Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Māori.This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants.Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.Australian New Zealand Clinical Trials Registry (ACTRN12609000937213) Globally, acute respiratory infections (ARI) cause more deaths and hospitalisations among Indigenous children compared with their age-matched counterparts; the greatest impact is among young children aged 0-4 years . SpecifiWhile there are multiple socioeconomic determinants of ARIs among Indigenous children, environmental tobacco smoke (ETS) exposure is arguably the most readily amenable to modification. The adverse health effects of ETS are well documented, especially its association with respiratory illness. The association between parental smoking and childhood respiratory disease is strongest at younger ages . In chilIn recognition of the damaging health effects of ETS, the World Health Organization (WHO) has prioritised the need to reduce parental smoking as a core component of improving health and development in early childhood . This isDespite the recognition of the adverse child health effects of ETS and the scale of the problem among disadvantaged populations in particular, exposure reduction in homes is a relatively recent area of scientific study . A recenThis study aims to test the efficacy of a culturally appropriate, family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and NZ.Infants (<12 months) of Indigenous mothers/caregivers who receive an intensive family-centred tobacco control program about ETS, compared with 'usual care,' will have fewer health care presentations for respiratory illness.The primary objective of this study is to determine the efficacy of a family-centred tobacco control program about ETS, to reduce health care presentations for respiratory illness in Indigenous infants in the first year of life. Secondary objectives include assessment of the effect of such a program on a range of measures of infant ETS exposure, including mother/caregiver's self-report of infant exposure to ETS and implementation of smoking restrictions in the home and/or car, infant urinary cotinine, household smoking status, mother/caregiver's smoking cessation and quit attempts. A process evaluation of the family-centred tobacco control program will also be undertaken.This study will be a parallel, randomized controlled study with allocation concealed from the study researchers. Participants will be randomly allocated to one of two study arms: the 'intervention' group who will receive the tobacco control program about ETS exposure over three home visits in the first three months of the infant's life, or the control group who will receive 'usual care' (i.e. they will not receive the tobacco control program). IHWs will be trained to deliver the intervention program, the goal of which is to reduce or eliminate exposure of infants to ETS. Data collection will occur at baseline (shortly after birth), and when the infant is four months and one year of age. The primary outcome of interest is the rate of health care presentations for doctor-diagnosed respiratory illness. Figure This study will be conducted in Darwin City and the Greater Darwin area in the Northern Territory, Australia; and within the Counties Manukau District Health Board region, Manukau City, NZ. The target populations for this study are Indigenous families who reside in these two geographical areas. The sampling unit is Indigenous newborn infants and their mothers/primary caregivers (aged 16 years and over).Infants will be eligible for inclusion if:• They are aged between 0-5 weeks. • Their mother/caregiver is Indigenous .• Their mother/caregiver is aged 16 years or over.• Their mother/caregiver currently smokes or the infant lives in a household where there is at least one other person who smokes (defined as smoking at least weekly).• Their mother/caregiver plans to reside permanently with the infant in Darwin or Greater Darwin areas of Australia or within the Counties Manukau District Health Board region, Manukau, NZ.• Their mother/caregiver has given signed written consent to participate in this research study.• Their mother/caregiver has given signed written consent for study staff to access the infant's health records.• They are a singleton or the first born in a multiple pregnancy delivery.• Their mother/caregiver speaks English and/or Māori.Infants will be excluded from the trial if:• They have serious neonatal respiratory complications .• They have other serious neonatal complications .• They have major organ abnormalities .The above exclusion criteria are because these infants will be given intense interventions to reduce ETS exposure regardless. Infants will also be excluded if:• Their mother/caregiver has previously been recruited in this research study.• They live in the same household as a mother/caregiver who has previously been recruited in this study.Participants will be randomized by computer with stratification using permuted blocks by country  and infant age . This will ensure a balance in these key prognostic indicators between the intervention and control groups. All participants (i.e. the infants) will be assigned a unique registration number allocated by a central computer following the submission of their details on a web-based form.This is an assessor blinded trial, with only the study researchers assigning the major primary and secondary outcome measures and trial statisticians blinded to group assignment. Research assistants, who will be responsible for collecting the minor outcome measures will accompany the health workers to the participants' homes for all visits and thus cannot be blinded. The primary outcome will however be a double-blinded measure.Globally, Indigenous notions of health and illness are generally defined more broadly than a Western biomedical definition that focuses more often on physical health or the absence of disease . In AustIn this study, the intervention program about ETS will be framed around an Indigenous model of health promotion, which attends to the psychological, physical, spiritual and cultural wellbeing of the individual and the family/community, as it relates to this project. In NZ, Te Whare Tapa Wha will be used. This model has been applied to understanding Māori smoking cessation behaviour  and for Participants will be told that they will be randomly assigned to a group that receives 'usual care', or a group that receives extra home visits by an IHW, and that a variety of study measurements will be taken over a 12-month period.Treatment group: The intervention program will (i) provide information and education about the health effects of ETS exposure and use behavioural 'coaching' techniques to help mothers/caregivers and family members implement strategies to reduce the infant's ETS exposure, as well as (ii) identify the smokers among other household members and deliver culturally appropriate smoking cessation advice, counselling and treatment options as requested. An eight weeks supply of free nicotine replacement therapy (NRT) (patches or gum) will be available to participants and other household members for whom such drug therapy is indicated . NRT will be provided by the IHW with appropriate counselling and follow-up. Furthermore, for those that are interested a fax referral to Quitline will be offered, with proactive call back by Quitline.• The intervention program will be delivered during three face-to-face home visits (of approximately 45-60 minutes) conducted over the first three months of the infant's life. Culturally appropriate resources  will be used to assist in both education and behavioural 'coaching'. These resources will be obtained from relevant health groups in each country who hold a repository of such resources . IHWs will deliver the program after appropriate training, and will complete standardised progress reports after each program session, which will be used at a weekly team meeting with the health workers and study personnel for discussion and ongoing training.Control group: The control group will receive 'usual' care through their community health provider. Usual care entails routine visits to maternal and child health providers at several defined time points during the first 12 months of the infant's life. At these postnatal visits, health providers check developmental milestones and general wellbeing. Additionally, mothers/caregivers routinely receive messages about smoking cessation and ETS exposure in their homes during these visits as part of general health promotion.• In addition to the above, the IHWs will briefly check that both groups have received the 'usual' care delivered to new mothers and their infants through routine 'well baby' visits in the first 12 months of life through their standard health provider . This will be undertaken at baseline, when the infant is four months and one year of age. The focus will be on key health promotion messages that should have been delivered at routine community health visits  Mothers/caregivers will be given a few key messages if they have not received this information, e.g. clear face, sleep on back for SIDS prevention. If these visits have not been attended or if the key messages have not been received by the mothers/caregivers, they will be referred back to their usual maternal and child health provider.Rate of health provider presentations for new primary episodes of ARI in the first year of life.Primary Outcome: All participating infants will be evaluated at baseline and when the infant is four and 12 months old, for the occurrence of medically attended acute respiratory illnesses (MAARI). These are defined as new onset events, including a change from the child's baseline medical status, referable to the upper and/or lower respiratory tracts. To identify episodes of ARI mothers/caregivers will be asked at baseline, and when the infant is four and 12 months old, whether their child has had any presentation to the clinic or hospital and the names of the clinics attended. Research assistants will collect the source data relevant to the primary outcome measures, so will review the individual child's health provider and hospital clinic records . Source documents will be photocopied, de-identified, labeled with the participant registration, and stored with the trial records. Two clinicians at each study centre will review the records and confirm documented respiratory illnesses without knowing the group allocation of the individual children. MAARI events will be evaluated by these clinicians to determine whether they are medically-attended upper respiratory infection (URI), lower respiratory infection (LRI) and/or otitis media infection .