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

NCT06028113 | Recruiting Phase 2 DMC

• 2 other identifiers: 2023-00271R01DK135497-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Obesity, Childhood; Weight Gain; Weight Gain Trajectory

Keywords

obesity prevention; infancy; integrated primary care; integrated behavioral health; responsive parenting; responsive feeding; sleep; soothing

Outcome Measures

Primary Outcomes (1)

• Conditional Weight Gain

  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-treatment time point.

  At infant age 9-months (post-treatment)

Secondary Outcomes (14)

• Conditional Weight Gain

  At infant age 12 months (follow-up)

• The Baby Eating Behavior Questionnaire

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

• The Infant Feeding Style Questionnaire

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

• The Food Frequency Questionnaire

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

• Baby Day Diary

  During active treatment at infant age: 2 months, 4 months, and 6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Behavioral: THRIVE 2.0

Control Group

NO 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.

Interventions

THRIVE 2.0 BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• born 2500 grams or greater
• delivery occurring between 37 and 42 weeks gestation
• English speaking
• infant receiving care provided at our pediatric primary care setting
• from a racial / ethnic minority group (i.e., non-white, or Hispanic or Latinx) and/or economically marginalized background (i.e., household income at or below 138% of federal poverty level; qualifying for Medicaid)

You may not qualify if:

• care in the Neonatal Intensive Care Unit (\>7 days)
• infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)
• infant exposure to illicit drugs in utero \[with the exception of tetrahydrocannabinol (THC)\]
• diminished or impaired caregiver cognitive functioning
• family intent to move from the area within 1 year

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Hopple Street Neighborhood Health Center

Cincinnati, Ohio, 45225, United States

RECRUITING

Related Publications (1)

• Rybak TM, Francis SE, Mara CA, Zion C, Modi AC, Crosby LE, Herbst RB, Lauer BA, Murphy BN, Harry KR, Patel DJ, Burkhardt MC. THRIVE 2.0: A randomized-controlled trial of an obesity prevention intervention designed for infants in pediatric primary care. Contemp Clin Trials Commun. 2025 Apr 21;45:101488. doi: 10.1016/j.conctc.2025.101488. eCollection 2025 Jun.

  PMID: 40336701 DERIVED

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Weight Gain; Body-Weight Trajectory

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Tiffany Rybak, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Rybak, PhD

CONTACT

513-517-7254; tiffany.rybak@cchmc.org

Sarah Francis, PhD

CONTACT

513-803-2605; sarah.francis@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not be notified of group status or details of participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase 2 pragmatic pilot and feasibility randomized controlled trial (RCT) of an obesity prevention intervention compared to usual pediatric care with 144 mother-infant dyads randomized n=72 per arm. Consistent with the definition of a pilot and feasibility clinical trial, our aims are to assess trial protocol feasibility based on THRIVE 2.0 and obtain effect sizes to inform the design of a Phase 3 multi-site efficacy trial.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 8, 2023
• Study Start: October 5, 2023
• Primary Completion: November 30, 2025
• Study Completion: January 30, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 12 months after completion of the study
• Access Criteria: Requested from PI

Locations

US (1)