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NCT04400214 · ClinicalTrials.gov registry record · NA

The Food Allergy Superheroes Training (FAST) Program

A NA study of Child, Only and Adherence, Treatment, sponsored by Kent State University.

Completed
Registry status
NA
Development phase
37
Enrollment target
1
Study location

NCT04400214: Completed NA study of Child, Only and Adherence, Treatment, sponsored by Kent State University.

NCT04400214 is a NA study of Child, Only and Adherence, Treatment that has completed, run by Kent State University. The registered enrollment target is 37 participants, below the 709-participant average among 5 other Child, Only trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04400214, a NA study of Child, Only and Adherence, Treatment, has completed, sponsored by Kent State University.

COMPLETED
Registry status
NA
Development phase
37 participants
Enrollment target
1
Study location

Study Summary

Among children with a food allergy, strict avoidance (e.g., elimination of allergenic foods from one's diet) is the only intervention capable of preventing potentially devastating health-related sequelae including anaphylaxis and death. Youths from low-income backgrounds are particularly impacted by food allergies and may be the population most apt to benefit from a brief, portable, and engaging skills-based intervention designed to teach young children the skills needed to remain adherent to food allergy safety guidelines. Data collected as part of the proposed project will lay the groundwork for a line of federally-funded intervention research broadly examining how to promote adherence to food allergy safety guidelines among young children from low-income backgrounds through implementation of a robust, efficient, and portable intervention.

Primary Outcome

Designed to provide an objective measure of a child's behavior to an unknown food-item in the real world. Modeled after similar methodology employed in prior skills training research. Child's response coded (see Research Strategy), based upon video assessment. Higher scores (ranging from 0 to 4) indicate greater adherence. Scores represent change from pre-intervention to one-month follow-up assessment.

Interventions

  • BEHAVIORAL Food Allergy Superheroes Training (FAST) Program
  • OTHER Food Allergy Knowledge Intervention

Study Locations (1)

Ohio

  • Kent State University - Kent

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2019-07-01
Est. Completion 2023-06-30
Phase NA
Kent State University

19 total trials

What the finished NCT04400214 record still lists

NCT04400214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 709-participant average among 5 other Child, Only trials with a reported enrollment target (95% lower).

The record links to 3 conditions, with Child, Only appearing as the primary indexed condition, and to 2 interventions - of which Food Allergy Superheroes Training (FAST) Program is the first listed.

NCT04400214 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT04400214 about?

NCT04400214 is a clinical study titled "The Food Allergy Superheroes Training (FAST) Program". Among children with a food allergy, strict avoidance (e.g., elimination of allergenic foods from one's diet) is the only intervention capable of preventing potentially devastating health-related sequelae including anaphylaxis and death. Youths from low-income backgrounds are particularly impacted by...

What is the current status of trial NCT04400214?

This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2019-07-01. Estimated completion is 2023-06-30.

What conditions does trial NCT04400214 study?

This clinical trial studies the following conditions: Child, Only, Adherence, Treatment, Allergy;Food.

What interventions are being tested in trial NCT04400214?

The interventions under investigation include: Food Allergy Superheroes Training (FAST) Program (BEHAVIORAL), Food Allergy Knowledge Intervention (OTHER).

Who is sponsoring clinical trial NCT04400214?

This trial is sponsored by Kent State University, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04400214 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04400214, the US trial registry maintained by the National Library of Medicine. NCT04400214 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.