A family-based behavioral group obesity randomized control feasibility trial across a clinical trials network: a focus on contact hours

OBJECTIVE: This ancillary study's purpose is to describe the relationship between dose of treatment and body mass index (BMI) outcomes in a tele-behavioral health program delivered in the IDeA States Pediatric Clinical Trials Network to children and their families living in rural communities.

METHODS: Participants randomized to the intervention were able to receive 26 contact hours (15 hr of group sessions and 11 hr of individual sessions) of material focused on nutrition, physical activity, and behavioral caregiver training delivered via interactive televideo. Dose of the intervention received by child/caregiver dyads (n = 52) from rural areas was measured as contact hours. The total doses of group, individual, and total contact hours were analyzed, and generalized linear mixed models were utilized to determine how dose received impacted BMI outcomes.

RESULTS: The majority (64.4%) of participants received the target of at least 80% (20.8 hr) of the total intervention dose. Older children (9-11 years) achieved significantly less intervention dose than targeted (M = 19.7; p = .031); as did males (M = 17.2; p < .001), children who identified as Black (M = 17.8; p < .001), and children from Site 3 (M = 18.0; p < .001). Dose was not significantly related to BMI outcomes in children or caregivers.

CONCLUSIONS: As this study is underpowered and took place during the early stages of the COVID-19 pandemic, results should be interpreted with caution, but contact hours did not predict health outcomes for families living in rural communities.