NCT06028113 A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
| NCT ID | NCT06028113 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2023-10-05 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 144 participants in total. It began in 2023-10-05 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Tiffany Rybak, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06028113 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06028113 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06028113 currently recruiting?
Yes, NCT06028113 is actively recruiting participants. Contact the research team at tiffany.rybak@cchmc.org for enrollment information.
Where is the NCT06028113 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06028113 clinical trial?
NCT06028113 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Tiffany Rybak, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 144 participants.
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