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

Creanor, S., Lloyd, J., Hillsdon, M., Dean, S., Green, C., Taylor, R. S. , Ryan, E. and Wyatt, K. (2016) 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, 17(1), 599. (doi: 10.1186/s13063-016-1737-y) (PMID:27978848) (PMCID:PMC5159986)

Abstract

Background: The Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9–10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned sensitivity analyses. Methods and design: The HeLP trial is a definitive, pragmatic, superiority, cluster randomised controlled trial with two parallel groups and blinded outcome assessment. This update article describes in detail (1) the primary and secondary outcomes, (2) the statistical analysis principles (including which children will be included in each analysis, how the clustered nature of the study design will be accounted for, which covariates will be included in each analysis, how the results will be presented), (3) planned sensitivity analyses, planned subgroup analyses and planned adherence-adjusted analyses for the primary outcome, (4) planned analyses for the secondary outcomes and (e) planned longitudinal analyses. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706. Registered on 1 May 2012.

• Item Type: Articles
• Additional Information: The definitive trial of HeLP is funded by the UK National Institute for Health Research (NIHR) Public Health Research Programme (10/3010/01) and a full report will be published on the NIHR website. KW and JL are partially supported by PenCLAHRC, the National Institute for Health Research (NIHR) CLAHRC for the Southwest Peninsula.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Taylor, Professor Rod
• Authors: Creanor, S., Lloyd, J., Hillsdon, M., Dean, S., Green, C., Taylor, R. S., Ryan, E., and Wyatt, K.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Copyright Holders: Copyright © 2016 The Authors
• First Published: First published in Trials 17(1):599
• Publisher Policy: Reproduced under a Creative Commons License