The Study Estimates the Longitudinal Impact of a Gamified Health Education App on Students' Health and Learning Outcomes
DVx-SCHOOL
DVx - SCHOOL: Digital Vaccine for Scalable Curricular Health Outcome Optimization and Learning
1 other identifier
interventional
240
1 country
1
Brief Summary
The primary aim of this study is to assess and quantify the longitudinal impact of a mobile App-based module - FYA-003 - which is a gamified health education module for children promoting nutrition, physical activity, health hygiene, and infectious disease risk reduction within the clinically proven app fooya!, on the dietary and physical activity habits, hygiene practices, clinical outcome measures, and related knowledge of children and their caregivers. The app will be delivered in the classroom setting through school-based health education.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2022
CompletedFirst Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 12, 2025
February 1, 2024
1.4 years
July 7, 2022
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Health Knowledge Score - Baseline
Our primary outcome of interest is the health knowledge score, calculated based on students' survey responses to questions testing their knowledge on health hygiene, physical activity, and nutrition. This will be measured as a percentage. Higher percentages indicate a better outcome.
Baseline
Health Knowledge Score - Week 4
Our primary outcome of interest is the health knowledge score, calculated based on students' survey responses to questions testing their knowledge on health hygiene, physical activity, and nutrition. This will be measured as a percentage. Higher percentages indicate a better outcome.
Week 4
Health Knowledge Score - Week 8
Our primary outcome of interest is the health knowledge score, calculated based on students' survey responses to questions testing their knowledge on health hygiene, physical activity, and nutrition. This will be measured as a percentage. Higher percentages indicate a better outcome.
Week 8
Health Knowledge Score - Week 12
Our primary outcome of interest is the health knowledge score, calculated based on students' survey responses to questions testing their knowledge on health hygiene, physical activity, and nutrition. This will be measured as a percentage. Higher percentages indicate a better outcome.
Week 12
Health Knowledge Score - Week 12 + 3mo
Our primary outcome of interest is the health knowledge score, calculated based on students' survey responses to questions testing their knowledge on health hygiene, physical activity, and nutrition. This will be measured as a percentage. Higher percentages indicate a better outcome.
3 months after Week 12
Health Knowledge Score - Week 12 + 6mo
Our primary outcome of interest is the health knowledge score, calculated based on students' survey responses to questions testing their knowledge on health hygiene, physical activity, and nutrition. This will be measured as a percentage. Higher percentages indicate a better outcome.
6 months after Week 12
Healthy Food Choice Score - Baseline
Observed "Good Food" choice indicator, as measured based on actual food choices by participants. This is a binary 0-1 value. 1 indicates a better outcome.
Baseline
Healthy Food Choice Score - Week 4
Observed "Good Food" choice indicator, as measured based on actual food choices by participants. This is a binary 0-1 value. 1 indicates a better outcome.
Week 4
Healthy Food Choice Score - Week 8
Observed "Good Food" choice indicator, as measured based on actual food choices by participants. This is a binary 0-1 value. 1 indicates a better outcome.
Week 8
Healthy Food Choice Score - Week 12
Observed "Good Food" choice indicator, as measured based on actual food choices by participants. This is a binary 0-1 value. 1 indicates a better outcome.
Week 12
Healthy Food Choice Score - Week 12 + 3mo
Observed "Good Food" choice indicator, as measured based on actual food choices by participants. This is a binary 0-1 value. 1 indicates a better outcome.
3 months after Week 12
Healthy Food Choice Score - Week 12 + 6mo
Observed "Good Food" choice indicator, as measured based on actual food choices by participants. This is a binary 0-1 value. 1 indicates a better outcome.
6 months after Week 12
Secondary Outcomes (17)
Clinical biomarkers: BMI Baseline
Baseline
Clinical biomarkers: BMI Week 12
Week 12
Clinical biomarkers: BMI Week 12 + 3mo
3 months after Week 12
Clinical biomarkers: BMI Week 12 + 6mo
6 months after Week 12
Clinical biomarkers: Average Temperature
Captured every week (Week 1 - Week 12)
- +12 more secondary outcomes
Study Arms (2)
Group 1: Usual Education + Weekly Exposure to FYA-003
EXPERIMENTALStudents in grades assigned to Group 1 play FYA-003 in the classroom for 30 minutes every week for 12 weeks on a day at a time determined by the school \& research team.
Group 2: Usual Education + Weekly exposure to non-health related educational mobile games
NO INTERVENTIONStudents in grades assigned to Group 2 play educational games unrelated to health in the classroom for 30 minutes every week for 12 weeks on a day at a time determined by the school \& research team.
Interventions
FYA-003: It is a gamified health education module for children aimed at promoting healthy nutrition, physical activity, health hygiene, and infectious diseases risk reduction within the clinically proven app fooya!
Eligibility Criteria
You may qualify if:
- Age 5-14
- Parents willing to participate (fill out parent surveys)
You may not qualify if:
- Children physically unable to use a device
- Children with special needs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carnegie Mellon Universitylead
- University of Michigancollaborator
- Voluntary Health Services Hospital, Chennai, Indiacollaborator
- Johns Hopkins Bloomberg School of Public Healthcollaborator
- FriendsLearncollaborator
- University of Oxfordcollaborator
Study Sites (1)
Panchayat Union Middle School
Kanchipuram, Tamil Nadu, 602105, India
Related Publications (1)
Kato-Lin YC, Kumar UB, Sri Prakash B, Prakash B, Varadan V, Agnihotri S, Subramanyam N, Krishnatray P, Padman R. Impact of Pediatric Mobile Game Play on Healthy Eating Behavior: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 18;8(11):e15717. doi: 10.2196/15717.
PMID: 33206054BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rema Padman, PhD
Carnegie Mellon University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Trustees Professor Of Management Science And Healthcare Informatics
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 14, 2022
Study Start
July 6, 2022
Primary Completion
December 5, 2023
Study Completion
December 31, 2024
Last Updated
February 12, 2025
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share