Dataset Information

Behavioural and weight status outcomes from an exploratory trial of the Healthy Lifestyles Programme (HeLP): a novel school-based obesity prevention programme.

ABSTRACT:

Objectives

To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme.

Design

Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme.

Setting

Four city primary schools (two control and two intervention) in the South West of England.

Participants

202 children aged 9-10?years, of whom 193 and 188 were followed up at 18 and 24?months, respectively. No child was excluded from the study; however, to be eligible, schools were required to have at least one single Year 5 class.

Intervention

Four-phase multicomponent programme using a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage and support schools, children and their families in healthy lifestyle behaviours. It runs over the spring and summer term of Year 5 and the autumn term of Year 6.

Primary and secondary outcomes

Weight status outcomes were body mass index, waist circumference and body fat standard deviation scores (SDS) at 18 and 24?months, and behavioural outcomes were physical activity, television (TV) viewing/screen time and food intake at 18?months.

Results

At 18?months of follow-up, intervention children consumed less energy-dense snacks and more healthy snacks; had less 'negative food markers', more 'positive food markers', lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools. Intervention children had lower anthropometric measures at 18 and 24?months than control children, with larger differences at 24?months than at 18?months for nearly all measures.

Conclusions

Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours, which, in turn, appear to affect weight status and body shape. A definitive trial is now justified.

SUBMITTER: Lloyd JJ

PROVIDER: S-EPMC3358612 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Publications

Behavioural and weight status outcomes from an exploratory trial of the Healthy Lifestyles Programme (HeLP): a novel school-based obesity prevention programme.

Lloyd Jennifer J JJ Wyatt Katrina M KM Creanor Siobhan S

BMJ open 20120514 3

<h4>Objectives</h4>To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme.<h4>Design</h4>Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme.<h4>Setting</h4>Four city primary schools (two control and two intervention) in the South West of England.<h4>Participants</h4>202 children aged 9-10 years, of whom 193 and 188 were followed up at 18 and 24 months, respective ...[more]

PMID: 22586282

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Project description:BackgroundAlthough childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9-10 years would prevent excessive weight gain after 24 months.MethodsThis pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (<19% [the national average] vs ≥19%). HeLP was delivered to year-5 children (ages 9-10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete.FindingsBetween March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention-control) at 24 months was -0·02 (95% CI -0·09 to 0·05), p=0·57. One parent reported an adverse event related to their child's eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator.InterpretationDespite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be sufficiently intense to affect both the school and the family environment, and hence the weight status of children. Future research should focus on more upstream determinants of obesity and use whole-systems approaches.FundingUK National Institute for Health Research, Public Health Research Programme.

Project description:BackgroundApproximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours.MethodsA process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis.ResultsFour schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement ('knowledge and awareness' and 'taking messages on board'). The latter could be broken down into 4 subthemes ('initiating discussion with family and friends', 'acceptance of family rules', 'increased responsibility' and 'the importance of the mode and agent of delivery'). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home, seek parental support and initiate family lifestyle behaviour change.ConclusionThe process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme, it has also allowed an understanding of how HeLP engages schools, children and their families. These findings have informed the process evaluation for the definitive trial.

Project description:Recruitment and retention of participants is crucial for statistical power and internal and external validity and participant engagement is essential for behaviour change. However, many school-based interventions focus on programme content rather than the building of supportive relationships with all participants and tend to employ specific standalone strategies, such as incentives, to improve retention. We believe that actively involving stakeholders in both intervention and trial design improves recruitment and retention and increases the chances of creating an effective intervention.The Healthy Lifestyles Programme, HeLP (an obesity prevention programme for children 9-10 years old) was developed using intervention mapping and involved extensive stakeholder involvement in both the design of the trial and the intervention to ensure that: (i) delivery methods were suitably engaging, (ii) deliverers had the necessary skills and qualities to build relationships and (iii) the intervention dovetailed with the National Curriculum. HeLP was a year-long intervention consisting of 4 multi-component phases using a range of delivery methods. We recruited 1324 children from 32 schools from the South West of England to a cluster-randomised controlled trial to determine the effectiveness of HeLP in preventing obesity. The primary outcome was change in body mass index standard deviation score (BMI SDS) at 24 months post randomisation. Secondary outcomes included additional anthropometric and behavioural (physical activity and diet) measures at 18 and 24 months.Anthropometric and behavioural measures were taken in 99%, 96% and 94% of children at baseline, 18 and 24 months, respectively, with no differential follow up between the control and intervention groups at each time point. All children participated in the programme and 92% of children and 77% of parents across the socio-economic spectrum were considered to have actively engaged with HeLP.We attribute our excellent retention and engagement results to the high level of stakeholder involvement in both trial and intervention design, the building of relationships using appropriate personnel and creative delivery methods that are accessible to children and their families across the social spectrum.International Standard Randomised Controlled Trials Register, ISRCTN15811706 . Registered on 1 May 2012.

