A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Recruiting · NCT06028113 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 disease)
- infant exposure to illicit drugs in utero \[with the exception of tetrahydrocannabinol (THC)\]
- diminished or impaired caregiver cognitive functioning
- family intent to move from the area within 1 year
Where it is running
1 location listed across 1 US state.
- Hopple Street Neighborhood Health Center - Cincinnati, Ohio, United States