Clinical trial NCT05458141: The Study Estimates the Longitudinal Impact of a Gamified Health Education App on Students' Health and Learning Outcomes
Official title: DVx - SCHOOL: Digital Vaccine for Scalable Curricular Health Outcome Optimization and Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Voluntary Health Services Hospital, Chennai, India
name: Johns Hopkins Bloomberg School of Public Health
name: FriendsLearn
name: University of Oxford
First posted: 2022-07-14
Enrollment: 240
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Knowledge Score - Baseline
timeFrame: Baseline
measure: Health Knowledge Score - Week 4
timeFrame: Week 4
measure: Health Knowledge Score - Week 8
timeFrame: Week 8
measure: Health Knowledge Score - Week 12
timeFrame: Week 12
measure: Health Knowledge Score - Week 12 + 3mo
timeFrame: 3 months after Week 12
measure: Health Knowledge Score - Week 12 + 6mo
timeFrame: 6 months after Week 12
measure: Healthy Food Choice Score - Baseline
timeFrame: Baseline
measure: Healthy Food Choice Score - Week 4
timeFrame: Week 4
measure: Healthy Food Choice Score - Week 8
timeFrame: Week 8
measure: Healthy Food Choice Score - Week 12
timeFrame: Week 12
measure: Healthy Food Choice Score - Week 12 + 3mo
timeFrame: 3 months after Week 12
measure: Healthy Food Choice Score - Week 12 + 6mo
timeFrame: 6 months after Week 12
Secondary outcomes:
measure: Clinical biomarkers: BMI Baseline
timeFrame: Baseline
measure: Clinical biomarkers: BMI Week 12
timeFrame: Week 12
measure: Clinical biomarkers: BMI Week 12 + 3mo
timeFrame: 3 months after Week 12
measure: Clinical biomarkers: BMI Week 12 + 6mo
timeFrame: 6 months after Week 12
measure: Clinical biomarkers: Average Temperature
timeFrame: Captured every week (Week 1 - Week 12)
measure: Food Log Health Score - Baseline
timeFrame: Baseline
measure: Food Log Health Score - Week 4
timeFrame: Week 4
measure: Food Log Health Score - Week 8
timeFrame: Week 8
measure: Food Log Health Score - Week 12
timeFrame: Week 8, Week 12, 3 months after Week 12, 6 months after Week 12
measure: Food Log Health Score - Week 12 + 3mo
timeFrame: 3 months after Week 12
measure: Food Log Health Score - Week 12 + 6mo
timeFrame: 6 months after Week 12
measure: Healthy Lifestyle Score - Baseline
timeFrame: Baseline
measure: Healthy Lifestyle Score - Week 4
timeFrame: Week 4
measure: Healthy Lifestyle Score - Week 8
timeFrame: Week 8
measure: Healthy Lifestyle Score - Week 12
timeFrame: Week 12
measure: Healthy Lifestyle Score - Week 12 + 3mo
timeFrame: 3 months after Week 12
measure: Healthy Lifestyle Score - Week 12 + 6mo
timeFrame: 6 months after Week 12
Other outcomes:
Locations:
city: Kānchipuram
country: India
facility: Panchayat Union Middle School
state: Tamil Nadu
Study officials:
affiliation: Carnegie Mellon University
name: Rema Padman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.