Project description:BACKGROUND:The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. METHODS:Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. RESULTS:All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. CONCLUSION:Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. TRIAL REGISTRATION:ISRCTN15811706.

Project description:BackgroundHome and school environments conducive for unhealthy eating and physical inactivity are precursors of obesity. The aim of this study is evaluation of the effectiveness of a multi-component school-based weight management programme for overweight and obese primary school children via a home-school joint venture.MethodsThis study made use of variety of behavioural modification strategies integrating into the Health Promoting School approach to promote healthy lifestyles. The participants were overweight and obese students aged between 8 and 12 from six participating schools. The interventions involved students attending ten 75 minutes after-school sessions and one 3-hour week-end session of practical interactive and fun activities on healthy eating and exercise, and meal plan together with parents and printed tailor-made management advices. Parents received an introductory seminar with 2 sets of specially designed exercise for their overweight children. The tools to measure bodyweight and fat percentage and standing height were bio-impedance body fat scale and a portable stadiometer. Self-administered questionnaire was used to measure knowledge, attitudes and behaviours. McNemar test was utilized to compare the proportions of behaviour changes within the same group to assess for the trends of changes. BMI z-score and body fat percentage of intervention participants at baseline, 4 month and 8 month were compared pair-wisely using tests of within subject contrasts in repeated measures ANOVA to assess for programme sustainability.ResultsThose students in the intervention group reduced their BMI z-score (-0.21, 95% CI -0.34 to -0.07, P = 0.003) and body fat (-2.67%, 95% CI -5.12 to -0.22, P = 0.033) compared to wait list control group with statistical significant, and the intervention group also had a significant reduction in BMI z-score (-0.06, 95% CI -0.11, -0.007, P = 0.028) and body fat (-1.71%, 95% CI, -3.44 to 0.02, P = 0.052) after a 4 month maintenance period. Improvement of dietary habits and positive attitudes towards exercise were observed among the intervention group.ConclusionSchool based weight management programme integrated into a Health Promoting School approach with improved school policies and environment in supporting individual skills of obese students and their parents appears to be a promising practice for sustaining weight control.Trial registrationISRCTN58795797.

Project description:BackgroundAlthough obesity and mental health disorders are two major public health problems in adolescents that affect academic performance, few rigorously designed experimental studies have been conducted in high schools.PurposeThe goal of the study was to test the efficacy of the COPE (Creating Opportunities for Personal Empowerment) Healthy Lifestyles TEEN (Thinking, Emotions, Exercise, Nutrition) Program, versus an attention control program (Healthy Teens) on: healthy lifestyle behaviors, BMI, mental health, social skills, and academic performance of high school adolescents immediately after and at 6 months post-intervention.DesignA cluster RCT was conducted. Data were collected from January 2010 to May of 2012 and analyzed in 2012-2013.Setting/participantsA total of 779 culturally diverse adolescents in the U.S. Southwest participated in the trial.InterventionCOPE was a cognitive-behavioral skills-building intervention with 20 minutes of physical activity integrated into a health course, taught by teachers once a week for 15 weeks. The attention control program was a 15-session, 15-week program that covered common health topics.Main outcome measuresPrimary outcomes assessed immediately after and 6 months post-intervention were healthy lifestyle behaviors and BMI. Secondary outcomes included mental health, alcohol and drug use, social skills, and academic performance.ResultsPost-intervention, COPE teens had a greater number of steps per day (p=0.03) and a lower BMI (p=0.01) than did those in Healthy Teens, and higher average scores on all Social Skills Rating System subscales (p-values <0.05). Teens in the COPE group with extremely elevated depression scores at pre-intervention had significantly lower depression scores than the Healthy Teens group (p=0.02). Alcohol use was 12.96% in the COPE group and 19.94% in the Healthy Teens group (p=0.04). COPE teens had higher health course grades than did control teens. At 6 months post-intervention, COPE teens had a lower mean BMI than teens in Healthy Teens (COPE=24.72, Healthy Teens=25.05, adjusted M=-0.34, 95% CI=-0.56, -0.11). The proportion of those overweight was significantly different from pre-intervention to 6-month follow-up (chi-square=4.69, p=0.03), with COPE decreasing the proportion of overweight teens, versus an increase in overweight in control adolescents. There also was a trend for COPE Teens to report less alcohol use at 6 months (p=0.06).ConclusionsCOPE can improve short- and more long-term outcomes in high school teens.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01704768.

