Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT01858506
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2013-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Lifestyle Assessment and Educational Tools
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': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2013-05-12', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medical regimen for diabetes management', 'timeFrame': 'Baseline, 1st, 2nd, 3rd, 6th, and 12th month.', 'description': 'Medical regimen for diabetes management, i.e. self-reported medical treatment for diabetes.'}], 'primaryOutcomes': [{'measure': 'Change in lifestyle knowledge', 'timeFrame': 'Baseline, 3rd,6th,12th months', 'description': 'Change in diabetes-related lifestyle (diet and physical activity) knowledge, will be assessed with a diet knowledge questionnaire specially adapted for this population. Change in physical activity knowledge will be measured with the SKILLD diabetes knowledge questionnaire.'}], 'secondaryOutcomes': [{'measure': "Patients' lifestyle monitoring", 'timeFrame': '1st,2nd,3rd,6th months', 'description': 'Patient engagement in monitoring diet intake and physical activity, assessed with 3-day dietary and physical activity records.'}, {'measure': 'Dietary and physical activity behaviours', 'timeFrame': 'Baseline and 12 months.', 'description': 'Dietary and physical activity behaviours, assessed with food frequency and physical activity questionnaires.'}, {'measure': 'SBGM practices', 'timeFrame': '1st, 2nd, 3rd, 6th, 12th months.', 'description': "Self Blood Glucose Monitoring practices. Information will be downloaded from the blood glucose meters' memory."}, {'measure': 'Glycaemic control', 'timeFrame': 'Baseline, 3rd,6th, and 12th months.', 'description': 'Glycaemic control, assessed with HbA1c levels.'}, {'measure': 'Weight and waist circumference', 'timeFrame': 'Baseline, 3rd, 6th, and 12th months.', 'description': 'Change of weight and waist circumference during follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes mellitus', 'Lifestyle counselling', 'Lifestyle assessment', 'Randomized controlled trial', 'Diabetes education'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31621640', 'type': 'DERIVED', 'citation': 'Abu-Saad K, Murad H, Barid R, Olmer L, Ziv A, Younis-Zeidan N, Kaufman-Shriqui V, Gillon-Keren M, Rigler S, Berchenko Y, Kalter-Leibovici O. Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus. J Med Internet Res. 2019 Oct 16;21(10):e13674. doi: 10.2196/13674.'}]}, 'descriptionModule': {'briefSummary': "Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and education among Arab people with diabetes who have varying literacy skills using an interactive computerized tool and graphically-enhanced patient logs for dietary and physical activity.\n\nThe investigators hypothesize that this tool will: a) increase patients' knowledge and understanding of the role of lifestyle (diet and physical activity) in diabetes management; b) improve patients' engagement in monitoring dietary intake and physical activity; c) improve dietary and physical activity behaviors and self-blood glucose monitoring (SBGM) practices; d) improve glycemic control; and, e) improve the efficiency of lifestyle assessment, education and counseling while increasing patients' engagement in the process.", 'detailedDescription': "Aim: To evaluate a culturally-adapted method of lifestyle assessment, counseling, and education among Arab people with diabetes who have varying literacy skills using an interactive computerized tool and graphically-enhanced patient logs for dietary and physical activity. The investigators will evaluate the effectiveness of this method for: a) increasing patients' knowledge and understanding of the role of lifestyle (diet and physical activity) in diabetes management; b) improving patients' engagement in monitoring dietary intake and physical activity; c) improving dietary and physical activity behaviors and self-blood glucose monitoring (SBGM) practices; d) improving glycaemic control; and, e) improving the efficiency of lifestyle assessment, education and counseling while increasing patients' engagement in the process."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40-64 years old\n* BMI 27-45 kg/m2\n* Diagnosis of type 2 diabetes mellitus in medical record\n* HbA1c 8.0%-11.5%\n\nExclusion Criteria:\n\n* Short-acting insulin treatment\n* Inadequate control of co-morbid conditions\n* Factors that may limit adherence to interventions (e.g., any medical or physical condition that limits the ability to participate in physical activity or standard diets recommended for people with diabetes, pregnancy, uncontrolled psychiatric condition, significant cognitive impairment, blindness).'}, 'identificationModule': {'nctId': 'NCT01858506', 'acronym': 'I-ACE', 'briefTitle': 'Diabetes Lifestyle Assessment and Educational Tools', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Development and Evaluation of Lifestyle Assessment and Educational Tools for Diabetic People With Limited Literacy', 'orgStudyIdInfo': {'id': 'EFSD_I-ACE'}, 'secondaryIdInfos': [{'id': '8677-11-SMC', 'type': 'OTHER', 'domain': 'Sheba Medical Center Helsinki Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I-ACE intervention arm', 'description': 'lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.', 'interventionNames': ['Procedure: I-ACE intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard lifestyle advice arm', 'description': 'lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.', 'interventionNames': ['Procedure: Standard Lifestyle Advice']}], 'interventions': [{'name': 'I-ACE intervention', 'type': 'PROCEDURE', 'description': 'lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.', 'armGroupLabels': ['I-ACE intervention arm']}, {'name': 'Standard Lifestyle Advice', 'type': 'PROCEDURE', 'description': 'lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.', 'armGroupLabels': ['Standard lifestyle advice arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hadera', 'country': 'Israel', 'facility': 'Clalit Health Services, Shomron administration', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Ofra Kalter-Leibovici, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center, the Gertner Institute for Epidemiology & Health Policy Research'}, {'name': 'Kathleen Abu-Saad, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gertner Institute for Epidemiology & Health Policy Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ofra Kalter-Leibovici MD', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Gertner Institute', 'class': 'OTHER'}, {'name': 'Clalit Health Services', 'class': 'OTHER'}, {'name': 'European Foundation for the Study of Diabetes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of the Unit of Cardiovascular Epidemiology, The Gertner Institute for Epidemiology & Health Policy Research.', 'investigatorFullName': 'Ofra Kalter-Leibovici MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}