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Completed

NCT Number: NCT05458141

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

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.

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Key information

Conditions

Infectious Disease Behavior Behavior, Animal COVID-19 Communicable Diseases Coronaviridae Infections Coronavirus Infections Disease Attributes Feeding Behavior Habit, Diet Health Behavior Infections Lung Diseases Motor Activity Nidovirales Infections Nutrition, Healthy Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Inactivity Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sedentary Behavior Virus Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Panchayat Union Middle School

Kanchipuram, Tamil Nadu, 602105, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FYA-003

Behavioral

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!

Primary outcomes

  1. Health Knowledge Score - Baseline

    Time frame: 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.

  2. Health Knowledge Score - Week 4

    Time frame: 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.

  3. Health Knowledge Score - Week 8

    Time frame: 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.

  4. Health Knowledge Score - Week 12

    Time frame: 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.

  5. Health Knowledge Score - Week 12 + 3mo

    Time frame: 3 months after 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.

  6. Health Knowledge Score - Week 12 + 6mo

    Time frame: 6 months after 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.

  7. Healthy Food Choice Score - Baseline

    Time frame: 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.

  8. Healthy Food Choice Score - Week 4

    Time frame: 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.

  9. Healthy Food Choice Score - Week 8

    Time frame: 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.

  10. Healthy Food Choice Score - Week 12

    Time frame: 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.

  11. Healthy Food Choice Score - Week 12 + 3mo

    Time frame: 3 months after 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.

  12. Healthy Food Choice Score - Week 12 + 6mo

    Time frame: 6 months after 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.

Secondary outcomes

  1. Clinical biomarkers: BMI Baseline

    Time frame: Baseline

    Body Mass Index of participants

  2. Clinical biomarkers: BMI Week 12

    Time frame: Week 12

    Body Mass Index of participants

  3. Clinical biomarkers: BMI Week 12 + 3mo

    Time frame: 3 months after Week 12

    Body Mass Index of participants

  4. Clinical biomarkers: BMI Week 12 + 6mo

    Time frame: 6 months after Week 12

    Body Mass Index of participants

  5. Clinical biomarkers: Average Temperature

    Time frame: Captured every week (Week 1 - Week 12)

    Average temperature of participants captured every weekly visit

  6. Food Log Health Score - Baseline

    Time frame: 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.

  7. Food Log Health Score - Week 4

    Time frame: 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.

  8. Food Log Health Score - Week 8

    Time frame: 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.

  9. Food Log Health Score - Week 12

    Time frame: Week 8, Week 12, 3 months after Week 12, 6 months after 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.

  10. Food Log Health Score - Week 12 + 3mo

    Time frame: 3 months after 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.

  11. Food Log Health Score - Week 12 + 6mo

    Time frame: 6 months after 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.

  12. Healthy Lifestyle Score - Baseline

    Time frame: 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.

  13. Healthy Lifestyle Score - Week 4

    Time frame: 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.

  14. Healthy Lifestyle Score - Week 8

    Time frame: 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.

  15. Healthy Lifestyle Score - Week 12

    Time frame: 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.

  16. Healthy Lifestyle Score - Week 12 + 3mo

    Time frame: 3 months after 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.

  17. Healthy Lifestyle Score - Week 12 + 6mo

    Time frame: 6 months after 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.

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DVx-SCHOOL

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 14, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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