Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity

Objectives: To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting. Design: Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey. Setting: Twenty nine general practices, Melbourne, Australia. Participants:(1) BMI survey: 2112 children visiting their general practitioner (GP) April–December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score Intervention: Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials. Main outcome measures: Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth. Results: Attrition was 10%. The adjusted mean difference (intervention–control) in BMI was -0.2 kg/m2 (95% CI: -0.6 to 0.1; P=0.25) at 9 months and -0.0 kg/m2 (95% CI: -0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms. Conclusions: This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level