Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00221234
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alberta Diabetes and Physical Activity Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Behaviour'}], 'secondaryOutcomes': [{'measure': 'HbA1c, CRP, lipid concentrations, fasting blood glucose, insulin, health related quality of life, psychosocial predictors of physical activity.'}]}, 'conditionsModule': {'keywords': ['Diabetes', 'Physical Activity'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '22922954', 'type': 'DERIVED', 'citation': 'Plotnikoff RC, Karunamuni N, Courneya KS, Sigal RJ, Johnson JA, Johnson ST. The Alberta Diabetes and Physical Activity Trial (ADAPT): a randomized trial evaluating theory-based interventions to increase physical activity in adults with type 2 diabetes. Ann Behav Med. 2013 Feb;45(1):45-56. doi: 10.1007/s12160-012-9405-2.'}, {'pmid': '20067626', 'type': 'DERIVED', 'citation': 'Plotnikoff RC, Courneya KS, Sigal RJ, Johnson JA, Birkett N, Lau D, Raine K, Johnson ST, Karunamuni N. Alberta Diabetes and Physical Activity Trial (ADAPT): a randomized theory-based efficacy trial for adults with type 2 diabetes--rationale, design, recruitment, evaluation, and dissemination. Trials. 2010 Jan 12;11:4. doi: 10.1186/1745-6215-11-4.'}]}, 'descriptionModule': {'briefSummary': 'This project will assess the incremental and cumulative impact of three behavioural intervention strategies for the promotion of physical activity in the adult general population with Type 2 diabetes.', 'detailedDescription': 'An increasing prevalence of Type 2 Diabetes is associated with the aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. In Canada, 4.9-7.0% over the age of 12 and 17% over the age of 64 are estimated to have diabetes, 90-95% of which will be Type 2. Strong evidence supports the importance of physical activity in the management of Type 2 Diabetes. However, current literature lacks clear understanding of best strategies for physical activity behaviour change in this target population. Existing studies employ resource intensive, one-to-one individual and clinically-based approaches with limited theoretical grounding for recommended health behaviour change. Most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. The call to move beyond the clinical focus by including theoretically population-based and "real-life" approaches for the management Type 2 Diabetes remains largely unheeded. The three interventions are: (1) standard print-based physical activity educational materials provided by the Canadian Diabetes Association (CDA); (2) CDA materials + pedometers and a log book + theoretical stage-matched print-based physical activity materials; and, (3) the same as intervention 2 with the addition of a 12-month physical activity telephone counseling protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\>18 years old, Type 2 Diabetes, Living in the province of Alberta, Can communicate in English.\n\nExclusion Criteria:\n\nSerious Contraindications to Physical Activity'}, 'identificationModule': {'nctId': 'NCT00221234', 'briefTitle': 'Alberta Diabetes and Physical Activity Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'The Development and Evaluation of Physical Activity Behavioural Strategies for Adults With Type 2 Diabetes: A Population Based Approach', 'orgStudyIdInfo': {'id': 'MOP-69070'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Print materials, pedometers/logbooks', 'type': 'BEHAVIORAL'}, {'name': 'Print materials, pedometers/logbooks, telephone counselling', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ron C Plotnikoff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}}}}