Status:
RECRUITING
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Obesity, Childhood
Eligibility:
All Genders
1+ years
Phase:
PHASE2
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 margina...
Detailed Description
Unprecedented rates of obesity are occurring in childhood and disproportionally affect Black or African American youth, Hispanic or Latinx youth, and youth from economically marginalized backgrounds b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06028113
Start Date
October 5 2023
End Date
January 30 2026
Last Update
March 5 2025
Active Locations (1)
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1
Hopple Street Neighborhood Health Center
Cincinnati, Ohio, United States, 45225