Obesity prevention program for high-risk infants
Official title: A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial
Run by Children's Hospital Medical Center, Cincinnati · NCT06028113 · Data updated 2026-11-12
This study is testing a parenting program to help prevent obesity in infants from low-income or minority communities during regular doctor visits.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Day and up |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | October 5, 2023 |
| Main results expected | November 30, 2025 |
| Study ends | January 30, 2026 |
| Registry record updated | March 5, 2025 |
| Trial ID | NCT06028113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants born at a healthy weight from racial or ethnic minority groups or economically marginalized backgrounds.
✕Probably not a fit
Patients who may not benefit from this study include those with congenital anomalies affecting feeding or those who have spent more than seven days in a Neonatal Intensive Care Unit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial tests a responsive parenting obesity prevention program aimed at infants and their caregivers from communities of color or economically marginalized backgrounds. The intervention is delivered through Integrated Behavioral Health during routine pediatric primary care visits. Participants will receive four prevention sessions and will be assessed at baseline, post-treatment, and at a 12-month follow-up to evaluate the program's feasibility and its effectiveness in preventing rapid weight gain. The study seeks to address the rising rates of obesity in infancy, particularly among high-risk populations.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of obesity in high-risk infants, leading to better long-term health outcomes.
How similar studies have gone: Other studies have shown promise in obesity prevention interventions targeting similar high-risk populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * born 2500 grams or greater * delivery occurring between 37 and 42 weeks gestation * English speaking * infant receiving care provided at our pediatric primary care setting * from a racial / ethnic minority group (i.e., non-white, or Hispanic or Latinx) and/or economically marginalized background (i.e., household income at or below 138% of federal poverty level; qualifying for Medicaid) Exclusion Criteria: * care in the Neonatal Intensive Care Unit (\>7 days) * infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease) * infant exposure to illicit drugs in utero \[with the exception of tetrahydrocannabinol (THC)\] * diminished or impaired caregiver cognitive functioning * family intent to move from the area within 1 year
Where it's running
-
Hopple Street Neighborhood Health Center
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Tiffany Rybak, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Tiffany Rybak, PhD
- Email: tiffany.rybak@cchmc.org
- Phone: 513-517-7254
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.