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

Study acronym: FIRST BITES
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07857057
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: American College of Allergy, Asthma and Immunology
Conditions
(from sponsor)
Food Allergy, Early Allergen Introduction
Related terms Food Hypersensitivity
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov