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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06028113
Phase
PHASE2
Status
Recruiting
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Conditions

  • Obesity
  • Obesity, Childhood
  • Weight Gain
  • Weight Gain Trajectory

Eligibility Criteria

Sex
ALL
Age
1 Day - N/A
Healthy Volunteers
Accepted

Interventions

  • THRIVE 2.0 — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Oct 5, 2023
Status verified
Mar 2025
Primary completion
Nov 30, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hopple Street Neighborhood Health CenterCincinnatiOhio45225
Sarah Francis
[email protected]

Find similar trials in Cincinnati, OH

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Hopple Street Neighborhood Health Center· Cincinnati, OH

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