Objectives: The objective was to evaluate if 2 pediatric weight management interventions delivered to Hispanic, low-income children (one in a health center the other in a Young Men's Christian Association) were effective in reducing BMI. We hypothesized that they would be equally effective.
Methods: A total 407 children aged 6 to 12 years with BMI ≥ 85th percentile receiving care at 2 health centers were randomly assigned to a healthy weight clinic (HWC) at the health center or to a modified Healthy Weight and Your Child (M-HWYC) intervention delivered in Young Men's Christian Associations. A total of 4037 children served as the comparison group. We completed a noninferiority test comparing the M-HWYC with the HWC, which was supported if the bounds of the 90% confidence interval (CI) for the difference in percentage of the 95th percentile (%BMIp95) change did not contain what we considered a minimally clinically important difference, on the basis of previous data (0.87). Then, using linear mixed models, we assessed yearly changes in BMI among intervention participants compared with the comparison sites.
Results: The mean difference in %BMIp95 between the M-HWYC and the HWC was 0.75 (90% CI: 0.07 to 1.43), which did not support noninferiority. Compared with the comparison sites, per year, children in the HWC had a -0.23 (95% CI: -0.36 to -0.10) decrease in BMI and a -1.03 (95% CI -1.61 to -0.45) %BMIp95 decrease. There was no BMI effect in the M-HWYC.
Conclusions: We were unable to establish noninferiority of the M-HWYC. The HWC improved BMI, offering an effective treatment of those disproportionately affected.
Trial registration: ClinicalTrials.gov NCT03012126.
Copyright © 2021 by the American Academy of Pediatrics.