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

Metabolic Syndrome Clinical Trial

Official title:

Impact of a Physical Health Promotion Program for People With Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292042
• Other study ID #: 109-17
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: February 2, 2019

Study information

• Verified date: September 2017
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
Spain	university hospital Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Metabolic syndrome prevalence	expressed as a percentage	6 months
Secondary	use of antipsychotic	Percentage of drugs prescribed by generic name	6 months
Secondary	Toxic habits	Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse	6 months
Secondary	Quality of life improvement	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).	6 months