Gaming Technology to Encourage Healthy Weight and Activity in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
研究概览
简要总结
The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.
详细描述
The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who will regularly video chat with the participant and virtually monitor gameplay. The study will advance the field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and obese children and 2) demonstrating the potential of exergaming to reduce body fat and improve children's cardiovascular health.
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
- 否
入选标准
- •BMI percentile > or equal to 85 on the CDC growth chart
- •Participating household has a high-speed internet connection
- •At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week
排除标准
- •Impairments that prevent normal ambulation
- •Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures
结局指标
主要结局
Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group
时间窗: Change between Baseline (Week 0) and 6 months (Week 24)
Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean
次要结局
- Changes in Fasting Glucose(Change between Baseline (Week 0) and 6 months (Week 24))
- Changes in Body Fat(Change between Baseline (Week 0) and 6 months (Week 24))
- Changes in Systolic Blood Pressure(Change between Baseline (Week 0) and 6 months (Week 24))
- Changes in Diastolic Blood Pressure(Change between Baseline (Week 0) and 6 months (Week 24))
- Changes in Total Cholesterol(Change between Baseline (Week 0) and 6 months (Week 24))
- Changes in Physical Activity(Change between Baseline (Week 0) and 6 months (Week 24))
- Changes in Diet(Change between Baseline (Week 0) and 6 months (Week 24))
研究者
Amanda Staiano
Principal Investigator
Pennington Biomedical Research Center