Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial

Abstract

Background: Recent studies have demonstrated the effectiveness of family-centered, pediatric weight management programs in reducing childhood obesity. Yet, programs to optimize the care of low-income children with obesity are needed. We sought to examine the comparative effectiveness of two, potentially scalable pediatric weight management programs delivered to low-income children in a clinical or community setting.

Materials and methods: The Clinic and Community Approaches to Healthy Weight Trial is a randomized trial in two communities in Massachusetts that serve a large population of low-income children and families. The two-arm trial compares the effects of a pediatric weight management program delivered in the Healthy Weight Clinics of two federally qualified health centers (FQHC) to the Healthy Weight and Your Child programs delivered in two YMCAs. Eligible children are 6 to 12 years old with a body mass index (BMI) ≥ 85th percentile seen in primary care at the two FQHCs. Both programs are one-year in duration and have at least 30 contact hours throughout the year. Measures are collected at baseline, 6 months, and 1 year. The main outcome is 1-year change in BMI (kg/m2) and percent change of the 95th percentile (%BMIp95).

Conclusion: The Clinic and Community Approaches to Healthy Weight Trial seeks to 1) examine the comparative effects of a clinical and community based intervention in improving childhood obesity, and 2) inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.

Trial registration: ClinicalTrials.gov NCT03012126.

Keywords: Childhood obesity treatment; Clinical and community approaches; Randomized controlled trial.

Conflict of interest statement

Competing Interests: The authors have no competing interests to declare.

Copyright © 2018 Elsevier Inc. All rights reserved.

Figures

Figure 1

Logic Model of the Clinic and Community Approaches to Healthy Weight (MA-CORD 2.0) Trial

Figure 2

Study Design and intervention components of the Clinic and Community Approaches to Healthy Weight (MA-CORD 2.0) Trial

Figure 3

Clinic and Community Approaches to Healthy Weight (MA-CORD 2.0) Randomized Controlled Trial Planned Participant Flow Chart