▪ Mother/caregiver's self-report of smoking restrictions in the home and car.▪ Mother/caregiver's self-report of smoking cessation: defined as mother/caregiver not smoking a single cigarette (not even a puff), in the preceding seven days. We will also be assessing prolonged abstinence .▪ Mother/caregiver's self-report of number quit attempts: defined as not smoking a cigarette for at least 24 hours.▪ Process evaluation indicators: a mix of quantitative and qualitative measures to assess how well the intervention program was implemented according to protocol e.g. number of 'coaching' activities completed, obstacles and successes in delivering program, parent satisfaction with the program.▪ A total sample size of 190 provides 90% power (5% significance) to detect a 25% reduction of new episodes of respiratory illness (primary outcome) in the intervention group compared to the control group. This is based on a conservative estimate of an average of 3 health provider visits per year in the control group, compared to an average of 2.25 visits in the intervention group . There are few published data on the community burden of ARIs in Northern Territory Indigenous children or NZ Māori children. In a recent study of disease burden and clinic attendances for young Indigenous children in two remote Northern Territory communities, the median number of presentations for upper respiratory illness in the first year of life was 7.5 (interquartile range 4-11) and for lower respiratory illness, 2.5 (interquartile range 1-5) . The oveIn Australia and NZ, mothers/caregivers will be approached for recruitment into the study through a range of community, Indigenous-controlled health and government hospital services. We will approach both pregnant women and new mothers to ascertain their interest in participating in the trial. If pregnant women are interested in the study, we will re-approach them after they have given birth. Eligible and interested mothers will be asked for their consent for randomization. Documented written consent will be obtained from all participants prior to entering the study. A range of project-specific advertising material will be produced  and local Indigenous media may be used to bolster recruitment.In 2006, there were approximately 240 Indigenous infants born to mothers who were resident in Darwin, Australia. We anticipate that 90% or 216 Indigenous infants/mothers will be eligible for recruitment annually into this study. In a separate study based in Darwin to improve ear health outcomes, 55% of Indigenous women approached in pregnancy have consented to participate in a randomized controlled vaccine study . Using these figures, we could confidently anticipate that approximately 108 eligible Indigenous mothers will agree to participate in our study each year, or 9 per month. This is likely to be an underestimation, as our proposed study is less invasive than the ongoing vaccine trial (which requires immunisation and repeated blood samples).It is anticipated that recruitment will be faster at the Auckland site owing to a larger eligible population. Approximately 580 babies are born each month at Middlemore Hospital, of which 21% are Māori . Data reported in 2003 showed that about 55% of Māori pregnant women in NZ were smoking at the time of conception, and 15% of these women quit smoking during their pregnancy From theFigure Participants may be withdrawn from the study if one or more of the following occurs:• Voluntary withdrawal: A parent or primary caregiver can voluntarily withdraw their infant from the project at any time without having to provide a reason for doing so.• Failure to meet eligibility criteria: An infant will be withdrawn from the project if their mother/caregiver has previously signed a consent form but they do not meet all the eligibility criteria at the baseline visit (when the infant is five weeks old +/- one week).• Failure to be located after multiple follow-up home visits• Death of infant• Significant illness requiring prolonged hospitalization• A serious and irreconcilable protocol violation (as determined by the Investigators)In the event that a study participant dies, their family contact will be asked if they require the information recorded to be disposed of as per other participants at the completion of the study, or whether they wish the information to be returned to the family.The design and management of all databases associated with this trial will be undertaken by the data management and information technology groups at the Clinical Trials Research Unit (CTRU), University of Auckland. The databases will be constructed in Oracle. Validation rules for each Case Report Form (CRF) will be specified by the site study managers, in association with the CTRU data manager. These rules will include range checks so that inaccuracies in data collection can be identified early. A query will be raised as soon as any values are entered that are outside the allowed range or if data are missing. The research assistants at each site will amend the CRF's as soon as a query is raised. All information collected from participants will be treated as strictly confidential. De-identified data will be stored in computers under a password secure file. Paper records will be stored under numerical code in a locked filing cabinet within a secure office area, and will only be accesses by approved study staff.An independent person will be appointed to monitor the study conduct. This monitor will audit both Australia and NZ study sites and the CTRU during the trial to ensure that the study protocol is being adhered to.At the study sites the monitor will audit every randomized participant's records to ensure their existence, that they meet the inclusion criteria and have provided written and signed informed consent, and that the NRT is been distributed within the limits of the protocol. The monitor will review the study documentation and records held at each site to ensure that (1) documentation is up-to-date [i.e. correct version of protocol and Manual of Procedures] and (2) record keeping meets the requirements specified in the protocol and complies with regulatory requirements. The monitor will visit each site early on during the study (after ten participants have been randomized), at study close-out and once during the course of the trial. At least 10% of paper copies of the CRF's will be checked for consistency with the electronic records by the monitor. 100% of electronic ARI endpoint data will be checked against source data.The monitor will audit the sites which hold the NRT to check that NRT supply records are in order and that there are sufficient supplies remaining, that the NRT are being stored appropriately and are not being used beyond expiry dates, and that the handling of unused NRT complies with study procedures.A Data Safety and Monitoring Committee will not be established as the trial does not meet any of the criteria stipulated by Ellenburg et al. (2002) for setting up such a Committee .a priori in a statistical analysis plan prepared by the study statistician . No planned interim analyses will be undertaken of the outcome data. A baseline data paper will be prepared after all baseline data for both countries has been collected. The number of episodes of ARI experienced after the intervention for each group will be analysed on an "intention to treat" basis. Each of the primary and secondary outcome variables will be examined separately. There are no plans to combine outcome variables into composite variables. Data will be analysed for each country separately and combined. All ETS exposure variables will be treated and examined as outcome variables, rather than as co-variates of the primary outcome variable. Intra-rater and inter-country agreement for grading of the primary outcome assessment will be assessed using the Kappa statistic (unweighted), with 95% confidence intervals for the kappa statistic calculated using the method described by Altman [Statistical analyses will be performed by statisticians at the CTRU. The statistical unit at Menzies School of Health Research (Menzies) will play an advisory role. Data from the trial will be entered into an Oracle database at the CTRU, and then extracted into SAS version 9.2 (SAS Institute Inc. Cary NC), and R version 2.8.1  for analysis. Data analyses will be specified y Altman .All known potential confounders will be measured at baseline, including mother/caregiver's smoking status (and stage of change), education level, marital status, breastfeeding status, smoking status of partner and other household members, crowding, and exposure of infant to other sources of environmental smoke . Thus, comparisons of the intervention and control groups will be performed both unadjusted and adjusted for these known confounders. This second adjusted analysis will control for any maldistribution after randomisation of the confounders between the two groups.Analysis of the primary outcome will involve comparing the rate of respiratory illness between the two groups. Simple unadjusted rates, relative risks and 95% confidence intervals will be obtained in the first instance, with subsequent multiple regression analysis adjusting for other variables. Two forms of regression analysis will be considered for the primary outcome: poisson regression analysis and negative binomial if there is evidence of overdispersion or underdispersion. Analysis of secondary outcomes will be conducted using standard statistical procedures applicable to categorical or continuous data. A per-protocol analysis will also be performed in order to check the robustness of the results. All tests of significance will be two-tailed.For treatment effects, sensitivity analyses will be carried out to determine the effect of missing data.The study will be conducted in accordance with the Australian National Health and Medical Research Council Guidelines on 'Ethical Matters in Aboriginal and Torres Strait Islander Health Research in Australia' . In AustProject Managers will be responsible for the day to day management of the trial, one in Darwin and the other in Auckland. The Project Managers' responsibilities include the development of Standard Operating Procedures, maintaining an up-to-date collection of essential documents (in line with GCP requirements), monitoring recruitment rates, attending to participant queries or concerns and managing the fieldwork staff.Two IHWs in each country will be responsible for recruiting participants into the study and for delivering the 'intervention' program, as well as collecting process