Childhood obesity prevention trials: A systematic review and meta-analysis on trial design and the impact of type 1 error.

Effect sizes from previously reported trials are often used to determine the meaningful change in weight in childhood obesity prevention interventions because information on clinically meaningful differences is lacking. Estimates from previous trials may be influenced by statistical significance; therefore, it is important that they have a low risk of type 1 error. A systematic review and meta-analysis were conducted to report on the design of child obesity prevention randomized controlled trials and effectiveness according to risk of type 1 error. Eighty-four randomized controlled trials were identified. A large range of assumptions were applied in the sample size calculations. The most common primary outcome was BMI, with detectable effect size differences used in sample size calculations ranging from 0.25 kg/m2 (followed up at 2 years) to 1.1 kg/m2 (at 9 months) and BMI z-score ranging from 0.1 (at 4 years) to 0.67 (at 3 years). There was no consistent relationship between low risk of type 1 error and reports of higher or lower effectiveness. Further clarity of the size of a meaningful difference in weight in childhood obesity prevention trials is required to support evaluation design and decision-making for intervention and policy. Type 1 error risk does not appear to impact effect sizes in a consistent direction.