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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Physical health promotion program

• Registration Number: NCT03292042
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-01
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Primary Completion: 2018-08-31
• Study Completion: 2019-02-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Physical health promotion program	This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months. The group will attend a session per week.

Primary Outcome Measures

Name	Time	Method
Decrease of at least 3 of the 5 criteria of metabolic syndrome	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 Outcome Measures

Name	Time	Method
Metabolic syndrome prevalence	6 months	expressed as a percentage
Quality of life improvement	6 months	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).
use of antipsychotic	6 months	Percentage of drugs prescribed by generic name
Toxic habits	6 months	Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse

Trial Locations

Locations (1)

university hospital Ramón y Cajal; 🇪🇸 Madrid, Spain