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NOT YET RECRUITING

NCT07857057

Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the feasibility, acceptability, perceived safety, and adherence outcomes of FIRST BITES (Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success), a supervised, community-based early peanut introduction model, in caregiver-infant dyads. The main questions it aims to answer are: * Can eligible caregiver-infant dyads be successfully recruited to and retained in community-based peanut introduction events, and do caregivers find the feeding event, educational materials, and intervention approach acceptable? * Does education plus structured behavioral reinforcement improve adherence to peanut feeding recommendations, caregiver self-efficacy, and caregiver anxiety related to early peanut introduction compared with education alone? Researchers will compare education alone with education plus behavioral reinforcement to determine whether behavioral reinforcement supports continued peanut feeding and improves caregiver confidence following peanut introduction. Participants will: * Attend a supervised community-based peanut introduction event. * Receive education about early peanut introduction. * Be randomized to receive either education alone or education plus behavioral reinforcement following the feeding event. * Complete surveys regarding peanut feeding practices, caregiver self-efficacy, anxiety related to peanut introduction, and perceptions of feasibility, acceptability, and safety. * Participate in follow-up assessments during the 6-week intervention period and at 3 months after enrollment. * Some participants may be invited to complete qualitative interviews regarding barriers and facilitators to early peanut introduction.

Official title: FIRST BITES (Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success): A Multi-Site Community-Based Translational Study of Early Peanut and Egg Introduction With Behavioral Reinforcement

Key Details

Gender

All

Age Range

4 Months - 8 Months

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-10

Completion Date

2027-06-30

Last Updated

2026-10-05

Healthy Volunteers

Yes

Conditions

Food Allergy Early Allergen Introduction

Interventions

BEHAVIORAL

Education and Reminders/Supportive Communication

In addition to the supervised community-based peanut introduction event and educational materials, reinforcements will also be added. Behavioral reinforcement may include reminder messages, prompts, and supportive communications intended to encourage adherence to peanut feeding recommendations and increase caregiver confidence with continued peanut introduction.

BEHAVIORAL

Education

Educational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction.

Inclusion Criteria: * Caregivers: * You are 18 years old or older. * You are the infant's parent or legal guardian. * You are able to give permission for yourself and your infant to participate in the study. * You can speak and read English. * You are interested in introducing peanut-containing foods to your infant and continuing to feed peanut regularly. * You are willing to attend the supervised peanut feeding event and complete study follow-up activities. * You are willing to receive study-related reminders and communications by phone, email, or text message. * Infants: * They are 4 to 8 months old at the time they join the study. * They are developmentally ready to safely eat foods by mouth. * They have never eaten peanut before. * The study team determines that they are an appropriate candidate for supervised peanut introduction. * Advisory Panel Participants: * You are 18 years of age or older. * You are able to provide informed consent. * You have experience related to one or more of the following: Community feeding events, Behavioral interventions, Pediatric allergy care, Community medical practice, Implementation or program development, Health equity, Participant recruitment and retention, Community engagement * You are willing to participate in a virtual discussion group or feedback session that may be audio recorded. Exclusion Criteria: * Caregiver-Infant Pairs * The infant has already eaten peanut. * The infant has a known peanut allergy or has been diagnosed with a peanut allergy by a doctor. * The infant has had a previous reaction that may have been caused by a peanut allergy. * The infant has a diagnosed feeding disorder. * The infant has a medical, developmental, or feeding condition that could make peanut introduction unsafe or make it difficult to participate in the study. * The caregiver is not the infant's parent or legal guardian. * The caregiver is unable or unwilling to provide consent for participation. * The caregiver is unable to participate in study activities and follow-up assessments in English. * The caregiver or infant has another condition or circumstance that the study doctor believes would make participation unsafe, impractical, or not in their best interest. * Advisory Panel Participants: * You are unable or unwilling to provide informed consent. * You are unable to participate in the virtual discussion group or feedback session. * The study team determines that a conflict of interest, role limitation, or other circumstance makes participation inappropriate.

Locations (3)

University of Arkansas for Medical Sciences/Arkansas Children's Research Institute

Little Rock, Arkansas, United States

Yale University

New Haven, Connecticut, United States

UTSW/Children's Medical Center

Dallas, Texas, United States