group exercise sessions) and in the acquisition of the data. KM participated in the development of the intervention protocols (laboratory issues) and in the acquisition of the data. MF was involved in the development of the study design and the intervention protocols. RL was the principal researcher and responsible for the study concept and design and she participated in the development of the intervention protocols. All authors participated in the interpretation of the data and preparation of the manuscript. Additionally, all authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:"} -{"text": "Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men.2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category and randomised to one of three groups: (1) SHED-IT Resources - provision of materials with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary behaviour, physical activity and dietary cognitions, sleepiness, quality of life, and perceived sexual health. Generalised linear mixed models will be used to assess all outcomes for the impact of group , time and the group-by-time interaction. These three terms will form the base model. 'Intention-to-treat' analysis will include all randomised participants.The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40 Obesity is a major cause of preventable death and is associated with a range of negative physiological and psychological consequences . In addiGut-Buster study was unique when published 14 years ago /height[m]Waist circumference was measured at two points: (i) level with the umbilicus, and (ii) at the largest circumference between the lower costal border and the umbilicus. Two measures were taken at each site, with accepted values within 0.5 cm. Further measures were taken if measurements were outside the acceptable range. The average of the two acceptable measures will be reported. To ensure follow up measurements were taken from the same location, the distances between the sternal notch and both waist circumference points were recorded. Each measurement was recorded with a non-extensible steel tape . This measure will be taken at each time point by one of two assessors with Level 1 Anthropometry qualifications to improve reliability.Blood pressure and resting heart rate were measured using NISSEI/DS-105E digital electronic blood pressure monitors under standardised procedures. Participants were seated for five minutes before the first blood pressure measurement and a rest period of two minutes between measures was used. Blood pressure was measured three times. Further measurements were taken if the blood pressure or resting heart rate values fell outside of the acceptable ranges i.e. Systolic within 10 mmHg, diastolic within 10 mmHg (preferably 5 mmHg) and resting heart rate within 5 bpm. The mean of the two closest systolic pressures and the diastolic pressure paired to them will be reported. The mean of the two lowest resting pulse pressures will be used.Bioimpedance was used for the assessment of body composition, including fat mass, fat free mass and total body water. Body composition was assessed by the InBody720 , a multi-frequency bioimpedance device featuring an eight-point tactile electrode system. This device has been shown to be a valid and reliable device for body composition assessment ,36.Physical activity was objectively measured using pedometers . Participants were sent pedometers in the mail 1-2 weeks prior to the baseline assessment and will be provided with the pedometer at follow-up assessments. Participants were instructed on how to attach the pedometers (at the waist on the right hand side) and asked to remove the pedometers only when sleeping, when the pedometer might get wet or during contact sports. Participants were asked to wear the pedometers for seven consecutive days and keep to their normal routine. At the end of the day participants were instructed to record their steps on a pedometer record sheet and reset their pedometers to zero. Participants were instructed to note down if they did an activity like cycling, swimming, contact sports or another activity that does not involve stepping and include details (type of activity and duration), or if they forgot to wear their pedometer. Participants will be included in all analyses if they have completed at least four weekdays of pedometer monitoring. The average of existing days will be imputed for participants who have included at least four days of data.Dietary intake was assessed using the Australian Eating Survey (AES). AES is a 120-item semi-quantitative Food Frequency Questionnaire (FFQ), used previously in Australian youth up to 16 years and currNutrient intakes from the AES will be computed from the most current food composition database of Australian foods available, the Australian AusNut 1999 database (All Foods) Revision 17 and AusFoods (Brands) Revision 5 to generate individual mean daily macro-and micro-nutrient intakes. The AES includes questions about the total number of daily serves of fruit, vegetables, bread, dairy products, eggs, fat spreads, sweetened beverages and snack foods, as well as asking the type of bread, dairy products and fat spreads used. Twelve questions relate to food-related behaviours, including items on frequency of take-away food consumption and eating while watching television.Portion size was assessed using portion size photographs from the Dietary Questionnaire for Epidemiological Studies Version 2 (DQES v2), FFQ from the Cancer Council Victoria . These pAlcohol consumption was measured using an adaptation of the Australian Government Department of Veteran Affairs, Alcohol Use Disorders Identification Test (AUDIT) 2009 . This inPhysical activity and nutrition beliefs were assessed using a number of validated instruments: physical activity self efficacy , physicaSedentary behaviours were assessed using an adaptation of the Sitting Questionnaire, which has been shown to be both a valid and reliable measure of sitting time in various domains ,52.Quality of Life and general health was assessed using the UK short form 12 (SF-12) questionnaire ,54.Daytime Sleepiness was assessed using the Epworth sleepiness scale which is a valid measure of general daytime sleepiness .Sexual Function was assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire which has been shown to be a valid measure of erectile function .Adherence to self-monitoring will be calculated from diaries for both treatment arms. In addition to this, men will hand in their SHED-IT support booklet at the 3- and 6-month time points, to be photocopied and posted back. We will also administer a detailed process questionnaire to examine men's perceptions of the SHED-IT program. This will include scales, individual items and open-ended questions that require men to describe the strengths and weaknesses of the program along with their suggestions for improvement. The process evaluation will cover issues such as the study feasibility, opinion of the allocated study group, use and appraisal of components of each intervention and their levels of overall satisfaction. We will also ask how much participants would be willing to pay for the offered intervention. The process evaluation will be administered at the 6-month time point.The sample size calculation is based on the primary outcome of weight loss at 6 months, which we have assumed will have a standard deviation of 5 kg ,57. ThirParticipants were randomised at an individual level by the trial statistician who will not have any contact with participants during the trial. Allocation was stratified by BMI category calculated at the baseline assessment and the allocation sequence within strata was generated by a computer-based random number-producing algorithm in block lengths of six. Randomisation codes are stored in a restricted computer folder, which is not accessible by those assessing participants, those involved in group allocating participants or those participating in data entry for the study. Complete separation was achieved between the statistician who generated the randomisation sequence and those who concealed allocation from those involved in implementation of assignments.Study information for the three different groups was pre-packed into identical black plastic opaque envelopes and consecutively numbered within the three BMI categories and ordered according to the randomisation schedule. The packing and sequencing of these envelopes was completed by a research assistant who was not involved in enrolment, assessment or allocation of participants. Study participants completed all baseline assessments before proceeding to a separate room to meet with a research assistant who was not involved with the baseline assessments. The allocation sequence was concealed during this process. Participants' BMI category was calculated from the baseline measurements and the participant was allocated the next available number in that BMI category before being provided with their information pack. At this point the envelope was opened by the research assistant and details of the particular information pack were provided to the participant using a standardised protocol.Randomisation was undertaken by the trial statistician and measures will be taken by trained staff at all times points. In order to ensure accurate and consistent measurements, the study weight scale was professionally calibrated and the height scale checked and recalibrated daily before measurements commenced. All assessments were completed by staff blinded to treatment allocation. When men are contacted (via phone and email) to book in for follow-up assessments they will be asked not to inform data collection personnel of their group allocation. Data will be entered by research assistants blind to group allocation and a program of plausibility checks will be used to identify unrealistic values. The primary outcome measure (weight) will be double entered to ensure accuracy and a random 20% sample of all other measures will also be double entered.t tests for continuous variables and chi-squared (χ2) tests for categorical variables. The significance level for the comparison of baseline characteristics will be set at 0.05.Analyses will be performed using Stata Version 11 or later. All variables will be checked for plausibility and missing values. Data will be presented as mean (sd) for continuous variables and counts (percentages) for categorical variables. Differences between groups at randomisation and characteristics of completers versus dropouts will be tested using independent Resources vs. Control; Online vs. Control; and Resources vs. Online). The independent variables in the model will include a variable for treatment group, time and the group-by-time interaction. The model will also include a term for the stratifying variable of BMI group at baseline. The coefficient and p-value for the group-by-6 month interaction term will be used to determine the efficacy of the interventions. Similar models will be used to examine differences in change in other outcome measures.A series of Generalised Linear Mixed Models (GLMMs) with a random intercept for individual will be used to test for differences between treatment groups in the mean level of weight after treatment. Separate models will be fit for each of the pair-wise comparisons and of interest will be the 3 way interaction of treatment group by time by SES. We will also examine a range of secondary outcomes to support the primary outcome . Additional exploratory models will be fitted to examine if the men who have the greatest reduction in weight are also those who have the greatest improvements in the secondary outcomes.Statistical significance of the primary efficacy analysis (3 pair-wise comparisons) will be based on Hochberg's multiple testing procedure with the family wise error rate held at 5%. All secondary hypothesis tests will be performed using a 2-sided 5% significance level. In addition, linear regression and GLMMs will be used to describe relationships among the various dependent and independent variables.Online and Resources component. Men who complied well with the assigned treatment, defined as completion of requested daily eating and exercise diaries (n >40) over the 3-month period and weekly check-ins (n >10). Results of the per-protocol group will be compared with non-compliers in each group i.e. those who did not meet the above adherence recommendations.A per protocol analysis will also be conducted and include men who complied with treatment from the The aim of this study is to evaluate the efficacy of two 'low dose' weight loss programs developed specifically for men that could be widely and inexpensively implemented throughout Australia. We will determine whether these innovative approaches to obesity treatment will result in greater initial weight loss and improvements in cardiovascular risk factors compared to a Control group in a community sample of overweight men. There is an urgent need to develop and evaluate novel approaches to weight loss that attract and engage large numbers of men. We will also determine whether web-based support is more effective than resources alone. This study is designed to address the gap in service provision of community-based programs for overweight and obese men. There is limited evidence to guide the design of effective obesity treatment programs for overweight men that would be sustainable in most health care settings that do not require multiple visits to treatment centres.Our trial targets a national health priority in Australia and focuses on a high-risk under studied population. To successfully combat the obesity epidemic, clinicians and health care systems require feasible, effective and evidence-based treatment options that can be provided to large numbers of men. This randomised controlled trial will test alternative, evidence-based and theoretically driven, easily disseminated strategies specifically for weight loss in men. The interventions are all designed so they could serve as prototypes for rapid translation of research findings into widely available practical applications and widespread implementation in both the public health and medical care sectors. If successful, this project will reduce the negative health, economic and social consequences of obesity through clinically meaningful risk reduction in large numbers of overweight men.The authors declare that they have no competing interests.The study chief investigators PJM, RC, CEC, PM, RCP and Associate Investigator JMW were responsible for identifying