Clinical trial
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Recruiting now · Phase 2 · 1 countries · Registry ID NCT06028113
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
THRIVE 2.0
Overview of content and strategies: 1) Education on stage of development specific to infant feeding, sleep and infant regulation, attunement to cues; 2) Attunement to cues: reinforcing and modeling accurate discernment \& responsiveness to cues; 3) Infant Soothing and Regulation: Coaching alternative strategies for soothing that feeding for non-hungry, fussy infants; 4) Routines \& Strategies: Promoting developmental activities during wake windows and longer consolidated sleep at night as the infant grows.
Primary outcomes
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 is calculated as standardized residuals from the linear regression of anthropometric data (e.g., weight and length) on birthweight, with age and sex entered as covariates. Scores closer to 0 are ideal, with scores higher than 0 indicating more rapid weight gain and scores below 1 indicating slower weight gain. Primary outcomes will include conditional weight gain scores at the 9-month post-treatm…