Abstract
Background: Patients with severe mental disorders have a higher prevalence of cardiovascular risk factors. Obesity and sedentarism are cardiovascular risk factors and their control reduces morbidity and mortality. Thus, interventions directed toward decreasing weight and/ or increasing the level of physical activity are necessary.Objectives: The aim of this study would be to evaluate the effectiveness of an educational intervention focused on diet and physical activity in order to change the amount of physical activity, Body Mass Index and waist circumference in these patients.Design: Randomized clinical trial with a control group with one-year follow-up.Setting: Outpatient Mental Health Teams of Barcelona and a residence for patients with severe mental disorders.Participants: Patients between 18 and 65 years of age diagnosed with schizophrenia, a schizoaffective disorder or bipolar disorder in treatment with antipsychotic medication and a low level of physical activity (240 patients in each randomized group).Intervention group: Physical activity group educational program of 24 sessions over 12 weeks and diet (16 sessions in the fist 8 weeks) carried out by nurses and physical activity specialists.Control group: Usual practice with regular checks and the usual treatment of their disease.Main outcome measures: Level of physical activity (IPAQ questionnaire), weight, Body Mass Index and waist circumference.Other outcomes: Cardiovascular risk, quality of life (SF-36 questionnaire), tobacco consumption, dietary habit (PREDIMED questionnaire), blood pressure and laboratory parameters (cholesterol, triglycerides, glucose).Evaluations will be masked and will be made at 0, 3, 6 and 12 months.Data analysis: Intention to treat analysis. Analysis of variance for repeated measures to adjust for differences attributable to the effect of the intervention for potential confounders (drug treatment, care level of intervention and mental status of the patient).Ethical aspects: The project has been evaluated and approved by the ethics committee (CEIC) of the Primary Healthcare-University Research Institute IDIAP Jordi Gol, with registration number P11/64.Trial registration: Clinicaltrials.gov NCT01729650.
Highlights
Patients with severe mental disorders have a higher prevalence of cardiovascular risk factors
It was decided to calculate the sample size using the Body mass index (BMI) because we found quite a bit of literature in which this measure was used
The increased mortality in patients with severe mental illness is due in large part to the increased presence of cardiovascular risk factors
Summary
Patients with severe mental disorders have a higher prevalence of cardiovascular risk factors. Despite being a predominantly young population, in comparison to the general population, these patients have a significantly higher presence of cardiovascular risk factors [CVRF] such as smoking, obesity, dyslipidemia, diabetes mellitus or metabolic syndrome [MS] [2, 3] along with a decrease in life expectancy of between 10 and 25 years [4] This increased risk is due to the interaction of multiple etiological factors [5]: Genetic predisposition [6], environmental factors due to unhealthy lifestyles (bad dietary habits, smoking and sedentarism) [7] and the increasingly evident contribution of antipsychotic drugs in metabolism disorders, especially clozapine and olanzapine [8]. They are associated with many other diseases
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