Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-07-20 @ 11:35 AM
Study NCT ID:
NCT02093702
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2014-03-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
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Community Family Health Team'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Serious and other \\[not including serious\\] adverse events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Structured PA Education Program for People With T2DM', 'description': 'Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard PA Education for People With T2DM (From a CDE)', 'description': 'Group of subjects receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Hemoglobin A1c (HbA1c) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PA Education for People With T2DM (From a CDE)', 'description': 'Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).'}, {'id': 'OG001', 'title': 'Structured PA Education Program for People With T2DM', 'description': 'Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.001', 'groupId': 'OG000', 'lowerLimit': '0.0007', 'upperLimit': '0.0013'}, {'value': '-0.007', 'groupId': 'OG001', 'lowerLimit': '-0.0073', 'upperLimit': '-0.0067'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 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'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard PA Education for People With T2DM (From a CDE)', 'description': 'Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).'}, {'id': 'OG001', 'title': 'Structured PA Education Program for People With T2DM', 'description': 'Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.6'}, {'value': '0.7', 'groupId': 'OG001', 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'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard PA Education for People With T2DM (From a CDE)', 'description': 'Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).'}, {'id': 'BG001', 'title': 'Structured PA Education Program for People With T2DM', 'description': 'Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2014-03-03', 'resultsFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-15', 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Hemoglobin A1c (HbA1c) Levels', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in Systolic Blood Pressure', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in Waist Circumference', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in Body Mass Index', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in Serum Total Cholesterol', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in HDL-C', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in LDL-C', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in Triglycerides (TGs)', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in Total Cholesterol: HDL-C Ratio', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Mean Change in Diastolic Blood Pressure', 'timeFrame': 'Baseline and 12 months'}], 'secondaryOutcomes': [{'measure': "Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations", 'timeFrame': 'Baseline and 12 months', 'description': "The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise."}, {'measure': "Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations", 'timeFrame': 'Baseline and 12 months', 'description': "The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'J.R. Fowles, C. Shields, R.J.L. Murphy and P Dunbar. Developing Competency in Diabetes Education Volume 3: Physical Activity and Exercise Professional Resource Manual. The Canadian Diabetes Association. 2012. Toronto, Ontario. 110 pages.'}, {'pmid': '24070961', 'type': 'BACKGROUND', 'citation': 'Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Booth G, Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Methods. Can J Diabetes. 2013 Apr;37 Suppl 1:S4-7. doi: 10.1016/j.jcjd.2013.01.010. Epub 2013 Mar 26. No abstract available.'}, {'pmid': '17192512', 'type': 'BACKGROUND', 'citation': 'Buse JB, Ginsberg HN, Bakris GL, Clark NG, Costa F, Eckel R, Fonseca V, Gerstein HC, Grundy S, Nesto RW, Pignone MP, Plutzky J, Porte D, Redberg R, Stitzel KF, Stone NJ; American Heart Association; American Diabetes Association. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2007 Jan 2;115(1):114-26. doi: 10.1161/CIRCULATIONAHA.106.179294. Epub 2006 Dec 27.'}, {'pmid': '27056541', 'type': 'BACKGROUND', 'citation': 'Gornall A, Levesque L, Sigal RJ. A Pilot Study of Physical Activity Education Delivery in Diabetes Education Centres in Ontario. Can J Diabetes. 2008;32(2):123-30. doi: 10.1016/S1499-2671(08)22009-5. Epub 2012 Dec 10.'}, {'type': 'BACKGROUND', 'citation': 'Canadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.'}, {'pmid': '21525503', 'type': 'BACKGROUND', 'citation': 'Chudyk A, Petrella RJ. Effects of exercise on cardiovascular risk factors in type 2 diabetes: a meta-analysis. Diabetes Care. 2011 May;34(5):1228-37. doi: 10.2337/dc10-1881.'}, {'pmid': '21540423', 'type': 'BACKGROUND', 'citation': 'Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.'}, {'pmid': '16888470', 'type': 'BACKGROUND', 'citation': 'Plotnikoff RC, Taylor LM, Wilson PM, Courneya KS, Sigal RJ, Birkett N, Raine K, Svenson LW. Factors associated with physical activity in Canadian adults with diabetes. Med Sci Sports Exerc. 