NCT06028113: THRIVE

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

Recruiting now Phase 2 Last updated 5 March 2025

What this trial tests

Phase 2 trial testing THRIVE 2.0 in Obesity in 144 participants. Currently enrolling.

Timeline

5 October 2023

Primary endpoint
30 November 2025

30 January 2026

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	144
Start date	5 October 2023
Primary completion	30 November 2025
Estimated completion	30 January 2026
Sites	1 location across United States

Drugs / interventions tested

• THRIVE 2.0

Conditions studied

• Obesity — all drugs for Obesity →
• Obesity, Childhood — all drugs for Obesity, Childhood →
• Weight Gain — all drugs for Weight Gain →
• Weight Gain Trajectory — all drugs for Weight Gain Trajectory →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

1 Day and older, any sex, with Obesity or Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. THRIVE 2.0: A randomized-controlled trial of an obesity prevention intervention designed for infants in pediatric primary care.
   Rybak TM, Francis SE, Mara CA, Zion C, et al · · 2025 · cited 1× · PMID 40336701 · DOI 10.1016/j.conctc.2025.101488