the research question, design of the study, obtaining ethics approval, the acquisition of funding and overseeing study implementation. Associate Investigator TB and research assistants NB, MDY, EJA and KLS have contributed to development of intervention materials, recruiting participants and/or study implementation. All authors were responsible for the drafting of this manuscript and have read and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/701/prepub"} -{"text": "A 36-year-old man presented with headache and right upper and lower limb weakness for 10 days. MRI revealed absence of the odontoid process of the C2 vertebral body, with resultant atlantoaxial dislocation along with myelomalacic changes involving the cervicomedullary junction. Developmental anomalies of the odontoid are uncommon. The clinical importance lies in their potential to cause serious neurological complications due to atlantoaxial instability.We report a case of congenital absence of the dens, with resultant atlantoaxial dislocation and partial fusion of the C2 and C3 vertebrae.A 36-year-old man presented with a history of minor trauma to the head following a sudden jerk while traveling in a bus. He complained of headache and right upper and lower limb weakness. On examination, power in the right upper and lower limbs was 4/5. The right plantar reflex was extensor. No sensory deficit or bladder/bowel involvement was seen.MRI of the brain and the cervical spine was performed, which revealed absence of the odontoid process of the C2 vertebra , with reCongenital anomalies involving the craniovertebral junction are clinically important because of their potential for producing serious neurological deficits. The clinical features are chiefly because of the associated atlantoaxial dislocation and include persistent neck pain, headache, and transient/permanent paresis. Often, pCongenital anomalies involving the odontoid process are rare. They can be classified into os odontoideum, ossiculum terminale, aplasia-hypoplasia, and duplThe development of the axis is complex . Four osIn our case, the dens itself, as well as the part of the dens assimilated by the body of C2, was absent , the latAnomalies of the odontoid can usually be diagnosed on a standard series of radiographs, plus flexion and extension lateral films. With the increasing importance of CT scan and MRI in the study of the craniovertebral junction, a detailed evaluation of such congenital anomalies is now possible, as demonstrated in our case.The first case of odontoid hypoplasia was reported by Roberts in 1933. Since th"} -{"text": "Henipavirus, are zoonotic paramyxoviruses that have been associated with sporadic outbreaks of severe disease and mortality in humans since their emergence in the late 1990s. Similar to other paramyxoviruses, their ability to evade the host interferon (IFN) response is conferred by the P gene. The henipavirus P gene encodes four proteins; the P, V, W and C proteins, which have all been described to inhibit the antiviral response. Further studies have revealed that these proteins have overlapping but unique properties which enable the virus to block multiple signaling pathways in the IFN response. The best characterized of these is the JAK-STAT signaling pathway which is targeted by the P, V and W proteins via an interaction with the transcription factor STAT1. In addition the V and W proteins can both limit virus-induced induction of IFN but they appear to do this via distinct mechanisms that rely on unique sequences in their C-terminal domains. The ability to generate recombinant Nipah viruses now gives us the opportunity to determine the precise role for each of these proteins and address their contribution to pathogenicity. Additionally, the question of whether these multiple anti-IFN strategies are all active in the different mammalian hosts for henipaviruses, particularly the fruit bat reservoir, warrants further exploration.Hendra and Nipah virus, which constitute the genus HeV wasus (NiV) . Humans us (NiV) . In humaus (NiV) . HeV andaviruses ,6. In Baaviruses . In addi2.2.1.Paramyxovirinae subfamily, extend the coding capacity of their genome via an mRNA editing mechanism that gives rise to multiple proteins from the P gene. During transcription of the P gene the polymerase stutters at a run of A and G residues referred to as the editing site and this results in the addition of non-templated G residues into the nascent mRNA. An unedited henipavirus P mRNA encodes the phosphoprotein (P), which participates in viral RNA synthesis as a cofactor for the polymerase. The insertion of one extra G residue shifts the frame and this mRNA encodes the V protein and NiV P (Ser-240 and Ser-472) . It is n2.3.The fourth protein encoded by the henipavirus P gene is the C protein, which is expressed from an alternate ORF present in P, V and W transcripts. This 18 kDa protein localizes to the cytoplasm in a punctate pattern and it can be detected at low levels in NiV virions . Interes3.Cellular detection of virus infection is the trigger for initiating synthesis of IFN-β, and the molecules described to serve as cytoplasmic sensors for RNA viruses are RIG-I and mda-5 ,24. The 3.1.Paramyxovirus V proteins limit the synthesis of type I IFN via a highly conserved mechanism . A studyThe V proteins are notably unable to interact with or inhibit signaling from the related RNA helicase, RIG-I . Due to 3.2.Like the V protein, the W protein of NiV can also prevent activation of the IFN-β promoter that is triggered by virus or intracellular dsRNA . As W ha4.Both type I (α/β) and type II (γ) interferons (IFN) mediate their effects on cells by binding to receptors on the cell surface and activating the JAK-STAT signaling pathway . STAT S. The act4.1.In the presence of either NiV P, V or W proteins, there are reduced levels of tyrosine 701 phosphorylated STAT1 in IFN-α/β-treated cells ,18. ThisIn an unstimulated cell STAT1 shuttles between the cytoplasm and nucleus but upon IFN treatment, the phosphorylated and dimerized form translocates to the nucleus. In cells that are expressing P and V proteins, STAT1 is retained exclusively in the cytoplasm in its inactive, non-phosphorylated form even in the presence of IFN-α/β or IFN-γ ,16,18. T4.2.As suggested by the strong co-localization data, the P, V and W proteins can all interact with STAT1 ,15–18. Tet al. [The STAT1 binding domain lies within the N-terminal portion of P, V and W ,15,17. Fet al. examinedet al. . Mutatioet al. . Intereset al. . For botet al. .KO and CKO/G121E viruses display identical growth properties in both 293T and Vero cells, although interestingly both are attenuated relative to the wild-type NiV. Crucially, infection with the CKO/G121E virus induces STAT1 phosphorylation in response to IFN-β whereas WT and CKO viruses do not [KO/G121E infected cells in response to IFN. In contrast the inactive form of STAT1 remains sequestered in the nuclei of NiV WT and CKO infected cells. As mentioned earlier, these data suggest that the nuclear W protein is functioning as the main obstacle to IFN signaling and that this is abolished by the G121E mutation, which eliminates the STAT1 interaction. The finding that the recombinant NiV lacking STAT1-binding has identical growth properties to its CKO parent virus, even in 293T cells , indicates that the lack of STAT1 inhibition is not detrimental to the virus. This suggests that additional anti-IFN mechanisms encoded by NiV are probably still intact. These could be either V-mediated inhibition of mda-5, W-mediated inhibition of IRF3 activity in the nucleus, or both acting in concert.In order to verify the importance of the residues conferring STAT1-binding within the context of the whole virus, it was necessary to determine whether they were also required for the polymerase co-factor function of the P protein. Using a NiV mini-genome assay to assess polymerase function, it was shown that the critical region for RNA synthesis lies within amino acids 81–113 of the P protein and that substitutions that affect STAT1 binding do not interfere with polymerase activity ,21. Thiss do not . Also, net al. [To date, only the V protein has been reported to interact with STAT2 ,18,36. Tet al. also demCurrently, there is limited information regarding the region of STAT1 that interacts with the NiV proteins. The domain structure of STAT1 can be broadly divided into an N-terminal domain, a coiled-coiled region, a DNA-binding domain, a linker domain, an SH2 domain and a transactivation domain . Using a5.KO virus which has attenuated growth properties relative to the wild-type virus [Of all the henipavirus P gene products, we know the least about the C protein. Plasmid-based expression of the NiV C protein has been shown to prevent the induction of a robust antiviral response but the pe virus . The facpe virus .6.In conclusion, through their unique coding strategy, henipaviruses produce multiple proteins that antagonize the antiviral response at multiple levels. While the shared N-terminal domains of the P, V and W proteins direct inhibition of STAT signaling, the C-terminal domains of the V and W proteins confer unique properties on these proteins that extend their antagonist function. For V this involves mda-5-binding and for W this involves nuclear localization and the ability to block a late stage of the IFN induction pathway. The question of whether all these mechanisms are active in an infected cell is something that still needs to be explored. Unfortunately the need for biosafety level 4 conditions has limited this work but the description of a reverse genetics system for NiV opens the door to addressing the contribution of each protein and/or mechanism. Another factor to consider is that the presence of multiple anti-IFN mechanisms may relate to the zoonotic nature of these viruses. Even though it has already been shown that the NiV V protein can prevent IFN signaling in cells from multiple species , some of"} -{"text": "Intimate partner violence (IPV) is a significant public health problem. There is a lack of data on IPV risk factors from longitudinal studies and from low and middle income countries. Identifying risk factors is needed to inform the design of appropriate IPV interventions.Data were from the Rakai Community Cohort Study annual surveys between 2000 and 2009. Female participants who had at least one sexual partner during this period and had data on IPV over the study period were included in analyses (N = 15081). Factors from childhood and early adulthood as well as contemporary factors were considered in separate models. Logistic regression was used to assess early risk factors for IPV during the study period. Longitudinal data analysis was used to assess contemporary risk factors in the past year for IPV in the current year, using a population-averaged multivariable logistic regression model.Risk factors for IPV from childhood and early adulthood included sexual abuse in childhood or adolescence, earlier age at first sex, lower levels of education, and forced first sex. Contemporary risk factors included younger age, being married, relationships of shorter duration, having a partner who is the same age or younger, alcohol use before sex by women and by their partners, and thinking that violence is acceptable. HIV infection and pregnancy were not associated with an increased odds of IPV.Using longitudinal data, this study identified a number of risk factors for IPV. These findings are useful for the development of prevention strategies to prevent and mitigate IPV in women. Violence against women is a serious and common human rights and public health problem, which causes significant morbidity and mortality worldwide . IntimatKnowledge of context-specific risk factors for IPV is important to be able to appropriately focus prevention efforts. A recent World Health Organization (WHO) review noted the lack of data on IPV risk factors from longitudinal studies and from low and middle income countries . This bri.e. communities which lack legal sanctions and where women lack access to shelters and family support, and in which there is less moral pressure for neighbours to intervene if a woman is beaten). Societal level factors are divorce regulations, a lack of legislation on IPV within marriage, protective marriage laws, and traditional gender and social norms [The WHO review identified risk factors for IPV and classified them into the four levels of an ecological framework: individual, relationship, community and societal levels factors . Individal norms .i.e. not legally or formally married) compared to being married, being married compared to having a boyfriend or other casual partner, having a partner who consumed alcohol before sex, and a woman perceiving her partner to have a higher risk of HIV infection were risk factors for IPV [Recent cross-sectional studies of women in sub-Saharan Africa have identified some of these same risk factors for IPV -6, as we for IPV ,8.In this study, we aimed to identify risk factors for IPV in women of reproductive age in Rakai District, Uganda, using longitudinal data from seven survey rounds of the Rakai Community Cohort Study between 2000 and 2009. We assessed characteristics shown to be risk factors in other settings -6.Since 1994, the Rakai Health Sciences Program has followed an open cohort of about 12,000 participants aged 15 to 49 years in 50 communities in the Rakai district of southwestern Uganda. The cohort has been described in detail elsewhere . In brieWomen who participated in the study between 2000 and 2009 were included in analyses if they reported at least one sexual partner during the study period and if they had provided any data on whether they experienced IPV during the study period.Intimate partner violence (IPV) was defined as any physical, sexual, or verbal violence by a partner in an intimate relationship. Questions on IPV were modified from the Revised Conflict Tactics Scales (CTS2), and, in some analyses, type of IPV was classified as minor or severe as per the CTS2 ,12. Minoi.e. in childhood or in early adulthood) and contemporary factors defined as variables that may affect women in their current lives. These two groups of variables were analysed separately.Potential risk factors for IPV were determined based on the literature and on which data were collected for the RCCS between 2000 and 2009. Since characteristics and experiences in early life may cause some of the characteristics and experiences in adulthood, and specifically, risk factors for IPV in adulthood