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

Carnegie Mellon University

Status: Completed

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

Treatments: Behavioral: FYA-003

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05458141

VHS/IEC/143/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Group 1: Usual Education + Weekly Exposure to FYA-003

Experimental group

Description:

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.

Treatment:

Behavioral: FYA-003

Group 2: Usual Education + Weekly exposure to non-health related educational mobile games

No Intervention group

Description:

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.