evaluation data. The development of Indigenous research workforce capacity is a vital aspect of this trial. Research assistants will collect urine samples and administer the face-to-face questionnaire to participants. They will also be responsible for data entry and data cleaning, and together with the IHWs, ensure that participant follow-up appointments are completed during the scheduled window periods.Two clinical investigators in Darwin and Auckland will review participating infants' clinical notes and code the clinical outcome data.Exposure to ETS is a strong but potentially preventable contributor to respiratory illness among young Indigenous children, when household ETS exposure of children is at its peak. Interventions aimed at encouraging smoking cessation as well as reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. This community-based, international trial has been designed to provide high-quality evidence of the efficacy of a theoretically and culturally sound, intensive family-centred tobacco control program to reduce ETS exposure among Indigenous peoples and so reduce the burden of ARI. As such, it will make a valuable contribution to future updates of the Cochrane review of family and carer smoking control programmes for reducing children's exposure to environmental tobacco smoke. The inclusion of a process evaluation as part of the study will inform the progress and shed additional light on the outcomes of the trial. Finally, this study seeks to incorporate Indigenous models of health to inform the design of the intervention and recruitment methods, and emphasizes Indigenous capacity building at all levels.ARI: Acute respiratory illness; ETS: Environmental tobacco smoke; sometimes referred to as second hand smoke. Usually refers to cigarette smoke in the environment of people who do not smoke; CTRU: Clinical Trials Research Unit; Auckland, NZ; IHW: Indigenous health worker - either Aboriginal or Torres Strait Islander or Māori; Menzies: Menzies School of Health Research, Darwin, Australia; NRT: Nicotine replacement therapy, available in a range of forms such as patch, gum lozenges, tablets and nasal spray. In this research study, NRT will be dispensed in the form of nicotine patches and/or gum only.The authors declare that they have no competing interests.VJ is an Australian Investigator. She contributed to the study design and drafted the first version of the study protocol. She has led the development of the intervention program, the questionnaires and the study set-up in Australia. NW is the Principal Investigator for this trial in NZ. She contributed to developing and writing the final version of the study protocol. She has contributed to the development of the study questionnaires and has led the study set-up in NZ. DT is the Principal Investigator for the trial in Australia. He contributed to the study design and drafting of the study protocol. MG is a Māori health researcher in NZ, and a co-investigator on this study. She was instrumental in developing the culturally appropriate intervention program and contributed to the development of the final study protocol. She led the consultative process with Māori and assisted with the recruitment and training of the Māori IHWs and research assistants. AC is an Australian Investigator. She originally conceived of the study and contributed to the study design. CB is a NZ Investigator and contributed to developing and writing the final version of the study protocol, especially in relation to the definition of the primary outcome. PM is an Australia Investigator. He contributed to the conception and design of the study. NB is an Aboriginal health researcher and an Australian Co-investigator. She contributed to the study design, particularly in relation to developing a culturally appropriate intervention and in providing advice on recruitment and retention of Indigenous families in Darwin. SV is a NZ Investigator. He is the trial statistician, and contributed to the protocol in matters relating to randomisation, study power and statistical analyses. RB is an Australian Investigator and contributed to the development of the questionnaire to assess the secondary outcomes for the study. CS is an Australian Investigator and contributed to the conception of the study. She also provided expert input initially into the questionnaire design. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin. TM is an Australian Investigator and contributed to the development of the intervention program and training of the Australian IHWs. DF is a NZ Investigator. She contributed to the study protocol, the development of the intervention program, and advice on recruitment and retention of Indigenous families in South Auckland. KE is an Australian Investigator and contributed to the development of the intervention program and provided advice on recruitment and retention of Indigenous families in Darwin.  All authors have provided critical review of this manuscript and have approved the final protocol.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/114/prepubCase Definitions for Acute Respiratory Infection. A table providing full definitions of acute respiratory infection for this studyClick here for file


Physical activity (PA) rates decline precipitously during the high school years and are consistently lower among adolescent girls than adolescent boys. Due to cultural barriers, this problem might be exacerbated in female Iranian adolescents. However, little intervention research has been conducted to try to increase PA participation rates with this population. Because PA interventions in schools have the potential to reach many children and adolescents, this study reports on PA intervention research conducted in all-female Iranian high schools.A randomized controlled trial was conducted to examine the effects of two six-month tailored interventions on potential determinants of PA and PA behavior. Students (N = 161) were randomly allocated to one of three conditions: an intervention based on Pender's Health Promotion model (HP), an intervention based on an integration of the health promotion model and selected constructs from the Transtheoretical model (THP), and a control group (CON). Measures were administered prior to the intervention, at post-intervention and at a six-month follow-up.Repeated measure ANOVAs showed a significant interaction between group and time for perceived benefits, self efficacy, interpersonal norms, social support, behavioral processes, and PA behavior, indicating that both intervention groups significantly improved across the 24-week intervention, whereas the control group did not. Participants in the THP group showed greater use of counter conditioning and stimulus control at post-intervention and at follow-up. While there were no significant differences in PA between the HP and CON groups at follow-up, a significant difference was still found between the THP and the CON group.This study provides the first evidence of the effectiveness of a PA intervention based on Pender's HP model combined with selected aspects of the TTM on potential determinants to increase PA among Iranian high school girls. Regular physical activity (PA) has a beneficial effect on overall health  and is iThe physiological and psychosocial changes experienced during the high school years may make adolescence a particularly high-risk period for girls to adopt sedentary habits . HoweverTheory-based research is necessary to conduct school-based interventions and one potentially useful theory is Pender's Health Promotion Model (HPM). This model is derived from Bandura's Social Cognitive Theory (SCT)  and inclOf particular interest to the current research, competing preferences are viewed as alternative behaviors  with powerful reinforcing properties over which individuals exert a relatively high level of control. They are last-minute urges based on one's preference hierarchy that can derail a plan of action for positive health action. For example, "giving in" to a competing preference might include watching television or playing computer games rather than being physically active. Individuals vary in their ability to sustain attention and avoid disruption of health behaviors but in general, the inhibition of competing preferences requires the exercise of control capabilities. In the HPM, competing preferences are proposed to directly affect the probability of occurrence of behavior as well as moderating the effect of commitment .Another model that can be applied to this research area is the transtheoretical model of behavior change (TTM), which includes the stages of change that a person moves through when adopting a behavior and the processes of change used in the stages to help in the adoption of a new behavior. The framework proposes that individuals move through a temporal sequence of five stages: pre-contemplation , contemplation , preparation , action , and maintenance (active for more than 6 months) . Marcus As no single theory can account for all complexities associated with behavior change, integration across major theories is recommended in research . TherefoResearchers have identified the importance of designing targeted interventions that address the needs of specific populations. Due to cultural barriers that prevent Iranian women from exercising in public places and do not encourage PA in general, research is needed to establish ways to help adolescent Iranian females to develop and sustain active lifestyles. Therefore, the purpose of this study was to evaluate the post-intervention and six month follow-up effects of a tailored PA intervention for Iranian adolescent girls based on the Pender's health promotion model (HPM) and selected constructs from the transtheoretical model (TTM), using a randomized control trial within schools as the medium for the intervention. Three groups were included in the study: an HPM intervention group with HPM interventions addressing stages of behavior change, an HPM with two TTM processes added group (THP), and a control group who received their usual PE program. The main study hypothesis was that the integrated model would result in improved PA maintenance. It was further hypothesized that the THP group would result in greater increases in PA-related cognitions and PA participation compared to the HPM only group.All three groups completed questionnaires prior to the start of the interventions, immediately following the intervention, and six months after the end of the interventions. The research was approved by the Tarbiat Modares University ethics board and the appropriate educational authorities. Prior to participation, investigators