<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03292042</url>
  </required_header>
  <id_info>
    <org_study_id>109-17</org_study_id>
    <nct_id>NCT03292042</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria</brief_title>
  <official_title>Impact of a Physical Health Promotion Program for People With Serious Mental Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce&#xD;
      the risk of metabolic syndrome in patients with serious mental illness who receive treatment&#xD;
      with antipsychotic medications.&#xD;
&#xD;
      The hypothesis of the study is that: the application of a physical health promotion program&#xD;
      in people with serious mental illness, who receive treatment with antipsychotic medications,&#xD;
      carried out by a mental health nurse, will decrease the presence of metabolic syndrome and&#xD;
      contribute to improve their quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">February 2, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease of at least 3 of the 5 criteria of metabolic syndrome</measure>
    <time_frame>6 months</time_frame>
    <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 &lt;40 mg/dL in men or &lt;50 mg/dL in women (or receiving drug therapy for reduced HDL-C) Waist circumference ≥102 cm in men or ≥88 cm in women</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic syndrome prevalence</measure>
    <time_frame>6 months</time_frame>
    <description>expressed as a percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of antipsychotic</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of drugs prescribed by generic name</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxic habits</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life improvement</measure>
    <time_frame>6 months</time_frame>
    <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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will carry out the lifestyle intervention (Physical health promotion program) during 6 months.&#xD;
The group will attend a session per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical health promotion program</intervention_name>
    <description>The program has 24 sessions. Each session has two parts:&#xD;
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.&#xD;
Second part: 1 hour of physical activity (walk)</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic of serious mental illness.&#xD;
&#xD;
          -  Treatment with antipsychotics.&#xD;
&#xD;
          -  Met at least 3 of the 5 criteria of metabolic syndrome According to the NCEP ATP III&#xD;
             definition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical contraindications to exercise&#xD;
&#xD;
          -  Admitted to hospital.&#xD;
&#xD;
          -  intellectual disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>university hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metabolic syndrome</keyword>
  <keyword>lifestyle intervention</keyword>
  <keyword>health promotion</keyword>
  <keyword>mental health nurse</keyword>
  <keyword>serious mental illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03292042
org study id: 109-17
nct id: NCT03292042
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Decrease of at least 3 of the 5 criteria of metabolic syndrome
time frame: 6 months
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
measure: Metabolic syndrome prevalence
time frame: 6 months
description: expressed as a percentage
measure: use of antipsychotic
time frame: 6 months
description: Percentage of drugs prescribed by generic name
measure: Toxic habits
time frame: 6 months
description: Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse
measure: Quality of life improvement
time frame: 6 months
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).
arm group label: Experimental Group
arm group type: Experimental
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 group label: Control group
arm group type: No Intervention
description: usual care
intervention type: Behavioral
intervention name: Physical health promotion program
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)
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: Undecided