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RecruitingAccepts healthy volunteersPhase 2

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

Children's Hospital Medical Center, Cincinnati · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT06028113

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
144
US sites recruiting
1
Study start
October 5, 2023
Record last updated
March 5, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: THRIVE 2.0

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Hopple Street Neighborhood Health Center

    Cincinnati, OH 45225

    Site contact: Sarah Francis · sarah.francis@cchmc.org

Study contacts (from the official record)

  • Tiffany Rybak, PhD · 513-517-7254 · tiffany.rybak@cchmc.org
  • Sarah Francis, PhD · 513-803-2605 · sarah.francis@cchmc.org
All weight loss studies in Ohio →
A Novel Obesity Prevention Program for High-Risk Infants in… (NCT06028113) | Bored Studies