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

Recruiting now · Phase 2

Conditions studied: Obesity, Obesity, Childhood, Weight Gain, Weight Gain Trajectory

In brief

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.

Key facts

Study ID

NCT06028113

Run by

Children's Hospital Medical Center, Cincinnati

People needed

144

Starts

2023-10-05

Expected to finish

2026-01-30

Last updated by the study team

2025-03-05

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Hopple Street Neighborhood Health Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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