Retention, blinding, and health outcomes from a rural pediatric obesity feasibility randomized control trial

OBJECTIVE: To evaluate the feasibility of a multi-state randomized control trial (RCT) evaluating iAmHealthy, a rurally tailored pediatric obesity treatment delivered via synchronous televideo. This study's primary outcomes included the evaluation of participant retention and the efficacy of blinding. Each intervention arm was hypothesized to retain >75% of randomized participants and preserve blinding. Additionally, the intervention's preliminary effectiveness was evaluated by comparing changes in health outcomes. METHODS: Youth aged 6-11 years with a body mass index (BMI) percentile ≥85th and their caregivers were recruited from rural communities across four states participating in the Environmental Influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network. One hundred four dyads were randomly assigned to iAmHealthy plus newsletter or newsletter-only control. Retention rates for each treatment arm were calculated. Blinding was assessed via the New Blinding Index (NBI). Child and parent BMI, child physical activity, and child dietary intake were assessed at baseline and post-treatment (6 months). RESULTS: A one-sample test of proportions indicated retention rates exceeded 75% for iAmHealthy (87%, p = .027) and control (96%, p < .001). Blinding was successful for both groups [iAmHealthy NBI = -0.12, 95% confidence interval (CI): -0.13 to 0.36; control NBI = 0.02, 95% CI: -0.24 to 0.28]. There were no significant differences in health outcomes. CONCLUSIONS: This iAmHealthy multi-state feasibility RCT demonstrated high retention and successful blinding of assessors. Although the study was not powered to detect health outcome differences, iAmHealthy exhibited a tendency toward greater improvement or attenuated declines in child health outcomes, which supports the conduct of a future fully powered RCT. CLINICALTRIALS.GOV IDENTIFIER: NCT04142034, Registered: 10-25-2019; Trial name: Feasibility Trial of the iAmHealthy Intervention; https://clinicaltrials.gov/study/NCT04142034?cond=iamhealthy&checkSpell=false&rank=1.