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

COVID-19 Clinical Trial

— DVx-SCHOOL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05458141
• Other study ID #: VHS/IEC/143/2022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 229
• Est. completion date: December 31, 2024
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Health Behavior
• Infections
• Infectious Disease
• Physical Inactivity

Intervention

Behavioral:
• FYA-003
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!

Locations

Country	Name	City	State
India	Panchayat Union Middle School	Kanchipuram	Tamil Nadu

Sponsors (6)

Lead Sponsor	Collaborator
Carnegie Mellon University	FriendsLearn, Johns Hopkins Bloomberg School of Public Health, University of Michigan, University of Oxford, Voluntary Health Services Hospital, Chennai, India

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Week 4
Primary	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.	Week 8
Primary	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.	Week 12
Primary	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.	3 months after Week 12
Primary	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.	6 months after Week 12
Primary	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.	Baseline
Primary	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.	Week 4
Primary	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.	Week 8
Primary	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.	Week 12
Primary	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.	3 months after Week 12
Primary	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.	6 months after Week 12
Secondary	Clinical biomarkers: BMI Baseline	Body Mass Index of participants	Baseline
Secondary	Clinical biomarkers: BMI Week 12	Body Mass Index of participants	Week 12
Secondary	Clinical biomarkers: BMI Week 12 + 3mo	Body Mass Index of participants	3 months after Week 12
Secondary	Clinical biomarkers: BMI Week 12 + 6mo	Body Mass Index of participants	6 months after Week 12
Secondary	Clinical biomarkers: Average Temperature	Average temperature of participants captured every weekly visit	Captured every week (Week 1 - Week 12)
Secondary	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.	Baseline
Secondary	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.	Week 4
Secondary	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.	Week 8
Secondary	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.	Week 8, Week 12, 3 months after Week 12, 6 months after Week 12
Secondary	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.	3 months after Week 12
Secondary	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.	6 months after Week 12
Secondary	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.	Baseline
Secondary	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.	Week 4
Secondary	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.	Week 8
Secondary	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.	Week 12
Secondary	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.	3 months after Week 12
Secondary	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.	6 months after Week 12