Actively Recruiting
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-03-05
144
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infant born weighing 2500 grams or greater
- Delivery occurred between 37 and 42 weeks gestation
- English speaking
- Infant receives care at the pediatric primary care setting conducting the study
- Infant is from a racial or ethnic minority group (non-white or Hispanic or Latinx) and/or economically marginalized background (household income at or below 138% of federal poverty level or qualifies for Medicaid)
You will not qualify if you...
- Infant required care in the Neonatal Intensive Care Unit for more than 7 days
- Infant has a congenital anomaly or neonatal condition affecting feeding (e.g., cleft lip/palate, metabolic disease)
- Infant exposed to illicit drugs in the womb except for tetrahydrocannabinol (THC)
- Caregiver has diminished or impaired cognitive functioning
- Family plans to move from the area within 1 year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hopple Street Neighborhood Health Center
Cincinnati, Ohio, United States, 45225
Actively Recruiting
Research Team
T
Tiffany Rybak, PhD
CONTACT
S
Sarah Francis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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