DVx - SCHOOL: Digital Vaccine for Scalable Curricular Health Outcome Optimization and Learning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Health Knowledge Score - Baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents willing to participate (fill out parent surveys)
排除标准
- •Children physically unable to use a device
- •Children with special needs
结局指标
主要结局
Health Knowledge Score - Baseline
时间窗: 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 12 + 3mo
时间窗: 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
时间窗: 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 - Week 12
时间窗: 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.
Health Knowledge Score - Week 4
时间窗: 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
时间窗: 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 + 6mo
时间窗: 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 - Week 12 + 3mo
时间窗: 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 - Baseline
时间窗: 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
时间窗: 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
时间窗: 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 + 6mo
时间窗: 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.
次要结局
- Clinical biomarkers: BMI Baseline(Baseline)
- Food Log Health Score - Week 12 + 6mo(6 months after Week 12)
- Clinical biomarkers: BMI Week 12(Week 12)
- Healthy Lifestyle Score - Week 12(Week 12)
- Healthy Lifestyle Score - Week 12 + 3mo(3 months after Week 12)
- Clinical biomarkers: BMI Week 12 + 6mo(6 months after Week 12)
- Clinical biomarkers: BMI Week 12 + 3mo(3 months after Week 12)
- Food Log Health Score - Week 12(Week 8, Week 12, 3 months after Week 12, 6 months after Week 12)
- Clinical biomarkers: Average Temperature(Captured every week (Week 1 - Week 12))
- Food Log Health Score - Baseline(Baseline)
- Food Log Health Score - Week 4(Week 4)
- Food Log Health Score - Week 8(Week 8)
- Healthy Lifestyle Score - Week 12 + 6mo(6 months after Week 12)
- Food Log Health Score - Week 12 + 3mo(3 months after Week 12)
- Healthy Lifestyle Score - Baseline(Baseline)
- Healthy Lifestyle Score - Week 4(Week 4)
- Healthy Lifestyle Score - Week 8(Week 8)
研究者
Rema Padman
Trustees Professor Of Management Science And Healthcare Informatics
Carnegie Mellon University