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RECRUITING
NCT06028113
PHASE2

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

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

Summary

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.

Official title: A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial

Key Details

Gender

All

Age Range

1 Day - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2023-10-05

Completion Date

2026-01-30

Last Updated

2025-03-05

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

THRIVE 2.0

Overview of content and strategies: 1) Education on stage of development specific to infant feeding, sleep and infant regulation, attunement to cues; 2) Attunement to cues: reinforcing and modeling accurate discernment \& responsiveness to cues; 3) Infant Soothing and Regulation: Coaching alternative strategies for soothing that feeding for non-hungry, fussy infants; 4) Routines \& Strategies: Promoting developmental activities during wake windows and longer consolidated sleep at night as the infant grows.

Locations (1)

Hopple Street Neighborhood Health Center

Cincinnati, Ohio, United States