Video Games for Obesity and Diabetes Prevention: Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in fasting insulin from baseline to immediate post intervention (approximately 3 months post baseline assessment) and 2-months post intervention (approximately 5 months post baseline assessment)
研究概览
简要总结
With the increasing rates of child obesity and diabetes, innovative programs are needed that capture children's attention and permit behavior change messages to get through. Serious video games with their immersive stories offer one such promising alternative due to their low cost approach to intervention since the games have already been developed, and can be broadly disseminated by simply reproducing and distributing their DVDs. While using video games for health promotion is controversial, this study will establish whether video games can effectively change diabetes and obesity risks (especially fasting insulin, diet and physical activity) among children.
"Escape from Diab" and "Nanoswarm: Invasion from Inner Space" are two video games that targeted children to increase fruit, vegetable and water intakes, reduce sedentary behaviors (SB), and increase physical activity in a pilot study with a relatively low risk children. In light of this, it is important to test whether these games can help decrease diabetes (i.e. fasting insulin) and obesity risks with high risk (85%tile < BMI < 99%tile) 10 to 12 year old children.
Children will be randomly assigned to treatment or control groups. The treatment group will play "Diab" and "Nano" over a 3-month time period. A wait-list control group will receive the "Diab" and "Nano" games at the end of their second post assessment (5-months post baseline assessment).
详细描述
This project is to conduct an efficacy trial of Diab and Nanoswarm to assess their potential for minimizing T2D and obesity risks. The proposed research will be conducted in two phases, covering a 3-year period: implementation and evaluation phase of 2.5 years and an analysis phase of 0.5 years.
Specific Aim 1: Conduct an efficacy outcome evaluation of Diab and Nano using a randomized clinical trial.
Hypothesis 1: Children will decrease fasting insulin by, at least, 2μU/dl, increase FV intake by at least 1.0 servings/day, and increase MVPA by at least 10 min/day from baseline to up to 3 months post baseline.
Hypothesis 2: Diet, MVPA and fasting insulin changes will not be moderated by demographic characteristics (e.g. gender, age, ethnic group).
Hypothesis 3: Fasting insulin change will be mediated by changes in diet, PA and SB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Child does not speak English (since both games are in English),
- •has a medical condition that influences diet, physical activity, obesity, or the ability to complete questionnaires,
- •has type 2 diabetes mellitus;
- •does not have a qualified computer and internet access at home.
研究组 & 干预措施
G4H-Diab-Nano
Intervention - play two videogames Diab and Nanoswarm (9 sessions each, 18 total sessions) over a 12-week time period.
干预措施: G4H-Diab-Nano (Behavioral)
Wait List Control
5-months after baseline assessment they will receive the two video games: 1) Diab and 2) Nanoswarm.
结局指标
主要结局
Change in fasting insulin from baseline to immediate post intervention (approximately 3 months post baseline assessment) and 2-months post intervention (approximately 5 months post baseline assessment)
时间窗: Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline)
次要结局
- Change in Fruit and Vegetable Intake(Three time points: baseline, post intervention (approximately three months post baseline), two month post intervention (approximately 5 months post baseline))
研究者
Thomas Baranowski
Professor of Pediatrics
Baylor College of Medicine