An interventional study of FYA-003 in Infectious Disease, COVID-19 and Physical Inactivity, sponsored by Carnegie Mellon University. Completed at 1 site in India. Open to participants aged 5 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Carnegie Mellon University · Not applicable, Interventional, and Health services research
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.
4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's enrollment of 240 is above the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Carnegie Mellon University is the lead sponsor of 46 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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!
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after Week 12
Clinical biomarkers: BMI Baseline
Body Mass Index of participants
Time frame: Baseline
Clinical biomarkers: BMI Week 12
Body Mass Index of participants
Time frame: Week 12
Clinical biomarkers: BMI Week 12 + 3mo
Body Mass Index of participants
Time frame: 3 months after Week 12
Clinical biomarkers: BMI Week 12 + 6mo
Body Mass Index of participants
Time frame: 6 months after Week 12
Clinical biomarkers: Average Temperature
Average temperature of participants captured every weekly visit
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after Week 12
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carnegie Mellon University