A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial
Children's Hospital Medical Center, Cincinnati
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.
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 developme…
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- Yes
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 diseas…
Interventions
- BehavioralTHRIVE 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.
Location
- Hopple Street Neighborhood Health CenterCincinnati, Ohio