Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-25 @ 6:33 AM
Study NCT ID:
NCT01729650
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2012-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2012-11-14', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical Global Impression, CGI', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'BPRS (Brief Psychiatric Rating Scale)', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}], 'primaryOutcomes': [{'measure': 'Change in weekly level of physical activity (IPAQ questionnaire),', 'timeFrame': ': the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'Body mass index (kg/m²)', 'timeFrame': ': the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'waist circumference (cm)', 'timeFrame': ': the outcome measure is studied at 3, 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'blood pressure (mm hg)', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'cardiovascular risk with the Regicor coronary risk to 10 years', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'Quality of life (SF-36 questionnaire)', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'Smoking habits: smoker/ ex-smoker/no-smoker. Number of cigarettes per day.', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'Dietary habits (PREDIMED questionnaire)', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}, {'measure': 'Analytical parameters: cholesterol , triglycerides, blood glucose mg/100 ml.', 'timeFrame': 'the outcome measure is studied at 3, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychotic Disorders,', 'Heart Diseases'], 'conditions': ['Schizophrenic Disorders', 'Schizoaffective Disorders', 'Bipolar Disorders']}, 'referencesModule': {'references': [{'pmid': '26521223', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age between 18 and 65 years old,\n* understand Catalan or Spanish\n* will be located for at least twelve months.\n* Psychiatric disorders with ICD-10 diagnosis codes: F20\\*, F31\\* and F25\\*.\n* Taking an antipsychotic drug at, a least, three months\n* Low physical activity level\n\nExclusion Criteria:\n\n* Active addiction to psychoactive drugs, except tobacco.\n* Pregnancy\n* Diseases that doesn't allow physical activity\n* Psychotic acute exacerbation in the last month"}, 'identificationModule': {'nctId': 'NCT01729650', 'acronym': 'CapiCor', 'briefTitle': 'Effectiveness of a Physical Activity and Diet Program in Patients With Psychotic Disorder (CapiCor)', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'PI11/01861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical and diet educational group', 'description': '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.', 'interventionNames': ['Behavioral: Physical and diet educational group']}, {'type': 'NO_INTERVENTION', 'label': 'Usual clinical care'}], 'interventions': [{'name': 'Physical and diet educational group', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Physical and diet educational group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08007', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Jordi Gol i Gurina Foundation', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'MARIA-ISABEL FERNANDEZ-SAN-MARTIN, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Carlos III Health Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}