BACKGROUND: This pragmatic evaluation investigated the effectiveness of the Children's Health, Activity and Nutrition: Get Educated! (CHANGE!) project, a cluster randomised intervention to promote healthy weight using an educational focus on physical activity and healthy eating. METHODS: Participants (n = 318, aged 10 to 11 years) from 6 intervention and 6 comparison schools took part in the 20 weeks intervention between November 2010 and March/April 2011. This consisted of a teacher-led curriculum, learning resources, and homework tasks. Primary outcome measures were waist circumference, body mass index (BMI), and BMI z-scores. Secondary outcomes were objectively-assessed physical activity and sedentary time, and food intake. Outcomes were assessed at baseline, at post-intervention (20 weeks), and at follow-up (30 weeks). Data were analysed using 2-level multi-level modelling (levels: school, student) and adjusted for baseline values of the outcomes and potential confounders. Differences in intervention effect by subgroup (sex, weight status, socio-economic status) were explored using statistical interaction. RESULTS: Significant between-group effects were observed for waist circumference at post-intervention (beta for intervention effect -1.63 (95% CI -2.20 to -1.07) cm, p < 0.001) and for BMI z-score at follow-up (beta -0.24 (95% CI -0.48 to -0.003), p = 0.04). At follow-up there was also a significant intervention effect for light intensity physical activity (beta 25.97 (95% CI 8.04 to 43.89) min, p = 0.01). Interaction analyses revealed that the intervention was most effective for overweight/obese participants (waist circumference beta -2.82 (95% CI -4.06 to -1.58) cm, p < 0.001), girls (BMI beta -0.39 (95% CI -0.81 to 0.03) kg/m2, p = 0.07), and participants with higher family socioeconomic status (breakfast consumption beta 8.82 (95% CI 6.47 to 11.16), p = 0.07). CONCLUSIONS: The CHANGE! intervention positively influenced body size outcomes and light physical activity, and most effectively influenced body size outcomes among overweight and obese children and girls. The findings add support for the effectiveness of combined school-based physical activity and nutrition interventions. Additional work is required to test intervention fidelity and the sustained effectiveness of this intervention in the medium and long term. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03863885.

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