Impact of a Physical Health Promotion Program for People With Serious Mental Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Decrease of at least 3 of the 5 criteria of metabolic syndrome
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental Group
This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months.
The group will attend a session per week.
Intervention: Physical health promotion program (Behavioral)
Control group
usual care
Outcomes
Primary Outcomes
Decrease of at least 3 of the 5 criteria of metabolic syndrome
Time Frame: 6 months
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
Secondary Outcomes
- use of antipsychotic(6 months)
- Toxic habits(6 months)
- Metabolic syndrome prevalence(6 months)
- Quality of life improvement(6 months)