Food Introduction for Risk Reduction, Support Tolerance: Behavioral Intervention for Toddler Eating Success (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
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Arkansas
-
Little Rock, Arkansas, Spojené státy, 72205
- University of Arkansas for Medical Sciences/Arkansas Children's Research Institute
-
Kontakt:
- Amy Scurlock, MD
- E-mail: ScurlockAmyM@uams.edu
-
-
Connecticut
-
New Haven, Connecticut, Spojené státy, 06520
- Yale University
-
Kontakt:
- Stephanie Leeds, MD
- E-mail: stephanie.leeds@yale.edu
-
-
Texas
-
Dallas, Texas, Spojené státy, 75235
- UTSW/Children's Medical Center
-
Vrchní vyšetřovatel:
- John Bird, MD
-
Kontakt:
- Study Coordinator
- E-mail: meilyn.madrigalbriceno@utsouthwestern.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
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.
- 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.
Exclusion Criteria:
-
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.
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Education Alone
|
Educational materials provide guidance on peanut feeding practices and recommendations for continued peanut consumption following the initial supervised introduction. |
|
Jiný: Education plus behavioral reinforcement
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Recruitment, Attendance, Retention, Assessment Completion, and Engagement Rates and Feasibility of Intervention Measure (FIM) Scores
Časové okno: 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. |
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
Časové okno: 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. |
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
Časové okno: 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. |
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
Časové okno: 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. |
Baseline, weekly during Weeks 1-6 for participants assigned to behavioral reinforcement, 6 weeks post-community feeding event, and 3 months post-enrollment.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Caregiver Self-Efficacy Measured by the PROMIS General Self-Efficacy Scale
Časové okno: Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
|
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. |
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
Časové okno: Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
|
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. |
Baseline (Day 0/community feeding event), Week 6 post-community feeding event, and Month 3 follow-up
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: John Bird, MD, University of Texas Southwestern Medical Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STU20261350
- FP00043943 (Jiné číslo grantu/financování: American College of Allergy Asthma and Immunology)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .