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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
332
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.
Jordi Gol i Gurina Foundation
Barcelona, Barcelona, Spain
Change in weekly level of physical activity (IPAQ questionnaire),
Time frame: : the outcome measure is studied at 3, 6 and 12 months
Body mass index (kg/m²)
Time frame: : the outcome measure is studied at 3, 6 and 12 months
waist circumference (cm)
Time frame: : the outcome measure is studied at 3, 6 and 12 months
blood pressure (mm hg)
Time frame: the outcome measure is studied at 3, 6 and 12 months
cardiovascular risk with the Regicor coronary risk to 10 years
Time frame: the outcome measure is studied at 3, 6 and 12 months
Quality of life (SF-36 questionnaire)
Time frame: the outcome measure is studied at 3, 6 and 12 months
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
Dietary habits (PREDIMED questionnaire)
Time frame: the outcome measure is studied at 3, 6 and 12 months
Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
Time frame: the outcome measure is studied at 3, 6 and 12 months
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