The Study Estimates the Longitudinal Impact of a Gamified Health Education App on Students' Health and Learning Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DVx - SCHOOL: Digital Vaccine for Scalable Curricular Health Outcome Optimization and Learning

Conditions
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Infectious Disease, COVID-19, Physical Inactivity, Health Behavior, Nutrition, Healthy, Habit, Diet

Intervention / Treatment
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* Behavioral: FYA-003


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Usual Education + Weekly Exposure to FYA-003<br>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<br>* 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!<br>|
| No Intervention: Group 2: Usual Education + Weekly exposure to non-health related educational mobile games<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Vaccine, Mobile Games, Physical Activity, Lifestyle Habit Formation, Infectious Diseases, Nutrition