Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria
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|ClinicalTrials.gov Identifier: NCT03292042|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Behavioral: Physical health promotion program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Impact of a Physical Health Promotion Program for People With Serious Mental Illness|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||May 1, 2019|
Experimental: 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.
Behavioral: Physical health promotion program
The program has 24 sessions. Each session has two parts:
No Intervention: Control group
- Decrease of at least 3 of the 5 criteria of metabolic syndrome [ Time Frame: 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
- Metabolic syndrome prevalence [ Time Frame: 6 months ]expressed as a percentage
- use of antipsychotic [ Time Frame: 6 months ]Percentage of drugs prescribed by generic name
- Toxic habits [ Time Frame: 6 months ]Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse
- Quality of life [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292042
|Contact: SARA FERNANDEZ GUIJARRO, Nurseemail@example.com|
|university hospital Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Contact: sara Fernández Guijarro, Nurse 686389386 firstname.lastname@example.org|
|Principal Investigator: sara Fernández Guijarro, Nurse|