The Study Estimates the Longitudinal Impact of a Gamified Health Education App on Students' Health and Learning Outcomes (DVx-SCHOOL)

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

University of Michigan, Voluntary Health Services Hospital, Chennai, India, Johns Hopkins Bloomberg School of Public Health, FriendsLearn, University of Oxford

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.

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.

Digital Vaccine, Mobile Games, Physical Activity, Lifestyle Habit Formation, Infectious Diseases, Nutrition

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.

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.

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!

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.