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. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions. RESULTS: The mean body mass index Z-score declined in both arms (P < 0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P = 0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P = 0.05), low-density lipoprotein cholesterol (P = 0.04), aspartate aminotransferase (P = 0.02), and alanine transaminase (P = 0.03) concentrations. CONCLUSIONS: Safety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.

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: N=263 papers were identified, and N=121 papers were included for evaluation. Overall, only a minority (21.5%) of studies incorporated ICC values for power analysis, fewer studies (8.3%) reported the estimated ICC, and 68.6% of studies applied appropriate multilevel models. A greater proportion of studies applied the appropriate models during the past five years (2013-2017) compared to the prior years (74.1% versus 63.5%, p=0.176). Significantly associated with application of appropriate models were a larger number of schools (p=0.030), a larger sample size (p=0.002), longer follow-up (p=0.014), and randomization at a cluster level (p < 0.001) and so were studies that incorporated the ICC into power analysis (p=0.016) and reported the estimated ICC (p=0.030). Conclusion: Although application of appropriate models has increased over the years, consideration of clustering effects in power analysis has been inadequate, as has report of estimated ICC. To increase rigor, future school-based trials should address these issues at both the design and analysis stages.