Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-29 @ 3:58 PM
Study NCT ID:
NCT02323802
Status:
UNKNOWN
Last Update Posted:
2014-12-23
First Post:
2014-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-18', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2014-12-18', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reduction of body weight', 'timeFrame': '6 months', 'description': 'The proportion of subjects with a 10% reduction in body weight at 6 months'}], 'secondaryOutcomes': [{'measure': 'Reduction of reinfarction and revascularization', 'timeFrame': '1 year'}, {'measure': 'general and specific mortality', 'timeFrame': '1 year', 'description': 'relative risk of death from all causes and from ischemic heart disease (no. of overall deaths and cardiovascular causes).'}, {'measure': 'quality of life', 'timeFrame': '6 months', 'description': 'quality of life (assessed by SF-36 questionnaire at baseline and 6 months after infarction).'}]}, 'conditionsModule': {'conditions': ['Obesity /Overweight', 'Acute Myocardial Infarction (STEMI/ NSTEMI)']}, 'descriptionModule': {'briefSummary': "Results after interventions on lifestyle in the secondary prevention of ischemic heart disease are not always consistent, and the Guidelines multidisciplinary measures aren't easily achievable.\n\nTherefore, the purpose of this research project is the identification of an interventional approach to effective secondary prevention and realistic feasibility, in a field of multifactorial risk. The study is open to patients who totaled a double chronic disease, obesity/overweight and coronary heart disease, and who experienced a first event of ischemic cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational intervention in a sample of overweight and obese patients (BMI \\> 24.9) incurred in a first episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic approach of prescriptive diet therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects of both sexes and age ≥ of 18 years consecutively admitted to the Coronary Unit of IRCCS Foundation Policlinico S. Matteo, at first episode of STEMI or non-STEMI AMI, with BMI greater than 24.9.\n\nExclusion Criteria:\n\nPatients who can not provide informed consent (because illiterate or with significant language barrier or severe deficit/cognitive decays). Subjects with diseases and/or disabling organ damage. Subjects affected by active neoplasm. Individuals who have submitted arhythmic complications in acute and/or heart failure, or people referring to post-AMI residential rehabilitation. Subjects that are carriers of severe psychiatric disorders diagnosed by DSM-V -TR.'}, 'identificationModule': {'nctId': 'NCT02323802', 'briefTitle': 'Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AMI-Obesity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'educational group intervention', 'description': 'The group educational food intervention: it provides the delivery of information leaflet and inclusion in groups on a weekly basis for the first 3 meetings, and then, there are other 2 meetings on the third and sixth month by the AMI.\n\nThe meetings will cover education to self-nutrition, physical activity and learning techniques for stimulus control and management of high-risk situations.', 'interventionNames': ['Behavioral: educational group intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prescriptive diet', 'description': 'An objectives food scheme elaborated for each patients will provide the reduction in caloric intake (equivalent to 500-600 calories in deficit if compared to the estimated daily requirement, based on the RDAs) and a reduced intake of lipids, which does not exceed 30% of total calories introduced, with a contribution of saturated fat no more than 7-9% .', 'interventionNames': ['Behavioral: prescriptive diet']}], 'interventions': [{'name': 'educational group intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['educational group intervention']}, {'name': 'prescriptive diet', 'type': 'BEHAVIORAL', 'armGroupLabels': ['prescriptive diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'PV', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Muggia, MD', 'role': 'CONTACT', 'email': 'c.muggia@smatteo.pv.it', 'phone': '+39 0382 502190'}, {'name': 'Chiara Muggia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Arturo Raisaro, MD', 'role': 'CONTACT', 'phone': '+39 0382 502587'}], 'facility': 'Cardiology department', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Chiara Muggia', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}