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Cover of Cluster randomised controlled trial and economic and process evaluation to determine the effectiveness and cost-effectiveness of a novel intervention [Healthy Lifestyles Programme (HeLP)] to prevent obesity in school children

Cluster randomised controlled trial and economic and process evaluation to determine the effectiveness and cost-effectiveness of a novel intervention [Healthy Lifestyles Programme (HeLP)] to prevent obesity in school children

Public Health Research, No. 6.1

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Author Information
Southampton (UK): NIHR Journals Library; .

Headline

The novel school-located Healthy Lfestyles Programme did not prevent obesity in 9- to 10-year-olds at 2-year follow-up.

Abstract

Background:

Approximately one-third of children in England leave primary school overweight or obese. There is little evidence of effective obesity prevention programmes for children in this age group.

Objective:

To determine the effectiveness and cost-effectiveness of a school-based healthy lifestyles programme in preventing obesity in children aged 9–10 years.

Design:

A cluster randomised controlled trial with an economic and process evaluation.

Setting:

Thirty-two primary schools in south-west England.

Participants:

Children in Year 5 (aged 9–10 years) at recruitment and in Year 7 (aged 11–12 years) at 24 months’ post-baseline follow-up.

Intervention:

The Healthy Lifestyles Programme (HeLP) ran during the spring and summer terms of Year 5 into the autumn term of Year 6 and included four phases: (1) building a receptive environment, (2) a drama-based healthy lifestyles week, (3) one-to-one goal setting and (4) reinforcement activities.

Main outcome measures:

The primary outcome measure was body mass index (BMI) standard deviation score (SDS) at 24 months post baseline measures (12 months post intervention). The secondary outcomes comprised waist circumference SDS, percentage body fat SDS, proportion of children overweight and obese at 18 and 24 months, accelerometer-assessed physical activity and food intake at 18 months, and cost-effectiveness.

Results:

We recruited 32 schools and 1324 children. We had a rate of 94% follow-up for the primary outcome. No difference in BMI SDS was found at 24 months [mean difference –0.02, 95% confidence interval (CI) –0.09 to 0.05] or at 18 months (mean difference –0.02, 95% CI –0.08 to 0.05) between children in the intervention schools and children in the control schools. No difference was found between the intervention and control groups in waist circumference SDS, percentage body fat SDS or physical activity levels. Self-reported dietary behaviours showed that, at 18 months, children in the intervention schools consumed fewer energy-dense snacks and had fewer negative food markers than children in the control schools. The intervention effect on negative food markers was fully mediated by ‘knowledge’ and three composite variables: ‘confidence and motivation’, ‘family approval/behaviours and child attitudes’ and ‘behaviours and strategies’. The intervention effect on energy-dense snacks was partially mediated by ‘knowledge’ and the same composite variables apart from ‘behaviours and strategies’. The cost of implementing the intervention was approximately £210 per child. The intervention was not cost-effective compared with control. The programme was delivered with high fidelity, and it engaged children, schools and families across the socioeconomic spectrum.

Limitations:

The rate of response to the parent questionnaire in the process evaluation was low. Although the schools in the HeLP study included a range of levels of socioeconomic deprivation, class sizes and rural and urban settings, the number of children for whom English was an additional language was considerably lower than the national average.

Conclusions:

HeLP is not effective or cost-effective in preventing overweight or obesity in children aged 9–10 years.

Future work:

Our very high levels of follow-up and fidelity of intervention delivery lead us to conclude that it is unlikely that school-based programmes targeting a single age group can ever be sufficiently intense to affect weight status. New approaches are needed that affect the school, the family and the wider environment to prevent childhood obesity.

Trial registration:

Current Controlled Trials ISRCTN15811706.

Funding:

This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 6, No. 1. See the NIHR Journals Library website for further project information.

Contents

About the Series

Public Health Research
ISSN (Print): 2050-4381
ISSN (Electronic): 2050-439X

Article history

The research reported in this issue of the journal was funded by the PHR programme as project number 10/3010/01. The contractual start date was in March 2012. The final report began editorial review in November 2016 and was accepted for publication in February 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Stuart Logan reports grants from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health, Research and Care. He also reports a grant from the NIHR Public Health Research programme during the conduct of the study. Colin Green served as a member of the funding panel for the NIHR Programme Grants for Applied Research programme from 2009 to 2013. Colin Green (2007–13) and Siobhan Creanor (2013–present) served as members of the NIHR Research Funding Committee for the South West Region of the Research for Patient Benefit Programme. Intervention costs for this study were paid for by the Peninsula College of Medicine and Dentistry. Stuart Logan (NF-SI-0515–10062) and Rod Taylor (NF-SI-0514–10155) are NIHR senior investigators. This study was undertaken in collaboration with the Peninsula Clinical Trials Unit (CTU), a UK Clinical Research Collaboration-registered CTU in receipt of NIHR CTU support funding. None of the funders had any involvement in the Trial Steering Committee, data analysis, data interpretation, data collection or writing of the report.

Last reviewed: November 2016; Accepted: February 2017.

Copyright © Queen’s Printer and Controller of HMSO 2018. This work was produced by Wyatt et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK476162PMID: 29356471DOI: 10.3310/phr06010

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