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| ID | Type | Description | Link |
|---|---|---|---|
| 20/SS/0101 | Other Identifier | South East Scotland Research Ethics Committee |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Liverpool John Moores University | OTHER |
| University of Exeter | OTHER |
| Medical Research Council |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth Technology | Experimental | 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). |
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| Exercise Counselling | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Programme and Counselling | Behavioral | A 6 month exercise and physical activity programme supported by an exercise specialist |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial | Information will be collected on: - The number of patients approached and reasons for not joining the study | 0-12 months |
| The number of these adults with newly diagnosed T2D who would be willing to take part in this trial | Information will be collected on: - The number of patients who actually enroll | 0-12 months |
| The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial | Information will be collected on: - Patient gender, age, and how patients are currently treating their T2D | 0-12 months |
| The number and percentage of participants retained at 12-months. | Information will be collected on: - Number and percentage of patients attending at 12-month follow up and reasons for drop-out. | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to exercise | Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ) | 0 months, 0-6 months, 0-12 months |
| Change in glycaemic control | Glycated hemoglobin (HbA1c), flash glucose monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and feasibility of the wearable intervention to patients | Post-intervention patient questionnaire that will assess the acceptability of the wearable intervention and exposure to other wearable technologies | 0-6 months, 0-12 months |
| Acceptability and feasibility of patients continuing the intervention on their own |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali McManus, PhD | Contact | 250-807-8192 | ali.mcmanus@ubc.ca | |
| Matthew S Cocks, PhD | Contact | 0151 904 6243 | M.S.Cocks@ljmu.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Recruiting | Kelowna | British Columbia | V1V1V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41398622 | Derived | 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. 2026 May 1;58(5):873-882. doi: 10.1249/MSS.0000000000003922. Epub 2025 Dec 16. | |
| 34836904 |
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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.
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Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
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.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| OTHER_GOV |
| Lancaster University | OTHER |
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| Polar Ignite and App | Device | 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 |
|
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| 0 months, 0-6 months, 0-12 months |
| Change in body composition | Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m^2) | 0 months, 0-6 months, 0-12 months |
| Change in weight | Weight (kilograms) | 0 months, 0-6 months, 0-12 months |
| Change in waist circumference | Waist circumference (centimeters) | 0 months, 0-6 months, 0-12 months |
| Change in blood pressure | Blood pressure taken with a cuff | 0 months, 0-6 months, 0-12 months |
| Change in blood lipids | Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein | 0 months, 0-6 months, 0-12 months |
| Diabetes related quality of life | SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life | 0 months, 0-6 months, 0-12 months |
| Behavioural regulation in exercise | Assessed using the Behavioural Regulation in Exercise Questionnaire | 0 months, 0-6 months, 0-12 months |
| Patient rapport with counsellor | Assessed using the Patient Rapport with Counsellor Questionnaire | 0 months, 0-6 months, 0-12 months |
Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention |
| 0-6 months, 0-12 months |
| Pilot methods for collecting outcome measures | Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use. | Approx. 1 month after baseline |
| Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients | Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments | 0-12 months |
| Determine availability and completeness of economic data | 5-level EQ-5D Questionnaire | 0 months, 0-6 months, 0-12 months |
| Determine healthcare usage | Questionnaire assessing healthcare usage in the last 12 weeks | 0 months, 0-6 months, 0-12 months |
| Derived |
| 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. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D005159 | Health Care Facilities Workforce and Services |