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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Schizophrenic Disorders, Schizoaffective Disorders, Bipolar Disorders

Intervention / Treatment
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* Behavioral: Physical and diet educational group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical and diet educational group<br>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<br>* 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.<br>|
| No Intervention: Usual clinical care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weekly level of physical activity (IPAQ questionnaire), |  | : the outcome measure is studied at 3, 6 and 12 months | 
| Body mass index (kg/m²) |  | : the outcome measure is studied at 3, 6 and 12 months | 
| waist circumference (cm) |  | : the outcome measure is studied at 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure (mm hg) |  | the outcome measure is studied at 3, 6 and 12 months | 
| cardiovascular risk with the Regicor coronary risk to 10 years |  | the outcome measure is studied at 3, 6 and 12 months | 
| Quality of life (SF-36 questionnaire) |  | the outcome measure is studied at 3, 6 and 12 months | 
| Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day. |  | the outcome measure is studied at 3, 6 and 12 months | 
| Dietary habits (PREDIMED questionnaire) |  | the outcome measure is studied at 3, 6 and 12 months | 
| Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml. |  | the outcome measure is studied at 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotic Disorders,, Heart Diseases