Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial.

importanceNovel approaches to care delivery that leverage clinical and community resources could improve body mass index (BMI) and family-centered outcomes.

objectiveTo examine the extent to which 2 clinical-community interventions improved child BMI z score and health-related quality of life, as well as parental resource empowerment in the Connect for Health Trial. DESIGN, SETTING, AND

participantsThis 2-arm, blinded, randomized clinical trial was conducted from June 2014 through March 2016, with measures at baseline and 1 year after randomization. This intent-to-treat analysis included 721 children ages 2 to 12 years with BMI in the 85th or greater percentile from 6 primary care practices in Massachusetts.

interventionsChildren were randomized to 1 of 2 arms: (1) enhanced primary care (eg, flagging of children with BMI ≥ 85th percentile, clinical decision support tools for pediatric weight management, parent educational materials, a Neighborhood Resource Guide, and monthly text messages) or (2) enhanced primary care plus contextually tailored, individual health coaching (twice-weekly text messages and telephone or video contacts every other month) to support behavior change and linkage of families to neighborhood resources. MAIN OUTCOMES AND MEASURES: One-year changes in age- and sex-specific BMI z score, child health-related quality of life measured by the Pediatric Quality of Life 4.0, and parental resource empowerment.

resultsAt 1 year, we obtained BMI z scores from 664 children (92%) and family-centered outcomes from 657 parents (91%). The baseline mean (SD) age was 8.0 (3.0) years; 35% were white (n = 252), 33.3% were black (n = 240), 21.8% were Hispanic (n = 157), and 9.9% were of another race/ethnicity (n = 71). In the enhanced primary care group, adjusted mean (SD) BMI z score was 1.91 (0.56) at baseline and 1.85 (0.58) at 1 year, an improvement of -0.06 BMI z score units (95% CI, -0.10 to -0.02) from baseline to 1 year. In the enhanced primary care plus coaching group, the adjusted mean (SD) BMI z score was 1.87 (0.56) at baseline and 1.79 (0.58) at 1 year, an improvement of -0.09 BMI z score units (95% CI, -0.13 to -0.05). However, there was no significant difference between the 2 intervention arms (difference, -0.02; 95% CI, -0.08 to 0.03; P = .39). Both intervention arms led to improved parental resource empowerment: 0.29 units (95% CI, 0.22 to 0.35) higher in the enhanced primary care group and 0.22 units (95% CI, 0.15 to 0.28) higher in the enhanced primary care plus coaching group. Parents in the enhanced primary care plus coaching group, but not in the enhanced care alone group, reported improvements in their child's health-related quality of life (1.53 units; 95% CI, 0.51 to 2.56). However, there were no significant differences between the intervention arms in either parental resource empowerment (0.07 units; 95% CI, -0.02 to 0.16) or child health-related quality of life (0.89 units; 95% CI, -0.56 to 2.33). CONCLUSIONS AND RELEVANCE: Two interventions that included a package of high-quality clinical care for obesity and linkages to community resources resulted in improved family-centered outcomes for childhood obesity and improvements in child BMI.

trial registrationclinicaltrials.gov Identifier: NCT02124460.