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.


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.


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.


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:


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


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.


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: