Recruiting
Phase 2

Obesity Prevention

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06028113

Conditions

Obesity

Obesity, Childhood

Weight Gain

Weight Gain Trajectory

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

THRIVE 2.0

Study Details

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 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 ID

NCT06028113

Start date

Oct 5, 2023

Status verified date

Mar, 2025

Completion date

Jan 30, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment Group

The Teaching Healthy Responsive Parenting during Infancy to promote Vital growth and rEgulation (THRIVE 2.0) group will consist of 4 sessions delivered by the trained IBH provider, in conjunction with the 1, 2, 4, and 6 month well-child visit in primary care. The THRIVE curriculum teaches responsive parenting principles targeted to establish healthy eating, sleeping, and regulation habits for infants.

no intervention: Control Group

Control arm: Usual Pediatric Care. The control condition is usual care delivered by pediatricians at 1, 2, 4, and 6 month well child visits.

Interventions

THRIVE 2.0

Overview of content and strategies: 1) Education on stage of development specific to infant feeding, sleep and infant regulation, attunement to cues; 2) Attunement to cues: reinforcing and modeling accurate discernment \& responsiveness to cues; 3) Infant Soothing and Regulation: Coaching alternative strategies for soothing that feeding for non-hungry, fussy infants; 4) Routines \& Strategies: Promoting developmental activities during wake windows and longer consolidated sleep at night as the infant grows.

Primary outcome measure

  • Conditional Weight Gain [ Time Frame: At infant age 9-months (post-treatment) ]

Central Contacts and Locations

Central contacts

Tiffany Rybak, PhD

513-517-7254tiffany.rybak@cchmc.org

Sarah Francis, PhD

513-803-2605sarah.francis@cchmc.org

Locations

Hopple Street Neighborhood Health Center

Recruiting

Cincinnati, Ohio, United States, 45225

Contacts

Sarah Francis

sarah.francis@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 5, 2025

Last verified

Mar, 2025

Keywords

  • obesity prevention
  • infancy
  • integrated primary care
  • integrated behavioral health
  • responsive parenting
  • responsive feeding
  • sleep
  • soothing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-03-05.