Life Style, Metabolic Syndrome
Conditions
Keywords
Telemedicine
Brief summary
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.
Detailed description
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.
Interventions
DEVICEtelemedicine lifestyle guidance
Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data.
Sponsors
Szeged University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 years and 75 years * Presence of at least three of the following five risk factors (Metabolic Syndrome ATP III Criteria): 1. waist width above 102 cm in men and 88 cm in women 2. treated diabetes or blood sugar above 5.6 mmol / l 3. treated hypertension or spontaneous blood pressure ≥ 130/85 mmHg 4. fibrate treatment or triglyceride levels above 1.7 mmol / l 5. blood HDL cholesterol levels below 1.03 mmol / l in men and 1.3 mmol / l in women
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of abdominal circumference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4. | 3 months | The safety of the device system |
| Impact of the system to the cardiovascular risk | 3 months | In patients with metabolic syndrome, high cardiovascular risk, the impact of complex lifestyle interventions initiated in different environments and then telemedicine, including lifestyle and physical activity, on the known cardiovascular risk factors and functional indicators |
Countries
Hungary
Contacts
Primary ContactIstván Kósa, MD, Ph.D.
Outcome results
None listed