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

Bipolar Disorders Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729650
• Other study ID #: PI11/01861
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: August 31, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorders
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorders
• Schizophrenia
• Schizophrenic Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	Jordi Gol i Gurina Foundation	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Global Impression, CGI		the outcome measure is studied at 3, 6 and 12 months	Yes
Other	BPRS (Brief Psychiatric Rating Scale)		the outcome measure is studied at 3, 6 and 12 months	Yes
Primary	Change in weekly level of physical activity (IPAQ questionnaire),		: the outcome measure is studied at 3, 6 and 12 months	Yes
Primary	Body mass index (kg/m²)		: the outcome measure is studied at 3, 6 and 12 months	Yes
Primary	waist circumference (cm)		: the outcome measure is studied at 3, 6 and 12 months	Yes
Secondary	blood pressure (mm hg)		the outcome measure is studied at 3, 6 and 12 months	Yes
Secondary	cardiovascular risk with the Regicor coronary risk to 10 years		the outcome measure is studied at 3, 6 and 12 months	Yes
Secondary	Quality of life (SF-36 questionnaire)		the outcome measure is studied at 3, 6 and 12 months	Yes
Secondary	Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.		the outcome measure is studied at 3, 6 and 12 months	Yes
Secondary	Dietary habits (PREDIMED questionnaire)		the outcome measure is studied at 3, 6 and 12 months	Yes
Secondary	Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.		the outcome measure is studied at 3, 6 and 12 months	Yes