The Effectiveness of Wearable Devices on Health Promotion in Individuals With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Step Counts
研究概览
简要总结
This proposed study involves human participants who will be prospectively randomized into either 1) intervention group with a activity tracker or 2) control group without an activity tracker. In addition, the proposed study is designed to evaluate the effect of using an activity tracker on cardiovascular health in the study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •diagnosed with type 2 diabetes (HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL)
- •willing to link a fitness tracker (Fitbit®) App to their own smartphone
排除标准
- •are unable to walk without assistive devices,
- •are current smokers,
- •are pregnant or breastfeeding,
- •already engage in ≥ 150 minutes of moderate-to-vigorous physical activity per week,
- •have any medical conditions (e.g., musculoskeletal diseases, cognitive dysfunction) that will interfere with physical activity,
- •undergo any insulin treatment.
结局指标
主要结局
Step Counts
时间窗: 4 weeks
Daily step counts (steps/day) were collected using the activity tracker and mobile app.
Walking distance
时间窗: 4 weeks
Daily walking distance (meters/day) was collected using the activity tracker and mobile app.
Energy expenditure
时间窗: 4 weeks
Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app.
Time spent in physical activity and sedentary behaviors
时间窗: 4 weeks
Time (hours : minutes) spent in physical activity and sedentary behaviors in a week was collected using the Global Physical Activity Questionnaire (GPAQ). The GPAQ consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport, and recreational activities) and time spent in sedentary behavior.
Blood pressure
时间窗: 4 weeks
Brachial systolic and diastolic blood pressure (mmHg) was collected using an automated sphygmomanometer. Pulse pressure and mean arterial pressure were calculated from systolic and diastolic blood pressure.
Augmentation index
时间窗: 4 weeks
Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Pulse wave velocity
时间窗: 4 weeks
Pulse wave velocity (meter/second), as an arterial stiffness indicator, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Subendocardial viability ratio
时间窗: 4 weeks
The subendocardial viability ratio (SEVR) was measured as an index of myocardial perfusion and coronary supply-demand balance, using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
次要结局
- Metabolic measures(4 weeks)
- Body mass index(4 weeks)
- Waist-to-hip ratio(4 weeks)
研究者
Eliza Wu
Assistant Professor
Pacific University