A staged approach to address youth unresponsive to initial obesity intervention: a randomized clinical trial.

BACKGROUND/OBJECTIVE Maintenance interventions inherently require BMI improvement to maintain. This overlooks individuals initially unresponsive to obesity interventions. Staged pediatric clinical treatment guidelines were adapted to the school setting to develop an escalated treatment option for individuals initially unresponsive. This staged randomized controlled trial examined differences between escalated treatment (Take CHARGE!) and a maintenance program (PE Planners). Take CHARGE was hypothesized to have greater improvements in BMI as a percentage of the 95th BMI Percentile (%BMIp95) than PE Planners. SUBJECTS/METHODS From 2018 to 2020, 171 middle and high schoolers (BMI Percentile ≥ 85) were recruited from a Houston school district to participate in a staged obesity intervention in their physical education (PE) class. After receiving a semester-long intensive lifestyle intervention (ILI) with established efficacy, all participants were randomized to Take CHARGE (n = 85) or PE Planners (n = 86). Take CHARGE escalated the behavioral treatment of obesity received in ILI with more frequent individual sessions, additional opportunities for parental and school staff involvement, and increased mentorship from trained college students. PE Planners allowed participants to decide how they wanted to be active in PE class. Mixed linear modeling examined %BMIp95 overtime between groups. This trial was registered at ClinicalTrials.gov (#NCT04362280). RESULTS Participants were 13.63 ± 1.32 years old; 59% were female, and 85% were Hispanic. Among those initially unresponsive to ILI, Take CHARGE had significantly greater decreases in %BMIp95 than PE Planners (β = -0.01, p < 0.01). Conversely, among those initially responsive, Take CHARGE had significantly smaller decreases in %BMIp95 than PE Planners (β = 0.02, p < 0.05). Intention-to-treat analysis had similar results. CONCLUSIONS Participant outcomes in semester two differed based on initial response. Individuals responsive to initial intervention were most likely to benefit from a maintenance intervention and those initially unresponsive benefited more from escalated treatment. This indicates the need for staged intervention protocols to better address obesity in the school setting.