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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Behavioral: Physical health promotion program

Study type: Interventional

Funder types: Other

Identifiers

NCT03292042

109-17

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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

Treatment:

Behavioral: Physical health promotion program

Control group

No Intervention group

Description:

usual care