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Search / Trial NCT06028113

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

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Aug 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Obesity Prevention Infancy Integrated Primary Care Integrated Behavioral Health Responsive Parenting Responsive Feeding Sleep Soothing

ClinConnect Summary

This clinical trial is studying a new program designed to help prevent obesity in infants, especially those from families of color or lower-income backgrounds. The program focuses on teaching responsive parenting techniques during regular pediatric visits, which means caregivers learn how to respond to their baby's needs in a way that supports healthy growth. The researchers want to find out if this program is easy for families to use and if it can help prevent infants from gaining weight too quickly during their first year of life.

To participate, infants must be born weighing more than 2,500 grams, be between 37 to 42 weeks old at birth, and speak English. They should be receiving care at the pediatric clinic and come from a racial or ethnic minority group or a low-income household. Families who join the study will attend four sessions over nine months, and researchers will check their baby's weight at different points to see how well the program works. It's a great opportunity for families to get support in raising healthy children while contributing to important research.

Gender

ALL

Eligibility criteria

  • 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

About Children's Hospital Medical Center, Cincinnati

Children's Hospital Medical Center in Cincinnati is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and comprehensive patient care. Renowned for its commitment to excellence, the center conducts a wide range of clinical trials aimed at developing and evaluating new treatments and therapies for pediatric populations. With a focus on multidisciplinary collaboration and ethical research practices, Children's Hospital Medical Center strives to improve health outcomes for children while contributing to the broader scientific understanding of pediatric medicine.

Locations

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Tiffany Rybak, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported