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

NCT ID: NCT03292042

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-02-02

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical health promotion program

Intervention Type: BEHAVIORAL

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)

Control group

usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical health promotion program

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

university hospital Ramón y Cajal

Madrid, , Spain

Countries

Spain

Other Identifiers

109-17

Identifier Type: -

Identifier Source: org_study_id