may be on the causal pathway from early factors to IPV , risk vai.e. from the first round of participation during the period under study.Early factors included sexual abuse in childhood or adolescence , age at Contemporary factors included demographic variables such as age -21,23-25For participants who reported multiple partners in the past year, data about the partner with whom the participant reported having had sex most recently was used for the variables type of relationship with partner, alcohol use by partner, length of sexual partnership, and difference in age with partner; it was not possible to determine which specific partner (if any) had perpetrated violence.The prevalence of IPV and of potential IPV risk factors was assessed. To identify early factors, logistic regression was used to estimate the bivariate and multivariable odds ratios (OR) and 95% confidence intervals (95% CI) associated with violence during the period of study participation. For contemporary factors, population-averaged logistic regression models were used to look at bivariate and multivariable associations , which aa priori as being of greater importance on the basis of known associations with violence, including sexual abuse in childhood or adolescence, coerced first sex, and education for early factors, and age, marital status, pregnancy status, difference in age with partner, use of alcohol, number of partners in past year, and attitudes toward violence for contemporary factors [i.e. age at first sex for early factors and beginning with relationship type for contemporary factors, until the first variable was encountered with a p value of p < 0.1, either by Wald test or by likelihood ratio test, depending on whether the variable was continuous, binary, or categorical.For each of early factors and contemporary factors, since there were multiple predictors of interest and to minimize the risk of Type I error of conventional backward selection models, an Allen-Cady modified backward selection procedure was used for the multivariable models . Candida factors ,27,32. ASeparate models were run to look at the associations between contemporary factors and risk of violence in the same year, in consideration of the fact that certain associations, such as the temporal association between pregnancy and violence, might not be adequately captured when looking at exposure and outcome data from sequential years. Analyses were done using Stata 12.During the period under study, the Rakai Community Cohort Study was approved by institutional review boards at the Scientific and Ethics Committee of the Uganda Virus Research Institute, the Uganda National Council of Science and Technology, Columbia University, Johns Hopkins University, Johns Hopkins Bloomberg School of Public Health, and the Western. Ethics approval was obtained for this analysis from the University of Toronto.Of the 20584 women who participated in the study over this period, 15081 (73.3%) were included in these analyses. One hundred twenty women were excluded because they were younger than 15 or older than 49 during the entire period under study, four women were excluded because they had a positive HIV test result and subsequent negative tests, 3228 women were excluded because they were not sexually active during the study period, and 2151 were excluded because they did not have any data on IPV during the study period.IPV was common in this population, as shown in Table Most women (66%) who experienced any violence experienced more than one form of violence concurrently. In the most recent survey round of participation for the 4367 women who reported any IPV, 1064 women (24.4%) reported experiencing verbal violence only, 322 (7.4%) reported sexual violence only, and 94 (2.2%) reported physical violence only. Six hundred eighty-three women (15.6%) experienced verbal and physical violence only, 218 (5.0%) women reported verbal and sexual violence only, and 443 (10.1%) reported physical and sexual violence only, while 1289 women (29.5%) reported all three forms of violence.Women commonly experienced violence early in life, with 31.3% of 1784 women reporting sexual abuse in childhood or adolescence and 17.5% of 11607 reporting coerced first sex, as shown in Table In bivariate analyses, as shown in Table The frequency of characteristics and behaviours was examined, as shown in Table Table Multivariable models of the association between contemporary factors in the current year and IPV in the current year revealed qualitatively similar associations (data not shown). Of note, pregnancy was not a risk factor for violence in the same year, and in fact was associated with a lower risk of IPV with an odds ratio of 0.91 .As found in diverse international studies, IPV is prevalent in this population and most women who experienced IPV reported experiencing more than one form of violence concurrently. Several of the risk factors identified in this longitudinal study are consistent with existing evidence , includie.g. which types of IPV were measured, may affect estimates of association. In this study, data on physical, verbal, and sexual IPV were included, however, there were no data collected on controlling behaviours, which could affect the magnitude of association identified if controlling behaviours were associated with pregnancy independently of other forms of IPV. Finally, the finding of a lack of association could reflect effect modification on the basis of geographical or cultural contexts, i.e. that the association between pregnancy and IPV may only exist in certain contexts.In contrast with much of the literature on risk factors for IPV , but coni.e. that prevalent and incident cases of HIV and IPV were included in the exposure and outcome, respectively, the types of IPV included as noted above, or the period in which the exposure and outcome were measured (i.e. one year), which may not reflect the relevant period of exposure for this association; the inclusion and control of relevant confounders; or that HIV leading to IPV is not a significant pathway in this population.Another notable finding of this study is that HIV infection was not associated with IPV in the subsequent year, with an unadjusted odds ratio of 1.02 and an adjusted odds ratio of 1.03 . In other population-based studies from East Africa, one cross-sectional study and one The strengths of this study are its large size, high participation rates, prospective design, the inclusion of several important variables as potential predictors, the separation of early and contemporary factors in analyses, and the focus on a low income country. There are several limitations to this study. Some risk factors which may be relevant were not included in the analyses because data were not available, such as number of children, income level, and the gap in income and education between partners, which may result in residual confounding of the associations between examined variables and IPV. Some variables may not specifically identify risky behaviour, for example the use of any alcohol before sex as opposed to heavy alcohol use or more general problematic alcohol consumption, which may dilute any association and bias the estimate of the effects of problematic alcohol use toward the null. The questions on IPV were modified from the CTS2, however, this version of the scale has not been validated in this population, which could contribute to measurement error. Also, as noted earlier, no data were collected on controlling behaviours as part of the definition of IPV, which could lead to an underestimate of associations. For contemporary factors, the exposure period was assumed to be the year prior to IPV, and for early factors, only IPV during the period under study was examined. In fact, the relevant exposure period for contemporary factors may be longer or shorter than a year, and for both early and contemporary factors, may take place closer to or further from any IPV incidents; these temporal relationships have not yet been well defined. Since we did not assess the role of early and contemporary factors together in one model, we are unable to determine whether contemporary factors are on the causal pathway between early factors and IPV, as hypothesized, or, in the event that contemporary factors are not in the causal pathway between early factors and IPV, whether early or contemporary factors are more strongly associated with experiencing IPV. Finally, it was not possible to discern whether data on violence were relevant to a specific partner for women who had more than one partner, however, this would not likely affect the validity of the results since consistently fewer than seven percent of women had more than one sexual partner in each survey round.i.e. sexual abuse in childhood or adolescence, lower levels of education, forced first sex, younger age, alcohol use by women and their partners, being in a relationship of shorter duration and thinking that violence is acceptable. The data also suggest that several hypothesized risk factors may not be associated with IPV, i.e. pregnancy and HIV positivity. Finally, the analysis also identifies novel risk factors for IPV in this setting, i.e. younger age at first sex, coerced first sex, and having a partner the same age or younger. These findings are likely generalizable to other rural areas in sub-Saharan Africa and potentially elsewhere, and have direct implications for public health action in terms of the primary and secondary prevention of IPV.In summary, this analysis confirms that certain established risk factors from other settings are associated with IPV in this setting, There are diverse approaches to addressing violence against women , and theThe authors declare that they have no competing interests.FK developed the research question and protocol, conducted analyses, and drafted the manuscript. LC, SB, and PO contributed to the analysis and interpretation of data. RG and JK were involved in the conception and design of the study, acquisition of data, and analysis and interpretation of data. DS, FN, GK, and MW were involved in conception and design of the study, and acquisition of data. All authors revised the manuscript and approved the final draft.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/13/566/prepub"} -{"text": "About 50% of patients in substance abuse treatment with a partner perpetrated and/or experienced intimate partner violence in the past year. To date, there are no screeners to identify both perpetrators and victims of partner intimate violence in a substance abusing population. We developed a 4 item screening instrument for this purpose, the Jellinek Inventory for assessing Partner Violence (J-IPV). Important strengths of the J-IPV are that it takes only 2 minutes to administer and is easy to use and to score.To investigate the validity of the J-IPV, two independent studies were conducted including 98 and 99 participants, respectively. Aim of the second study was to cross-validate findings from the first study. Psychometric properties of the J-IPV were determined by calculating sensitivity, specificity, positive and negative predictive value, and positive and negative likelihood ratio’s by comparing J-IPV outcomes to outcomes on the Revised Conflict Tactics Scales (‘gold standard’). Also, receiver operator characteristics (ROC)-curves were determined to weight sensitivity and specificity as a result of different J-IPV cutoffs, and the area under the curve (AUC) was calculated.any as well as severe intimate partner violence. Results from the second study replicated findings from the first study.Results of the first study demonstrated that the J-IPV possesses good psychometric properties to detect perpetrators and victims of We recommend administering the J-IPV to patients entering substance abuse treatment. If perpetrators and victims of partner violence are identified, action can be taken to stop IPV perpetration and arrange help for victims, for example by offering perpetrators treatment or by providing safety planning or advocacy interventions to victims. Consequences of physical IPV can be severe for victims and may result in injuries, chronic pain, depression, posttraumatic stress disorder, suicidality, and substance use disorders ar e.g., .Because of the serious consequences of IPV and its high prevalence among patients in substance abuse treatment, it is important to assess IPV perpetration among these individuals. Ideally, IPV perpetrators should be identified at intake in order to prevent further assault of victims victimization of IPV in the past year; the latter two questions address perpetration of IPV in the past year On the basis of the criteria described above we developed the 4 items counting Jellinek Inventory for assessing Partner Violence (J-IPV), a screener that takes only 2 minutes to administer, and is simple to use and score. The first two questions of the J-IPV address year see . The itell e.g., , it was To determine psychometric properties of the J-IPV for detecting 1) any IPV perpetration, 2) severe IPV perpetration, 3) any IPV victimization, and 4) severe IPV victimization, the following values were determined: 1) sensitivity , 2) specificity , 3) positive predictive value , and 4) negative predictive value were computed. In addition, positive likelihood ratio and negative likelihood ratio were calculated as suggested, for example, by There are no universal criteria to determine the minimum standards of a screening instrument, since it depends on the situation whether greater value is attached to sensitivity or specificity The study was approved by the ethical committee of the University of Amsterdam (reference number 2010-kp-1350). Written informed consent was obtained from all participants.th 2011 and April 22nd 2011 in Amsterdam or between December 28th 2011 and October 17th 2012 in Hilversum. Patients were included if they 1) fulfilled DSM-IV-TR criteria for substance abuse or dependence (with the exclusion of nicotine dependence as the sole substance use disorder diagnosis), 2) had a partner for at least 3 months in the past year, 3) had sufficient knowledge of the Dutch language , and 4) were at least 18 years old. Patients were excluded in case of 1) severe withdrawal or intoxication symptoms during the intake, 2) severe mental illness , and 3) severe cognitive disorders, such as Korsakoff’s syndrome or dementia.The two studies were conducted at two different locations of Jellinek, a large substance abuse treatment facility, in Amsterdam (study 1) and Hilversum (study 2), the