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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical health promotion program
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, lifestyle intervention, health promotion, mental health nurse, serious mental illness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • university hospital Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control group

Arm Description

This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months. The group will attend a session per week.

usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Metabolic syndrome prevalence
expressed as a percentage
use of antipsychotic
Percentage of drugs prescribed by generic name
Toxic habits
Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse
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).

Full Information

First Posted
September 20, 2017
Last Updated
February 27, 2019
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators
University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT03292042
Brief Title
Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria
Official Title
Impact of a Physical Health Promotion Program for People With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
February 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators
University of Barcelona

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
metabolic syndrome, lifestyle intervention, health promotion, mental health nurse, serious mental illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months. The group will attend a session per week.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Physical health promotion program
Intervention Description
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)
Primary Outcome Measure Information:
Title
Decrease of at least 3 of the 5 criteria of metabolic syndrome
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Metabolic syndrome prevalence
Description
expressed as a percentage
Time Frame
6 months
Title
use of antipsychotic
Description
Percentage of drugs prescribed by generic name
Time Frame
6 months
Title
Toxic habits
Description
Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse
Time Frame
6 months
Title
Quality of life improvement
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
university hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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