Food AllergyFIRST BITESNCT07857057
Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success
A study testing Education and Reminders/Supportive Communication and Education in people with Food Allergy and Early Allergen Introduction, run by University of Texas Southwestern Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy, Early Allergen Introduction
- What is being tested?
- Education and Reminders/Supportive Communication and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
UTSW/Children's Medical Center
Dallas, Texas, 75235
Study Coordinator, meilyn.madrigalbriceno@utsouthwestern.edu
John Bird, MD
University of Arkansas for Medical Sciences/Arkansas Children's Research Institute
Little Rock, Arkansas, 72205
Amy Scurlock, MD, ScurlockAmyM@uams.edu
Yale University
New Haven, Connecticut, 06520
Stephanie Leeds, MD, stephanie.leeds@yale.edu
About this study
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
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:
Read more
- 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.
- Conditions
- Food Allergy, Early Allergen Introduction
- Being tested
- Education and Reminders/Supportive Communication, Education
- Keywords
- Infant Feeding, Caregiver Education
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Reminders/Supportive CommunicationBehavioural
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.
EducationBehavioural
Educational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction.
| Study group | Role | What they receive |
|---|---|---|
| Education Alone | Other | Not described Receives: Behavioral: Education |
| Education plus behavioral reinforcement | Other | Not described Receives: Behavioral: Education and Reminders/Supportive Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: Baseline, weekly during Weeks 1-6 for participants assigned to behavioral reinforcement, 6 weeks post-community feeding event, and 3 months post-enrollment.
Secondary outcomes (2)
Caregiver Self-Efficacy Measured by the PROMIS General Self-Efficacy Scale
Caregiver self-efficacy will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy Scale, a 4-item caregiver-reported measure, and additional study-specific items related to caregiver confidence in introducing and maintaining peanut in the infant's diet. PROMIS General Self-Efficacy Scale total scores range from 4 to 20, with higher scores indicating greater self-efficacy and confidence in managing challenges related to infant peanut introduction and feeding.
Measured: 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
Caregiver anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Caregiver Anxiety Scale, an 8-item caregiver-reported measure. Total scores range from 8 to 40, with higher scores indicating greater anxiety and more severe anxiety symptoms. Scores will be summarized and compared across study assessment time points.
Measured: Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Allergy, Asthma and Immunology
- Responsible party
- Principal investigator, Drew Bird, University of Texas Southwestern Medical Center
- Investigators
- John Bird, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857057
- Sponsor's protocol ID
- STU20261350
- Other IDs
- FP00043943
- Acronym
- FIRST BITES
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07857057
- Acronym / sponsor ID
- FIRST BITES / STU20261350
- Conditions
- Food Allergy, Early Allergen Introduction
- Keywords
- Infant Feeding, Caregiver Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- American College of Allergy, Asthma and Immunology
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Alone | Other | Behavioral: Education |
| Education plus behavioral reinforcement | Other | Behavioral: Education and Reminders/Supportive Communication |
Who may qualify
- Ages
- 4 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Caregivers:
- Infants:
- Advisory Panel Participants:
Key exclusion criteria (14 listed)
- Caregiver-Infant Pairs
- Advisory Panel Participants:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and Reminders/Supportive CommunicationIn 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. | Behavioural | Education plus behavioral reinforcement |
| EducationEducational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction. | Behavioural | Education Alone |
Primary outcome
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)
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.
Acceptability of Community Feeding Events and Behavioral Reinforcement Strategy Measured by Acceptability of Intervention Measure (AIM) Scores and Qualitative Interview Findings
Time frame: 6 weeks post-community feeding event (end of intervention)
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.
Caregiver-Reported Comfort, Staff-Observed Safety Events, Adverse Events, Emergency Medical Interventions, and Safety Concerns During Supervised Peanut Introduction
Time frame: Community feeding event (Day 0), Week 6 post-community feeding event, and Month 3 follow-up.
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.
Caregiver-Reported Peanut Offering, Peanut Ingestion, Feeding Frequency, and Peanut Protein Consumption
Time frame: Baseline, weekly during Weeks 1-6 for participants assigned to behavioral reinforcement, 6 weeks post-community feeding event, and 3 months post-enrollment.
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.
2 secondary outcomes
Caregiver Self-Efficacy Measured by the PROMIS General Self-Efficacy Scale
Time frame: 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
Time frame: Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Arkansas for Medical Sciences/Arkansas Children's Research Institute
Little Rock, United States
John Bird, MD principal investigator
University of Texas Southwestern Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Reminders/Supportive Communication and Education in people with Food Allergy and Early Allergen Introduction, run by University of Texas Southwestern Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.