Methods: This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a
multi-ethnic, socioeconomically diverse population of children aged 6–7 years.
The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase
time spent doing physical activity within the school day, participation in the ‘Villa Vitality’ programme (a programme
that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning
opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents
and children, and provision of information to families signposting local leisure opportunities. The primary (clinical)
outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention
completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children
split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC
≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined
using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for
pre-specified baseline school and child level covariates.
Methods: This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including amulti-ethnic, socioeconomically diverse population of children aged 6–7 years.The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increasetime spent doing physical activity within the school day, participation in the ‘Villa Vitality’ programme (a programmethat is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learningopportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parentsand children, and provision of information to families signposting local leisure opportunities. The primary (clinical)outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-interventioncompletion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 childrensplit across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examinedusing mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust forpre-specified baseline school and child level covariates.
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