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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Healthy Volunteers: t
View:

• 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)

Locations
United States
Ohio
Hopple Street Neighborhood Health Center
RECRUITING
Cincinnati
Contact Information
Primary
Tiffany Rybak, PhD
tiffany.rybak@cchmc.org
513-517-7254
Backup
Sarah Francis, PhD
sarah.francis@cchmc.org
513-803-2605
Time Frame
Start Date: 2023-10-05
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 144
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov