A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
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:
🦠 Obesity 🦠 Obesity, Childhood 🦠 Weight Gain 🦠 Weight Gain Trajectory
🗓️ Study Start (Actual) 5 October 2023
🗓️ Primary Completion (Estimated) 30 May 2025
✅ Study Completion (Estimated) 1 June 2026
👥 Enrollment (Estimated) 144
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Cincinnati, Ohio, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 1 Day to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 July 2023
  • First Submitted that Met QC Criteria 28 August 2023
  • First Posted 8 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 March 2024
  • Last Update Posted 27 March 2024
  • Last Verified March 2024