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Trial record 62 of 138 for:    Mental Disorders | Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Physical health promotion program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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:

  • 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)

No Intervention: Control group
usual care



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Metabolic syndrome prevalence [ Time Frame: 6 months ]
    expressed as a percentage

  2. use of antipsychotic [ Time Frame: 6 months ]
    Percentage of drugs prescribed by generic name

  3. Toxic habits [ Time Frame: 6 months ]
    Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse

  4. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: SARA FERNANDEZ GUIJARRO, Nurse 686389386 sfguijarro@salud.madrid.org

Locations
Spain
university hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: sara Fernández Guijarro, Nurse    686389386    sfguijarro@salud.madrid.org   
Principal Investigator: sara Fernández Guijarro, Nurse         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
University of Barcelona

Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT03292042     History of Changes
Other Study ID Numbers: 109-17
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
metabolic syndrome
lifestyle intervention
health promotion
mental health nurse
serious mental illness

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases