NCT06028113RecruitingPhase 2
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 18 Jul 2023
- Start date
- 5 Oct 2023
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Obesity
- NCT number
- NCT06028113
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 144
- From 5 Oct 2023 to the primary completion date, 30 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- infant exposure to illicit drugs in utero \[with the exception of tetrahydrocannabinol (THC)\]
Other illness
- infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)
Other
- care in the Neonatal Intensive Care Unit (\>7 days)
- diminished or impaired caregiver cognitive functioning
- family intent to move from the area within 1 year
Who the study is looking for
- 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)
Age in the registry: 1 day to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopple Street Neighborhood Health Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.