sent a written information sheet and consent form for the parents and participants to sign.Participants came from three, all female, Iranian, public secondary schools that were randomly selected using a random number table from a possible 31 schools in the area. All selected schools chose to participate. The teachers were all female and all schools were from the same socioeconomic background. Participants within the schools were eligible for inclusion in this study if they were in the preparation stage of exercise behavior change at baseline and were in grades nine or ten . This inclusion criterion was used because it is participants in the preparation stage who are recommended for recruitment to exercise programs as they are most likely to benefit . FurtherAll the instruments were translated into Persian by a bilingual researcher and then validated using standard back translation technique  by a natIntervention study questionnaires were administered by the researcher to students in their classrooms. The investigator remained in the room during questionnaire administration and answered any questions. For each of the next six consecutive days following questionnaire administration (Saturday through Thursday) each participant completed a child/adolescent/activity log (CAAL) .Stage of change was assessed using an adapted two question measure . In the Perceived self-efficacy was adapted from an existing exercise self-efficacy scale . This scPA was assessed using a modified child/adolescent activity log (CAAL) . The CAAs = .76 to .77, P < 0.001).The discriminant validity of the log in this study was supported by the stages of change. As expected, those adolescents who were in later stages  reported more minutes of PA (M = 62.88 min ± 27.05 min) than those in earlier stages  . Furthermore, stage of change and total number of minutes and mean of minutes activity per week on the CAAL were significantly correlated  which included 18 items measuring both benefits  and barriers . Each item was measured on a 4-point Likert scale ranging from 1  to 4 (very true) . The meaThree subscales developed by Garcia and colleagues  were usePA preferences were measured by a scale based on Pender's instrument for measuring variables in the health promotion model . The 9-iCounter conditioning  and stimulus control  process of change questions were adapted from a questionnaire developed by Marcus and colleagues . IndividThe various components of the interventions, the timeline, constructs targeted and educational methods used are outlined in Table The THP group also received education on the two processes of change: counter conditioning and stimulus control. The counter conditioning education included information on walking or bicycling to school or the store instead of using the bus, getting on or off the bus several blocks away from the destination, taking the stairs instead of the elevator, and taking fitness break by walking or doing desk exercises instead of taking a sedentary coffee break. The stimulus control training included tips on how to change one's environment by posting motivating messages and by removing things in the environment that contribute to inactivity. The control group received no educational or counseling sessions but did receive the educational pamphlets after administration of the final follow-up questionnaires.In addition to the educational sessions, each participant from the two intervention groups received a 20 to 25 minute individual counseling session based on personal responses to the questionnaire at baseline, and at the fourth, tenth, and eighteenth weeks of the intervention. These counseling sessions helped the participants to set and review personal PA goals, to determine strategies to overcome barriers to PA, and to review her social network. Each participant was also provided with a reminder card of her goals and asked to display the card in a suitable place at home or in her school notebook.th week (68% participation) and one at the 18th week (71% participation) of the intervention were held with the participants' mothers to help the mothers understand the benefits of PA, to highlight the importance of social support, and to help them when they tried to help their daughters reach their PA goals. Further, during the 22nd week of the intervention, each participant was telephoned by the researcher to encourage the participant to maintain her PA and to further discuss her PA goals. During the last week of the intervention the participants went mountaineering with their mothers and teachers, a popular means to be active in Iran, to further encourage PA and social support in the participants.Teachers in the two intervention schools attended sessions aimed at educating them about the intervention models and the importance of social support and modeling. This was done so the teachers could provide role modeling by doing exercise in the schools and could also provide support to help the participants to reach their PA goals. Two 60 minute sessions, one at the 102. For all analyses alpha levels were set at p < 0.05.The analyses were conducted with the Statistical Package for the Social Sciences (SPSS), version 15.0. Variables were assessed for normality of distribution and logarithmic transformations were performed on self-efficacy, social support and mean PA whereas square root transformations were performed on perceived barriers, stimulus control and preferences. Where assumptions of homogeneity of variance and sphericity could not be satisfied, non-parametric tests were used. At post-test and follow-up, stages of readiness to change PA behavior were merged into two categories: pre-action  and action (action and maintenance). This decision was made because at follow-up 40 percent of cells had an expected count of less than five. Although there was not a similar limitation at post-intervention, groups were also collapsed at that time so that equivalent analyses could be conducted. Chi-square tests were used to compare these categories between the three groups at post-intervention and follow-up. Progression in the stages through the time points for the three groups was compared using the Friedman test. Changes in outcome variables from baseline through post intervention and follow-up were assessed by a repeated measure ANOVA to determine differences between intervention groups. Where significant interactions were found, follow-up univariate analyses of covariance (ANCOVA) were conducted to reveal main effects. In these analyses the baseline measures were included as the covariate with the follow-up variable as the dependent variable. All post hoc tests were performed with adjustment for multiple comparisons and intervention effect sizes were calculated using Partial ηX2 (4) = 51.61, p = 0.001, and at follow-up, X2(4) = 20.2, p = 0.001. There was a statistically significant increase in the number of participants in both THP and HP groups who progressed through the stages from baseline to follow-up (Friedman X2 (2) = 49.6, 2 p < .001, and X2 (2) = 43.1, p = 0 .001), whereas limited progression occurred in the control group (X2 (2) = 1.90, p = .38). At the six-month follow-up the THP group had a larger percentage of participants in the action stages than the HP group. The percentage of participants in each stage at posttest and follow-up is summarized in Table Demographic characteristics at baseline are summarized in Table p = .000, η2 = .16, stimulus control, F = 14.82, p = .000, η2 = .15, overall minutes PA per week, F = 31.50, p = .000, η2 = .29 and mean minutes PA per day, F = 39.94, p = .000, η2 = .34. It was noted that the assumption of homogeneity of variance was not met for stimulus control, counter conditioning and mean PA per day. However, equivalent non-parametric analyses revealed similar significant results. Post hoc analyses showed that the differences for counter conditioning and stimulus control were not significant between the THP and HP groups but there were significant differences between the two intervention groups and the control group (p = .003 – .006).Table p = .001, stimulus control, F = 14.02, p = .04, overall minutes PA per week, F = 4.32, p = .01, and mean minutes PA per day, F = 5.0, p = .008. At follow-up, results showed no significant differences between the THP and HP groups for any of above outcomes except stimulus control p = .02, but the two intervention groups and the control group differed for both behavioral processes (p = .000 – .02). No significant differences were found between the HP and control group for overall minutes and mean of PA.There was no significant difference between the THP and HP groups for overall and mean PA minutes. However, students in both intervention groups reported significantly more PA than students in the control group. Main effects tests by group at follow-up, controlling for the differences in baseline values, found significant differences for counter conditioning, F = 7.83, p = .000) and a decrease between post-intervention and follow-up (p = .004). There was also an increase for stimulus control between baseline and follow-up for the THP and HP groups (p = .001 and .004 respectively). Using the same procedure for counter conditioning showed the THP group had a significant increase between baseline, post-intervention (p = .000) and follow-up (p = .04). However, there was a significant decrease in counter conditioning between post-intervention and follow-up (p = .001). Main effects tests for time showed that the two intervention groups had significantly increased their mean PA between baseline and post-intervention (p = .000) and also from baseline to follow-up (p = .000).Main effects for time showed that the THP group had a significant increase for stimulus control between baseline and post-intervention  from the TTM in conjunction within the HPM would result in greater increases in PA related cognitions and PA behavior. This integration of models was hypothesized to address the lack of consideration of environmental influences within the HPM and acknowledges the substantial body of research showing that TTM tailored interventions can promote an individual's progression through stages -37. All As already mentioned, participants in the THP group also reported more PA at post intervention than the HP group, although these differences were not statistically significant. At the end of intervention period both the THP and HP groups reported spending about one hour more in activity per day compared to participants in the control group who increased their activity by only six minutes per day compared to baseline. This finding is likely related to