Jordi Gol i Gurina Foundation
Barcelona, 08007, Spain
NCT Number: NCT01729650
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Barcelona, 08007, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: : the outcome measure is studied at 3, 6 and 12 months
Time frame: : the outcome measure is studied at 3, 6 and 12 months
Time frame: : the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Time frame: the outcome measure is studied at 3, 6 and 12 months
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Other
Effectiveness of a Physical Activity and Diet Program, Coordinated Between Primary Care and Mental Health, to Modify Cardiovascular Risk Factors in Patients With Schizophrenia or Bipolar Disorder (CapiCor)
Acronym: CapiCor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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