A Novel Obesity Prevention Program for High-Risk Infants in Primary Care

The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are: * 1\) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized? * 2\) Will it prevent rapid weight gain during infancy? Participants will complete baseline (newborn), post-treatment (9 months), and follow-up assessments (12 months). Participants assigned to treatment will receive 4 prevention sessions as part of their typical well-child visit in pediatric primary care. Researchers hypothesize that infants in the obesity prevention intervention will have stable weight gain compared to infants in the control group (treatment as usual) will experience more rapid weight gain.

NCT Number	NCT06028113
Lead Sponsor	Children's Hospital Medical Center, Cincinnati Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions	Obesity, Obesity, Childhood, Weight Gain, Weight Gain Trajectory
Enrollment	144 participants
Start Date	2023-10-05
Primary Completion	2025-11-30 (estimated)
Study Completion	2026-01-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-05