the overall advancement into action stages by participants in both intervention groups because a number of other researchers have found that participants in the action stages reported more PA than those are in the pre-action stages -37. WhilSubstantial relapses in behavior are generally observed in many intervention studies "when the intensive intervention ends and external supports are withdrawn" . TherefoA unique aspect of this research was the involvement of the participants' teachers and mothers with the intention of changing cultural norms and providing vicarious learning for the participants through observing important others engaged in PA. As noted in the introduction, the cultural norms for Iranian females to be active are restrictive. Therefore, it may be that by asking the participants' teachers and mothers to encourage the participants to be more active and to express their expectations that the girls be more active, a shift occurred around social norms for the participants within this study. However, it also may be that changes occurred due to peer learning and further research is required to clarify this finding. In general however, this is an extremely encouraging finding that can be used when creating interventions with similar populations.Another important strength of the current study was the duration of the intervention (24 weeks) and the inclusion of follow-up assessments. To achieve significant changes in deeply entrenched behaviors, interventions among adolescents should last longer than one semester . While pThere were several limitations of the present study. First, the data were measured by self-report questionnaire which introduces the possibility of biased results. Another limitation is the assessment of the validity of the CAAL and it is recommended that the CAAL be further validated with an objective measure in Iranian adolescents. It should be noted however, that test-retest reliability of the CAAL in this study was .98. Another limitation is the restriction of these interventions to participants in the preparation stage at baseline. Future research should expand these interventions to include participants at other stages of change at baseline. Such research would also necessitate expanding to other processes of change such as consciousness raising for participants in precontemplation.Outcome evaluation showed a positive short-term effect for the intervention groups on stage of readiness, potential determinants of PA and on amount of PA, as both intervention groups increased their PA by approximately one hour per day. Although participants in the THP group reported using more behavioral processes than those in the HP group, no significant differences were found between the THP and HP groups for PA at the post intervention. However, the THP group recorded more PA and more positive results on most of the potential determinants compared to the control group and therefore appears to be the stronger intervention. At the six month follow-up, PA levels had decreased from posttest and fewer students in both intervention groups were in the action stages of behavior change. However, the significant differences between the HP and control groups for PA were not present at the six-month follow-up, but some differences between the THP and control groups were still present indicating that this was the stronger intervention.Iranian girls face many barriers to an active lifestyle, including lack of suitable places to be active, access to facilities and resources, cultural limitations, and the low importance placed on exercising over other activities such as doing homework or home responsibilities. Therefore, access to equipment and facilities and a supportive environment are important strategies for promoting PA among this group of adolescents . Indeed,The author(s) declare that they have no competing interests.PT participated in the design of the study, performed the statistical analysis and drafted the manuscript. TB participated in the statistical analysis, helped to draft the manuscript, and read the paper critically for theoretical content and interpretation of study findings. DL participated in the sequence alignment and helped to draft the manuscript. SN and FG conceived of the study and participated in its design and coordination. All authors read and approved the final manuscript.


The prevalence of overweight and obesity (OW/OB) among adolescents worldwide has increased since the 60 s. Spain has reached one of the highest OW/OB prevalence rates among adolescents from European countries. The aim of this methodological paper is to describe the design and evaluation in the EVASYON study .st to 9th visits), and extensive during the last 11 months (10th to 20th visits). In order to assess the efficacy of the treatment, 8 dimensions were measured: diet; physical activity and fitness; eating behaviour; body composition; haematological profile; metabolic profile; minerals and vitamins; immuno-inflammatory markers. Moreover, genetic polymorphisms were also determined.The EVASYON was planned by a multidisciplinary team to treat OW/OB in Spanish adolescents. The EVASYON is a multi-centre study conducted in 5 hospitals in 5 Spanish cities  and two hundred and four OW/OB Spanish adolescents were recruited for this intervention. The treatment was implemented for approximately one-year follow-up. The adolescents were treated in groups of a maximum of 10 subjects; each group had 20 visits during the treatment period in two phases: intensive during the first 2 months (1The treatment programme developed in the EVASYON study was designed as a national pilot study to be implemented as an effective treatment for adolescents with OW/OB into the Spanish Health Care Service. Adolescence is characterized by important changes in body size and composition. Obesity started to appear as a public health problem in the last decades of the 20th century ; currentOverweight prevalence among adolescents around the world has increased since the 1960s. Approximately 14-15% of all 15-yr-old youngsters in the United States may be classified as obese . OverweiIt is widely accepted that treating childhood overweight is an important contribution to the multilevel response to the obesity epidemic . EffectiThe main aims of the EVASYON study  were: 1) to develop a treatment programme including education on nutrition and physical activity, 2) to implement this programme for one year in Spanish adolescents with overweight and obesity and 3) to evaluate its efficacy.For comparative and popularization purposes with previous and future studies, the aim of this paper was to describe the design and evaluation methods during the EVASYON study.The design of the EVASYON Study is an interventional study in a cohort of overweight and obese adolescents aged 13 to 16 years. Despite the lack of control group, we aim to assess the determinants of the treatment effectiveness.In order to estimate the sample size, we considered the results obtained in the AVENA study, a multicenter evaluation of the nutritional status of Spanish adolescents , showed Before starting the EVASYON programme, a screening was performed of all candidates. Several inclusion criteria were defined to homogenize sample characteristics. Inclusion criteria in the EVASYON programme are shown in Table Nine measurement categories were assessed: 1) Diet; 2) Physical activity and health-related physical fitness; 3) Psychological profile; 4) Body composition; 5) Haematological profile; 6) Biochemistry and metabolic profiles; 7) Mineral and vitamin profile; 8) Immunological profile; 9) Genetic profile.All the parameters of each measurement category, excluding genetic profile were assessed at least at four points Figure : baselinA trained dietician conducted face-to-face interviews with participants and their parents  at the beginning of the programme and visits 1, 9, and 20 . Nutrient intake scores were computed with and om Spain ,31.Physical activity was assessed applying a combination of methods. Participants in the EVASYON study wore the ActiGraph GT1M activity monitor . The ActiGraph GT1M is a small and lightweight uniaxial accelerometer  validated widely in laboratory and free-living conditions with children and adolescents . AccordiIn the EVASYON study, health-related physical fitness was assessed using the validated and standardized tests included in the EUROFIT  and FITN2max may be estimated with the Leger equation.The progressive 20-m shuttle-run test published by Leger and Lambert in 1982 and revised in 1988  is one o©; Takei, Tokyo, Japan). Dynamometer was adjusted by sex and hand size for each subject [Subjects perform the test in a standard bipedal position and with the arm in complete extension without touching any part of the body with the hand-dynamometer  as fast as possible.Proposed in the FITNESSGRAM battery, this test measures the flexibility of the hamstring muscles. The test is performed with a standard and sturdy box with a scale on the top of the box. Back-saver sit and reach is similar to the traditional sit and reach except that the measurement is performed on one side at a time, so each side has its individual score.The questionnaires used during the EVASYON Study were the following:In order to assess self-esteem, the AF-5  multidimThe ABOS scale was developed to evaluate patient's symptoms based on the relatives' description of the subject's eating behaviour. This test is useful in a clinical setting for evaluation of patients with eating disorders. The original version  evaluateEDI-2 is a self-report instrument that assesses the cognitive and behavioural characteristics commonly found in individuals with eating disorders . It is oThe anthropometry protocol used in the EVASYON study was identical to the standardized protocol used in the AVENA study with more than 2000 Spanish adolescents .2). Skinfold thickness were measured on the left side of the body [Each measurement was taken three times but not consecutively. A complete set of measurements was performed and then repeated twice more. Weight and height are obtained by standardized procedures. Body mass index is calculated as weigh/height squared  the subject contracts muscle biceps as much as possible, and the tape is passed around the arm so that it touches the skin surrounding the maximum circumference. To measure the waist circumference, the tape is applied horizontally midway between the lowest rib margin and the iliac crest, at the end of gentle expiration. The hip circumference measurement is taken at the point yielding the maximum circumference over the buttocks, with the tape held in a horizontal plane. Proximal