Infectious DiseaseDVx-SCHOOLNCT05458141
The Study Estimates the Longitudinal Impact of a Gamified Health Education App on Students' Health and Learning Outcomes
A study testing FYA-003 in people with Infectious Disease and COVID-19, run by Carnegie Mellon University at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, COVID-19, Physical Inactivity
- What is being tested?
- FYA-003
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jul 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 5-14
- Parents willing to participate (fill out parent surveys)
Who cannot join
- Children physically unable to use a device
- Children with special needs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DVx - SCHOOL: Digital Vaccine for Scalable Curricular Health Outcome Optimization and Learning
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.
Read the detailed 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.
- Conditions
- Infectious Disease, COVID-19, Physical Inactivity, Health Behavior, Nutrition, Healthy, Habit, Diet
- Being tested
- FYA-003
- Keywords
- Digital Vaccine, Mobile Games, Physical Activity, Lifestyle Habit Formation, Infectious Diseases, Nutrition
- Medical subject headings
- Communicable Diseases, COVID-19, Sedentary Behavior, Health Behavior, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FYA-003Behavioural
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!
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Usual Education + Weekly Exposure to FYA-003 | Experimental | 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. Receives: Behavioral: FYA-003 |
| Group 2: Usual Education + Weekly exposure to non-health related educational mobile games | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after Week 12
Secondary outcomes (17)
Clinical biomarkers: BMI Baseline
Body Mass Index of participants
Measured: Baseline
Clinical biomarkers: BMI Week 12
Body Mass Index of participants
Measured: Week 12
Clinical biomarkers: BMI Week 12 + 3mo
Body Mass Index of participants
Measured: 3 months after Week 12
Clinical biomarkers: BMI Week 12 + 6mo
Body Mass Index of participants
Measured: 6 months after Week 12
Clinical biomarkers: Average Temperature
Average temperature of participants captured every weekly visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start6 Jul 2022
- Primary completion5 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Voluntary Health Services Hospital, Chennai, India, Johns Hopkins Bloomberg School of Public Health, FriendsLearn, University of Oxford
- Responsible party
- Principal investigator, Rema Padman, Carnegie Mellon University
- Investigators
- Rema Padman, PhD, Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458141
- Sponsor's protocol ID
- VHS/IEC/143/2022
- Acronym
- DVx-SCHOOL
- Status last verified
- Feb 2024
- First submitted
- 7 Jul 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33206054
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DVx - SCHOOL: Digital Vaccine for Scalable Curricular Health Outcome Optimization and Learning
- ClinicalTrials.gov ID
- NCT05458141
- Acronym / sponsor ID
- DVx-SCHOOL / VHS/IEC/143/2022
- Conditions
- Infectious Disease, COVID-19, Physical Inactivity, Health Behavior, Nutrition, Healthy, Habit, Diet
- Keywords
- Digital Vaccine, Mobile Games, Physical Activity, Lifestyle Habit Formation, Infectious Diseases, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Voluntary Health Services Hospital, Chennai, India, Johns Hopkins Bloomberg School of Public Health, FriendsLearn, University of Oxford
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Usual Education + Weekly Exposure to FYA-003 | Experimental | Behavioral: FYA-003Students 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. |
| Group 2: Usual Education + Weekly exposure to non-health related educational mobile games | No intervention | –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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 5-14
- Parents willing to participate (fill out parent surveys)
Key exclusion criteria (2 listed)
- Children physically unable to use a device
- Children with special needs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FYA-003FYA-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! | Behavioural | Group 1: Usual Education + Weekly Exposure to FYA-003 |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
17 secondary outcomes
Clinical biomarkers: BMI Baseline
Time frame: Baseline
Clinical biomarkers: BMI Week 12
Time frame: Week 12
Clinical biomarkers: BMI Week 12 + 3mo
Time frame: 3 months after Week 12
Clinical biomarkers: BMI Week 12 + 6mo
Time frame: 6 months after Week 12
Clinical biomarkers: Average Temperature
Time frame: Captured every week (Week 1 - Week 12)
Food Log Health Score - Baseline
Time frame: Baseline
Food Log Health Score - Week 4
Time frame: Week 4
Food Log Health Score - Week 8
Time frame: Week 8
Food Log Health Score - Week 12
Time frame: Week 8, Week 12, 3 months after Week 12, 6 months after Week 12
Food Log Health Score - Week 12 + 3mo
Time frame: 3 months after Week 12
Food Log Health Score - Week 12 + 6mo
Time frame: 6 months after Week 12
Healthy Lifestyle Score - Baseline
Time frame: Baseline
Healthy Lifestyle Score - Week 4
Time frame: Week 4
Healthy Lifestyle Score - Week 8
Time frame: Week 8
Healthy Lifestyle Score - Week 12
Time frame: Week 12
Healthy Lifestyle Score - Week 12 + 3mo
Time frame: 3 months after Week 12
Healthy Lifestyle Score - Week 12 + 6mo
Time frame: 6 months after Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Results publication: PubMed 33206054Kato-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rema Padman, PhD principal investigator
Carnegie Mellon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FYA-003 in people with Infectious Disease and COVID-19, run by Carnegie Mellon University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Knowledge Score - Baseline (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.