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X Demographics
Mendeley readers
| 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
|
|---|---|
| Published in |
Trials, December 2016
|
| DOI | 10.1186/s13063-016-1737-y |
| Pubmed ID | |
| 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 |
| Abstract |
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. 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. International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706 . Registered on 1 May 2012. |
X Demographics
The data shown below were collected from the profiles of 4 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Saudi Arabia | 1 | 25% |
| Peru | 1 | 25% |
| Unknown | 2 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 75% |
| Practitioners (doctors, other healthcare professionals) | 1 | 25% |
Mendeley readers
The data shown below were compiled from readership statistics for 121 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 121 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 16 | 13% |
| Student > Bachelor | 15 | 12% |
| Student > Ph. D. Student | 12 | 10% |
| Student > Master | 7 | 6% |
| Student > Doctoral Student | 6 | 5% |
| Other | 15 | 12% |
| Unknown | 50 | 41% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 19 | 16% |
| Nursing and Health Professions | 13 | 11% |
| Social Sciences | 7 | 6% |
| Sports and Recreations | 7 | 6% |
| Psychology | 5 | 4% |
| Other | 19 | 16% |
| Unknown | 51 | 42% |