Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-28 @ 8:22 AM
Study NCT ID:
NCT01028066
Status:
UNKNOWN
Last Update Posted:
2009-12-11
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feeding Education in Patients Submitted to Coronary Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-10', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes)', 'timeFrame': '1 year (all outcomes) and 3 years (all outcomes)'}], 'secondaryOutcomes': [{'measure': '- Evaluate changes in eating habits, according to the transtheoretical model to adopt healthy eating habits - Check change in food intake - Identify the nutritional status and cardiovascular risk', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nutritional intervention', 'nutritional counseling', 'feeding behavior', 'food consumption', 'angioplasty'], 'conditions': ['Coronary Angioplasty', 'Coronary Disease']}, 'descriptionModule': {'briefSummary': 'The simple knowledge that practices healthy lifestyle are important to reduce or prevent the progression of cardiovascular diseases it is not enough for effective changes accordingly. To nutritional education be successful, needs to promote changes in eating habits and not just transmit information. This is a behavioral intervention study in 200 consecutive patients submitted to percutaneous transluminary coronary angioplasty. The participants were randomized in two groups: intervention and control.\n\nThe intervention was a dialogic nutritional counseling and the control arm was a traditional nutritional counseling.\n\nAll participants will undergo long-term follow-up for cardiovascular events.', 'detailedDescription': 'Patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease.\n\nAll data were obtained by a trained nutritionist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preserved cognitive status\n\nExclusion Criteria:\n\n* no availability to attend the meetings of nutritional guidance'}, 'identificationModule': {'nctId': 'NCT01028066', 'acronym': 'PTCA-Nutri', 'briefTitle': 'Feeding Education in Patients Submitted to Coronary Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CAPPesq 0443/07'}, 'secondaryIdInfos': [{'id': 'FAPESP 2007/54652-8'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional', 'description': 'Traditional nutritional counseling', 'interventionNames': ['Other: Traditional']}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral', 'description': 'Dialogic nutritional counseling', 'interventionNames': ['Behavioral: Behavioral']}], 'interventions': [{'name': 'Traditional', 'type': 'OTHER', 'description': 'The control group will have access to the nutritionist to clear any doubts about the diet prescribed when went out the hospital and will be invited to attend a meeting nutrition in dialogic character at the end of 1 year to ensure fairness in action.', 'armGroupLabels': ['Traditional']}, {'name': 'Behavioral', 'type': 'BEHAVIORAL', 'description': 'The intervention group will go through 4 meetings of food education, to be held within the institution, with approximately 1 hour long, composed of 3 to 8 patients, who may or may not be accompanied by a relative. The first three meetings will be monthly and the fourth will be 6 months after the last one. Each meeting will be developed within the context of dialogic and participatory education, directed to the adoption of a healthy diet and prevention and control of cardiovascular risk factors. The meetings will follow the order: Investigation, Contextualization, Awareness and Strengthening the nutritional concepts, according to the didactics of educator Paulo Freire.', 'armGroupLabels': ['Behavioral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Moacyr Roberto Cucê Nobre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute HCFMUSP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Moacyr Roberto Cucê Nobre', 'oldOrganization': 'Heart Institute (InCor) HCFMUSP'}}}}