Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Physical Health Promotion Program for People With Serious Mental Illness

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Physical health promotion program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic of serious mental illness. Treatment with antipsychotics. Met at least 3 of the 5 criteria of metabolic syndrome According to the NCEP ATP III definition. Exclusion Criteria: Medical contraindications to exercise Admitted to hospital. intellectual disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months. The group will attend a session per week. | Behavioral: Physical health promotion program<br>* The program has 24 sessions. Each session has two parts: first part: half an hour of theoretical content, about the Metabolic syndrome, the effect of unhealthy lifestyle, toxic habits such as smoking or drinking alcohol, dietary habits or physical activity. Second part: 1 hour of physical activity (walk)<br>|
| No Intervention: Control group<br>usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome prevalence | expressed as a percentage | 6 months | 
| use of antipsychotic | Percentage of drugs prescribed by generic name | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, lifestyle intervention, health promotion, mental health nurse, serious mental illness