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

Primary Purpose

Diabetes Mellitus, Type 2, Telemedicine, Mobile Applications

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise Programme and Counselling
Polar Ignite and App
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Humans, Blood Glucose, Exercise, Life Style, Counseling, Biomedical Technology

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mHealth Technology

Exercise Counselling

Arm 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).

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.

Outcomes

Primary Outcome Measures

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
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
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
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.

Secondary Outcome Measures

Adherence to exercise
Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)
Change in glycaemic control
Glycated hemoglobin (HbA1c), flash glucose monitoring
Change in body composition
Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m^2)
Change in weight
Weight (kilograms)
Change in waist circumference
Waist circumference (centimeters)
Change in blood pressure
Blood pressure taken with a cuff
Change in blood lipids
Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein
Diabetes related quality of life
SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life
Behavioural regulation in exercise
Assessed using the Behavioural Regulation in Exercise Questionnaire
Patient rapport with counsellor
Assessed using the Patient Rapport with Counsellor Questionnaire

Full Information

First Posted
November 19, 2020
Last Updated
April 26, 2021
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Liverpool John Moores University, University of Exeter, Medical Research Council, Lancaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04653532
Brief Title
Mobile Health to Enhance Exercise in Type 2 Diabetes
Acronym
MOTIVATET2D
Official Title
Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Liverpool John Moores University, University of Exeter, Medical Research Council, Lancaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Telemedicine, Mobile Applications, Exercise Therapy
Keywords
Humans, Blood Glucose, Exercise, Life Style, Counseling, Biomedical Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mHealth Technology
Arm Type
Experimental
Arm 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).
Arm Title
Exercise Counselling
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Programme and Counselling
Intervention Description
A 6 month exercise and physical activity programme supported by an exercise specialist
Intervention Type
Device
Intervention Name(s)
Polar Ignite and App
Other Intervention Name(s)
Polar Watch, Polar Flow
Intervention 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
Primary Outcome Measure Information:
Title
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
Description
Information will be collected on: - The number of patients approached and reasons for not joining the study
Time Frame
0-12 months
Title
The number of these adults with newly diagnosed T2D who would be willing to take part in this trial
Description
Information will be collected on: - The number of patients who actually enroll
Time Frame
0-12 months
Title
The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial
Description
Information will be collected on: - Patient gender, age, and how patients are currently treating their T2D
Time Frame
0-12 months
Title
The number and percentage of participants retained at 12-months.
Description
Information will be collected on: - Number and percentage of patients attending at 12-month follow up and reasons for drop-out.
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Adherence to exercise
Description
Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)
Time Frame
0 months, 0-6 months, 0-12 months
Title
Change in glycaemic control
Description
Glycated hemoglobin (HbA1c), flash glucose monitoring
Time Frame
0 months, 0-6 months, 0-12 months
Title
Change in body composition
Description
Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m^2)
Time Frame
0 months, 0-6 months, 0-12 months
Title
Change in weight
Description
Weight (kilograms)
Time Frame
0 months, 0-6 months, 0-12 months
Title
Change in waist circumference
Description
Waist circumference (centimeters)
Time Frame
0 months, 0-6 months, 0-12 months
Title
Change in blood pressure
Description
Blood pressure taken with a cuff
Time Frame
0 months, 0-6 months, 0-12 months
Title
Change in blood lipids
Description
Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein
Time Frame
0 months, 0-6 months, 0-12 months
Title
Diabetes related quality of life
Description
SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life
Time Frame
0 months, 0-6 months, 0-12 months
Title
Behavioural regulation in exercise
Description
Assessed using the Behavioural Regulation in Exercise Questionnaire
Time Frame
0 months, 0-6 months, 0-12 months
Title
Patient rapport with counsellor
Description
Assessed using the Patient Rapport with Counsellor Questionnaire
Time Frame
0 months, 0-6 months, 0-12 months
Other Pre-specified Outcome Measures:
Title
Acceptability and feasibility of the wearable intervention to patients
Description
Post-intervention patient questionnaire that will assess the acceptability of the wearable intervention and exposure to other wearable technologies
Time Frame
0-6 months, 0-12 months
Title
Acceptability and feasibility of patients continuing the intervention on their own
Description
Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention
Time Frame
0-6 months, 0-12 months
Title
Pilot methods for collecting outcome measures
Description
Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use.
Time Frame
Approx. 1 month after baseline
Title
Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients
Description
Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments
Time Frame
0-12 months
Title
Determine availability and completeness of economic data
Description
5-level EQ-5D Questionnaire
Time Frame
0 months, 0-6 months, 0-12 months
Title
Determine healthcare usage
Description
Questionnaire assessing healthcare usage in the last 12 weeks
Time Frame
0 months, 0-6 months, 0-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali McManus, PhD
Phone
250-807-8192
Email
ali.mcmanus@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew S Cocks, PhD
Phone
0151 904 6243
Email
M.S.Cocks@ljmu.ac.uk
Facility Information:
Facility Name
University of British Columbia
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Low

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://opendata.ljmu.ac.uk/
Citations:
PubMed Identifier
34836904
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.
Results Reference
derived

Learn more about this trial

Mobile Health to Enhance Exercise in Type 2 Diabetes

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