Netherlands. Patients were included if they had an intake between February 28The J-IPV is a 4 item-screening device that was developed to assess IPV perpetration in patients entering substance abuse treatment. FK formulated the items of the J-IPV and EV, AS, and PE independently reviewed the items; the final items were based on consensus. The questions are administered as a structured interview and questions are answered with ‘yes’ or ‘no’. Two native English speakers translated the J-IPV from Dutch into English. Translations were compared with one another and led to the final English version of the J-IPV see .physical IPV, we only used item pairs assessing physical violence (2×12 items). To make the transition to the physical violence items more gradual, firstly 3 items pairs addressing verbal violence were administered . Subsequently, the physical violence items of the CTS2 were administered in the same order in which they appear in the CTS2. The other CTS2 items were not used in this study. The physical violence items of the CTS2 were used to categorize participants as perpetrator and/or victim of any/severe physical IPV. Participants were rated as perpetrator of any IPV when answering ‘yes’ to at least one physical IPV perpetration item and were rated as victim of any IPV after at least one ‘yes’ to any of the physical IPV victimization items. Further, participants were classified as having perpetrated severe physical IPV or being victimized by severe physical IPV if at least one of the severe physical violence perpetration or victimization items was answered with “yes”. The adapted version of the CTS2 was administered as a structured interview, a method that was supported by The CTS2 The MATE During the intake, psychologists from the treatment staff who regularly conducted the intakes and were not involved in the factual studies administered the MATE. Subsequently, patients were informed about the study. If they agreed to participate, informed consent was obtained. Hereafter, the J-IPV and CTS2 were administered successively as structured interview. Since the aim of the study was to investigate whether the J-IPV predicted the outcome on the CTS2, we did not counterbalance administration of the J-IPV and CTS2. To help participants remember the 7-point rating scale of the CTS2, they were given a form with response categories written out. The first study was conducted at Jellinek Amsterdam; the second study at Jellinek Hilversum in order to cross-validate findings from the first study.Demographics of participants of the 2 studies were compared using chi-square tests for categorical variables ; an independent samples t-test for normally distributed continuous variables (age); and a Mann-Whitney test for nonnormally distributed continuous variables (relationship length). To determine psychometric properties of the J-IPV, sensitivity, specificity, PPV, NPV, LR+, LR−, and AUC were calculated for the J-IPV compared to the CTS2 as ‘gold standard’ only both J-IPV perpetration items were used (items 3 and 4) and 3) the separate items addressing IPV perpetration (items 3 and 4) were used. Psychometric properties of the J-IPV to detect any/severe IPV victimization were determined when 1) all J-IPV items were used, 2) only both J-IPV victimization items were used (items 1 and 2) and 3) the separate items addressing IPV victimization (items 1 and 2) were used. After determining psychometric properties for these different options, the optimal cutoff or scoring method was selected to classify participants as 1) perpetrator of any IPV, 2) perpetrator of severe IPV, 3) victim of any IPV, and 4) victim of severe IPV. As mentioned in the introduction, we valued high sensitivity and NPV the most important psychometric properties the J-IPV should possess because it might be harmful to overlook perpetrators and victims of IPV. Therefore, the following steps were taken to decide on the optimal cutoff or scoring method. First, it was examined which cutoff or scoring method resulted in highest sensitivity and NPV. Then, it was observed whether this scoring method also yielded the highest AUC, and finally it was examined whether specificity and PPV were still acceptable.Prior to the start of this study, the J-IPV had been used in clinical practice for 20 months. Clinical observations taught that some patients who had committed physical IPV but saw themselves primarily as victim (and not perpetrator), did answer positively to one or both victimization items, but not to any of the perpetrator items. This demonstrates that people tend to underreport IPV perpetration e.g., but alsoA total of 115 participants met inclusion criteria. Seventeen participants (14.8%) were excluded: 7 participants (6.1%) refused participation, 5 (4.3%) suffered from severe mental illness, 4 (3.5%) dropped-out because of logistic reasons, and 1 (0.9%) suffered from a severe cognitive disorder see . The finOn the basis of the CTS2, participants were classified as 1) no perpetrator, no victim, 2) perpetrator only, 3) victim only, and 4) both perpetrator and victim of physical IPV see . About hA total of 158 participants met inclusion criteria. Fifty-nine participants (37.3%) were excluded: 8 participants (5.1%) refused participation, 11 (7.0%) suffered from severe mental problems, 4 (2.5%) suffered from a severe cognitive disorder; 2 (1.3%) were severely intoxicated, 3 (1.9%) dropped-out because the intaker was not yet trained in administering the J-IPV and CTS2, and 31 (19.6%) dropped-out because of logistic reasons see . The finIn addition, as in study 1, participants were classified as (non) perpetrator and/or victim of IPV see . Again, 2 (2) = 6.21; p<.05). Standardized residuals indicated that more participants of study 1 had a non-European nationality than participants in study 2. In addition, participants of study 1 and 2 differed significantly form one another regarding relationship length (F (186) = 4.52; p<.05); participants of study 2 had significantly longer relationships than participants of study 1. Participants of study 1 and 2 did not differ significantly regarding gender, age, living together, relationship at the time of the intake, children under 18, treatment intensity, and primary substance use disorder diagnosis. In addition, there were no differences between the 2 studies regarding prevalence rates of any/severe past year IPV perpetration/victimization. Also, there were no differences in rates of reciprocality of IPV psychometric properties of both J-IPV perpetration items (items 3 and 4) were calculated, and 3), diagnostic efficiency was calculated for items 3 and 4, separately (see any of the J-IPV items) resulted in highest sensitivity (.80) and NPV (.85) (the indicators that were decided to be most important to the J-IPV). Also, the largest AUC (.80) was obtained when all 4 J-IPV items were used. In addition, specificity (.80) and PPV (.75) were still acceptable for this option, as well as LR+ (4.17), and an LR− (.24). For study 2, similar results were found see . For illTo detect severe IPV perpetration, using a cutoff of 2 resulted in optimal psychometric properties in study 1 psychometric properties of both J-IPV victimization items (items 1 and 2) were calculated, and 3) diagnostic efficiency fore detecting IPV victimization was calculated for the separate victimization items (1 or 2). A cutoff of 1 resulted in the most favorable psychometric properties . Similar results were obtained in study 2 . ROC-curves are displayed in Psychometric properties for detecting any physical IPV victimization using CTS2 victimization items as ‘gold standard’ are displayed in severe physical IPV victimization were determined and NPV . In other words, 80/84% of IPV perpetrators screened positive for IPV perpetration on the J-IPV; after screening negative, 85/82% of the participants had indeed not committed IPV. 2) To detect severe IPV perpetration, optimal results were found for a cutoff of 2, which resulted in sensitivity and NPV of 1.00 in both studies. 3) To detect any IPV victimization, we recommend using a cutoff of 1, which resulted in highest sensitivity (.83 and.80) and NPV (.87 and.86). It is noticeable that the same cutoff was suggested for detecting any IPV perpetration; this could be explained by the fact that in about 70% of the cases IPV was reciprocal .The aim of the present study was to validate and cross-validate the J-IPV by determining its sensitivity, NPV, AUC, specificity, PPV, LR+, and LR−. It was decided that sensitivity and NPV, which we considered the most important properties of the J-IPV, should be at least ≥.80. Based on the results of the two studies, it is suggested to use the following cutoffs for the different purposes of the J-IPV. 1) To detect ocal see . 4) To dnot factually involved in severe IPV is preferred above missing patients who are indeed involved in severe IPV. Moreover, patients who screened positive for severe IPV but were in fact not involved in severe IPV, were likely involved in non-severe IPV. Finally, likelihood ratios, ranging from 4.17–8.33 (LR+) and from 0–.25 (LR−), demonstrated that participants who screened positive were 4–8 times more likely than patients who screened negative to have perpetrated/experienced any/severe IPV, and that after screening negative, the odds were 0–25% to have perpetrated/experienced any/severe IPV. In sum, two independent studies demonstrated that the J-IPV is a valid screener with sensitivities and NPV’s ≥.80 to detect IPV in patients in substance abuse treatment. The second study replicated results from the first study, despite differences in population , and despite the fact that the first study was conducted in a large city and the second in a smaller town. Although it was expected that the second study would perform less than the first study For the other psychometric properties, the following results were found for the different cutoffs. AUCs that varied between.84 and.94 indicated that there was an 84–94% chance that a randomly selected perpetrator/victim of any/severe IPV scored higher on the J-IPV than a randomly selected patient that did not perpetrate/experience any/severe IPV. Further, specificities ranged from.79–.88, indicating that 79–88% of factual non-IPV perpetrators screened indeed negative. PPV’s were found between.45–.80, indicating that 45–80% of all positive screening participants actually committed/experienced any/severe IPV in the past year. PPV’s of the J-IPV to detect severe IPV perpetration and victimization were on the low side . However, we do not consider this problematic. The J-IPV is developed to screen for IPV and to identify patients in whom IPV should be further assessed. We argue that additional assessment of IPV in patients who are not to study the predictive validity of the CTS2 and the J-IPV. Further, it is noticeable that more men than women participated in the two studies. However, men are overrepresented in substance abuse treatment and this does not reflect a selection bias. Finally, in the second study, 31 patients (19.1%) were excluded from the study because of logistic reasons, such as that the intaker had forgotten to administer the J-IPV or that there was not sufficient time in the intake to administer the J-IPV and CTS2.There were several limitations to the study. In the first place, both the J-IPV and the CTS2 rely on self-report of participants, which implies that the results do not automatically reflect the physical violence that actually took place. Participants may deny or minimize the violence they have committed or were victimized by. On the other hand, although people tend to underreport violence in their relationship when completing the CTS In addition, there are several issues that should be addressed in future research. First, although the J-IPV demonstrated good psychometric properties in two different substance abuse treatment centers, these finding do not necessarily generalize to other settings , since psychometric properties depend on the prevalence of a ‘disease’ in a population severe IPV perpetration and/or victimization if limited time or resources are available. Second, using the J-IPV would help overcome personal barriers to screening for IPV; the J-IPV is conducted as structured interview, which makes it easier for intakers to address this sensitive topic. Finally, also patient-related barriers can be disputed on the basis of the present study. These problems are prevalent among patients in substance abuse treatment and no problems in administering the J-IPV have been encountered. An additional comment is that since Since the J-IPV demonstrated good psychometric properties, it is recommended to routinely administer the J-IPV, which is available in the public domain, during intakes in substance abuse treatment facilities. If patients answer ‘yes’ to one or more of four J-IPV questions, IPV should be further assessed (stepped assessment), for instance, by administering the CTS2. Also, when using the J-IPV, various barriers on screening for IPV as reported by not to screen for IPV in substance abuse treatment facilities.After a positive J-IPV score and careful subsequent assessment, appropriate treatment for IPV perpetrators and/or victims should be arranged. However, to date, no evidence-based treatments addressing IPV perpetration exist Appendix S1.(DOCX)Click here for additional data file.Charts S1Receiver operator characteristics (ROC)-curves to detect any and severe IPV perpetration and victimization for optimal scoring methods.(DOCX)Click here for additional data file."