thigh circumference is measured just below the gluteal fold and perpendicular to its long axis; the subject stands erect with the feet slightly apart and the body mass evenly distributed between both legs. In addition to the anthropometry measurements, in Zaragoza and Granada, we used laboratory techniques. Participants in these cities (n≈80) were assessed by bioelectrical impedance (BIA), and dual energy X-ray absortiometry (DXA). BOD PODPubertal development was assessed according to the five established Tanner stages . Each stBlood pressure was measured using a validated digital automatic blood pressure monitor  according to the International Protocol of the European Society of Hypertension .Blood collection was performed upon an empty stomach between 8 and 10 AM, after fasting for 10 h. Health state of human volunteers was optimal for blood sample collection.In all cases, blood was extracted from the antecubital vein 21.5 mL). Blood collection was carried out by experienced clinical staff. Blood samples were divided into aliquots as follows: 1.5 mL in EDTA tube , 10 mL in EDTA tube (for plasma extraction) and 10 mL in gel containing tube (for serum extraction). To avoid erroneous values due to sample deterioration, blood cell counts and differentials were analyzed in the laboratories of each hospital that participated in this study. Within 1-h of collection, blood was centrifuged and aliquots of plasma or serum were stored at -80°C. Serum samples were sent to each laboratory at convenient time intervals . Haematological, lipidic-metabolic, vitamins, immunological and genetic studies were centralized in each participating laboratory. The parameters included in each of these categories are presented in Tables 1.5 mL. B®, Bio Rad Diagnostics Group, Irvine, CA, USA) was used to assess precision. Na+, Cl- and K+ were measured with an electrolyte analyser . Urine samples were diluted 2:1 (urine: diluent) with diluent for urine S2490 . QualitycheckTM S2480 and S2470 were used as internal standards  to assess precision. Urine total volume and pH were also monitored.48 h urine samples were collected coinciding with the two last days of 72 h dietary records. Subjects were given detailed verbal and written instructions about how to collect a complete 48 h urine sample and given 3 L sterile plastic bottles. Collection began with the second urine of the second day and ended with the first urine of the last day of 72 h dietary record. Urine creatinine concentration was determined by kinetic Jaffe reaction on a Cobas centrifugal analyser . Urinary Ca was determined by atomic absorption spectrometry . Phosphorous was analysed by photocolorimetry . Quantitative urine control  and the EEC Good Clinical Practice recommendations , and current Spanish legislation regulating clinical research in humans . The study was approved by the Ethics Committee of each hospital that participated in this project and by the Ethics Committee of the Spanish Council for Scientific Research (CSIC). The study was explained to the participants before starting, and the volunteers, parents or tutors signed an informed consent.Access to the database was restricted to the researchers that participated in this study. Therefore, the information obtained in the study was considered as confidential, although the sanitary authorities have full access rights for inspection purposes.The studied parameters are treated considering some fixed variability factors: gender, age, tanner, BMI classification . AttendaFirstly, an assessment of missing data and the identification of potential outliers are carried out. The statistic processes is as follows:1) Univariate descriptive analysis, study of data distribution, basic statistics such as central and dispersion values. The interrelationship among variables is assessed by studying the correlation coefficients on the basis of their distribution and their association to those groups defined upon random and fixed factors. Pair comparison tests with previous analysis of the homogeneity of variance are used. Chi-Squared tests and exact probability calculations are also performed to study the relationship among qualitative variables.2) General lineal models for each point in time and as a function of time . Multivariate models are used from different perspectives: classical regression models and continuous or categorical principal component analysis are used to describe multivariate interrelationship among selected variables. Also, multivariate analyses are used to predict the intervention success at a selected period of time and at the end of the study by variables that measure the health improvement of the patients.The analysis of the data will be done using the statistical packages SPSS and SAS.The EVASYON study develops, for the first time in Spain, a multidisciplinary treatment programme for adolescents with overweight and obesity that is aimed at all possibly involved areas of the individual, such as dietary habits, physical activity and cognitive and psychological profiles, in order to prevent the development, in an immediate future and in the long term, of chronic diseases associated with obesity such as diabetes, hypertension, cardiovascular diseases, metabolic syndrome, etc. Health-related researchers who participate in this study expect that the programme, once its efficacy has been proved, may be applicable in any hospital or clinic from the Spanish System of Health with a multidisciplinary group consisting of paediatricians, endocrinologists, psychiatrists, psychologists, physical activity specialists and dieticians.The EVASYON study is essentially characterized for being a multidisciplinary and multicentre project. Thus, both the assessment of the efficacy and the protocols of the treatment have been developed by professionals in each of the specific fields: psychology, nutrition, physical activity, fitness, paediatrics, body composition, genetics, immunology and biochemistry. Moreover, the study has been conducted in 5 hospitals from 5 Spanish cities, respectively . Adaptation of the protocol for 5 different hospitals had as principal advantage that the treatment programme potentially will be easier to implement in any healthcare centre of the Spanish Health Care Service.Nonetheless, organizing a single educational treatment for all the centres and the assessment protocols was a complex process. Training workshops for all the EVASYON members, who were going to take part in the programme and in the assessment, were conducted to unify criteria and to test the methodologies presented in this article before beginning the study. One pilot group in each hospital served to solve starting-up problems in the treatment programme, doubts, human and technical resources and coordination with adolescents and their families. Some decisions were also made in the workshops on how to send blood samples, protocols of physical fitness test to carry out in hospitals, possible postbariatric surgery or follow-up of participants after the study ended.The EVASYON study has both strengths and weaknesses. Several strengths that the EVASYON study presents are as follows: 1) the sample size achieved of 204 adolescents with overweight and obesity provides an acceptable statistical power to conduct multivariable analysis . Few studies performed in clinical settings have recruited, to our knowledge, a greater number of participants than the EVASYON study -26 the dThe EVASYON study also involves weaknesses that must be taken into account: 1) the study does not include a control group of overweight or obese adolescents. This makes it difficult to understand the progress, maintenance or deterioration of the baseline health of participants. Strong weight loss studies with educational therapeutic programme based on physical activity and nutrition have included control groups  or not ; 2) an iInitiatives as the EVASYON study contribute to the development of the Spanish Strategy for Nutrition, Physical Activity and the Prevention of Obesity (NAOS Strategy) initiated in 2005 by the Ministry of Health and Consumer Affairs . The NAOIn summary, the EVASYON study is an interventional study assessing the effectiveness of an educational therapeutic model in physical activity and nutrition in Spanish adolescents with overweight and obesity. The EVASYON programme attempts to be a national pilot study that may be implemented as a method of treatment of obesity in adolescents into the Spanish Health Care Service. This multidisciplinary and multicenter study assesses changes in participants for approximately 1-year follow-up over 8 dimensions: 1) diet, 2) physical activity and health-related physical fitness, 3) psychology, 4) body composition, 5) haematology, 6) biochemical and metabolic profiles, 7) mineral and vitamin profiles, and 8) immunology profile. Genetic profile was also assessed for examining the influence of gene-environmental interactions on obesity.The authors declare that they have no competing interests.DMG, SGM, and MAP contributed equally to this work. AM, CRF, CC, AM, JMG designed the study and obtained funding. DMG, SGM, MAP, EN, JW, OLV, CA, MPV, MD, JAM, MGF and LAM provided insight into the study design. All authors participated in the writing of the paper and provided comments on the drafts and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/9/414/prepub


