We thank all of the pupils, teachers, head teachers, teaching assistants and parents/carers for participating in the study. We thank the HeLP co-ordinators, the drama teams, the director of Headbangers Theatre Company, Just4Funk, Attik Dance, Exeter Chiefs and Plymouth Raiders for their enthusiasm and support in delivering the programme. We thank all of the HeLP study staff, trained assessors and trainers who delivered assessment training, as well as data management and administrative staff who provided fabulous support throughout the trial. We are indebted to our Public Advisory Group whose advice and ongoing support were invaluable in ensuring that the trial design and intervention were feasible and acceptable to schools, children and their families. We also thank the chairperson and members of the TSC for their advice and support throughout the trial. We would also like to acknowledge the NIHR Collaboration for Leadership in Applied Health Research and Care for providing non-financial methodological support during the transition from the exploratory trial to the definitive evaluation.
Trial registration and ethics approval
The trial was registered with the International Standard Randomised Controlled Trial Number 15811706. Ethics approval for this study was given by the Peninsula College of Medicine and Dentistry Research Ethics Committee (reference number 12/03/140) in March 2012.
Funding
This project was funded by the NIHR Public Health Research programme (project number 10/3010/01). The trial was conducted with the support of the Peninsula Clinical Trials Unit, a UK Clinical Research Collaboration-registered clinical trials unit (registration number 31) in receipt of NIHR Clinical Trials Unit support funding.
Contributions of authors
Katrina Wyatt (Associate Professor of Health Research, University of Exeter Medical School) led the study, co-designed the HeLP intervention and co-led the process evaluation. She was involved in all stages of the HeLP trial, including conception, design, interpretation of data, drafting and critical revision of the report for important intellectual content and approval of the final version, and co-ordinated responses from other authors.
Jenny Lloyd (Senior Research Fellow Child Health, University of Exeter Medical School) co-led the project, co-designed the HeLP intervention, led the process evaluation and managed the delivery of the trial. She was involved in all stages of the HeLP trial, including conception, design, interpretation of data, drafting and critical revision of the report for important intellectual content and approval of the final version.
Siobhan Creanor [Associate Professor (Reader) in Clinical Trials & Medical Statistics, Plymouth University Peninsula Schools of Medicine and Dentistry] co-led the project, led the statistical analyses and was involved in all stages of the HeLP trial, including conception, design, interpretation of data, drafting and critical revision of the report for important intellectual content and approving of the final version.
Colin Green (Professor of Health Economics, University of Exeter Medical School) co-led the project, led the economic evaluation and was involved in all stages of the HeLP trial, including conception, design, interpretation of data, drafting and critical revision of the report for important intellectual content and approval of the final version.
Sarah G Dean (Associate Professor of Psychology Applied to Rehabilitation and Health, University of Exeter Medical School) co-led the project, led the psychometric evaluation of the MLQ and was involved in all stages of the HeLP trial, including conception, design, interpretation of data, drafting and critical revision of the report for important intellectual content and approval of the final version.
Melvyn Hillsdon (Associate Professor of Sport and Health Sciences, University of Exeter) co-led the project, led the physical activity analyses and was involved in the interpretation of data, drafting and critical revision of the report for important intellectual content and approval of the final version.
Charles Abraham (Professor of Psychology Applied to Health, University of Exeter Medical School) co-led the project, and advised on the theoretical design of the trial and evaluation and of the psychological and behavioural measures of change. He supported the drafting and critical revision of the report for important intellectual content and approval of the final version.
Richard Tomlinson (Consultant Paediatrician, Royal Devon and Exeter NHS Trust) co-led the project and provided input and understanding regarding child health from a NHS perspective. He supported the drafting and critical revision of the report for important intellectual content and approval of the final version.
Virginia Pearson (Director of Public Health Devon) co-led the project, provided input into understanding the public health context and policy implications, and supported the recruitment of schools and the attainment of school data.
Rod S Taylor (Professor of Health Services Research, University of Exeter Medical School) co-led the project, provided input into the statistical analysis plan and was involved in all stages of the HeLP trial, including conception, design, interpretation of data, drafting and critical revision of the report for important intellectual content and approval of the final version.
Emma Ryan (Special Education Support Assistant, ISCA Academy) co-led the project, supported the wider stakeholder involvement, supported the recruitment of schools, children and HeLP co-ordinators and provided input into understanding the school context.
Adam Streeter (Research Fellow in Medical Statistics, Plymouth University Peninsula Schools of Medicine and Dentistry) undertook the majority of the statistical programming and analyses and contributed to the mediational analysis. He co-wrote Chapters 2 and 3 and supported the drafting and critical revision of the report for important intellectual content and approval of the final version.
Camilla McHugh (Associate Research Fellow Child Health, University of Exeter Medical School) was a HeLP co-ordinator for the trial. She contributed to the collection and analysis of the qualitative data for the process evaluation, as well as supporting the writing of the process evaluation section of the monograph.
Alison Hurst (Data Manager, Associate Research Fellow Child Health, University of Exeter Medical School) was the data manager for the trial and contributed to the analysis of the process evaluation data for the monograph.
Lisa Price (Lecturer in Sport and Health Sciences, University of Exeter) was responsible for the collection, analysis and interpretation of the physical activity data. She was also involved in baseline data collection for anthropometric and questionnaire data, alongside data entry.
Louise Crathorne (Honorary Research Associate Health Economics, University of Exeter Medical School) contributed to the economic analysis and co-wrote Chapter 4 of the report.
Chris Krägeloh (Associate Professor Health Sciences, Auckland University of Technology) co-led the psychometric evaluation of the MLQ and carried out the meditational analyses.
Richard Siegert (Professor of Psychology and Rehabilitation, Auckland University of Technology) co-led the psychometric evaluation of the MLQ and carried out the meditational analyses.
Stuart Logan (Director of Institute for Health Research, University of Exeter Medical School) co-led the project, co-designed the intervention and was involved in all stages of the HeLP trial, including conception, design, interpretation of data, drafting and critical revision of the report for important intellectual content and approval of the final version.
All authors made critical revisions to the monograph.
Publications
Wyatt KM, Lloyd JJ, Abraham C, Creanor S, Dean S, Densham E, et al. The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial. BMC Trials 2013;14:95.
Lloyd JJ, Wyatt KM. Qualitative findings from an exploratory trial of the Healthy Lifestyles Programme (HeLP) and their implications for the process evaluation in the definitive trial. BMC Public Health 2014;14:578.
Lloyd J, Wyatt K. The Healthy Lifestyles Programme (HeLP) – an overview of and recommendations arising from the conceptualisation and development of an innovative approach to promoting healthy lifestyles for children and their families. IntJ Environ Res Public Health 2015;12:1003–19.
Lloyd J, Wyatt K. Uptake, retention and engagement of children participating in the cluster randomised controlled trial of the Healthy Lifestyles Programmes (HeLP). Educ Health 2015;33:88–95.
Creanor S, Lloyd J, Hillsdon M, Dean S, Green C, Taylor RS, et al. Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children. Trials 2016;17:599.
Lloyd J, Creanor S, Logan S, Green C, Dean SG, Hillsdon M, et al. Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial [published online ahead of print November 28 2017]. Lancet Child Adolesc Health 2017.
Data sharing statement
We are keen for these data to be used widely by the scientific community. Details of the study can be found on the website (http://medicine.exeter.ac.uk/help) and anyone interested in using these data should contact the corresponding author in the first instance. We do not have funds for data extraction and putting data files together for collaborators and so may have to charge for providing this service.
Disclaimers
This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health.