Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-31 @ 4:04 AM
Study NCT ID:
NCT04653532
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health to Enhance Exercise in 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': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-26', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acceptability and feasibility of the wearable intervention to patients', 'timeFrame': '0-6 months, 0-12 months', 'description': 'Post-intervention patient questionnaire that will assess the acceptability of the wearable intervention and exposure to other wearable technologies'}, {'measure': 'Acceptability and feasibility of patients continuing the intervention on their own', 'timeFrame': '0-6 months, 0-12 months', 'description': 'Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention'}, {'measure': 'Pilot methods for collecting outcome measures', 'timeFrame': 'Approx. 1 month after baseline', 'description': 'Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use.'}, {'measure': 'Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients', 'timeFrame': '0-12 months', 'description': 'Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments'}, {'measure': 'Determine availability and completeness of economic data', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': '5-level EQ-5D Questionnaire'}, {'measure': 'Determine healthcare usage', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Questionnaire assessing healthcare usage in the last 12 weeks'}], 'primaryOutcomes': [{'measure': 'Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial', 'timeFrame': '0-12 months', 'description': 'Information will be collected on:\n\n\\- The number of patients approached and reasons for not joining the study'}, {'measure': 'The number of these adults with newly diagnosed T2D who would be willing to take part in this trial', 'timeFrame': '0-12 months', 'description': 'Information will be collected on:\n\n\\- The number of patients who actually enroll'}, {'measure': 'The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial', 'timeFrame': '0-12 months', 'description': 'Information will be collected on:\n\n\\- Patient gender, age, and how patients are currently treating their T2D'}, {'measure': 'The number and percentage of participants retained at 12-months.', 'timeFrame': '0-12 months', 'description': 'Information will be collected on:\n\n\\- Number and percentage of patients attending at 12-month follow up and reasons for drop-out.'}], 'secondaryOutcomes': [{'measure': 'Adherence to exercise', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)'}, {'measure': 'Change in glycaemic control', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Glycated hemoglobin (HbA1c), flash glucose monitoring'}, {'measure': 'Change in body composition', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m\\^2)'}, {'measure': 'Change in weight', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Weight (kilograms)'}, {'measure': 'Change in waist circumference', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Waist circumference (centimeters)'}, {'measure': 'Change in blood pressure', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Blood pressure taken with a cuff'}, {'measure': 'Change in blood lipids', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein'}, {'measure': 'Diabetes related quality of life', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life'}, {'measure': 'Behavioural regulation in exercise', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Assessed using the Behavioural Regulation in Exercise Questionnaire'}, {'measure': 'Patient rapport with counsellor', 'timeFrame': '0 months, 0-6 months, 0-12 months', 'description': 'Assessed using the Patient Rapport with Counsellor Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Humans', 'Blood Glucose', 'Exercise', 'Life Style', 'Counseling', 'Biomedical Technology'], 'conditions': ['Diabetes Mellitus, Type 2', 'Telemedicine', 'Mobile Applications', 'Exercise Therapy']}, 'referencesModule': {'references': [{'pmid': '41398622', 'type': 'DERIVED', 'citation': 'Low JL, Hesketh K, Falkenhain K, Jung ME, Singer J, Jones CA, Russon C, Cocks M, McManus A, Little JP; MOTIVATE T2D Team. Improved Glycemic Control in Adults with Type 2 Diabetes is More Strongly Associated with Exercise Duration Than with Volume, Frequency, or Consistency. Med Sci Sports Exerc. 2025 Dec 16. doi: 10.1249/MSS.0000000000003922. Online ahead of print.'}, {'pmid': '34836904', 'type': 'DERIVED', 'citation': 'Hesketh K, Low J, Andrews R, Jones CA, Jones H, Jung ME, Little J, Mateus C, Pulsford R, Singer J, Sprung VS, McManus AM, Cocks M. Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): protocol for a feasibility randomised controlled trial. BMJ Open. 2021 Nov 26;11(11):e052563. doi: 10.1136/bmjopen-2021-052563.'