Introduction Family- and school-based interventions for childhood obesity have been widely applied; however, the prevalence of childhood obesity remains high. The purpose of this RCT is to evaluate the effectiveness of a family-individual-school-based comprehensive intervention model. Design Cluster RCT. Setting/participants Fourteen primary schools were selected from 26 primary schools in a district of Shanghai, China, and then randomly divided into intervention and control groups with seven schools in each. The trial started with first-grade students. A total of 1,287 students in the intervention group and 1,159 in the control group were studied overall. Intervention The baseline study was conducted in January 2011, and family-individual-school-based interventions started in March 2011 and ended in December 2013 for intervention group students. Three follow-up studies were conducted in January 2012, January 2013, and January 2014. Data analysis was conducted in March 2014. Main outcome measures Students' weight and height were measured. The prevalence of obesity/overweight and BMI z-scores were calculated and analyzed using a generalized estimating equation approach. Results The overall prevalence of overweight/obesity declined from 28.92% in 2011 to 24.77% in 2014, with a difference of 4.15% in the intervention group compared with a 0.03% decline (from 30.71% to 30.68%) in the control group. The intervention group had significantly lower odds of developing obesity or overweight and had decreased average BMI z-scores compared with the control group, especially for obese or overweight students. Conclusions The family-individual-school-based comprehensive intervention model is effective for controlling childhood obesity and overweight.
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