} -{"text": "Intimate partner violence (IPV) against women is a global public health and human rights concern. Despite a growing body of research into risk factors for IPV, methodological differences limit the extent to which comparisons can be made between studies. We used data from ten countries included in the WHO Multi-country Study on Women's Health and Domestic Violence to identify factors that are consistently associated with abuse across sites, in order to inform the design of IPV prevention programs.Standardised population-based household surveys were done between 2000 and 2003. One woman aged 15-49 years was randomly selected from each sampled household. Those who had ever had a male partner were asked about their experiences of physically and sexually violent acts. We performed multivariate logistic regression to identify predictors of physical and/or sexual partner violence within the past 12 months.Despite wide variations in the prevalence of IPV, many factors affected IPV risk similarly across sites. Secondary education, high SES, and formal marriage offered protection, while alcohol abuse, cohabitation, young age, attitudes supportive of wife beating, having outside sexual partners, experiencing childhood abuse, growing up with domestic violence, and experiencing or perpetrating other forms of violence in adulthood, increased the risk of IPV. The strength of the association was greatest when both the woman and her partner had the risk factor.IPV prevention programs should increase focus on transforming gender norms and attitudes, addressing childhood abuse, and reducing harmful drinking. Development initiatives to improve access to education for girls and boys may also have an important role in violence prevention. Intimate partner violence (IPV) against women is a global human rights and public health concern. The WHO Multi-Country Study on Women's Health and Domestic Violence documented the widespread nature of IPV , with liDesigning effective IPV prevention programmes involves identification of risk factors--both those that are direct causes of IPV, and those that point to common characteristics of victims and/or perpetrators thus allowing appropriate tailoring and targeting of services. Studies in various countries have identified a range of factors that influence IPV risk -13, but It is difficult to make comparisons between settings using existing individual studies as differences in identified risk factors may either be methodological artefacts or a real reflection of contrasting phenomena. Selected Demographic and Health Surveys ,15 have We use population-based data from the WHO Multi-Country Study on Women's Health and Domestic Violence, which was specifically designed to better understand the factors associated with violence in different settings. Comparability of data was maximised through use of a standardised questionnaire, standardised interviewer training and data-collection procedures across all participating sites, and a rigorous set of quality control procedures. We drew on current models of IPV risk, including those of Heise ,18 and JDetails of the study methods, sampling, response rates, and prevalence of different types of partner violence in each setting have been reported elsewhere see Add. BrieflyTrained female interviewers completed interviews with one randomly selected woman aged 15-49 from each sampled household. 24,097 women were interviewed in total, using a standardised questionnaire which was developed by the study team and translated into 14 languages.Specially developed ethical guidelines emphasised the importance of ensuring confidentiality and privacy, both to protect the safety of respondents and field staff and to improve the quality of the data . Ethical1 The analysis compared women who reported having experienced any act of physical and/or sexual violence in the past year with women who did not report any partner violence ('current' versus 'never'). Those who had experienced partner violence during their lifetime but not in the past year were excluded from the analysis so as not to dilute associations.Currently- or previously-partnered women were asked a series of questions about whether they had ever experienced specific violent acts between early-life experiences and later IPV. Clustering of outcomes in each site was 'small' ; hence wa priori) across the site-models except for the addition of certain relationship characteristics (polygamy and bride price/dowry) that were only relevant in some sites. As our overall aim was to identify similarities and differences in patterns of association between settings, we did not attempt to fit the most parsimonious model for each site. Neither did we place too much emphasis on the statistical significance of individual associations. Instead we focused on exploring the extent to which, keeping all other features of the model constant, patterns of associations were similar or different between sites.We included the same variables between 0.95 > OR < 1.05 as indicative of no association, ORs of 1.05 or greater as risk-factors for IPV, and ORs of 0.95 or less as protective-factors for IPV. We use the terms risk- and protective-factors loosely to indicate the direction of association with IPV rather than to imply causality, as we are analysing cross-sectional data. Statistical significance is considered at the 5% level.19,517 women reported having ever had a partner and were thus asked about partner violence. In total, having excluded women reporting lifetime but not past-year experience of violence, and those with missing data for key variables in the models, 15,207 women were included in the 'prior to relationship' analyses, and 15,058 in the 'current situation' analyses . Achieving secondary education by either the woman or her partner was associated with decreased IPV in almost two thirds of the sites (3 significant for each partner), when compared to situations where neither the woman nor her partner completed the level. However, the most consistent protective effect against IPV was observed where both the woman and her partner had completed the relevant schooling level . This most highly educated exposure group also had the lowest ORs for IPV in 10 out of 14 sites, compared to couples where one or both had not completed the level.A history of abuse was strongly associated with the occurrence of IPV, with reports of abuse of the woman's mother, her partners' mother, or both (compared to no known reported abuse of either mother) being associated with increased risk of IPV in all sites . ORs for IPV tended to be highest where women reported that both their mothers and their partners' mothers experienced abuse (observed in 10/15 sites). Evidence from bivariate analysis in most sites showed that women who did not know whether their partners had histories of abuse were also at increased risk of IPV compared to those who reported their partners did not have these experiences.Other experiences of violence were also associated with past year IPV, with a history of childhood sexual abuse of the woman, childhood beatings of her partner, or both consistently associated with increased risk of IPV, compared to no reports of abuse by either partner . Women in relationships where both she and her partner were abused in childhood are at the highest risk of IPV (true in 11/14 sites), . A similar pattern was seen in bivariate analysis for partner's age but this variable was excluded from multivariate models due to its strong correlation with the woman's age. In contrast, associations between IPV and an age-gap of at least 5 years between the woman and her partner were weak in most settings and the direction of the effect was context dependent. Older age of the woman was often associated with increased risk of IPV, but in only three out of fifteen sites was older age of the partner associated with increased risk of IPV. Weak associations were also seen in the other direction for age-gaps favouring either the woman or her partner.There was some suggestion that inequality in educational level between a woman and her partner may increase her risk of experiencing IPV. This was true in nine out of 15 sites where the woman had the higher level of education (1 significant), and the same where her partner had the higher level. Associations tended to be weak, however, and some were also observed in the opposite direction.There was no consistent pattern of association between IPV and relative employment status. Compared to couples in which both partners work, couples where just the man works appear to experience slightly lower levels of IPV in some settings . In some settings women who work when their partners do not may be at increased risk of IPV . There is some evidence that women in relationships where neither she nor her partner work are at increased risk of IPV . However, non-significant associations in opposite directions are also observed for these variables.Higher socioeconomic status (SES) was associated with decreased IPV in fourteen sites (significant in 8 sites when comparing the highest status group to the lowest). This variable was more strongly associated with IPV before adjustment for other variables that may confound or mediate the effects of socioeconomic status on IPV risk.In almost all sites, women who had attitudes supportive of a husband beating his wife had increased odds of IPV .In all sites odds of IPV were higher in relationships where one or both partners had problems with alcohol, compared to relationships where neither of them did . In the majority of sites frequent drunkenness among men yielded higher ORs for IPV than problematic drinking by the woman (8/11), and in ten of the eleven sites ORs were higher when both had problems with alcohol.Both a woman's experience of non-partner violence and her partner's involvement in fights with other men emerged as strong risk factors for IPV. Women's experiences of non-partner physical or sexual abuse over the age of 15 emerged as a risk-factor for IPV in almost all sites . Likewise, women whose partners were involved in a fight with another man in the past year experienced higher levels of IPV than those with partners who did not fight (significant in 13/15 sites). These factors were more strongly associated with IPV risk in the bivariate analysis. It is likely that both IPV and non-partner violence share common antecedents, such as CSA in the case of women, or a history of antisocial personality and alcohol abuse among men, which may account for all or part of this association ,24Women with children from previous relationships were at increased risk of experiencing IPV in most sites . Women whose partners had had relationships with other women during their relationship also experienced higher levels of IPV than women with faithful partners (significant in 14/15 sites). Lack of knowledge/disclosure about a partner's involvement with other women was also associated with increased IPV in most sites.Women who were cohabiting with a partner without being formally married were at increased risk of IPV . By contrast, women not living with their partners experienced lower levels of IPV . There was some suggestion that those in newer relationships were at increased risk of IPV, with higher levels of IPV in relationships of less than five years compared to longer relationships, in half of the sites (mostly non-significant). There were also several sites where weak associations in the opposite direction were seen for the newest relationships (5).A woman's participation in her choice of husband was associated with IPV differently across sites. In 6 out of 15 sites her lack of participation was associated with higher levels of IPV (3 significant), while in 8 sites it was associated with decreased IPV (1 significant).Payment of dowry and bride price was associated with IPV in some sites, though patterns of risk were difficult to interpret. In the 6 sites where dowry was paid, it was associated with higher levels of IPV in 4 sites (3 significant) and lower IPV in 1 site (not significant). Bride price was associated with decreased IPV in 4 sites (2 significant) and increased IPV in two sites (neither significant).Women whose husbands had more than one wife were at increased risk of IPV in all 6 sites where polygamy is practised . The same was true for women who reported not knowing whether their husbands had other wives, compared to those who knew.Despite the wide variations in the prevalence of IPV across the study sites, many risk factors appear to affect IPV risk similarly, with secondary education, high SES, and formal marriage offering protection, and alcohol abuse, cohabitation, young age, attitudes supporting wife beating, outside sexual relationships, experiencing childhood abuse, growing up with domestic violence, and perpetrating or experiencing other forms of violence in adulthood, increasing the risk of IPV. We also found that the strength of the association was greater when both the woman and her partner had the risk or protective factor, suggesting the possibility of achieving greater prevention impact through targeting programs to couples most at risk.Overall, our analysis demonstrates far more consistency in risk and protective factors across sites than reported by Hindin and Kishor in their analysis of violence among couples from 10 recent Demographic and Health Surveys (DHS) . Among tOur analysis confirms that completing secondary education has a protective effect on IPV risk, whereas primary education alone fails to confer similar benefits . StudiesHigher socioeconomic status is generally associated with lower levels of physical and/or sexual partner violence. Even if it is not an independent or proximate risk factor but one that is partially confounded by or mediated through other factors , socioeconomic status of households should be taken into account when designing and targeting IPV intervention programmes .Early life experiences of abuse emerge as consistently strong risk factors for IPV. In order to intervene in this inter-generational cycle of abuse, interventions must address childhood abuse and respond appropriately to children who have witnessed IPV against their mothers. Although the importance of the sexual abuse of children and the witnessing of marital violence by children has been documented in other studies, the potential importance of the physical abuse of boys has received less attention and merits further exploration. The consistent association between IPV and other forms of violence against women also point to the need for integrated responses to violence across sectors and programmes ,31. For Male behaviours commonly associated with 'traditional' masculinity , such asProblematic alcohol use, among both women and their partners, is consistently and strongly associated with IPV. While it is difficult to establish the temporality of the observed associations, this relationship has been repeatedly been demonstrated in studies of IPV ,34-36. HImportantly, not all variables demonstrated consistent relationships with IPV across sites, suggesting that policymakers should be cautious about any 'one model fits all' approach to IPV prevention. For example, risk associated with age disparity among partners, a woman working where her partner does not, and a woman taking an active role in choosing her partner, varies by setting. What constitutes empowerment in one setting may represent an unacceptable transgression of gender norms elsewhere. Jewkes highlights that transgression of gender norms and failure