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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 belowSelect...
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)
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 moreTHRIVE 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.
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,530,526 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,377 Previous Clinical Trials
4,315,667 Total Patients Enrolled
35 Trials studying Weight Gain
19,259 Patients Enrolled for Weight Gain
Tiffany Rybak, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
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