}]}, 'descriptionModule': {'briefSummary': 'Being physically active and exercising is important for the treatment of Type 2 diabetes as it helps control blood sugar and improve physical function. Lots of people find it hard to be physically active and sticking with exercise is difficult for most people. In this project we will investigate two strategies to support people with Type 2 diabetes to increase and then maintain a physically active lifestyle, which includes exercising regularly. Participants in one group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular (virtual) contact with an exercise specialist. Participants in the second group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App). The fitness watch and mobile App will allow the exercise specialist to provide greater support and feedback throughout the programme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with T2D within the previous 5-24 months\n* Male or Female\n* Aged 40-75\n* Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)\n* For those prescribed Metformin: have used a stable dose for 3-months or more\n\nExclusion Criteria:\n\n* Aged under 40 or over 75\n* Glycated hemoglobin level (HbA1c) more than 10% (\\>86mmol/mol)\n* Blood pressure higher than 160/110 mmHg\n* Treat diabetes with an antidiabetic drug other than Metformin (Sulfonylureas, Thiazolidinedione, dipeptidylpeptidase-4 inhibitors, sodium glucose co-transporter 2 inhibitors, glucagon-like peptide-1 receptor agonist, Acarbose, meglitinides)\n* Prescription of Insulin\n* Unstable angina (frequent chest pain)\n* Myocardial infarction (heart attack) within the previous 3 months\n* Transient ischemic attack (TIA) within the previous 6 months\n* Heart failure ≥class 2\n* Arrhythmia\n* Inability to increase activity\n* Pregnancy or planning to become pregnant\n* Less than 6 months post childbirth or stopped breastfeeding less than 1 month ago\n* Not owning a smartphone/ or having no data plan or access to WiFi\n* currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week).'}, 'identificationModule': {'nctId': 'NCT04653532', 'acronym': 'MOTIVATET2D', 'briefTitle': 'Mobile Health to Enhance Exercise in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial', 'orgStudyIdInfo': {'id': 'H20-01936'}, 'secondaryIdInfos': [{'id': '20/SS/0101', 'type': 'OTHER', 'domain': 'South East Scotland Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mHealth Technology', 'description': 'Participants in this group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App).', 'interventionNames': ['Behavioral: Exercise Programme and Counselling', 'Device: Polar Ignite and App']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Counselling', 'description': 'Participants in this group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular contact with an exercise specialist.', 'interventionNames': ['Behavioral: Exercise Programme and Counselling']}], 'interventions': [{'name': 'Exercise Programme and Counselling', 'type': 'BEHAVIORAL', 'description': 'A 6 month exercise and physical activity programme supported by an exercise specialist', 'armGroupLabels': ['Exercise Counselling', 'mHealth Technology']}, {'name': 'Polar Ignite and App', 'type': 'DEVICE', 'otherNames': ['Polar Watch', 'Polar Flow'], 'description': 'A fitness watch that links to a mobile phone application (App) which enables the exercise specialist to provide greater support and feedback throughout the programme', 'armGroupLabels': ['mHealth Technology']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1V1V7', 'city': 'Kelowna', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jonathan Low', 'role': 'CONTACT'}], 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}], 'centralContacts': [{'name': 'Ali McManus, PhD', 'role': 'CONTACT', 'email': 'ali.mcmanus@ubc.ca', 'phone': '250-807-8192'}, {'name': 'Matthew S Cocks, PhD', 'role': 'CONTACT', 'email': 'M.S.Cocks@ljmu.ac.uk', 'phone': '0151 904 6243'}]}, 'ipdSharingStatementModule': {'url': 'http://opendata.ljmu.ac.uk/', 'timeFrame': 'Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.', 'ipdSharing': 'YES', 'description': "Pseudonymised data from this study will be made available for sharing with other investigators, after publication of the study's key papers. Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/). This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services. A DOI will be generated for datasets as they are deposited to the repository. Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.", 'accessCriteria': 'Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/). This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services. A DOI will be generated for datasets as they are deposited to the repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Liverpool John Moores University', 'class': 'OTHER'}, {'name': 'University of Exeter', 'class': 'OTHER'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'Lancaster University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Jonathan Little', 'investigatorAffiliation': 'University of British Columbia'}}}}