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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

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

THRIVE Trial 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.Check my eligibility

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.See study design

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.

THRIVE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I was born weighing 2500 grams or more.

THRIVE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Baby Basic Needs Questionnaire

Baby Day Diary

Brief Infant Sleep Questionnaire - Revised

+11 more

THRIVE 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,447 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,448 Total Patients Enrolled

35 Trials studying Weight Gain

19,259 Patients Enrolled for Weight Gain

Tiffany Rybak, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study have an age restriction for participants?

"The qualifications for this clinical trial are limited to individuals who are aged 1 Day and up to 30 Days. 262 studies have been conducted on people below 18 years old, while 707 trials have assessed the safety of treatments in patients over 65."

Answered by AI

How many subjects are being monitored within the parameters of this research?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently accepting new participants, having initially been published on October 5th 2023 with the most recent update posted a day later. The study requires 144 volunteers to be recruited from one medical centre."

Answered by AI

Is enrollment for this experiment still open?

"Yes, the details on clinicaltrials.gov indicate that this trial is still open for recruitment. It was initially published on October 5th 2023 and has been updated recently on October 6th 2023. The aim of this study is to enrol 144 individuals at a single location."

Answered by AI

Is it possible for me to enroll in this experiment?

"This clinical trial seeks young patients between 1 day and 30 days old, who have been diagnosed with obesity. To date, 144 participants are enrolled in the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Novel Obesity Prevention Program for High-Risk Infants in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028113.

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