Schizophrenic DisordersCapiCorNCT01729650
Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)
A study testing Physical and diet educational group in people with Schizophrenic Disorders and Schizoaffective Disorders, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenic Disorders, Schizoaffective Disorders, Bipolar Disorders
- What is being tested?
- Physical and diet educational group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active addiction to psychoactive drugs, except tobacco.
- Pregnancy
- Diseases that doesn't allow physical activity
- Psychotic acute exacerbation in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
- Being tested
- Physical and diet educational group
- Keywords
- Psychotic Disorders,, Heart Diseases
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical and diet educational groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical and diet educational group | Experimental | group educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks), carried out by mental health nurses. Receives: Behavioral: Physical and diet educational group |
| Usual clinical care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly level of physical activity (IPAQ questionnaire),
Measured: : the outcome measure is studied at 3, 6 and 12 months
Body mass index (kg/m²)
Measured: : the outcome measure is studied at 3, 6 and 12 months
waist circumference (cm)
Measured: : the outcome measure is studied at 3, 6 and 12 months
Secondary outcomes (6)
blood pressure (mm hg)
Measured: the outcome measure is studied at 3, 6 and 12 months
cardiovascular risk with the Regicor coronary risk to 10 years
Measured: the outcome measure is studied at 3, 6 and 12 months
Quality of life (SF-36 questionnaire)
Measured: the outcome measure is studied at 3, 6 and 12 months
Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.
Measured: the outcome measure is studied at 3, 6 and 12 months
Dietary habits (PREDIMED questionnaire)
Measured: the outcome measure is studied at 3, 6 and 12 months
Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
Measured: the outcome measure is studied at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729650
- Sponsor's protocol ID
- PI11/01861
- Acronym
- CapiCor
- Status last verified
- Aug 2016
- First submitted
- 14 Nov 2012
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Masa-Font R, Fernandez-San-Martin MI, Martin Lopez LM, Alba Munoz AM, Oller Canet S, Martin Royo J, San Emeterio Echevarria L, Olona Tabuena N, Ibarra Jato M, Barroso Garcia A, Gonzalez Tejon S, Tajada Vitales C, Diaz Mujica B, Vinas Cabrera L, Sanchis Catalan R, Salvador Barbarroja T. The effectiveness of a program of physical activity and diet to modify cardiovascular risk factors in patients with severe mental illness after 3-month follow-up: CAPiCOR randomized clinical trial. Eur Psychiatry. 2015 Nov;30(8):1028-36. doi: 10.1016/j.eurpsy.2015.09.006. Epub 2015 Oct 30.
PubMed 26521223
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01729650
- Acronym / sponsor ID
- CapiCor / PI11/01861
- Keywords
- Psychotic Disorders,, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical and diet educational group | Experimental | Behavioral: Physical and diet educational groupgroup educational PA program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks), carried out by mental health nurses. |
| Usual clinical care | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Active addiction to psychoactive drugs, except tobacco.
- Pregnancy
- Diseases that doesn't allow physical activity
- Psychotic acute exacerbation in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical and diet educational groupeducational 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. | Behavioural | Physical and diet educational group |
Primary outcome
Change in weekly level of physical activity (IPAQ questionnaire),
Time frame: : the outcome measure is studied at 3, 6 and 12 months
Body mass index (kg/m²)
Time frame: : the outcome measure is studied at 3, 6 and 12 months
waist circumference (cm)
Time frame: : the outcome measure is studied at 3, 6 and 12 months
6 secondary outcomes
blood pressure (mm hg)
Time frame: the outcome measure is studied at 3, 6 and 12 months
cardiovascular risk with the Regicor coronary risk to 10 years
Time frame: the outcome measure is studied at 3, 6 and 12 months
Quality of life (SF-36 questionnaire)
Time frame: the outcome measure is studied at 3, 6 and 12 months
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
Dietary habits (PREDIMED questionnaire)
Time frame: the outcome measure is studied at 3, 6 and 12 months
Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.
Time frame: the outcome measure is studied at 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Derived from this study: PubMed 26521223Masa-Font R, Fernandez-San-Martin MI, Martin Lopez LM, Alba Munoz AM, Oller Canet S, Martin Royo J, San Emeterio Echevarria L, Olona Tabuena N, Ibarra Jato M, Barroso Garcia A, Gonzalez Tejon S, Tajada Vitales C, Diaz Mujica B, Vinas Cabrera L, Sanchis Catalan R, Salvador Barbarroja T. The effectiveness of a program of physical activity and diet to modify cardiovascular risk factors in patients with severe mental illness after 3-month follow-up: CAPiCOR randomized clinical trial. Eur Psychiatry. 2015 Nov;30(8):1028-36. doi: 10.1016/j.eurpsy.2015.09.006. Epub 2015 Oct 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical and diet educational group in people with Schizophrenic Disorders and Schizoaffective Disorders, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly level of physical activity (IPAQ questionnaire), (time frame: : the outcome measure is studied at 3, 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016; AzTrials last refreshed its copy on 4 Nov 2026.