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Obesity Prevention Program for High-Risk Infants

This study is testing a new program called THRIVE 2.0 to help prevent obesity in infants who are at higher risk. This includes infants from racial/ethnic minority groups or those from economically disadvantaged backgrounds. The program teaches parents about infant feeding, sleep, and how to understand their baby's cues. Researchers want to see if THRIVE 2.0 can be easily used by families and if it helps prevent rapid weight gain in infants. Success will be measured by how much weight infants gain by 9 months of age. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 144 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will complete assessments when their baby is a newborn, at 9 months (after the program), and at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at 12 months after the initial assessments.

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NCT06028113

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

Recruiting
PHASE2Ages 1+InterventionalPrevention
Children's Hospital Medical Center, Cincinnati
~144 participants
Updated 2025-03-05 on ClinicalTrials.gov
What's tested:THRIVE 2.0

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Conditional Weight Gain
Measured over At infant age 9-months (post-treatment)

Conditions

Obesity
Obesity, Childhood
Weight Gain
Weight Gain Trajectory

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

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

Who to contact

Tiffany Rybak, PhD
[email protected]
513-517-7254
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Conditional Weight GainAt infant age 9-months (post-treatment)

    Conditional Weight Gain scores will be calculated using length and weight of the infants. Length and weight will be measured in triplicate by masked research-reliable trained assessors and with standardized anthropometric procedures and averaged at each time point. Infants will be weighed unclothed, in a dry diaper using a Scale-Tronix 4802D Infant scale that is calibrated every day. Infant length will be measured using a Pediatric Stadiometer by O'Leary (PED LB35-07-X). Conditional weight gain is calculated as standardized residuals from the linear regression of anthropometric data (e.g., weight and length) on birthweight, with age and sex entered as covariates. Scores closer to 0 are ideal, with scores higher than 0 indicating more rapid weight gain and scores below 1 indicating slower weight gain. Primary outcomes will include conditional weight gain scores at the 9-month post-treatment time point.