Trial Characteristics and Appropriateness of Statistical Methods Applied for Design and Analysis of Randomized School-Based Studies Addressing Weight-Related Issues: A Literature Review.

Objective: To evaluate whether clustering effects, often quantified by the intracluster correlation coefficient (ICC), were appropriately accounted for in design and analysis of school-based trials.

Methods: We searched PubMed and extracted variables concerning study characteristics, power analysis, ICC use for power analysis, applied statistical models, and the report of the ICC estimated from the observed data.

Results: =263 papers were identified, and =121 papers were included for evaluation.

Embedding weight management into safety-net pediatric primary care: randomized controlled trial.

Background: Implementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States).

Methods: In a 12-month trial, families of children (age 7-12 years; body mass index ≥85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n = 360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program.