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

NCT03292042 | Completed

• 1 other identifier: 109-17
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

metabolic syndrome; lifestyle intervention; health promotion; mental health nurse; serious mental illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Metabolic syndrome prevalence

  6 months

• use of antipsychotic

  6 months

• Toxic habits

  6 months

• Quality of life improvement

  6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

usual care

Interventions

Physical health promotion program 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)

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Medical contraindications to exercise
• Admitted to hospital.
• intellectual disability

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• University of Barcelona: collaborator

Study Sites (1)

university hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: September 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: February 2, 2019
• Last Updated: February 28, 2019

Record last verified: 2017-09

Locations

ES (1)