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Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation

The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9–10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP...

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation

The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9–10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP...

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

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...