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

Primary Purpose

Schizophrenic Disorders, Schizoaffective Disorders, Bipolar Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical and diet educational group
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenic Disorders focused on measuring Psychotic Disorders,, Heart Diseases

Eligibility Criteria

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

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

Sites / Locations

  • Jordi Gol i Gurina Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical and diet educational group

Usual clinical care

Arm 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.

Outcomes

Primary Outcome Measures

Change in weekly level of physical activity (IPAQ questionnaire),
Body mass index (kg/m²)
waist circumference (cm)

Secondary Outcome Measures

blood pressure (mm hg)
cardiovascular risk with the Regicor coronary risk to 10 years
Quality of life (SF-36 questionnaire)
Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.
Dietary habits (PREDIMED questionnaire)
Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.

Full Information

First Posted
November 14, 2012
Last Updated
August 31, 2016
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Carlos III Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01729650
Brief Title
Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)
Acronym
CapiCor
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Carlos III Health Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenic Disorders, Schizoaffective Disorders, Bipolar Disorders
Keywords
Psychotic Disorders,, Heart Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical and diet educational group
Arm Type
Experimental
Arm 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 Title
Usual clinical care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical and diet educational group
Intervention 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.
Primary Outcome Measure Information:
Title
Change in weekly level of physical activity (IPAQ questionnaire),
Time Frame
: the outcome measure is studied at 3, 6 and 12 months
Title
Body mass index (kg/m²)
Time Frame
: the outcome measure is studied at 3, 6 and 12 months
Title
waist circumference (cm)
Time Frame
: the outcome measure is studied at 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
blood pressure (mm hg)
Time Frame
the outcome measure is studied at 3, 6 and 12 months
Title
cardiovascular risk with the Regicor coronary risk to 10 years
Time Frame
the outcome measure is studied at 3, 6 and 12 months
Title
Quality of life (SF-36 questionnaire)
Time Frame
the outcome measure is studied at 3, 6 and 12 months
Title
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
Title
Dietary habits (PREDIMED questionnaire)
Time Frame
the outcome measure is studied at 3, 6 and 12 months
Title
Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
Time Frame
the outcome measure is studied at 3, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Clinical Global Impression, CGI
Time Frame
the outcome measure is studied at 3, 6 and 12 months
Title
BPRS (Brief Psychiatric Rating Scale)
Time Frame
the outcome measure is studied at 3, 6 and 12 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH
Organizational Affiliation
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordi Gol i Gurina Foundation
City
Barcelona
ZIP/Postal Code
08007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26521223
Citation
Masa-Font R, Fernandez-San-Martin MI, Martin Lopez LM, Alba Munoz AM, Oller Canet S, Martin Royo J, San Emeterio Echevarria L, Olona Tabuena N, Ibarra Jato M, Barroso Garcia A, Gonzalez Tejon S, Tajada Vitales C, Diaz Mujica B, Vinas Cabrera L, Sanchis Catalan R, Salvador Barbarroja T. The effectiveness of a program of physical activity and diet to modify cardiovascular risk factors in patients with severe mental illness after 3-month follow-up: CAPiCOR randomized clinical trial. Eur Psychiatry. 2015 Nov;30(8):1028-36. doi: 10.1016/j.eurpsy.2015.09.006. Epub 2015 Oct 30. Erratum In: Eur Psychiatry. 2017 Mar;41:e1.
Results Reference
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Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)

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