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

RecruitingPhase 2Ages 1 Day - anyAllChildren's Hospital Medical Center, Cincinnati
NCT06028113 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pre

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📋 Eligibility rules (as published)
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
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What it tests

  • THRIVE 2.0
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Where

1 site
Hopple Street Neighborhood Health Center
Cincinnati, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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