Risk Reduction in Patients With Metabolic Syndrome Through Telemedicine-led Lifestyle Interventions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change of abdominal circumference
研究概览
简要总结
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.
详细描述
The patients are using mobile phone-based nutrition diary with heart rate monitoring watch (including activity meter) connected to a mobile phone with bluetooth technology worn on a wrist. These devices, and the weight scale, blood pressure monitor are connected with bluetooth to an IT system, that transmits and displays data from these devices. the patients are using the devices during 3 months, and get instructions about lifestyle.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 75 years
- •Presence of at least three of the following five risk factors (Metabolic Syndrome ATP III Criteria):
- •waist width above 102 cm in men and 88 cm in women
- •treated diabetes or blood sugar above 5.6 mmol / l
- •treated hypertension or spontaneous blood pressure ≥ 130/85 mmHg
- •fibrate treatment or triglyceride levels above 1.7 mmol / l
- •blood HDL cholesterol levels below 1.03 mmol / l in men and 1.3 mmol / l in women
排除标准
- •Low level of physical activity (less than 30 minutes a day)
- •IT proficiency at least for basic use of mobile phones (answering / making voice calls).
- •For women with childbearing potential, by definition, all women who are able to conceive physiologically use dual contraception
- •Signing an informed consent.
- •The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.
研究组 & 干预措施
Active group
The active group get telemedicine devices, and lifestyle interventions.
干预措施: telemedicine lifestyle guidance (Device)
Comparator Group
The comparator group get the evidence based treatment.
结局指标
主要结局
Change of abdominal circumference
时间窗: 3 months
To investigate the effect of telemedicine-assisted lifestyle intervention on anthropometric parameters, with particular reference to the reduction of abdominal circumference in patients with metabolic syndrome.
次要结局
- Impact of the system to the cardiovascular risk(3 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.(3 months)