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

NCT01729650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2016-09-01

No results posted yet for this study

Summary

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.

Conditions

  • Schizophrenic Disorders
  • Schizoaffective Disorders
  • Bipolar Disorders

Interventions

BEHAVIORAL

Physical and diet educational group

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.

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH · Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01729650 on ClinicalTrials.gov