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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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 criteria

Qualifiers

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

Disqualifiers

care in the Neonatal Intensive Care Unit (>7 days)

infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)

infant exposure to illicit drugs in utero [with the exception of tetrahydrocannabinol (THC)]

diminished or impaired caregiver cognitive functioning

Trial design

Treatments tested in this trial

  • THRIVE 2.0

Treatment groups

144 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital Medical Center, Cincinnati

Lead sponsor

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

Collaborator