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NCT06028113 · ClinicalTrials.gov registry record · Phase 2
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
A Phase 2 study of Obesity and Obesity, Childhood, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT06028113: Recruiting Phase 2 study of Obesity and Obesity, Childhood, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT06028113 is a Phase 2 study of Obesity and Obesity, Childhood that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 144 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06028113, a Phase 2 study of Obesity and Obesity, Childhood, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL THRIVE 2.0
Study Locations (1)
Ohio
- Hopple Street Neighborhood Health Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2023-10-05 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 2 |
What NCT06028113 shows while recruiting
NCT06028113 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
The record links to 4 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which THRIVE 2.0 is the first listed.
NCT06028113 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06028113 about?
NCT06028113 is a clinical study titled "A Novel Obesity Prevention Program for High-Risk Infants in Primary Care". 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 primar...
What is the current status of trial NCT06028113?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2023-10-05. Estimated completion is 2026-01-30.
What conditions does trial NCT06028113 study?
This clinical trial studies the following conditions: Obesity, Obesity, Childhood, Weight Gain, Weight Gain Trajectory.
What interventions are being tested in trial NCT06028113?
The interventions under investigation include: THRIVE 2.0 (BEHAVIORAL).
Who is sponsoring clinical trial NCT06028113?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06028113 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06028113's enrollment target sits among peer trials
144 396th of 1053 higher than 657 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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