Maintaining a healthy weight and undertaking regular physical activity are important for the secondary prevention of cardiovascular disease (CVD). However, many people with CVD are overweight and insufficiently active. In addition, in Australia only 20-30% of people requiring cardiac rehabilitation (CR) for CVD actually attend. To improve outcomes of and access to CR the efficacy, effectiveness and cost-effectiveness of alternative approaches to CR need to be established.This research will determine the efficacy of a telephone-delivered lifestyle intervention, promoting healthy weight and physical activity, in people with CVD in urban and rural settings. The control group will also act as a replication study of a previously proven physical activity intervention, to establish whether those findings can be repeated in different urban and rural locations. The cost-effectiveness and acceptability of the intervention to CR staff and participants will also be determined.This study is a randomised controlled trial. People referred for CR at two urban and two rural Australian hospitals will be invited to participate. The intervention  group will participate in four telephone delivered behavioural coaching and goal setting sessions over eight weeks. The coaching sessions will be on weight, nutrition and physical activity and will be supported by written materials, a pedometer and two follow-up booster telephone calls. The control  group will participate in a six week intervention previously shown to increase physical activity, consisting of two telephone delivered behavioural coaching and goal setting sessions on physical activity, supported by written materials, a pedometer and two booster phone calls. Data will be collected at baseline, eight weeks and eight months for the intervention group . The primary outcome is weight change. Secondary outcomes include physical activity, sedentary time and nutrition habits. Costs will be compared with outcomes to determine the relative cost-effectiveness of the healthy weight and physical activity interventions.This study addresses a significant gap in public health practice by providing evidence for the efficacy and cost-effectiveness of a low cost, low contact, high reach intervention promoting healthy weight and physical activity among people with CVD in rural and urban areas in Australia. The replication arm of the study, undertaken by the control group, will demonstrate whether the findings of the previously proven physical activity intervention can be generalised to new settings. This population-based approach could potentially improve access to and outcomes of secondary prevention programs, particularly for rural or disadvantaged communities.ACTRN12610000102077 Cardiovascular disease (CVD) is the leading cause of death in Australia  and contThus the challenge is to improve health outcomes for the majority of people with CVD who do not attend CR. In response to this challenge, investigating alternative service models for delivering CR programs shows promise . To deteDistance interventions, delivered remotely via print, telephone or internet, are likely to have improved population reach, accessibility, cost-effectiveness and maintenance of gains at follow-up compared to centre-based programs . SystemaReports of interventions promoting healthy weight and physical activity in people with CVD are scarce. A recent Australian study identified significant benefits of a telephone-delivered, pedometer-based intervention on physical activity levels among people with cardiac disease who attended outpatient CR . AnotherEven fewer interventions address the majority of cardiac patients who do not attend CR. The CHOICE program included a face-to-face consultation and four follow-up phone calls and was effective in improving cardiac risk factors for people with cardiac disease who had not attended CR . Furber Cost effectiveness analyses are rarely conducted on health care interventions  and to oThe PANACHE  randomised control trial will investigate if a home-based approach  can decrease obesity and increase physical inactivity in people with CVD in urban and rural areas in Australia. It will also determine whether the outcomes of an intervention previously found to increase physical activity ,27 are rThis study is a randomised controlled trial comparing the efficacy of a healthy weight telephone coaching intervention (intervention group) with a physical activity telephone coaching intervention (control group). An outline is shown in Figure Approval to conduct this research has been granted by the Human Research Ethics Committees from University of Wollongong, South Eastern Sydney and Illawarra Area Health Service, Greater Southern Area Health Service and the University of New South Wales. All people referred to outpatient CR over a 12-18 month period at two Sydney and two NSW rural hospitals in Australia will be invited to participate in the study, whether or not they attend outpatient CR. Based on a previous Australian study , it is aParticipants will be recruited six-eight weeks after referral to CR by which time they would be likely to be clinically stable in their recovery process. Brief written information about the study will be included in the information packs distributed to people referred to CR. A personalised invitation letter will also be mailed, followed up with a telephone call.During the follow up telephone call participants will be randomised by the researcher into intervention and control groups when they agree to be enrolled in the study. Participants will be block randomized within site. Microsoft Excel will be used to generate random numbers and the Statistical Analysis System (SAS) will be used to randomise these numbers into sets of two letters  by blocks of four to ensure a balanced sample size across both study groups . The ranThe intervention  group will receive an eight week healthy weight intervention based on social cognitive theory ,34 which2 participants will be recommended to lose weight [2 the focus will be on weight maintenance [Goals will be individualized and if the participant's BMI is greater than 24.9 kg/me weight  and to untenance  and 30 mThe healthy weight intervention was piloted with nine rural participants. The findings were used to refine evaluation questions and procedures, modify the telephone coaching guide and improve the suitability of written support materials.The control  group will receive the same six week physical activity intervention previously found to be efficacious ,27. AlsoQuestionnaires will be completed by telephone at baseline, eight weeks and eight months for the intervention group and at baseline, six weeks and six months for the control group. Researchers administering the questionnaires will be trained to follow written standard procedures. They will be supervised during the administration of the initial questionnaires and thereafter at random intervals. All objective measures will be obtained by the same researcher following a written standard protocol.Semi-structured interviews will be conducted with urban and rural CR staff to assess their views of the usefulness and acceptability of the program and its implementation in their setting. Focus groups will be held with rural and urban study participants regarding their experiences of the program and its delivery. Participants will also provide information on process measures when they complete the telephone questionnaires at week eight (intervention) and week six (control) on the acceptability of program activities and materials such as resources on weight control, nutritional and physical activity, and coaching advice. The weight, nutrition and physical activity goals set by participants during their telephone coaching sessions will also be recorded.The primary outcome is self-reported weight and BMI . SecondaTo validate self-reported changes in height, weight, food intake and physical activity, objective data will be collected at baseline and at eight months from a sub-group of 25% of the intervention group (a convenience sample of 45 participants). At baseline and at eight months the researcher will meet with this sub-group to measure their height, weight and waist circumference after they have self-reported these measures in the questionnaires administered via telephone at baseline and eight months. Participants will then be asked to record their intake of food and drink for three days (two weekdays and one weekend day) and to wear an MTI Actigraph accelerometer to record their physical activity for the next seven days. At the end of the week in which the accelerometer is worn the self-report questions on physical activity, sedentary activity and nutrition habits, which ask about these activities over the last seven days, will be completed. Thus the objective data obtained using a food diary and accelerometer will be collected over the same time period as the self-reported data. A three-day food diary collected over two week days and one weekend day has been found to be a reliable measure of usual energy intake . AccelerCosts calculated will include program costs , direct health care costs related to participants' cardiac conditions  and other costs (for example participant's expenditure on exercise related products and services such as shoes and exercise classes). Information will be collected regarding the number of days absent from work or normal activities due to cardiac problems.2 BMI between the intervention and control group (based on the COACH study effects on weight loss [To detect a reduction of 1.3 kg in weight and 0.5 kg/mght loss ) with a The analyses of the trial will be based on (i) intention to treat and (ii) treatment received. Bivariate and multivariate analyses will assess the effects of the intervention (compared to controls) on weight loss, sedentary behaviour, nutrition and physical activity adjusted for residence , age and sex for all cases and then treatment received after initial intention to treat analysis. Continuous data will be analysed with paired t-tests and linear regression and categorical variables with chi square tests and logistic regression with p < 0.05 as the level of significance but adjusted appropriately when multiple testing is conducted. Analyses will be performed with PASW 18.0 . Food diaries will be analysed using FoodWorks 2007 (Xyris Software).The economic evaluation will be conducted using accepted guidelines . To deteThematic analysis will be used to examine transcripts of the interviews with CR staff and the focus groups with study participants. Two researchers will independently code the themes arising and then compare and discuss their coding. For the purpose of triangulation, these researchers will then discuss the themes with an additional researcher. The steps taken in the thematic analysis and the reasons for taking them will be documented to provide an audit trail.Despite the effectiveness of conventional centre-based CR programs, participation rates are low and the majority of people requiring CR are missing out on evidence-based health benefits of lifestyle interventions for cardiac patients. In addition, little research has been conducted on improving health outcomes for the majority of cardiac patients who do not attend CR. This study addresses these gaps in public health practice, firstly by testing an alternative delivery mode for CR, secondly by targeting the entire population of people referred for CR, irrespective of whether they attend a CR program or not, and thirdly by establishing the efficacy of a healthy weight intervention for people with cardiac disease. The economic impact of secondary prevention programs for CVD is an under-researched area. The economic analysis conducted alongside this study will provide important information on the relative costs and benefits of the intervention.This study will show whether the population-based, low contact, high reach intervention tested can promote healthy weight and physical activity among people with CVD in rural and urban settings and whether it can be delivered cost effectively. By replicating the previously proven physical activity only program ,27 in thThe findings of this study will have significant implications for the management of people with CVD. In addition to improving health outcomes for people with cardiac disease, these interventions have the potential to reduce costs and improve access to CR services, particularly for disadvantaged and rural people. They could be a feasible addition to existing services and could also be delivered to people with CVD who have already attended CR programs as a "maintenance" program.The authors declare that they have no competing interests.JS drafted the manuscript, contributed to the study design and is coordinating the study. SF, MA-F, MH, PP, AM and AB contributed to the study design, advised on coordination of the study and reviewed the manuscript. All authors read and agreed to the manuscript as written.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2261/10/17/prepub


