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.
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.
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.
Parallel
Education and Reminders/Supportive Communication
BehavioralIn 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
BehavioralEducational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction.
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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
American College of Allergy, Asthma and Immunology
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
