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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 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.

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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.

Interventions

  • BEHAVIORAL THRIVE 2.0

Study Locations (1)

Ohio

  • Hopple Street Neighborhood Health Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2023-10-05
Est. Completion 2026-01-30
Phase Phase 2

What the Registry Record Tells You About NCT06028113

The ClinicalTrials.gov registry entry for NCT06028113 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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