Diabetes Mellitus, Type 2MOTIVATET2DNCT04653532
Mobile Health to Enhance Exercise in Type 2 Diabetes
A study testing Exercise Programme and Counselling and Polar Ignite and App in people with Diabetes Mellitus, Type 2 and Telemedicine, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Telemedicine, Mobile Applications
- What is being tested?
- Exercise Programme and Counselling and Polar Ignite and App
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with T2D within the previous 5-24 months
- Male or Female
- Aged 40-75
- Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)
- For those prescribed Metformin: have used a stable dose for 3-months or more
Who cannot join
- Aged under 40 or over 75
- Glycated hemoglobin level (HbA1c) more than 10% (>86mmol/mol)
- Blood pressure higher than 160/110 mmHg
- 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)
- Prescription of Insulin
- Unstable angina (frequent chest pain)
Show all 15Show fewer
- Myocardial infarction (heart attack) within the previous 3 months
- Transient ischemic attack (TIA) within the previous 6 months
- Heart failure ≥class 2
- Arrhythmia
- Inability to increase activity
- Pregnancy or planning to become pregnant
- Less than 6 months post childbirth or stopped breastfeeding less than 1 month ago
- Not owning a smartphone/ or having no data plan or access to WiFi
- currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Kelowna, British Columbia, V1V1V7
Jonathan Low
About this study
Official title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial
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.
- Being tested
- Exercise Programme and Counselling, Polar Ignite and App
- Keywords
- Humans, Blood Glucose, Exercise, Life Style, Counseling, Biomedical Technology
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Programme and CounsellingBehavioural
A 6 month exercise and physical activity programme supported by an exercise specialist
Polar Ignite and AppDevice
Also called Polar Watch, Polar Flow
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Exercise Programme and Counselling; Device: Polar Ignite and App |
| 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. Receives: Behavioral: Exercise Programme and Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 0-12 months
Secondary outcomes (10)
Adherence to exercise
Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)
Measured: 0 months, 0-6 months, 0-12 months
Change in glycaemic control
Glycated hemoglobin (HbA1c), flash glucose monitoring
Measured: 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)
Measured: 0 months, 0-6 months, 0-12 months
Change in weight
Weight (kilograms)
Measured: 0 months, 0-6 months, 0-12 months
Change in waist circumference
Waist circumference (centimeters)
Measured: 0 months, 0-6 months, 0-12 months
Change in blood pressure
Blood pressure taken with a cuff
Measured: 0 months, 0-6 months, 0-12 months
Change in blood lipids
Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein
Measured: 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
Measured: 0 months, 0-6 months, 0-12 months
Behavioural regulation in exercise
Assessed using the Behavioural Regulation in Exercise Questionnaire
Measured: 0 months, 0-6 months, 0-12 months
Patient rapport with counsellor
Assessed using the Patient Rapport with Counsellor Questionnaire
Measured: 0 months, 0-6 months, 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Liverpool John Moores University, University of Exeter, Medical Research Council, Lancaster University
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653532
- Sponsor's protocol ID
- H20-01936
- Other IDs
- 20/SS/0101
- Acronym
- MOTIVATET2D
- Status last verified
- Apr 2021
- First submitted
- 19 Nov 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41398622Hesketh 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.
PubMed 34836904
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT04653532
- Acronym / sponsor ID
- MOTIVATET2D / H20-01936
- Keywords
- Humans, Blood Glucose, Exercise, Life Style, Counseling, Biomedical Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Liverpool John Moores University, University of Exeter, Medical Research Council, Lancaster University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Technology | Experimental | Behavioral: Exercise Programme and Counselling, Device: Polar Ignite and AppParticipants 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). |
| Exercise Counselling | Active comparator | Behavioral: Exercise Programme and CounsellingParticipants in this group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular contact with an exercise specialist. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with T2D within the previous 5-24 months
- Male or Female
- Aged 40-75
- Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)
- For those prescribed Metformin: have used a stable dose for 3-months or more
Key exclusion criteria (15 listed)
- Aged under 40 or over 75
- Glycated hemoglobin level (HbA1c) more than 10% (>86mmol/mol)
- Blood pressure higher than 160/110 mmHg
- 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)
- Prescription of Insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Programme and CounsellingA 6 month exercise and physical activity programme supported by an exercise specialist | Behavioural | Exercise Counselling, mHealth Technology |
| Polar Ignite and AppAlso: Polar Watch, Polar FlowA fitness watch that links to a mobile phone application (App) which enables the exercise specialist to provide greater support and feedback throughout the programme | Device | mHealth Technology |
Primary outcome
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Time frame: 0-12 months
Information will be collected on: - The number of patients approached and reasons for not joining the study
The number of these adults with newly diagnosed T2D who would be willing to take part in this trial
Time frame: 0-12 months
Information will be collected on: - The number of patients who actually enroll
The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial
Time frame: 0-12 months
Information will be collected on: - Patient gender, age, and how patients are currently treating their T2D
The number and percentage of participants retained at 12-months.
Time frame: 0-12 months
Information will be collected on: - Number and percentage of patients attending at 12-month follow up and reasons for drop-out.
10 secondary outcomes
Adherence to exercise
Time frame: 0 months, 0-6 months, 0-12 months
Change in glycaemic control
Time frame: 0 months, 0-6 months, 0-12 months
Change in body composition
Time frame: 0 months, 0-6 months, 0-12 months
Change in weight
Time frame: 0 months, 0-6 months, 0-12 months
Change in waist circumference
Time frame: 0 months, 0-6 months, 0-12 months
Change in blood pressure
Time frame: 0 months, 0-6 months, 0-12 months
Change in blood lipids
Time frame: 0 months, 0-6 months, 0-12 months
Diabetes related quality of life
Time frame: 0 months, 0-6 months, 0-12 months
Behavioural regulation in exercise
Time frame: 0 months, 0-6 months, 0-12 months
Patient rapport with counsellor
Time frame: 0 months, 0-6 months, 0-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 41398622Low 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.
- Derived from this study: PubMed 34836904Hesketh 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Programme and Counselling and Polar Ignite and App in people with Diabetes Mellitus, Type 2 and Telemedicine, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali McManus, PhD (250-807-8192, ali.mcmanus@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial (time frame: 0-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04653532, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.