Nutritional and Anthropometric Characteristics of Children With Food Allergy
NCT07530861
Behavior, Breast Feeding
Konya, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT05093114
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!".
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Notify Me8 year–12 year
All sexes
Observational
The central goal of this project was to develop an interactive, game-based application (App) for school-aged children (aged 8-12) with food allergies (FA) that would increase knowledge, improve behavioral skills for disease management, and ultimately reduce risk of negative outcomes. An effective FA intervention for children should target content areas of food avoidance and reaction management, and across these areas facilitate knowledge acquisition, develop behavioral skills, and provide practice using these skills in social contexts. Our Friends, Family, and Food App (F3A-App), consists of four related parts: (a) an interactive, game-based application that is the core of the program, (b) the experiential scenarios in interactive environments (e.g., school cafeteria vignette) that target knowledge and behavioral skills practice in social contexts, (c) two engaging multi-level games to build skills in food avoidance (Label Learning: Like it or Lose it!) and symptom assessment (Reaction Action!), and (d) a multi-tiered reward system that uses token economy-based reinforcement to enhance motivation and engagement (SeaLife Spectacular). From a user perspective, the interactive, game-based application provides opportunities to practice behavioral skills (e.g. negotiating pressures to accept trigger foods, requesting assistance from adults, responding to teasing/bullying) in role-play situations with immediate feedback and reinforcement.
In this Phase II project, we proposed to produce a fully-developed version of the F3A-App, including added content and enhanced features, and evaluate the final product in a randomized clinical trial.
The specific aims of Phase II were:
This record describes only the Open Trial portion of this Phase II STTR project.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Session 2, about 5 weeks after Session 1 and post-intervention
A semi-structured interview assessing child participants' opinions and feedback regarding game segments.
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Child report
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Child report
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Parent/Caregiver report
Time frame: Baseline (pre-intervention/control condition), and Follow up (post-intervention/control condition; approximately 5 week after baseline)
Parent/Caregiver report
Rhode Island Hospital
Other
Friends, Family and Food: Interactive Virtual Environments for Children With Food Allergies
Acronym: F3A-App
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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