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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Schizoaffective Disorders; Schizophrenic Disorders; Bipolar Disorders

Treatments: Behavioral: Physical and diet educational group

Study type: Interventional

Funder types: Other

Identifiers

NCT01729650

PI11/01861

Details and patient eligibility

About

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.

Enrollment: 332 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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332 participants in 2 patient groups

Physical and diet educational group

Experimental group

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.

Treatment:

Behavioral: Physical and diet educational group

Usual clinical care

No Intervention group