P < .001) and fat mass (P < .001) was greater in the exercise group. The one-year gain in body mass-adjusted knee extensor and flexor PT at 180 deg/sec was significantly greater in the intervention group compared with the control group . There was no group difference in VJH. In conclusion, the increase in school-based physical education from 60 to 200 minutes per week enhances the development of lean body mass and muscle strength in pre-pubertal boys.This prospective controlled intervention study over 12 months evaluated the effect of exercise on muscular function, physical ability, and body composition in pre-pubertal boys. Sixty-eight boys aged 6–8 years, involved in a general school-based exercise program of 40 min per school day (200 min/week), were compared with 46 age-matched boys who participated in the general Swedish physical education curriculum of mean 60 min/week. Baseline and annual changes of body composition were measured by dual energy X-ray absorptiometry (DXA), stature, and body mass by standard equipments, isokinetic peak torque (PT) of the knee extensors, and flexors at 60 and 180 deg/sec by computerized dynamometer (Biodex) and vertical jump height (VJH) by a computerized electronic mat. The annual gain in stature and body mass was similar between the groups whereas the increase in total body and regional lean mass ( Physical activity has been regarded as one of the most important life style factors that could improve a variety of health-related aspects, including musculoskeletal health. But studies have indicated that children and adults in the recent decades have become less physically active , and thePhysical activity includes a variety of activities as it is defined as any bodily movement produced by skeletal muscles that result in energy expenditure . PhysicaIn children and adolescents, it is well established that gains in strength and power are possible following prospective controlled short-term progressive resistance training programs two to three times per week. Reports show that muscle strength, muscle mass, and physical performance improved in both boys and girls –9. ThereTo our knowledge there is not an extant literature on general exercise training of longer duration and its effect on neuromuscular development in young children. However, reports show positive effects on fat mass, physical fitness, and performance. A school-based program with expanded physical education lessons (4 lessons/week) during three years was effective in increasing children's physical performance and preventing excessive weight gain . SimilarThese studies provide important information about the musculoskeletal effects of resistance training programs in volunteers or of exercise training programs of longer duration but with obesity or physical fitness as main outcome. However, it still remains unclear whether a long-term, general, and moderately intense exercise program on population level could improve muscle mass and performance in children 6–8 years old. We have previously reported that this goal could be reached in Prepubertal girls  but therA population-based general exercise intervention program of moderate intensity was created by increasing the frequency of compulsory school physical education, and not the intensity, as to be able to include all children in the intervention, not only those who could stand a more high intense training. This study was designed to evaluate whether this intervention program could improve body composition, lower extremity muscle strength, and physical performance in Prepubertal boys. We hypothesized that the 12-month program would confer these benefits.The Malmö Pediatric Osteoporosis Prevention (POP) Study, is a prospective controlled exercise intervention study designed to annually assess skeletal and muscle development in children from school start onwards , 22. BasThe study design has previously been reported in detail when reporting changes in bone mass , but in In order to ascertain whether there was any selection bias at baseline, we have previously reported that there were no significant differences in the grade 1 examination regarding stature, body mass, and BMI of the boys, when a drop-out analysis compared the study participants and the nonparticipants . FurtherThe intervention program included the general exercise program used within the Swedish school physical education curriculum, supervised by the regular physical educational teachers but with the training increased to 40 minutes per day, corresponding to 200 minutes per week, but no specific registration was done as regard participation rate. Before the study the intervention school had had the same duration of physical education as the control schools. The duration was chosen in order to maximize a range of health-related benefits beyond just the gain in bone mass, which has been shown to respond to shorter bouts of body mass-bearing exercise –31. AlsoA questionnaire, previously used in several pediatric studies but slightly modified for the POP study , 22, 33,2 (kg/m2). A research nurse assessed the Tanner  and expressed as the absolute or percentage change from baseline. Analyses of covariance (ANCOVA) were then used to compare the trait-specific annual changes in the groups, and baseline age and baseline peak torque values were included as covariates if there was a significant difference between the groups at baseline. Life style factors prior to and after study start were analysed with Fisher's exact test and Student Ex60) with 80% power and an alpha level of 0.05. The reason we chose PTEx60 as our primary muscle force outcome is that there is evidence in the literature for a greater absolute increase in knee extensor compared to flexor muscle strength from age 9 to 21 years [The study design would detect a minimal difference of 0.123 Nm/kg in the annual change in muscle strength (PT21 years . Trainin21 years .P = .05) (Fl60 and PTFl180 (body mass-adjusted both P < .001) were both higher in the control group  . Furtherol group . Ex180 and PTFl180) were significantly greater in the intervention than in the control group   and PTFl180   . Similar < .001) .This 12-month prospective, controlled, school-based exercise intervention study indicates that an increase in the duration of general moderately intense physical education in the school from 60 to 200 minutes per week is associated with an increased lower limb peak muscle strength gain in Prepubertal boys. A statistically significant difference between the groups can not automatically be transferred to a difference of biological and clinical significance; however, these findings still may have important public health implications as they provide evidence-based data to support the benefit of school-based physical education as an effective strategy to enhance muscular health in Prepubertal boys. There are several reasons why it is beneficial to enhance musculoskeletal health during growth. Bone density, muscle mass, and muscle strength are all traits that play an important role in reducing the risk of a number of chronic musculoskeletal diseases in adulthood , 39 and Several effects may explain the benefits seen in muscle strength from increased physical activity. Training may confer neuromuscular adaptations in conjunction with increases in muscle mass and muscle size, which all increase during puberty in association with the increased secretion of sex steroids , 44. Butin vivo techniques of measuring muscle mass [r2) indicates that the duration of physical activity during the study explained no more than 3.6%–14.4% of the variance in the reported traits  and long jump  [Despite reports that general physical training can improve muscle strength in children, there are conflicting reports as to whether these benefits translate into improvements in other physical performance estimates such as athletic performance, VJH, long jump, or sprint speed , 50, 51.P = .10) . The lacP = .10) , it coulAn unexpected finding in our study was the greater annual gain in arm fat mass in the intervention group compared with the controls . Howeverin vivo techniques [There are limitations to this study. This was not a randomized, controlled study, as randomization was refused by the principals, teachers, parents, and children since it was neither feasible nor practical for some children to be given additional exercise during compulsory school hours while others were not. But since all schools had a similar amount of regular school physical education before study start and since there were no differences in anthropometry between participants and nonparticipants or between participants and dropouts, the risk of selection bias seems minimal. Due to lack of resources in our research laboratory, the control group boys were not remeasured until after two years. However, as all the boys remained Prepubertal during the study, it was possible to compare the annual changes between the groups as the development of muscle strength is proportional to the gains in stature and body mass that occur linearly during this period , 55. Thichniques , 48, it chniques . Anotherchniques . FinallyIn conclusion, increasing the amount of moderately intense exercise within the school curriculum physical education to 40 minutes per day provides a feasible strategy to enhance muscle strength in Prepubertal boys. These findings have important clinical implications, as the first two decades in life may represent the most opportune time to reduce the risk of a number of chronic musculoskeletal health conditions . Thus, t