Implementation of a Scalable Family-Based Behavioral Treatment for Childhood Obesity Delivered through Primary Care Clinics: Description of the Missouri Childhood Obesity Research Demonstration Study Protocol.

Background: Significant gaps exist in access to evidence-based pediatric weight management interventions, especially for low-income families who are disproportionately affected by obesity. As a part of the Centers for Disease Control and Prevention's Childhood Obesity Research Demonstration project (CORD 3.0), the Missouri team (MO-CORD) aims to increase access to and dissemination of an efficacious pediatric obesity treatment, specifically family-based behavioral treatment (FBT), for low-income families. Methods/Design: The implementation pilot study is a multisite matched-comparison group pilot of packaged FBT in pediatric clinics for low-income children with obesity, of ages 5 to 12 years old. The study is implemented in two Missouri pediatric primary care clinical sites, Freeman Health System Pediatric Clinics (rural Joplin) and Children's Mercy Hospital Pediatric Clinics (urban Kansas City). The design focuses on pragmatism through utilization of PRECIS (Pragmatic Explanatory Continuum Indicator Summary) domains, such as open eligibility criteria, limited follow-up intensity, reliance on medical records for creating a usual care comparison group data, and unobtrusive measurement of participant and provider adherence. The evaluation focuses on effectiveness as well as implementation outcomes and barriers to inform implementation scale up. Conclusions: Findings from this study will advance both science and practice by providing novel and immediately useful information to families, health care providers, health care organizations, payers, and other state Medicaid plans by developing and optimizing evidence-based pediatric weight management treatment for implementation and dissemination in health systems to address health disparities among low-income populations most affected by overweight and obesity.