2006 Aug;38(8):1526-34. doi: 10.1249/01.mss.0000228937.86539.95.'}, {'type': 'BACKGROUND', 'citation': 'McManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.'}, {'type': 'BACKGROUND', 'citation': 'Majumdar SR, Johnson JA, Bowker SL, Booth GL, et al. A Canadian consensus for the standardized evaluation of quality improvement interventions in type 2 diabetes. Can J Diabetes. 2005 2005;29:220-229.'}, {'pmid': '14597589', 'type': 'BACKGROUND', 'citation': "McSweeney JC, Cody M, O'Sullivan P, Elberson K, Moser DK, Garvin BJ. Women's early warning symptoms of acute myocardial infarction. Circulation. 2003 Nov 25;108(21):2619-23. doi: 10.1161/01.CIR.0000097116.29625.7C. Epub 2003 Nov 3."}, {'pmid': '19495557', 'type': 'BACKGROUND', 'citation': 'Zanuso S, Jimenez A, Pugliese G, Corigliano G, Balducci S. Exercise for the management of type 2 diabetes: a review of the evidence. Acta Diabetol. 2010 Mar;47(1):15-22. doi: 10.1007/s00592-009-0126-3. Epub 2009 Jun 3.'}, {'pmid': '12421890', 'type': 'BACKGROUND', 'citation': 'Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.'}, {'pmid': '12610001', 'type': 'BACKGROUND', 'citation': 'Duncan GE, Perri MG, Theriaque DW, Hutson AD, Eckel RH, Stacpoole PW. Exercise training, without weight loss, increases insulin sensitivity and postheparin plasma lipase activity in previously sedentary adults. Diabetes Care. 2003 Mar;26(3):557-62. doi: 10.2337/diacare.26.3.557.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess whether a structured exercise program compared to routine recommendation for exercise has any positive impact on disease outcome in patients with type 2 diabetes.\n\nThis study aims to assess whether a structured exercise program has an impact on the following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids, body mass index and waist circumference. It also aims to assess the compliance and retention of patients with type 2 diabetes in a structured exercise program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Man or woman with type 2 diabetes\n* Ready to begin regular physical activity\n* Age equal to or greater than 18\n* Age equal to or less than 64.\n\nExclusion Criteria:\n\n* Any vascular disease\n* Exhibits symptoms of coronary artery disease (CAD)\n* History of losing balance because of dizziness\n* History of losing consciousness\n* Has a bone or joint problem that could be made worse by a change in physical activity\n* Pregnant\n* Has been excluded by the Patient's Physician for any other health-related reason not stated under these exclusion criteria."}, 'identificationModule': {'nctId': 'NCT02093702', 'briefTitle': 'Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Royal Victoria Hospital, Canada'}, 'officialTitle': 'Impact of Structured Physical Activity Education Delivery on Hemoglobin A1c Levels, Blood Pressure, Lipid Profile, Body Mass Index, Waist Circumference, and Adherence to Canadian Diabetes Association Clinical Practice Guidelines Weekly Physical Activity Recommendations for Patients With Type 2 Diabetes Mellitus: A Pilot Study.', 'orgStudyIdInfo': {'id': 'AW-100-SD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unstructured Physical Activity and Exercise Education Delivery', 'description': '50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator.', 'interventionNames': ['Behavioral: Unstructured Physical Activity and Exercise Education']}, {'type': 'EXPERIMENTAL', 'label': 'Structured Physical Activity and Exercise Education Delivery', 'description': '50 subjects will receive physical activity and exercise education and behaviour counseling from a qualified Exercise Specialist (Registered Kinesiologist). These subjects will receive access to a community health and fitness centre as well as exercise instruction and on-going support and motivation from a YMCA Wellness Coach who focuses on establishing healthy behaviors towards the attainment of personal goals. Subjects will be requested to complete a lifestyle questionnaire at each appointment with their Wellness Coach. Subjects will receive a Physical Activity and Exercise Journal that will help them keep track of their weekly physical activity and exercise activities.', 'interventionNames': ['Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach']}], 'interventions': [{'name': 'Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Structured Physical Activity and Exercise Education Delivery']}, {'name': 'Unstructured Physical Activity and Exercise Education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Unstructured Physical Activity and Exercise Education Delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L4M 6L2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Barrie and Community Family Health Team Diabetes Program', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}], 'overallOfficials': [{'name': 'Dr. Andrew Wozniak, MD, CCFP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barrie and Community Family Health Team'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Victoria Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, CCFP', 'investigatorFullName': 'Dr. Andrew Wozniak', 'investigatorAffiliation': 'Royal Victoria Hospital, Canada'}}}}