Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigation of the effect of a 3-month telemedicine-led lifestyle intervention on cardiovascular risk factors, functional indicators, in patients with metabolic syndrome.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental | The active group get telemedicine devices, and lifestyle interventions. |
|
| Comparator Group | No Intervention | The comparator group get the evidence based treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemedicine lifestyle guidance | Device | Telemedicine lifestyle advices are given during 3 months, based on telemonitoring system data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of abdominal circumference | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4. | The safety of the device system | 3 months |
| Impact of the system to the cardiovascular risk | 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 |
Not provided
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):
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| István Kósa, MD, Ph.D. | Contact | +36 70 320 1192 | office.prevmedicina@med.u-szeged.hu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Szeged | Recruiting | Szeged | 6720 | Hungary |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| D009750 |
| Nutritional and Metabolic Diseases |