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

NCT06028113 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-03-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Tiffany Rybak, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2025-11-30
Completion
2026-01-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028113 on ClinicalTrials.gov