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Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor) (CapiCor)

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ClinicalTrials.gov Identifier: NCT01729650
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : September 1, 2016
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenic Disorders Schizoaffective Disorders Bipolar Disorders Behavioral: Physical and diet educational group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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)
Study Start Date : June 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Physical and diet educational group
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.
Behavioral: Physical and diet educational group
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.

No Intervention: Usual clinical care



Primary Outcome Measures :
  1. Change in weekly level of physical activity (IPAQ questionnaire), [ Time Frame: : the outcome measure is studied at 3, 6 and 12 months ]
  2. Body mass index (kg/m²) [ Time Frame: : the outcome measure is studied at 3, 6 and 12 months ]
  3. waist circumference (cm) [ Time Frame: : the outcome measure is studied at 3, 6 and 12 months ]

Secondary Outcome Measures :
  1. blood pressure (mm hg) [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ]
  2. cardiovascular risk with the Regicor coronary risk to 10 years [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ]
  3. Quality of life (SF-36 questionnaire) [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ]
  4. 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 ]
  5. Dietary habits (PREDIMED questionnaire) [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ]
  6. Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml. [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ]

Other Outcome Measures:
  1. Clinical Global Impression, CGI [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ]
  2. BPRS (Brief Psychiatric Rating Scale) [ Time Frame: the outcome measure is studied at 3, 6 and 12 months ]


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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:

  • age between 18 and 65 years old,
  • understand Catalan or Spanish
  • will be located for at least twelve months.
  • Psychiatric disorders with ICD-10 diagnosis codes: F20*, F31* and F25*.
  • Taking an antipsychotic drug at, a least, three months
  • Low physical activity level

Exclusion Criteria:

  • Active addiction to psychoactive drugs, except tobacco.
  • Pregnancy
  • Diseases that doesn't allow physical activity
  • Psychotic acute exacerbation in the last month

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): NCT01729650


Locations
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Spain
Jordi Gol i Gurina Foundation
Barcelona, Spain, 08007
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Carlos III Health Institute
Investigators
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Principal Investigator: MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH Jordi Gol i Gurina Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01729650    
Other Study ID Numbers: PI11/01861
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Keywords provided by Jordi Gol i Gurina Foundation:
Psychotic Disorders,
Heart Diseases
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders