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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Update

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

Authors: Siobhan Creanor, Jenny Lloyd, Melvyn Hillsdon, Sarah Dean, Colin Green, Rod S. Taylor, Emma Ryan, Katrina Wyatt, on behalf of the HeLP Trial Management Group

Published in: Trials | Issue 1/2016

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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.
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Metadata
Title
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
Authors
Siobhan Creanor
Jenny Lloyd
Melvyn Hillsdon
Sarah Dean
Colin Green
Rod S. Taylor
Emma Ryan
Katrina Wyatt
on behalf of the HeLP Trial Management Group
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1737-y

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