NCT06028113

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

A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

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.

Detailed description

Unprecedented rates of obesity are occurring in childhood and disproportionally affect Black or African American youth, Hispanic or Latinx youth, and youth from economically marginalized backgrounds beginning as early as infancy. Obesity in infancy is not outgrown, tracks into adulthood, and places infants and children with obesity at a higher risk for significant medical comorbidities (e.g., cardiometabolic complications) in adulthood. The healthcare cost of obesity is \~$260 billion annually across the lifespan. Recent evidence suggests that infancy may be a critical period for the development of this high weight trajectory, as 10% of infants meet criteria for high weight-for-length; with the incidence being even higher among infants of color (16.3%), infants of Hispanic/Latinx ethnicity (12.1%), and economically marginalized infants (12.2%). Several modifiable predictors of obesity risk have been identified in infancy, including rapid weight gain in the first year, parental use of food to regulate infant distress, early introduction to solid foods, and insufficient infant total cumulative sleep. Given the greater risk for obesity, there is a critical need to identify and improve access to the most effective obesity prevention treatments for this population as a means of reducing the long-term healthcare burden. This pilot RCT will compare a responsive parenting intervention to treatment as usual in pediatric primary care with 144 infants who are from communities of color (e.g., non-White; Hispanic or Latinx) and/or economically marginalized backgrounds (i.e., publicly insured). Families will receive four prevention sessions with the integrated behavioral health specialist at their routine primary care well-child visits during the first six months of life. The primary outcome measured is conditional weight gain (an indicator of rapid weight gain) at 9 months of age. The responsive parenting approach, delivered by an integrated behavioral health expert, has been culturally adapted for infants and caregivers who are economically marginalized and/or from communities of color through focus groups. The delivery of this intervention via integrated behavioral health in a pediatric primary care setting has the potential to have a significant public health impact in terms of preventing pediatric obesity later in life; and thus, improving health outcomes and reducing health disparities.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-11-30
• Completion: 2026-01-30
• First posted: 2023-09-08
• Last updated: 2025-03-05

Locations

1 site across 1 country: United States