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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Infectious Disease; Health Behavior; Physical Inactivity; Nutrition, Healthy; Habit, Diet
• Intervention / Treatment: Behavioral: FYA-003

Detailed Description

A 2-arm cluster randomized controlled trial with pre-, during- and post-treatment measurements will be conducted in a school in Chennai (India) - Panchayat Union Middle School (PUMS), Katchipedu - to assess and quantify the longitudinal impact of a proposed Digital Vaccine candidate, called FYA-003®, on students' knowledge, behaviors and outcomes related to diet, physical activity and health hygiene. After following the protocol for recruitment and informed consent, the investigators will pair up grades in the school (site) in consecutive order, such as grades 1-2, 3-4, 5-6, and 7-8, and randomly assign one grade in the pair to Group 1 and the other to Group 2. These pairs are assumed to be close to each other in age, maturity levels, health related knowledge, and exposure to mobile apps, hence appropriate for pairing up for the study.

A team of research staff located in Chennai will coordinate the execution of the experiment. After following the protocol for participation by the school administrator and staff, and the protocol for student recruitment and informed consent, the investigators will adopt a cluster-randomized trial design, where treatment assignment will be done at the grade level. Actual food choice, clinical measurements, survey data, and food logs will be collected by the site PI with support from a research project coordinator during weekly visits to the school. Game play data will be collected automatically whenever the mobile device is connected to the internet and will be downloaded to a secure server after the school visits. The research team will coordinate the gameplay timing with the school officials.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Kānchipuram, Tamil Nadu, India, 602105
      • Panchayat Union Middle School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 5-14
• Parents willing to participate (fill out parent surveys)

Exclusion Criteria:

• Children physically unable to use a device
• Children with special needs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Usual Education + Weekly Exposure to FYA-003; Students 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.	Behavioral: FYA-003; 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!
No Intervention: Group 2: Usual Education + Weekly exposure to non-health related educational mobile games; Students 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical biomarkers: BMI Baseline	Body Mass Index of participants	Baseline
Clinical biomarkers: BMI Week 12	Body Mass Index of participants	Week 12
Clinical biomarkers: BMI Week 12 + 3mo	Body Mass Index of participants	3 months after Week 12
Clinical biomarkers: BMI Week 12 + 6mo	Body Mass Index of participants	6 months after Week 12
Clinical biomarkers: Average Temperature	Average temperature of participants captured every weekly visit	Captured every week (Week 1 - Week 12)
Food Log Health Score - Baseline	Proportion of "Healthy" food items consumed in the weekly food logs recorded by the participants. Scale of 0 to 100. Higher score means better outcomes.	Baseline
Food Log Health Score - Week 4	Proportion of "Healthy" food items consumed in the weekly food logs recorded by the participants. Scale of 0 to 100. Higher score means better outcomes.	Week 4
Food Log Health Score - Week 8	Proportion of "Healthy" food items consumed in the weekly food logs recorded by the participants. Scale of 0 to 100. Higher score means better outcomes.	Week 8
Food Log Health Score - Week 12	Proportion of "Healthy" food items consumed in the weekly food logs recorded by the participants. Scale of 0 to 100. Higher score means better outcomes.	Week 8, Week 12, 3 months after Week 12, 6 months after Week 12
Food Log Health Score - Week 12 + 3mo	Proportion of "Healthy" food items consumed in the weekly food logs recorded by the participants. Scale of 0 to 100. Higher score means better outcomes.	3 months after Week 12
Food Log Health Score - Week 12 + 6mo	Proportion of "Healthy" food items consumed in the weekly food logs recorded by the participants. Scale of 0 to 100. Higher score means better outcomes.	6 months after Week 12
Healthy Lifestyle Score - Baseline	Self-reported Weekly Healthy Lifestyle Score measured on the basis of participant survey responses to questions on physical activity, nutrition behavior, hygiene habits. Scale of 0 to 100. Higher score means better outcomes.	Baseline
Healthy Lifestyle Score - Week 4	Self-reported Weekly Healthy Lifestyle Score measured on the basis of participant survey responses to questions on physical activity, nutrition behavior, hygiene habits. Scale of 0 to 100. Higher score means better outcomes.	Week 4
Healthy Lifestyle Score - Week 8	Self-reported Weekly Healthy Lifestyle Score measured on the basis of participant survey responses to questions on physical activity, nutrition behavior, hygiene habits. Scale of 0 to 100. Higher score means better outcomes.	Week 8
Healthy Lifestyle Score - Week 12	Self-reported Weekly Healthy Lifestyle Score measured on the basis of participant survey responses to questions on physical activity, nutrition behavior, hygiene habits. Scale of 0 to 100. Higher score means better outcomes.	Week 12
Healthy Lifestyle Score - Week 12 + 3mo	Self-reported Weekly Healthy Lifestyle Score measured on the basis of participant survey responses to questions on physical activity, nutrition behavior, hygiene habits. Scale of 0 to 100. Higher score means better outcomes.	3 months after Week 12
Healthy Lifestyle Score - Week 12 + 6mo	Self-reported Weekly Healthy Lifestyle Score measured on the basis of participant survey responses to questions on physical activity, nutrition behavior, hygiene habits. Scale of 0 to 100. Higher score means better outcomes.	6 months after Week 12

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: Johns Hopkins Bloomberg School of Public Health; University of Michigan; University of Oxford; Voluntary Health Services Hospital, Chennai, India; FriendsLearn
• Investigators: Principal Investigator: Rema Padman, PhD, Carnegie Mellon University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 10, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Nutrition; Infectious Diseases; Digital Vaccine; Mobile Games; Lifestyle Habit Formation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: VHS/IEC/143/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No