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| Name | Class |
|---|---|
| University of Barcelona | OTHER |
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The aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce the risk of metabolic syndrome in patients with serious mental illness who receive treatment with antipsychotic medications.
The hypothesis of the study is that: the application of a physical health promotion program in people with serious mental illness, who receive treatment with antipsychotic medications, carried out by a mental health nurse, will decrease the presence of metabolic syndrome and contribute to improve their quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months. The group will attend a session per week. |
|
| Control group | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical health promotion program | Behavioral | The program has 24 sessions. Each session has two parts:
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of at least 3 of the 5 criteria of metabolic syndrome | Fasting glucose ≥110 mg/dL (or receiving drug therapy for hyperglycemia) Blood pressure ≥130/85 mm Hg (or receiving drug therapy for hypertension) Triglycerides ≥150 mg/dL (or receiving drug therapy for hypertriglyceridemia) HDL-C <40 mg/dL in men or <50 mg/dL in women (or receiving drug therapy for reduced HDL-C) Waist circumference ≥102 cm in men or ≥88 cm in women | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic syndrome prevalence | expressed as a percentage | 6 months |
| use of antipsychotic | Percentage of drugs prescribed by generic name |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university hospital Ramón y Cajal | Madrid | 28034 | Spain |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| 6 months |
| Toxic habits | Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse | 6 months |
| Quality of life improvement | EuroQol- 5 Dimension (EQ-5D) includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |