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Objectives: To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme., Design: Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme., Setting: Four city primary schools (two control and two intervention) in the South West of England., Participants: 202 children aged 9-10 years, of whom 193 and 188 were followed up at 18 and 24 months, respectively. No child was excluded from the study; however, to be eligible, schools were required to have at least one single Year 5 class., Intervention: Four-phase multicomponent programme using a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage and support schools, children and their families in healthy lifestyle behaviours. It runs over the spring and summer term of Year 5 and the autumn term of Year 6., Primary and Secondary Outcomes: Weight status outcomes were body mass index, waist circumference and body fat standard deviation scores (SDS) at 18 and 24 months, and behavioural outcomes were physical activity, television (TV) viewing/screen time and food intake at 18 months., Results: At 18 months of follow-up, intervention children consumed less energy-dense snacks and more healthy snacks; had less 'negative food markers', more 'positive food markers', lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools. Intervention children had lower anthropometric measures at 18 and 24 months than control children, with larger differences at 24 months than at 18 months for nearly all measures., Conclusions: Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours, which, in turn, appear to affect weight status and body shape. A definitive trial is now justified.

Objectives: To develop a school-based obesity prevention programme and evaluate the feasibility and acceptability of the intervention and the planned definitive cluster randomised trial., Design: This was a three stage pilot involving six schools (398 children) in South West England, including an exploratory randomised controlled trial and qualitative interviews and focus groups with teachers, parents and children., Intervention: The Healthy Lifestyle Programme uses a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage schools, children and their families., Results: Of the 398 eligible children in the three pilot phases, only four opted out and a further three withdrew from the exploratory trial. In the exploratory trial, baseline measurements (anthropometric and behavioural) were obtained for 202/204 eligible children in four schools and both 18- and 24-month outcome measurements for 193/204 and 187/204 participants, respectively. Qualitative data show that delivery of the intervention is feasible within schools and acceptable to teachers, children and families. In the exploratory trial, 18/80 children (24%) in the intervention schools and 31/122 (26%) in the control schools were overweight or obese at baseline, increasing, at 18-month follow-up, to 38/119 (32%) in the control schools compared with 18/74 (24%) in the intervention schools. At 24 months the proportion of overweight and obese children in the control schools remained at 32% (36/114), whereas the proportion in the intervention schools decreased slightly to 22% (16/73)., Conclusion: The Healthy Lifestyle Programme is feasible to deliver and acceptable to schools, children and their families. We recruited, retained and obtained outcome measurements from 92% of eligible children in the exploratory trial, including measurements taken after transition to secondary school, suggesting that a definitive trial is likely to be deliverable.