Background
Access to evidence- and family-based childhood obesity (FBCO) treatment interventions in the US is a challenge, especially in medically underserved regions where disparities in childhood obesity persist.
Methods
A comparative effectiveness RCT of two 6-month FBCO treatment interventions varied in structure and contact hours—iChoose (high intensity) and Family Connections (low intensity)—in a medically underserved region. Guided by a systems-based and community-based participatory research approach and the RE-AIM planning and evaluation framework, this paper reports on effectiveness (BMI z-scores) and implementation outcomes. Changes in parent outcomes, secondary outcomes (e.g. QOL, nutrition, physical activity), engagement, and implementation costs are also reported. Analyses included descriptive statistics and intention-to-treat Heckman treatment effect models with cluster robust inference adjustment.
Results
Enrolled children (n = 139, mean age 10.1 ± 1.7 years, 30% overweight, 70% obese, 45% black, 63% on Medicaid) were randomly assigned to iChoose (n = 70) or Family Connections (n = 69). Retention rates were 63% for iChoose and 84% for Family Connection. Among children, 6-month BMI z-score changes were not statistically significant within iChoose [BMI z-score 0.03 (95% CI = -0.13, 0.19)] or Family Connections [BMI z-score 0.00 (95% CI = -0.16, 0.16)]. Likewise, relative between condition effects were not statistically significant and similar null effects were found in parents’ BMI changes. Yet relative to iChoose, Family Connections parents had significant improvement in quality of life (p = 0.03). Both programs were delivered with high fidelity (77–100%). iChoose engagement was 30% family classes, 36% IVR calls, and 25% physical activity classes; Family Connections engagement was 52% parent classes and 61% IVR calls. Implementations costs per children with improved BMI z-score was $2,841 for iChoose and $955 for Family Connections.
Conclusions
Both FBCO treatment interventions were delivered with high fidelity; yet neither yielded significant improvements in child or parent BMI. Relative to iChoose, descriptive data indicated higher retention, better engagement, and lower costs for Family Connections—suggesting that a lower intensity program may better fit the intended audience’s context. Future research efforts need to address lack of program effects and further explore strategies to leverage higher engagement in lower intensity programs for populations in medically underserved areas.
Trial registration:
Clincialtrials.gov: NCT03245775. Registered 10 August 2017. https://clinicaltrials.gov/ct2/show/NCT03245775?term=NCT03245775&draw=2&rank=1