THRIVE 2.0: A randomized-controlled trial of an obesity prevention intervention designed for infants in pediatric primary care.
Tiffany M Rybak, Sarah E Francis, Constance A Mara...
https://pubmed.ncbi.nlm.nih.gov/40336701Actively Recruiting
Phase 2
Age: 1Day +
All Genders
Healthy Volunteers
ID06028113
A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-03-05
144
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a responsive parenting program aimed at preventing obesity in infants from communities of color and/or economically marginalized backgrounds. This study focuses on delivering the program through Integrated Behavioral Health in pediatric primary care to see if it is feasible, acceptable, and effective in preventing rapid weight gain during infancy. The trial involves infants who are publicly insured or belong to non-White or Hispanic/Latinx racial or ethnic groups, populations at higher risk for early childhood obesity and related health problems. The trial compares the THRIVE 2.0 responsive parenting intervention with usual pediatric care. The intervention includes four sessions delivered by a trained integrated behavioral health specialist during routine well-child visits at 1, 2, 4, and 6 months of age. THRIVE 2.0 focuses on teaching healthy feeding, sleeping, and regulation habits tailored to infant developmental stages. The control group receives standard pediatric care at the same visits without the additional intervention. Participants will complete assessments at baseline (newborn), after treatment (9 months), and at follow-up (12 months). Researchers will measure infant weight gain patterns as the primary outcome and evaluate various feeding, sleeping, behavior, and caregiver-related questionnaires. The study monitors infant growth and development through well-child visits, questionnaires, and diaries, aiming to understand the impact of the parenting program on infant health and obesity risk over the first year of life.
CONDITIONS
Brief Title
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Who Can Participate
Age: 1Day +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Infant born weighing 2500 grams or greater
- Delivery between 37 and 42 weeks gestation
- English speaking caregiver
- Infant receives care at the pediatric primary care setting of the study
- Infant from a racial or ethnic minority group (non-white or Hispanic/Latinx) and/or economically marginalized background (household income at or below 138% of federal poverty level or qualifies for Medicaid)
You will not qualify if you...
- Infant cared for in Neonatal Intensive Care Unit for more than 7 days
- Infant has congenital anomaly or neonatal condition affecting feeding (e.g., cleft lip/palate, metabolic disease)
- Infant exposed to illicit drugs in utero except tetrahydrocannabinol (THC)
- Caregiver has diminished or impaired cognitive functioning
- Family plans to move from the area within 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - First 6 months of infant's life
Participants attend routine pediatric primary care well-child visits where they receive four prevention sessions focused on responsive parenting to promote healthy eating, sleeping, and regulation habits for infants.
4 visits (in-person) at 1, 2, 4, and 6 months
Follow-up
Duration - Up to infant age 12 months
Participants' infants are monitored for growth and health outcomes following the intervention period to assess long-term effects on weight gain and related behaviors.
2 visits (in-person) at 9 and 12 months
Trial Site Locations
Total: 1 location
1
Hopple Street Neighborhood Health Center
Cincinnati, Ohio, United States, 45225
Actively Recruiting
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Research Team
T
Tiffany Rybak, PhD
S
Sarah Francis, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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