Feasibility and Explorative Study to Test the Superiority of Connected Health Care Using Wearable Device to Improve Body Composition and Fitness Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Waist circumference
研究概览
简要总结
Many kinds of wearable technology have become available, but the superiority of those devices in weight loss compared to the standard care without them is uncertain. The possible problems are long-term self-motivation, utility and validity of the device, and outcome measures in clinical trials. The connected health care with motivational interviewing as an intervention, and body composition parameters in addition to body weight as outcome measures are employed in the project. The expected outcome is that connected health care, which is more individualized approach by heath care professionals, is more effective compared to self-monitoring using wearable devices. Two types of wearable device are going to be used to monitor 1) body activity and 2) heart rate variables during exercise which reflect fitness level in this study in order to investigate appropriate monitoring parameters to predict outcome measures.
The hypothesis is that addition of connected health system will result in improvement of body composition and fitness level compared to self-monitoring.
详细描述
Patients with age 18 to 59 years old and body mass index between 30 to 39.9 are to be enrolled at Mayo Clinic in Arizona. All enrolled subjects receive wearable monitoring devices with remote tracking capability and brochure regarding nutrition and physical exercise with basic instruction. Subjects are randomly assigned to connected health care group versus self-monitoring group. Connected health care group will have 2 interviews about physical exercise and 6 communications with individualized instruction and counseling of their exercise including the usage of the monitoring devices. Self-monitoring group will do physical exercise following the initial basic instruction and self-monitor them.
All subjects visit Mayo Clinic to get outcome measures at 0, 12, and 24weeks. Outcome measures will be compared before, at 12 weeks, and after the 24 weeks of the fitness program.
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
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index of 30 to <40 kg/m^2
排除标准
- •End of organ damage from hypertension
- •Liver disease
- •Chronic lung disease
- •Neuromuscular disease
- •Any conditions that limit exercise
- •Currently involved in other weight program
研究组 & 干预措施
Connected Health
This group will get 2 interviews about physical exercise (exercise instruction with motivational interview) and 6 communications with individualized instruction and counseling of their physical exercise (investigators can access activity data and exercise log) including the usage of the monitoring device.
干预措施: Exercise instruction with motivational interview (Behavioral)
Self-Monitoring
This group will do physical exercise following the initial instruction and self-monitor them. Investigators can access activity data and exercise log but will not discuss with the subjects about the data.
干预措施: Self-monitoring (Behavioral)
结局指标
主要结局
Change in Waist circumference
时间窗: Baseline and 24 weeks
Waist circumference is measured by tape at the end expiration while the patient is standing. Units centimeters.
次要结局
- Change in body fat percentage(Baseline and 24 weeks)
- Change in weight(Baseline and 24 weeks)
- Change in physical activity score(Baseline and 24 weeks)
- Change in Physical Activity Vital Sign(Baseline and 24 weeks)
- Change in Veterans Specific Activity Questionnaire(Baseline and 24 weeks)
- Change in heart rate variables(Baseline and 24 weeks)
- Change in 6 minute walk test(Baseline and 24 weeks)
研究者
Regis Fernandes
Principal Investigator
Mayo Clinic