Project description:ObjectivesTo develop a school-based obesity prevention programme and evaluate the feasibility and acceptability of the intervention and the planned definitive cluster randomised trial.DesignThis was a three stage pilot involving six schools (398 children) in South West England, including an exploratory randomised controlled trial and qualitative interviews and focus groups with teachers, parents and children.InterventionThe Healthy Lifestyle Programme uses a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage schools, children and their families.ResultsOf the 398 eligible children in the three pilot phases, only four opted out and a further three withdrew from the exploratory trial. In the exploratory trial, baseline measurements (anthropometric and behavioural) were obtained for 202/204 eligible children in four schools and both 18- and 24-month outcome measurements for 193/204 and 187/204 participants, respectively. Qualitative data show that delivery of the intervention is feasible within schools and acceptable to teachers, children and families. In the exploratory trial, 18/80 children (24%) in the intervention schools and 31/122 (26%) in the control schools were overweight or obese at baseline, increasing, at 18-month follow-up, to 38/119 (32%) in the control schools compared with 18/74 (24%) in the intervention schools. At 24 months the proportion of overweight and obese children in the control schools remained at 32% (36/114), whereas the proportion in the intervention schools decreased slightly to 22% (16/73).ConclusionThe Healthy Lifestyle Programme is feasible to deliver and acceptable to schools, children and their families. We recruited, retained and obtained outcome measurements from 92% of eligible children in the exploratory trial, including measurements taken after transition to secondary school, suggesting that a definitive trial is likely to be deliverable.

Project description:IntroductionBehavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2 or ≥35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients' use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients' weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being.Methods and analysisIn the pilot phase, the app will be adapted, piloted and optimised for BWL treatment following a participatory patient-oriented approach. In the subsequent single-centre, assessor-blind, exploratory randomised controlled trial, 90 adults with SO will be randomised to BWL treatment over 6 months with versus without adjunctive app. Primary outcome is the amount of weight loss (kg) at post-treatment (6 months), compared with pretreatment, derived from measured body weight. Secondary outcomes encompass feasibility, acceptance, weight management skills use, well-being and anthropometrics assessed at pretreatment, midtreatment (3 months), post-treatment (6 months) and 6-month follow-up (12 months). An intent-to-treat linear model with randomisation arm, pretreatment weight and stratification variables as covariates will serve to compare arms regarding weight at post-treatment. Secondary analyses will include linear mixed models, generalised linear models and regression and mediation analyses. For safety analysis (serious) adverse events will be analysed descriptively.Ethics and disseminationThe study was approved by the Ethics Committee of the University of Leipzig (DE-21-00013674) and notified to the Federal Institute for Drugs and Medical Devices. Study results will be disseminated through peer-reviewed publications.RegistrationThis study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de.Trial registration numberDRKS00026018.

Project description:BACKGROUND:After-school care programs have garnered interest in recent years as the hours of 3:00-6:00?p.m. are an opportune time for children to engage in healthy behaviours, specifically healthy eating and physical activity. Care providers are major influencers within the after-school care setting, impacting health promoting opportunities for children. However, little is known regarding the role care providers play in health promotion interventions in the after-school care setting, specifically those using comprehensive approaches. The purpose of this research was to explore care providers' role and experience promoting healthy eating and physical activity through the after-school care health promotion intervention School's Out … Let's Move (SOLMo). SOLMo was guided by the evidence-based comprehensive school health framework. SOLMo had two main goals: [1] to serve a healthy snack with vegetable or fruit, and milk or water as the drink; [2] to include 30?min of moderate to vigorous physical activity. The intervention included resources and coaching for care providers to promote healthy eating and physical activity for children and took place in four after-school sites over a six-month period. Three of four sites were located in a school. The primary researcher was engaged with the sites over 22-months. METHODS:This research was guided by the qualitative method focused ethnography. Semi-structured interviews with care providers (n?=?13) taking part in SOLMo were conducted. Participant observation was included as part of data generation to further understand care provider roles. Latent content analysis was utilized iteratively and concurrently throughout data generation. RESULTS:Overall, care providers were supportive of promoting health behaviours in the after-school setting. Through analysis, five themes and eight subthemes emerged related to care providers' role and experience promoting healthy eating and physical activity through SOLMo: 1) enhanced awareness; 2) improved programming; 3) strong relationships; 4) collaborative approach; and 5) role tension. CONCLUSIONS:As major influencers, care providers play a crucial role in promoting healthy lifestyle behaviours for children. This research provides valuable insight into this role and the implementation of comprehensive health promotion approaches in the after-school setting. Findings contribute to the implementation knowledge base and help inform the promotion of healthy lifestyle behaviours for children.

Dataset Information

Behavioural and weight status outcomes from an exploratory trial of the Healthy Lifestyles Programme (HeLP): a novel school-based obesity prevention programme.

Objectives

Design

Setting

Participants

Intervention

Primary and secondary outcomes

Results

Conclusions

Publications

Behavioural and weight status outcomes from an exploratory trial of the Healthy Lifestyles Programme (HeLP): a novel school-based obesity prevention programme.

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