<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/NCT01729650</url>
  </required_header>
  <id_info>
    <org_study_id>PI11/01861</org_study_id>
    <nct_id>NCT01729650</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)</brief_title>
  <acronym>CapiCor</acronym>
  <official_title>Effectiveness of a Physical Activity and Diet Program, Coordinated Between Primary Care and Mental Health, to Modify Cardiovascular Risk Factors in Patients With Schizophrenia or Bipolar Disorder (CapiCor)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carlos III Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim is to evaluate the effectiveness of an intervention based on a program of physical&#xD;
      activity and diet coordinated between primary care teams (PCT) and Mental Health Centres&#xD;
      (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist&#xD;
      circumference in patients with severe mental disorder diagnoses. To assess changes in&#xD;
      cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized&#xD;
      clinical trial with a control group, of one year of follow-up, carried out in four MHC&#xD;
      Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18&#xD;
      - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with&#xD;
      antipsychotic medication and a low level of PA. 240 patients will be selected in each group&#xD;
      (difference to be detected in the BMI:&gt; 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention:&#xD;
      group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8&#xD;
      sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of PA&#xD;
      (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure,&#xD;
      cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED&#xD;
      questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose.&#xD;
      Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for&#xD;
      repeated measures to adjust for differences attributable to the effect of the intervention&#xD;
      for potential confounders: pharmacological treatment, care level of intervention and mental&#xD;
      state.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in weekly level of physical activity (IPAQ questionnaire),</measure>
    <time_frame>: the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body mass index (kg/m²)</measure>
    <time_frame>: the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>waist circumference (cm)</measure>
    <time_frame>: the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood pressure (mm hg)</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiovascular risk with the Regicor coronary risk to 10 years</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36 questionnaire)</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary habits (PREDIMED questionnaire)</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Global Impression, CGI</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BPRS (Brief Psychiatric Rating Scale)</measure>
    <time_frame>the outcome measure is studied at 3, 6 and 12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">332</enrollment>
  <condition>Schizophrenic Disorders</condition>
  <condition>Schizoaffective Disorders</condition>
  <condition>Bipolar Disorders</condition>
  <arm_group>
    <arm_group_label>Physical and diet educational group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks), carried out by mental health nurses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual clinical care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical and diet educational group</intervention_name>
    <description>educational group of: physical activity program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks, carried out by mental health nurses.</description>
    <arm_group_label>Physical and diet educational group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 65 years old,&#xD;
&#xD;
          -  understand Catalan or Spanish&#xD;
&#xD;
          -  will be located for at least twelve months.&#xD;
&#xD;
          -  Psychiatric disorders with ICD-10 diagnosis codes: F20*, F31* and F25*.&#xD;
&#xD;
          -  Taking an antipsychotic drug at, a least, three months&#xD;
&#xD;
          -  Low physical activity level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active addiction to psychoactive drugs, except tobacco.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diseases that doesn't allow physical activity&#xD;
&#xD;
          -  Psychotic acute exacerbation in the last month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jordi Gol i Gurina Foundation</name>
      <address>
        <city>Barcelona</city>
        <zip>08007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>August 31, 2016</last_update_submitted>
  <last_update_submitted_qc>August 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychotic Disorders,</keyword>
  <keyword>Heart Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729650
org study id: PI11/01861
nct id: NCT01729650
lead sponsor: 
collaborator: 
has dmc: No
The aim is to evaluate the effectiveness of an intervention based on a program of physical
      activity and diet coordinated between primary care teams (PCT) and Mental Health Centres
      (MHC) to modify the weekly physical activity (PA) amount, body mass index (BMI) and waist
      circumference in patients with severe mental disorder diagnoses. To assess changes in
      cardiovascular risk, quality of life and lifestyles, secondarily. Methods: A randomized
      clinical trial with a control group, of one year of follow-up, carried out in four MHC
      Barcelona and Santa Coloma, and PCT of reference. The investigators studied patients aged 18
      - 65 years old, diagnosed with schizophrenia, schizoaffective or bipolar disorder, with
      antipsychotic medication and a low level of PA. 240 patients will be selected in each group
      (difference to be detected in the BMI:> 1.89 kg/m2; common SD: 6.2, 30% loss). Intervention:
      group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (8
      sessions in the first 8 weeks) by nurses and specialists in PA. Key measurements: level of PA
      (IPAQ questionnaire), physical examinations: BMI, waist circumference, blood pressure,
      cardiovascular risk, quality of life (SF-36), smoking habits, dietary habits (PREDIMED
      questionnaire), analytical parameters: cholesterol , triglycerides, blood glucose.
      Evaluations will be masked and conducted at 0, 3, 6 and 12 months. Analysis of variance for
      repeated measures to adjust for differences attributable to the effect of the intervention
      for potential confounders: pharmacological treatment, care level of intervention and mental
      state.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in weekly level of physical activity (IPAQ questionnaire),
time frame: : the outcome measure is studied at 3, 6 and 12 months
measure: Body mass index (kg/m²)
time frame: : the outcome measure is studied at 3, 6 and 12 months
measure: waist circumference (cm)
time frame: : the outcome measure is studied at 3, 6 and 12 months
measure: blood pressure (mm hg)
time frame: the outcome measure is studied at 3, 6 and 12 months
measure: cardiovascular risk with the Regicor coronary risk to 10 years
time frame: the outcome measure is studied at 3, 6 and 12 months
measure: Quality of life (SF-36 questionnaire)
time frame: the outcome measure is studied at 3, 6 and 12 months
measure: Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.
time frame: the outcome measure is studied at 3, 6 and 12 months
measure: Dietary habits (PREDIMED questionnaire)
time frame: the outcome measure is studied at 3, 6 and 12 months
measure: Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
time frame: the outcome measure is studied at 3, 6 and 12 months
measure: Clinical Global Impression, CGI
time frame: the outcome measure is studied at 3, 6 and 12 months
measure: BPRS (Brief Psychiatric Rating Scale)
time frame: the outcome measure is studied at 3, 6 and 12 months
arm group label: Physical and diet educational group
arm group type: Experimental
description: group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks), carried out by mental health nurses.
arm group label: Usual clinical care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Physical and diet educational group
description: educational group of: physical activity program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks, carried out by mental health nurses.
arm group label: Physical and diet educational group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH
role: Principal Investigator
affiliation: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Bipolar Disorder
mesh term: Psychotic Disorders
mesh term: Schizophrenia