Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Dec 15;17(1):599.
doi: 10.1186/s13063-016-1737-y.

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

Siobhan Creanor  1 , Jenny Lloyd  2 , Melvyn Hillsdon  3 , Sarah Dean  2 , Colin Green  2 , Rod S Taylor  2 , Emma Ryan  4 , Katrina Wyatt  2 ; HeLP Trial Management Group
Affiliations
Randomized Controlled Trial

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

Siobhan Creanor et al. Trials. .

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.

Keywords: Childhood obesity; Cluster randomised controlled trial; School-based; Statistical analysis plan.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flow of schools and children through the HeLP trial
See this image and copyright information in PMC

References

    1. The Health and Social Care Information Centre. National Child Measurement Programme: England, 2014/15 school year. London: The Health and Social Care Information Centre; 2016. Available from: http://www.hscic.gov.uk/catalogue/PUB16070/nati-chil-meas-prog-eng-2013-.... Accessed on 13 Dec 2016.
    1. 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. Int J Environ Res Public Health. 2015;12(1):1003–1019. doi: 10.3390/ijerph120101003. - DOI - PMC - PubMed
    1. Wyatt KM, Lloyd JJ, Creanor S, Logan S. HeLP: the development, feasibility and acceptability of a school based obesity prevention programme: results from three phases of piloting. BMJ Open. 2011;1:e000026. doi: 10.1136/bmjopen-2010-000026. - DOI - PMC - PubMed
    1. Lloyd JJ, Wyatt KM, Creanor S. Behavioural and weight status outcomes from an exploratory trial of the Healthy Lifestyles Programme (HeLP): a novel school-based obesity prevention programme. BMJ Open. 2012;2:e000390. doi: 10.1136/bmjopen-2011-000390. - DOI - PMC - PubMed
    1. 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. doi: 10.1186/1471-2458-14-578. - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data