Friends, Family & Food: Food Allergy App for Youth ( F3A-App )

NCT05093114 | Completed DMC

• 2 other identifiers: R42 HD075524 (Open Trial)R42HD075524
• Study Type: observational
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: This Phase II STTR grant incorporated user feedback collected in an earlier development project to build interactive, web-based software that helps children with food allergies learn about their condition and gain self-management skills. This highly interactive game allows children to progress through virtual scenes to help them learn about food avoidance, symptom detection, and reaction management. In addition, this project built gaming complexity, with more levels and game options, of the two interactive games "Label Learning: Like it or Lose it!" and "Reaction Action!".

Conditions

Food Allergy in Children

Keywords

Food Allergy; Intervention; Virtual; Pediatric

Outcome Measures

Primary Outcomes (1)

• Feedback interviews

  A semi-structured interview assessing child participants' opinions and feedback regarding game segments.

  Session 2, about 5 weeks after Session 1 and post-intervention

Secondary Outcomes (4)

• Food Allergy Knowledge Questionnaire

  Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)

• Food Allergy Management Efficacy

  Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)

• Food Allergy Independent Measure

  Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)

• Food Allergy Caregiver-Child Communication

  Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with food allergy to one of the four most common FAs that may cause anaphylaxis (peanut, tree nut, milk, and egg)

You may qualify if:

• child must be 8 -12 years of age
• child must have an active diagnosis of food allergy (FA), specifically one or more of the four most common FAs that may cause anaphylaxis (peanut, tree nut, milk, and egg), confirmed by a physician within the past two years
• child and parent must speak and read English
• child must have access to a computer with internet access
• child must have access to a smartphone or tablet

You may not qualify if:

• Any chronic health condition requiring substantial dietary self-management (e.g., diabetes).

Sponsors & Collaborators

• Rhode Island Hospital: lead

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kathy Mann-Koepke, PhD

  Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 26, 2021
• Study Start: May 18, 2015
• Primary Completion: February 2, 2016
• Study Completion: February 2, 2016
• Last Updated: October 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share