Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT03579420
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 226}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-06-25', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c at 6 months', 'timeFrame': '6 months'}, {'measure': 'Treatment success at 6 months', 'timeFrame': '6 months', 'description': 'HbA1c within predefined target without any increase in pharmacological therapy'}], 'secondaryOutcomes': [{'measure': 'Treatment success at 24 months', 'timeFrame': '24 months', 'description': 'HbA1c within predefined target without any increase in pharmacological therapy'}, {'measure': 'HbA1c at 24 months', 'timeFrame': '24 months'}, {'measure': 'MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores', 'timeFrame': '24 months', 'description': '14-item questionnaire with scores ranging from 0 (low adherence) to 18 (high adherence)'}, {'measure': 'International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores', 'timeFrame': '24 months', 'description': '7-item questionnaire with scores ranging from 0 (no activity) to 7 (high activity)'}, {'measure': 'Well-being Enquiry in Diabetics (WED) questionnaire total score', 'timeFrame': '24 months', 'description': '50-item questionnaire measuring diabetes-specific health-related quality of life, with scores ranging from 0 (low) to 50 (high). Only total score will be used in analysis 1. Mannucci E, et al., Diabetes Nutr Metab 9: 89-102, 1996).'}, {'measure': 'Body Mass Index', 'timeFrame': '6 months'}, {'measure': 'Waist circumference', 'timeFrame': '6 months'}, {'measure': 'Body Mass Index', 'timeFrame': '24 months'}, {'measure': 'Waist circumference', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The study will compare two different programs for lifestyle intervention in type 2 diabetes:\n\n1. A brief group program, with three weekly sessions\n2. A longer group program, with six weekly sessions, which has been routinely used for the management of type 2 diabetic patients in this hospital for several years.\n\nThe aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* HbA1c between 48 and 75 mmol/mol\n\nExclusion Criteria:\n\n* Axis I Mental Disorders\n* Heart failure (NYHA Class III or IV)\n* Foot ulcers or lower limb amputations'}, 'identificationModule': {'nctId': 'NCT03579420', 'briefTitle': 'Efficacy of a Brief Lifestyle Intervention in Type 2 Diabetes, Compared With a Longer Group Educational Program', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Efficacy of a Brief Group Program Versus a Longer Structured Program for Therapeutic Education of Patients With Type 2 Diabetes.', 'orgStudyIdInfo': {'id': 'bPEGT2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief lifestyle program', 'description': '3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach', 'interventionNames': ['Behavioral: Brief lifestyle program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional lifestyle longer program', 'description': '6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods', 'interventionNames': ['Behavioral: Conventional lifestyle program']}], 'interventions': [{'name': 'Brief lifestyle program', 'type': 'BEHAVIORAL', 'description': '3-session program for modification of lifestyle habits (exercise and diet)', 'armGroupLabels': ['Brief lifestyle program']}, {'name': 'Conventional lifestyle program', 'type': 'BEHAVIORAL', 'description': '6-session program for modification of lifestyle habits (exercise and diet)', 'armGroupLabels': ['Traditional lifestyle longer program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Monami, MD', 'role': 'CONTACT', 'email': 'matteo.monami@unifi.it', 'phone': '3384027484'}], 'facility': 'Diabetologia AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'centralContacts': [{'name': 'Mattreo Monami, MD', 'role': 'CONTACT', 'email': 'matteo.monami@unifi.it', 'phone': '3384027484'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Diabetology', 'investigatorFullName': 'Edoardo Mannucci', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria Careggi'}}}}