Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Other Outcome Measures
- Clinical Global Impression, CGI [the outcome measure is studied at 3, 6 and 12 months]
- BPRS (Brief Psychiatric Rating Scale) [the outcome measure is studied at 3, 6 and 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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age between 18 and 65 years old,
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understand Catalan or Spanish
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will be located for at least twelve months.
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Psychiatric disorders with ICD-10 diagnosis codes: F20*, F31* and F25*.
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Taking an antipsychotic drug at, a least, three months
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Low physical activity level
Exclusion Criteria:
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Active addiction to psychoactive drugs, except tobacco.
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Pregnancy
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Diseases that doesn't allow physical activity
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Psychotic acute exacerbation in the last month
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jordi Gol i Gurina Foundation | Barcelona | Spain | 08007 |
Sponsors and Collaborators
- Jordi Gol i Gurina Foundation
- Carlos III Health Institute
Investigators
- Principal Investigator: MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH, Jordi Gol i Gurina Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI11/01861