Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT02631902
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2015-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-17', 'studyFirstSubmitDate': '2015-10-11', 'studyFirstSubmitQcDate': '2015-12-13', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Risk', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'UKPDS Risk Engine'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'SF-36 Health Survey'}], 'secondaryOutcomes': [{'measure': 'Food Literacy', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'General Nutrition Knowledge Questionnaire for Adults'}, {'measure': 'Dietary Pattern', 'timeFrame': 'Baseline, 9 and 21 months', 'description': '3-day Food Record'}, {'measure': 'Physical Fitness', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Physical Fitness Test Battery'}, {'measure': 'Diabetic Foot Risk', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'International Working Group on the Diabetic Foot Risk Classification)'}, {'measure': 'Exercise-Related Adverse Events', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Number of acute injuries or adverse events during exercise sessions'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'mmHg'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'mmHg'}, {'measure': 'Glycemic Control', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Glycated Hemoglobin'}, {'measure': 'Fast blood glucose', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'mg/dL'}, {'measure': 'Total Cholesterol', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'mg/dL'}, {'measure': 'Body Fat Mass', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Bioelectrical impedance analysis'}, {'measure': 'Body Lean Mass', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Bioelectrical impedance analysis'}, {'measure': 'Quality of Sleep', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Pittsburgh Sleep Quality Index'}, {'measure': 'Symptoms of Anxiety and Depression', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Hospital Anxiety and Depression Scale'}, {'measure': 'Chronic Pain', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Brief Pain Inventory Questionnaire'}, {'measure': 'Diabetes-Dependent Quality of Life', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Audit of Diabetes-Dependent Quality of Life Questionnaire'}, {'measure': 'Habitual Physical Activity', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'International Physical Activity Questionnaire'}, {'measure': 'Waist Circumference', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'cm'}, {'measure': 'Falls Risk', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Timed Up and Go Test'}, {'measure': 'Sitting-Time', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'Hours per day'}, {'measure': 'Energy Expenditure', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'kcal/kg/min'}, {'measure': 'Body Mass Index', 'timeFrame': 'Baseline, 9 and 21 months', 'description': 'kg/m2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Community-based intervention', 'Exercise program', 'Dietary intervention program', 'Health promotion', 'Subjective well-being', 'Cardiovascular risk'], 'conditions': ['Type 2 Diabetes Mellitus', 'Diabetes-Related Complications']}, 'referencesModule': {'references': [{'pmid': '29477503', 'type': 'BACKGROUND', 'citation': 'Matos M, Mendes R, Silva AB, Sousa N. Physical activity and exercise on diabetic foot related outcomes: A systematic review. Diabetes Res Clin Pract. 2018 May;139:81-90. doi: 10.1016/j.diabres.2018.02.020. Epub 2018 Feb 23.'}, {'pmid': '31284568', 'type': 'RESULT', 'citation': 'Vasconcelos C, Almeida A, Cabral M, Ramos E, Mendes R. The Impact of a Community-Based Food Education Program on Nutrition-Related Knowledge in Middle-Aged and Older Patients with Type 2 Diabetes: Results of a Pilot Randomized Controlled Trial. Int J Environ Res Public Health. 2019 Jul 6;16(13):2403. doi: 10.3390/ijerph16132403.'}, {'pmid': '31350159', 'type': 'RESULT', 'citation': 'Vasconcelos C, Almeida A, Sa C, Viana J, Cabral M, Ramos E, Mendes R. Nutrition-related knowledge and its determinants in middle-aged and older patients with type 2 diabetes. Prim Care Diabetes. 2020 Apr;14(2):119-125. doi: 10.1016/j.pcd.2019.06.007. Epub 2019 Jul 24.'}], 'seeAlsoLinks': [{'url': 'http://www.diabetesemmovimento.com', 'label': 'Official site'}]}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population and is associated with a high cardiovascular mortality by coronary artery disease and cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are widely recommended to the control of type 2 diabetes and its complications. This study aims to analyse the effects of different community-based lifestyle programs (exercise or exercise plus dietary intervention) on health and well-being in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with diagnosed type 2 diabetes at least for six months;\n2. Both genders;\n3. Aged between 50 and 80 years old;\n4. Non-smokers;\n5. Not engaged in supervised exercise;\n6. Community-dwelling;\n7. Medical recommendation for lifestyle intervention;\n8. Known medical history;\n9. Diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy;\n10. No cardiovascular, respiratory and musculoskeletal contraindications to exercise;\n11. No gait and balance problems;\n12. Not taking insulin or sulfonylureas for less than three months;\n13. Volunteer participation with signed informed consent.\n\nExclusion Criteria:\n\n1. Participation in another supervised exercise program during the study;\n2. Participation in another supervised dietary intervention during the study;\n3. Aggravation of a diabetes complication or another major health problem;'}, 'identificationModule': {'nctId': 'NCT02631902', 'briefTitle': 'Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Trás-os-Montes and Alto Douro'}, 'officialTitle': 'Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being', 'orgStudyIdInfo': {'id': 'UTras'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Community-based exercise program', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise plus dietary intervention', 'description': 'Community-based exercise and dietary intervention program', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Dietary intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Habitual physical activity and habitual dietary pattern'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Community-based exercise program with 3 weekly exercise sessions', 'armGroupLabels': ['Exercise', 'Exercise plus dietary intervention']}, {'name': 'Dietary intervention', 'type': 'BEHAVIORAL', 'description': 'Community-based dietary intervention program', 'armGroupLabels': ['Exercise plus dietary intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000-801', 'city': 'Vila Real', 'country': 'Portugal', 'facility': 'University of Trás-os-Montes e Alto Douro', 'geoPoint': {'lat': 41.3001, 'lon': -7.7432}}], 'overallOfficials': [{'name': 'Romeu Mendes, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Trás-os-Montes e Alto Douro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trás-os-Montes and Alto Douro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Romeu Duarte Carneiro Mendes', 'investigatorAffiliation': 'University of Trás-os-Montes and Alto Douro'}}}}