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NCT Number: NCT01729650

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordi Gol i Gurina Foundation

Barcelona, 08007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 65 years old,
  • understand Catalan or Spanish
  • will be located for at least twelve months.
  • Psychiatric disorders with ICD-10 diagnosis codes: F20*, F31* and F25*.
  • Taking an antipsychotic drug at, a least, three months
  • Low physical activity level

Exclusion criteria

  • Active addiction to psychoactive drugs, except tobacco.
  • Pregnancy
  • Diseases that doesn't allow physical activity
  • Psychotic acute exacerbation in the last month

Treatment and study plan

Physical and diet educational group

Behavioral

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.

Primary outcomes

  1. Change in weekly level of physical activity (IPAQ questionnaire),

    Time frame: : the outcome measure is studied at 3, 6 and 12 months

  2. Body mass index (kg/m²)

    Time frame: : the outcome measure is studied at 3, 6 and 12 months

  3. waist circumference (cm)

    Time frame: : the outcome measure is studied at 3, 6 and 12 months

Secondary outcomes

  1. blood pressure (mm hg)

    Time frame: the outcome measure is studied at 3, 6 and 12 months

  2. cardiovascular risk with the Regicor coronary risk to 10 years

    Time frame: the outcome measure is studied at 3, 6 and 12 months

  3. Quality of life (SF-36 questionnaire)

    Time frame: the outcome measure is studied at 3, 6 and 12 months

  4. 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

  5. Dietary habits (PREDIMED questionnaire)

    Time frame: the outcome measure is studied at 3, 6 and 12 months

  6. Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.

    Time frame: the outcome measure is studied at 3, 6 and 12 months

Other outcomes

  1. Clinical Global Impression, CGI

    Time frame: the outcome measure is studied at 3, 6 and 12 months

  2. BPRS (Brief Psychiatric Rating Scale)

    Time frame: the outcome measure is studied at 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2012
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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