The effectiveness of a program of physical activity and diet to modify cardiovascular risk factors in patients with severe mental illness (CAPiCOR Study)

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 t reatment 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 o f 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.