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FIRST BITES
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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · American College of Allergy Asthma and Immunology
interventional
300
1 country
3
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2026
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 5, 2026
Actual (reported)April 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Recruitment, Attendance, Retention, Assessment Completion, and Engagement Rates and Feasibility of Intervention Measure (FIM) Scores
Feasibility will be assessed using recruitment, enrollment, attendance, retention, and engagement metrics, including the number of families expressing interest, screened, eligible, enrolled, attending a community feeding event, completing supervised peanut introduction, randomized, completing the 6-week assessment, and completing the 3-month assessment. Engagement will be assessed using response rates during weekly text-message check-ins among participants assigned to behavioral reinforcement. Feasibility will also be assessed using the Feasibility of Intervention Measure (FIM), a 4-item participant-reported measure. Total scores range from 4 to 20, with higher scores indicating greater perceived feasibility of the intervention.
Recruitment through Week 6 post-community feeding event (end of intervention)
Acceptability of Community Feeding Events and Behavioral Reinforcement Strategy Measured by Acceptability of Intervention Measure (AIM) Scores and Qualitative Interview Findings
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) and qualitative caregiver interview data. The AIM will assess caregiver perceptions of the acceptability of the community feeding event and, for participants assigned to the intervention arm, the 6-week behavioral reinforcement text message program. The AIM is a 4-item participant-reported measure with total scores ranging from 4 to 20, with higher scores indicating greater acceptability. Qualitative interviews will assess caregiver perceptions of the acceptability of the community feeding event, educational materials, peanut preparation demonstration, supervised feeding process, behavioral reinforcement strategy, and follow-up procedures. Interview data will be analyzed to identify caregiver-reported barriers, facilitators, perceived strengths, and suggested refinements.
6 weeks post-community feeding event (end of intervention)
Caregiver-Reported Comfort, Staff-Observed Safety Events, Adverse Events, Emergency Medical Interventions, and Safety Concerns During Supervised Peanut Introduction
Caregiver Self-Efficacy Measured by the PROMIS General Self-Efficacy Scale
Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
Caregiver Anxiety Measured by PROMIS Caregiver Anxiety Scale Scores
Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
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.
Educational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction.
University of Arkansas for Medical Sciences/Arkansas Children's Research Institute
Little Rock, Arkansas, 72205, United States
Yale University
New Haven, Connecticut, 06520, United States
UTSW/Children's Medical Center
Dallas, Texas, 75235, United States
John Bird, MD
University of Texas Southwestern Medical Center
First Submitted
September 24, 2026
First Posted
October 5, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2027
Perceived safety will be assessed using caregiver-reported comfort with the supervised peanut introduction process, study staff observations during the community feeding event, documentation of observed or reported symptoms and adverse events, emergency medication administration, emergency medical services activation, and caregiver-reported safety concerns. Safety outcomes will be summarized descriptively overall and by study site.
Community feeding event (Day 0), Week 6 post-community feeding event, and Month 3 follow-up.
Caregiver-Reported Peanut Offering, Peanut Ingestion, Feeding Frequency, and Peanut Protein Consumption
Adherence to ongoing peanut feeding will be assessed using caregiver-reported peanut offering and ingestion. Measures will include whether peanut was offered to the infant, whether the infant ingested peanut, frequency of peanut offering and ingestion, and estimated quantity of peanut protein consumed. Data will be collected at baseline, 6 weeks, and 3 months. For participants assigned to the behavioral reinforcement arm, weekly text-message check-ins during the 6-week intervention period will also be used to assess week-by-week adherence patterns.
Baseline, weekly during Weeks 1-6 for participants assigned to behavioral reinforcement, 6 weeks post-community feeding event, and 3 months post-enrollment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
Individual participant data will not be made available to external researchers. Data sharing will be limited to authorized study personnel at participating sites as necessary for study conduct, safety monitoring, regulatory compliance, and reporting.
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Source: ClinicalTrials.gov.
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