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

Conditions

• Early Allergen Introduction
• Food Allergy

Eligibility Criteria

Sex

ALL

Age

4 Months - 8 Months

Healthy Volunteers

Accepted

Interventions

• Education and Reminders/Supportive Communication — BEHAVIORAL
  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.
• Education — BEHAVIORAL
  Educational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction.

Study Details

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.

Key Dates

First listed

Oct 5, 2026

Start date

Oct 31, 2026

Status verified

Sep 2026

Primary completion

Apr 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Other: Education Alone
• Other: Education plus behavioral reinforcement

Primary Outcome Measure

Recruitment, Attendance, Retention, Assessment Completion, and Engagement Rates and Feasibility of Intervention Measure (FIM) Scores [ Time Frame: Recruitment through Week 6 post-community feeding event (end of intervention) ]

Locations (3)

Find similar trials in Little Rock, AR

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