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Behavioural Intervention

THRIVE 2.0 Program for Preventing Childhood Obesity (THRIVE Trial)

Phase 2

Recruiting

Led By Tiffany Rybak, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Born 2500 grams or greater

Must not have

Infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)

Care in the Neonatal Intensive Care Unit (>7 days)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an obesity prevention program for infants & caregivers of color &/or from low-income backgrounds. The aim is to prevent rapid infant weight gain & assess feasibility/acceptability. Participants receive 4 prevention sessions & assessments at baseline, post-treatment & follow-up.

Who is the study for?

This trial is for infants of color or from low-income families, born weighing at least 2500 grams and delivered between 37-42 weeks. They must be receiving care in the study's pediatric primary care setting and have English-speaking caregivers. Infants with certain health conditions, drug exposures, or whose families plan to move away within a year are excluded.

What is being tested?

The THRIVE 2.0 program aims to prevent obesity by teaching responsive parenting during regular well-child visits in pediatric primary care for high-risk infants. The study will compare weight gain between those who receive this intervention and those who get usual treatment over a period of up to one year.

What are the potential side effects?

Since THRIVE 2.0 is an educational intervention focusing on parenting practices rather than medication, there are no direct medical side effects expected from participating in this program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was born weighing 2500 grams or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My baby has a birth condition affecting feeding, like cleft palate.

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My newborn was in the NICU for more than a week.

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My caregiver has trouble with thinking or memory.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Baby Basic Needs Questionnaire

Baby Day Diary

Brief Infant Sleep Questionnaire - Revised

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment1 Intervention

The Teaching Healthy Responsive Parenting during Infancy to promote Vital growth and rEgulation (THRIVE 2.0) group will consist of 4 sessions delivered by the trained IBH provider, in conjunction with the 1, 2, 4, and 6 month well-child visit in primary care. The THRIVE curriculum teaches responsive parenting principles targeted to establish healthy eating, sleeping, and regulation habits for infants.

Group II: Control GroupActive Control1 Intervention

Control arm: Usual Pediatric Care. The control condition is usual care delivered by pediatricians at 1, 2, 4, and 6 month well child visits.

0 / 4Eligibility criteria met