to fulfil cultural expectations of good womanhood and successful manhood are among the most important triggers for intimate partner violence . She argThe primary strength of our analysis is that it is based on fully comparable data from 15 culturally, economically and socially diverse sites. This type of comparison has not been possible to date in the field of IPV research, with the exception of the less tightly controlled DHS surveys. Obviously, the cross-sectional nature of this study limits the extent to which we can draw conclusions regarding temporality or the causal nature of observed associations. However, by distinguishing between early life and current characteristics, we do separate out those factors where temporality is clear from those where it is less certain.A further limitation is that the study interviewed only women, and hence relies on women's reports of their partner's characteristics. The data on partner characteristics refers to the woman's current or most recent partner, who in some cases may not be the perpetrator of the reported violence. Since the analysis considers only past year IPV, however, the number of cases where the reported violence was perpetrated by a more distant partner is likely to be small. Any resulting misclassification would bias results towards the null rather than invalidate observed associations.The multi-faceted nature of the factors that influence partner violence highlights the need for a multi-sectoral response that combines development activities, including improved access to secondary education for girls and boys, with initiatives to transform gender norms and attitudes, address prior histories of abuse, and reduce harmful drinking. Since risk of IPV is highest in younger women, schools are also an important setting for primary prevention activities, with potential to address issues of relationships, gender roles, power and coercion within existing youth violence and bullying programmes. Although there is no magic bullet to reduce partner violence, the consistency of our findings across sites suggests that a prevention strategy, once validated and refined, might have relevance in a wide range of settings. Initiatives to reduce partner violence require commitment and vision--by the international community, local governments and civil society. The time to act is now. As highlighted in the recent UN Campaign against violence against women--Women Won't Wait--such responses are urgently needed.IPV: intimate partner violence; CSA: childhood sexual abuse; DHS: Demographic and Health Survey; SES: socioeconomic status; WHO: World Health Organisation; UN: United Nations;The authors declare that they have no competing interests.CG-M, HAFMJ, ME, LH and CHW all participated in the study design and implementation. CG-M was the study coordinator. HAFMJ set up and supported data collection and processing in the countries and managed the central database. TA carried out the statistical analysis for this paper and drafted the manuscript. LH and CW helped draft the manuscript. KD and LK provided support with the statistical analysis and helped draft the manuscript. CG-M reviewed a draft of the manuscript. All authors read and approved the final manuscript.1Women were defined as ever partnered if they had ever been married or lived with a partner (and therefore had been at risk of intimate partner violence). In practice, this definition varied slightly between countries in accordance with local notions of partnerships.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/11/109/prepubPrevalence of physical and/or sexual intimate partner violence among ever-partnered women, by site. Prevalence data on lifetime and past-year experience of physical and/or sexual intimate partner violence among ever-partnered women for each of the sites included in the WHO study. These data are among those core study findings previously published in the Lancet :1260-1269.Click here for file"} -{"text": "Serious forms of violence against women include Female Genital Mutilation (FGM) and Intimate Partner Violence (IPV). The aim of this study was to determine if FGM is associated with IPV, using data obtained from the Demographic and Health Survey (DHS) 2012 in Ivory Coast.Participants for this study were drawn from the 2011-12 Ivory Coast Demographic and Health Survey (CDHS), a nationally representative sample of 10060 women aged 15 to 49 years. The analysis of this paper is restricted to the sample of women who responded to the FGM and domestic violence modules (N = 5005).The lifetime prevalence of physical violence was 24.8%, sexual violence, 5.7%, and emotional violence, 19.0%, and the prevalence of any lifetime IPV was 32.1%. In all, 40.6% reported female genital cutting or mutilation (FGM). Women reporting FGM were two times as likely to experience sexual IPV , while other subtypes of IPV were higher in women reporting FGM but they were not significant. Of the socio-demographic covariates, urban residence and having a primary education were associated with most subtypes of IPV, while being a Muslim seemed protective from any type, sexual and emotional IPV. Having seen the father beating the mother was positively associated with most IPV subtypes, and having been diagnosed with a sexually transmitted infection (STI) in the previous 12 months was associated with physical and sexual IPV.Significant rates of FGM and IPV were found among this sample of Ivorian women calling for the need for multiple strategies to reduce FGM and IPV. Female genital mutilation (FGM) – defined by the World Health Organization (WHO) and the United Nations (UN) agencies as “the partial or total removal of the female external genitalia or other injury to the female genital organs for non-medical reasons” is a deeply rooted tradition in many communities in 28 countries in Africa and in some countries in Asia and the Middle East , rangingAccording to WHO the globTwo previous studies in Egypt and Mali have shown a positive association between FGM and intimate partner violence (IPV) ,9. SalihParticipants for this study were drawn from the 2011-12 Ivory Coast Demographic and Health Survey (CDHS), a nationally representative sample of 10060 women aged 15 to 49 years. The 2011/12 CDHS employed a two-stage stratified sample, where systematic sampling with probability proportional to size was applied [The questionnaire included demographic variables such as age, formal education, work status, residence, marriage type, religious denomination and wealth status, a composite index based on the household’s ownership of consumer items such as television, car, drinking water, toilet facilities, etc.Female Genital Mutilation (FGM) was assessed from the survey item ‘Respondent Circumcised,’ which was a dichotomous (Yes/No) variable. Further, those who indicated that they had been circumcised were asked several items regarding circumcision, including ‘flesh removed from the genital area’, ‘genital area just nicked without removing any flesh’ and ‘Genital area sewn closed’ and the timing of circumcision [umcision .The domestic violence module of the Ivory Coast DHS includes 11 items that capture violence committed by a male partner or spouse. From these questions, IPV was categorised into three main subtypes: physical, sexual and emotional. Physical violence referred to any exposure to one or several of the following acts against women by a current or former husband or partner ever: i) pushing, shaking or throwing something at her; ii) slapping her or twisting her arm; iii) punching or hitting her with something harmful; iv) kicking or dragging her; v) strangling or burning her; vi) threatening her with a weapon (e.g. Gun or knife); and vii) attacking her with a weapon. Sexual violence referred to any exposure to one or several of the following acts against women by a current or former husband or partner ever: i) forced sexual intercourse; and ii) other sexual acts when undesired. Emotional IPV was assessed with two items, ‘ever humiliation’ and ‘ever threatened harm’, and was defined as a woman’s report of ever experiencing an act of emotional violence by a partner. Exposure to each of these types of violent acts were scored as 1 (any experience of violence ever) and 0 (no experience of violence ever).Women were further categorised as those who experienced one type of IPV and those who experienced two or more types of IPV ,9.In addition, several risk factors for IPV were assessed, including increased risk of HIV/STI and witnData analysis was performed using STATA software version 11.0 . The analysis in STATA took into account the multilevel stratified cluster sample design of the study. Frequencies as estimation of prevalence of IPV were obtained. Logistic regression analysis was conducted to estimate the association between relevant predictor variables including FGM and IPV. Adjusted odds ratios are reported for selected predictor variables while considering IPV as a dependent variable. In the analysis, weighted percentages are reported. The reported sample size refers to the sample that was asked the target question. The two-sided 95% confidence intervals are reported. The p-value less or equal to 5% is used to indicate statistical significance. Both the reported 95% confidence intervals and the p-value are adjusted for the multi-stage stratified cluster sample design of the study.Overall, 5005 women were administered the domestic violence and female genital cutting modules of the 2012 Ivory Coast DHS. Their demographic characteristics are provided in Table The adjusted odds ratios (AOR) and 95% confidence intervals (95% CI) for the association between FGM and IPV are shown in Table The lifetime prevalence of IPV and its subtypes in the Ivory Coast seem lower than the average in the WHO African region . The preThe study findings show that FGM was only partially associated with IPV, namely with sexual violence only, while having witnessed interparental violence in childhood was found to be associated with most IPV subtypes; the latter was also found in a DHS survey in Bolivia . TherefoFurther, the study found that having been diagnosed with a sexually transmitted infection (STI) in the previous 12 months was associated with physical and sexual IPV. IPV has been identified to increase the risk of HIV/STI . Of the Caution should be taken when interpreting the results of this study due to certain limitations. Since this was a cross-sectional study, causality between the compared variables cannot be concluded. A further limitation was that some factors known to be contributing to IPV were not assessed .Significant rates of FGM and IPV were found among this sample of Ivorian women calling for the need for multiple strategies to reduce FGM and IPV.The authors declare that they have no competing interests.KP performed the analysis and drafted the manuscript. SP developed the idea of the analysis and provided comments on the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6874/14/13/prepub"} -{"text": "To examine correlates of perpetration and victimization of intimate partner violence (IPV) under and not under the influence of a substance, we conducted a study among women in Russia.In 2011, a cross-sectional survey was conducted among patients receiving services at a clinic for sexually transmitted infections in St. Petersburg, Russia. Multinomial logistic regression was used for analysis.Of 299 women, 104 (34.8%) and 113 (37.8%) reported a history of IPV perpetration and victimization, respectively. Nearly half (47.1%) of perpetrators and 61.1% of victims reported that the latest IPV event was experienced under the influence of a substance. Factors independently associated with IPV victimization under the influence of a substance were alcohol misuse and a higher number of lifetime sex partners, whereas only experience of childhood abuse was independently associated with IPV victimization that did not occur under the influence of a substance. Childhood physical abuse, lower age of first sex, sensation seeking, and alcohol misuse were independently associated with IPV perpetration under the influence of a substance, while only childhood abuse was independently associated with IPV perpetration that did not occur under the influence of a substance.IPV under and not under the influence of a substance had different correlates . Despite the strong association between substance use and IPV, experience of childhood abuse is an important predictor of IPV perpetration and victimization in Russia, above and beyond substance use. Intimate partner violence (IPV) has been a significant public concern worldwide due to its high prevalence and wide range of adverse health consequences such as injury, chronic pain, sexually transmitted infections (STIs) and mental health problems Although a variety of studies revealed that a number of factors are associated with IPV Experience of childhood abuse, particularly physical abuse, is another key factor that has been found to be consistently associated with IPV perpetration in different studies, including a cross-sectional study using data collected from a large representative U.S. national sample of couples and a 20-year longitudinal study Sensation seeking is another factor associated with IPV. This association is less consistent in the literature partly because IPV is a complex phenomenon which may not be fully explained by a single factor or simple model Substance use, particularly alcohol and drug use, is an important public health problem in Russia, and has been associated with several negative outcomes including IPV and HIV risk behaviors This study used multinomial logistic regression to simultaneously investigate three levels of outcome: IPV under the influence of a substance, IPV not under the influence of a substance, and no IPV. The primary purpose of the present study was to examine correlates of perpetration and victimization of IPV under and not under the influence of a substance (each compared to no IPV) among women receiving health services in St. Petersburg, Russia. We hypothesized that: (1) IPV under and not under the influence of a substance has different correlates; (2) experience of childhood abuse is associated with IPV perpetration and victimization with and without the influence of a substance; and (3) sensation seeking is associated with IPV perpetration independently of whether it occurs under the influence of a substance.Consecutive adult patients (aged 18 years and older) who required STI services in a dermatovenereology dispensary (STI