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Mobile Health to Enhance Exercise in Type 2 Diabetes (MOTIVATET2D)

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ClinicalTrials.gov Identifier: NCT04653532
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Liverpool John Moores University
University of Exeter
Medical Research Council
Lancaster University
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Telemedicine Mobile Applications Exercise Therapy Behavioral: Exercise Programme and Counselling Device: Polar Ignite and App Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mHealth Technology
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).
 Behavioral: Exercise Programme and Counselling
A 6 month exercise and physical activity programme supported by an exercise specialist

Device: Polar Ignite and App
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
Other Names:
  • Polar Watch
  • Polar Flow
Active Comparator: Exercise Counselling
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.
 Behavioral: Exercise Programme and Counselling
A 6 month exercise and physical activity programme supported by an exercise specialist


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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.



Secondary Outcome Measures :
  1. Adherence to exercise [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)

  2. Change in glycaemic control [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Glycated hemoglobin (HbA1c), flash glucose monitoring

  3. Change in body composition [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m^2)

  4. Change in weight [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Weight (kilograms)

  5. Change in waist circumference [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Waist circumference (centimeters)

  6. Change in blood pressure [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Blood pressure taken with a cuff

  7. Change in blood lipids [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein

  8. Diabetes related quality of life [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life

  9. Behavioural regulation in exercise [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Assessed using the Behavioural Regulation in Exercise Questionnaire

  10. Patient rapport with counsellor [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Assessed using the Patient Rapport with Counsellor Questionnaire


Other Outcome Measures:
  1. Acceptability and feasibility of the wearable intervention to patients [ Time Frame: 0-6 months, 0-12 months ]
    Post-intervention patient questionnaire that will assess the acceptability of the wearable intervention and exposure to other wearable technologies

  2. Acceptability and feasibility of patients continuing the intervention on their own [ Time Frame: 0-6 months, 0-12 months ]
    Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention

  3. Pilot methods for collecting outcome measures [ Time Frame: Approx. 1 month after baseline ]
    Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use.

  4. Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients [ Time Frame: 0-12 months ]
    Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments

  5. Determine availability and completeness of economic data [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    5-level EQ-5D Questionnaire

  6. Determine healthcare usage [ Time Frame: 0 months, 0-6 months, 0-12 months ]
    Questionnaire assessing healthcare usage in the last 12 weeks


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653532


Contacts
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Contact: Ali McManus, PhD 250-807-8192 ali.mcmanus@ubc.ca
Contact: Matthew S Cocks, PhD 0151 904 6243 M.S.Cocks@ljmu.ac.uk

Locations
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Canada, British Columbia
University of British Columbia Recruiting
Kelowna, British Columbia, Canada, V1V1V7
Contact: Jonathan Low         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Liverpool John Moores University
University of Exeter
Medical Research Council
Lancaster University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonathan Little, associate professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04653532    
Other Study ID Numbers: H20-01936
20/SS/0101 ( Other Identifier: South East Scotland Research Ethics Committee )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Time Frame: Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
Access Criteria: 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.
URL: http://opendata.ljmu.ac.uk/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Little, University of British Columbia:
Humans
Blood Glucose
Exercise
 Life Style
Counseling
Biomedical Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases