RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial

Quick Facts

Study Start:2023-10-05
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06028113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * born 2500 grams or greater
  2. * delivery occurring between 37 and 42 weeks gestation
  3. * English speaking
  4. * infant receiving care provided at our pediatric primary care setting
  5. * 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)
  1. * care in the Neonatal Intensive Care Unit (\>7 days)
  2. * infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)
  3. * infant exposure to illicit drugs in utero \[with the exception of tetrahydrocannabinol (THC)\]
  4. * diminished or impaired caregiver cognitive functioning
  5. * family intent to move from the area within 1 year

Contacts and Locations

Study Contact

Tiffany Rybak, PhD
CONTACT
513-517-7254
tiffany.rybak@cchmc.org
Sarah Francis, PhD
CONTACT
513-803-2605
sarah.francis@cchmc.org

Principal Investigator

Tiffany Rybak, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Hopple Street Neighborhood Health Center
Cincinnati, Ohio, 45225
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Tiffany Rybak, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-05
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2023-10-05
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • obesity prevention
  • infancy
  • integrated primary care
  • integrated behavioral health
  • responsive parenting
  • responsive feeding
  • sleep
  • soothing

Additional Relevant MeSH Terms

  • Obesity
  • Obesity, Childhood
  • Weight Gain
  • Weight Gain Trajectory