out-patient clinic) in St. Petersburg, Russia were invited to participate in a cross-sectional study which aimed to examine factors associated with female reproductive health from May 2011 to November 2011. A total of 502 patients agreed to participate in and completed a computer-assisted interviewer-administered questionnaire. Written informed consent was obtained from all participants and the study was approved by the institutional review boards of the Biomedical Center in St. Petersburg, Russia and Yale University, CT, USA. Of the 300 women recruited into the study, 299 answered the questions about intimate partner violence and therefore comprised the final analytic sample. The decision to include only women in the present analyses was made to reduce the complexity of research questions because women and men had different recruitment criteria. Eligibility for women’s participation included: (1) age between 18 and 50; (2) sexually active during the past 6 month; (3) not trying to get pregnant; and (4) biologically able to have children.A questionnaire was used to collect information including demographic and health characteristics, alcohol and illicit drug use, sexual behaviors, sensation seeking and experience of violence including history of childhood abuse and IPV. The questionnaire was constructed in English, translated to Russian, and then translated back to English to ensure the integrity of the syntax and meaning. Demographic information included age at survey, marital status, level of education, employment status and income level.Alcohol and illicit drug use: Alcohol consumption was assessed using the Alcohol Use Disorders Identification Test (AUDIT) which includes 10 questions with a total score that ranges from 0 to 40 Sexual behaviors: Participants were asked the age of their first sexual experience and the number of sexual partners in their lifetime. Considering that some participants had a much higher number of sexual partners, this variable was dichotomized according to the median value.Sensation seeking: The Brief Sensation Seeking Scale (BSSS-8) developed by Hoyle et al. was used to measure sensation seeking History of childhood abuse: We assessed experiences of childhood abuse from two aspects, emotional abuse and physical abuse, respectively, based on two questions: “How often did your parent or caretaker insult, swear or threaten you” and “How often did your parent or caretaker push, grab, pinch or beat you” during their first 18 years. Although we asked a question related to childhood sexual abuse, “How often did your parent or caretaker touch you in a sexual way or had you touch him/her in a sexual way,” only one woman had such an experience. Thus, childhood sexual abuse was not included in the present analysis. These questions were adapted from the Conflict Tactics Scale (CTS) and the response categories were never, rarely, frequently and way too frequentlyPerpetration and victimization of IPV: IPV perpetration was defined as having ever (a) insulted, sworn at, or threatened a sexual partner; (b) pushed, grabbed, slapped, punched, beaten up, or choked a sexual partner; or (c) physically forced a sexual partner to have sex or do something sexually that he or she did not want to do. IPV victimization was defined as having ever been the target of the aforementioned actions by a sexual partner. These partner violence items were adapted from the CTS and have been successfully used in Russia to measure intimate partner violence p<.05 and the data were analyzed using SAS software version 9.1 .Chi-square tests and ANOVA F-tests were used to examine group differences by last IPV status for categorical and continuous variables, respectively. Multinomial logistic regression was used to determine significant correlates of IPV under and not under the influence of a substance. None of the demographic characteristics were significantly associated with either IPV perpetration or victimization in the multinomial logistic regression; therefore they were not included in the final models. The significance level was defined as p = 0.01). Other characteristics were not significantly different across status of last IPV victimization.The mean age of the participants was 28 years (standard deviation = 7.8), ranging from 18 to 50 years. Nearly 50% of the participants were married, 42% were never married and the rest were divorced, widowed or separated. About 49% of the participants had completed university or higher education. The majority (57%) of the participants were full-time employed and 43% had monthly incomes below 15,000 rubles (about 500 U.S. dollars). None of these demographic characteristics differed by status of last IPV perpetration . When these demographic characteristics were compared by status of last IPV victimization , however, age of the participants was significantly different . Among 190 women who had experience of childhood abuse, 118 (62.1%) only had experience of childhood emotional abuse and 72 (37.9%) had childhood physical abuse experience with 70 of 72 reporting both experiences.Both IPV perpetration and victimization were common. Of the women in the study, one did not answer IPV questions; 104 (34.8%) reported a history of IPV perpetration and 113 (37.8%) reported a history of IPV victimization, with 75 (25.1%) reporting both perpetration and victimization experiences in their lives. More specifically, the percentages of women who experienced verbal, physical and sexual IPV were 32.1, 18.1 and 11.0%, respectively; the percentages of women who perpetrated verbal, physical and sexual IPV were 28.4, 21.4 and 2.7%, respectively. Of 104 women who had ever perpetrated IPV, 49 (47.1%) reported last perpetration under the influence of a substance. Among 113 women who had ever been a victim of IPV, 69 (60.6%) reported last victimization under the influence of a substance.p-values ranging from <.0001 to 0.001 , in which couples with experience of IPV had higher sensation seeking scores than those without IPV experience As with most studies, our study is not without limitations. First and foremost, our data may be subject to recall bias. The measurement of experience of childhood abuse and last IPV under and not under the influence of a substance was based upon self-reporting. It is possible that participants may not accurately recall their exposure to violence in their childhood and exposure to substance if the last IPV occurred many years ago. The misclassification resulting from recall bias is likely to attenuate the observed association. Second, the measurement of IPV may also be subject to social desirability bias. As a result, IPV may be underreported. Furthermore, some participants may use substances as an excuse for their IPV acts even in a situation where no substance was actually involved in their last IPV episode. However this possibility should be low since the proportion of IPV under the influence of a substance in the present study is consistent with results from other studies In conclusion, IPV under and not under the influence of a substance had different correlates and experience of childhood abuse can be an important predictor of IPV perpetration and victimization, above and beyond substance use. The findings also support the growing body of work suggesting that, in addition to childhood physical abuse, childhood emotional abuse only can be a risk factor of IPV which warrants more research and clinical attention."} -{"text": "Intimate partner violence (IPV) is widely prevalent in Tanzania. Inequitable gender norms manifest in men's and women's attitudes about power and decision making in intimate relationships and are likely to play an important role in determining the prevalence of IPV. We used data from the RESPECT study, a randomized controlled trial that evaluated an intervention to prevent sexually transmitted infections in a cohort of young Tanzanian men and women, to examine the relationship between couples' attitudes about IPV, relationship power, and sexual decision making, concordance on these issues, and women's reports of IPV over 12 months. Women expressed less equitable attitudes than men at baseline. Over time, participants' attitudes tended to become more equitable and women's reports of IPV declined substantially. Multivariable logistic regression analyses suggested that inequitable attitudes and couple discordance were associated with higher risk of IPV. Our findings point to the need for a better understanding of the role that perceived or actual imbalances in relationship power have in heightening IPV risk. The decline in women's reports of IPV and the trend towards gender-equitable attitudes indicate that concerted efforts to reduce IPV and promote gender equity have the potential to make a positive difference in the relatively short term. Intimate partner violence (IPV) is a major public health and human rights concern in Tanzania . AccordiIt is widely accepted that gender inequities, perpetuated by cultural norms regarding gender roles and manifest in men's and women's ideas about power and decision making in relationships, have a profound impact on the perpetration and experience of IPV . SeveralSurvey data lend support to the observation that both men and women in Tanzania condone IPV as a normal part of an intimate relationship , 13. AccAlthough research has explored men's and women's attitudes about IPV, few studies have empirically examined the association between these attitudes and IPV risk . For exaTo our knowledge, the association between couples' attitudes towards IPV, couple concordance in attitudes and IPV risk has not been examined in Tanzania. Using data from the Rewarding STI Prevention and Control in Tanzania (RESPECT) study, we examined men's and women's attitudes about IPV, relationship power, and sexual decision making and couples' concordance on these issues, and whether these attitudes were associated with women's experience of IPV at baseline and over time. The year-long RESPECT study was a randomized controlled trial designed to evaluate whether conditional cash transfers (CCT) promoted safe sex and reduced the incidence of sexually transmitted infections (STIs) and perpetration of IPV (men). They also underwent STI and HIV counseling and testing. Participants in the CCT arms received cash payments for every 4 monthly negative STI laboratory test result. All enrolled individuals were invited to group counseling sessions that focused on relationship and life skills training based on the Stepping Stones curriculum . The analysis is guided by a social-ecological framework, which posits that IPV risk is shaped by the interplay of a host of individual, community, and societal factors, including individual beliefs and practices within an intimate relationship as well as community and societal norms regarding gender and power . It is aIn this analysis, we considered attitudes toward IPV as proximate determinants, and gender norms as a key underlying, distal determinant of IPV. For example, women's access to education and employment is limited in social and cultural environments that are highly patriarchal, increasing their economic dependence on male partners, which is a known risk factor for IPV . SimilarWe outlined our hypotheses about the causal relationships between all variables in a Directed Acyclic Graph and used the DAG to determine the minimum variables necessary to include in multivariable analyses to remove confounding of the main effects. Our primary hypothesis is that men's and women's attitudes about IPV, relationship power, and sexual decision making (including couple concordance/discordance on these attitudes) are proximate determinants of women's experience of IPV. Specifically, we proposed that women's and men's espousal of inequitable gender attitudes would be associated with greater experience of IPV at baseline and over time. We also hypothesized that couples' discordance on these issues would be associated with a heightened risk of IPV at baseline, and that this relationship would persist over time. We further hypothesized that the very fact of discordance between couples is more important than the nature of that discordance; that is, we proposed that lack of agreement between a woman and her partner (regardless of which partner held the more inequitable attitudes) would be associated with a higher risk of IPV than if she agreed with her partner. This finding would be consistent with earlier studies that have found that women themselves often exhibit highly inequitable attitudes about IPV as a way of fitting in with their communities and protecting themselves from violence , 25. Study protocols were approved by institutional review boards in Tanzania and the United States. All study participants gave written informed consent to participate in the study. Couples were interviewed separately at a study station that was set up on the outskirts of the village, and care was taken to ensure privacy and confidentiality. Study interviewers received in-depth training on interviewing techniques, gender and reproductive health, and the study protocols. A study liaison was identified in each village to help participants gain access to further information, counseling services, and study personnel. In addition, study counselors received training on how to offer psychosocial support and were equipped with information on domestic violence-related services.The outcome of interest—women's self-report of intimate partner violence over the previous 4-month period—was measured using a dichotomous variable based on four questions from the RESPECT questionnaire: “have you been hit, kicked, or beaten by your partner and/or a family member for any reason during the last 4 months?”, “Has your partner or another family member done any of the following during the last 4 months: humiliated you in front of others, insulted you, tried to scare you, threatened to hurt you or someone you care about?”, “Have you been physically forced to have sexual intercourse when you did not want to during the last 4 months?”, and “Did you, during the last 4 months, have sexual intercourse when you did not want to because you were afraid of what your partner might do?”. Participants who responded “yes” to one or more of these questions were coded as having experienced violence, while those who responded “no” to all four questions were coded as not having experienced violence. The RESPECT questionnaire did not ask women about lifetime experience of violence; at all rounds, women were asked about their experience of violence in the previous four months. Although the RESPECT questionnaire asked similar questions regarding male participants' perpetration of violence against their partners, couples did not always agree on violence within their relationships (data not shown). Given this disagreement and our primary interest in examining women's experience of IPV during the course of the study, we decided to focus on women's report of violence as the outcome measure. Our analyses focused on the association between women's reports of IPV and women's and men's attitudes about IPV, relationship power, and sexual decision making and couples' concordance. Men's and women's attitudes towards IPV and opinions about power within relationships were assessed using four exposure variables. The first question (“is a husband justified in beating his wife if…”) measured the acceptability of physical IPV in five hypothetical situations: if a wife goes out without telling her husband, if she neglects the children, if she argues with her husband, if she refuses to have sex with her husband, or if she burns the food. A binary variable was created to measure acceptability of IPV, coded as “1” if a participant responded in the affirmative to any of these five situations and coded as “0” if the participant did not agree that violence was justified in any of these situations. The second question assessed the acceptability of IPV as a response to a wife refusing to have sex with her husband: “if a woman refuses to have sex with her husband when he wants her to, he has the right to: get angry and reprimand her, refuse to give her money or other means of financial support, use force and have sex with her even if she doesn't want to, or go and have sex with another woman.” A binary variable (yes/no) was created on the basis of whether participants thought IPV was acceptable in response to a wife's refusal to have sex. For each of these questions, couples were coded as having concordant responses if both partners shared the same binary response.Our third and fourth exposure variables of interest assessed participants' opinions about power within their relationship. These were ascertained using the following two questions: “who usually has more say about whether you have sex?” and “in general, who do you think has more power in your relationship?” Participants were given the response options “myself”, “my partner”, or “both people equally.” Couples were determined to be concordant if they shared the same response about which partner had more to say about having sex or had more power in the relationship, regardless of which partner this was or whether they agreed that they shared these decisions equally. Other covariables we considered included age (measured as a continuous variable), education status , and socioeconomic position . We also examined differences in reported IPV by study arm.Analyses were conducted using data from the subset of heterosexual couples who were enrolled in the study together. All couples were included in the baseline data analysis, and couples on whom data were available for a minimum of two out of the four rounds were included in the longitudinal analyses. For each round, couples were included in the analysis as long as there were no missing data on the variables of interest. t-tests. Next, we looked at changes in women's reports of IPV as well as changes in participant's attitudes about IPV and relationship power during the follow-up period. We conducted tests for trend to determine whether changes were statistically significant. Preliminary analyses focused on the cross-sectional relationships between age, education, and socioeconomic position and ever having experienced IPV at baseline using contingency tables, Chi-square analyses, and Student's To examine the independent relationship between the exposure variables (women's and men's attitudes towards IPV and relationship power and partner concordance on attitudes) and IPV, we fit separate logistic regression models for each indicator. We also ran a multivariable logistic regression model to examine the association of each main exposure variable and IPV, adjusting for socioeconomic status, age, and education. Finally, to examine the longitudinal relationship between the exposure variables of interest and women's experience of IPV, we used multivariable random effects logistic regression models . These mSocioeconomic position, age, education, and round of data collection were included in the models as confounders. Interactions between these confounders and the exposures of interest were also considered. However because they were not statistically significant, they were not included in the final model. We examined three “families” of hypotheses: based on women's attitudes and opinions, men's attitudes and opinions, and couple concordance. We believed that an individual hypothesis within each family would have to be considered in light of the additional tests performed on other hypotheses within the subgroup. Since each family of hypotheses included four exposure variables, we determined that an appropriate significance level for each hypothesis test would be set at 0.05/4 or 0.0125. Out of a total of 2,399 individuals enrolled in RESPECT, 567 couples were identified and included in this analysis. A comparison of individuals who reported being married or living together as married and who did not enroll as a couple and those who did enroll as a couple indicated that there were no statistically significant demographic differences between the two groups. A total of 26 couples were lost to follow up: seven after the baseline round and an additional 19 between rounds 2 and 4. Additionally, at each round, between two and four couples were missing data on one or more variables and were excluded from the analysis. Couples who were lost to follow or excluded due to missing data did not differ in terms of demographic characteristics or women's reports of IPV (data not shown). Participant characteristics at baseline including demographic background, experiences of IPV, attitudes about violence and opinions about sexual decision making and relationship power are shown in P < 0.0005) and was not associated with demographic characteristics or study arm. In addition, at 12 months, fewer women and men noted that violence against a wife was acceptable, and a larger proportion of participants reported that sexual decision making was shared by both partners decreased steadily over time from 20.5% at baseline to 11.8% at 12 months (data not shown). The decrease was statistically significant . This longitudinal analysis suggests that couples' attitudes towards violence and opinions about sexual decision making and relationship power are proximate determinants of women's experience of IPV. The study also provides some evidence that discordance among couples on these issues may heighten women's risk of experiencing IPV. Our observation that gender inequitable attitudes were more commonly reported by women than men is consistent with findings from other studies . It is pIt is encouraging to note that men and women tended to express more gender equitable attitudes by the end of the study. The fact that attitudes about the acceptability of IPV changed far more than opinions about sexual decision making and power within participants' relationships suggests that the changes could have been partly a result of social desirability bias. However, reported 1PV declined steadily over the course of the study from 20% at baseline to 12% at the end of one year of followup, and were not associated with demographic characteristics or intervention/control status. Since we have data on levels of IPV only from RESPECT study participants, we cannot determine whether this result reflects a declining trend in IPV in this region. However, to our knowledge, no major interventions on IPV occurred during this time period and it is unlikely that such a substantial reduction in IPV could be explained in this fashion. The reduction in women's reports of IPV—despite improved rapport between participants and study staff (which may have improved IPV disclosure)—suggests that changes in men's attitudes and behaviors may have resulted from study participation. Given that the proportion of individuals who participated in the group counseling sessions on relationship and life skills was low (data not shown), and that STI/HIV counseling did not explicitly address relationship issues, we hypothesize that repeated exposure to survey questions on relationship dynamics and the opportunity to participate in the study as a couple may have contributed to these shifts. Engaging men and women—as individuals, couples, and community members—is widely accepted as an important component of IPV prevention efforts worldwide , 29. At Results of the longitudinal regression analyses point to the potential benefits of promoting notions of equity in relationships. Women who reported that they shared sexual decision making and relationship power with their partner were consistently less likely to report IPV. In contrast, IPV was reported more frequently when men and women espoused inequitable attitudes or reported that women had more decision making control in the relationship although few of these associations were statistically significant. These findings underscore the need to better understand the delicate balance of power in intimate relationships and the role that perceived or actual imbalances in power have in heightening women's risk of IPV. Further qualitative research may shed light on the dynamics of power, conflict, and violence within relationships in which partners hold similar or differing views.The association between couples' concordance on attitudes about IPV and relationship power and women's experience of violence also merits further investigation. Our study had limited statistical power to investigate the relationship between different types of concordance/discordance and IPV risk. Thus, we were unable to examine whether IPV risk differed depending on who held more equitable attitudes within a relationship. For example, future research should explore whether risk is higher among women who feel IPV is unjustified and whose partners feel it is justified. Previous research has suggested that discordance within a couple arising from perceived or actual gains in power by women can result in backlash, including IPV by men , 29, 30.Overall, much remains to be learned about how women and men perceive and engage with ideas of greater equity in intimate relationships. Gender norms and values are dynamic, and their relationship with individual behaviors and experiences is complex. Further in-depth examination of young women's and men's evolving ideas about gender, identity, and relationships is needed. Several questions merit study. For example, do young men and women perceive their relationship to be “healthy”? Do they desire greater equity and how do they define equity in a relationship? Are these views—and concordance/discordance in views within a couple—associated with how partners communicate with each other, handle conflicts, and experience or perpetrate IPV? A better understanding of these questions will further illuminate the ways in which gender norms and relationship dynamics influence women's risk of experiencing of violence and help identify entry points for IPV prevention efforts.Our study has additional limitations. First, the decision to measure IPV as a binary variable without accounting for frequency or type of IPV, while providing us with more statistical power, may have prevented us from observing crucial differences in the associations between attitudes and IPV risk. Second, it is especially difficult to draw strong conclusions about the heightened risk of IPV among couples holding discordant attitudes without a finer understanding of how the composition of this discordance might differently impact women's experience of IPV. Third, the decision to use only partnered couples in these analyses also raises issues of potential selection bias. It is possible that partners who both chose to participate in the RESPECT study differed in important ways from participants whose partners chose not to be in the study, including on attitudes about the acceptability of IPV. Finally, it is possible that women who experience IPV are more likely to report that violence is justified. Despite its limitations, this research provides some new insights on the role of women's and men's attitudes toward IPV and relationship power, including the role of partner discordance, in influencing women's experience of IPV. Unlike most previous research in Tanzania, this study prospectively examined the relationship between attitudes about gender relations and IPV among young couples. The widespread acceptance of IPV and inequitable power within relationships in this population highlights the urgent need for programs that help young people acknowledge, understand and challenge gender-based hierarchies. Greater understanding of young people's perceptions of “gender equity”—by focusing on women and men who do not condone IPV and who share power within their relationship—will facilitate the development of antiviolence programs. Furthermore, couple-based programs for HIV testing and treatment have been successful in sub-Saharan Africa and offer a foundation for antiviolence efforts . The dec"} -{"text": "Intimate partner violence (IPV) is associated with increased risk of HIV among women globally. There is limited evidence and understanding about IPV and potential HIV risk pathways among sex workers (SWs). This study aims to longitudinally evaluate prevalence and correlates of IPV among street and off-street SWs over two-years follow-up.Longitudinal data were drawn from an open prospective cohort, AESHA in Metro Vancouver, Canada (2010–2012). Prevalence of physical and sexual IPV was measured using the WHO standardized IPV scale (version 9.9). Bivariate and multivariable logistic regression using Generalized Estimating Equations (GEE) were used to examine interpersonal and structural correlates of IPV over two years., 387 SWs had a male, intimate sexual partner and were eligible for this analysis. One-fifth experienced recent physical/sexual IPV at baseline and 26.2% over two-years follow-up. In multivariable GEE analysis, factors independently correlated with physical/sexual IPV in the last six months include: childhood (<18 years) sexual/physical abuse , inconsistent condom use for vaginal and/or anal sex with intimate partner ,