Mobile Health to Enhance Exercise in Type 2 Diabetes

Not Applicable

Conditions: Diabetes Mellitus, Type 2
Mobile Applications
Telemedicine
Exercise Therapy

Interventions: Behavioral: Exercise Programme and Counselling
Device: Polar Ignite and App

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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
mHealth Technology	Exercise Programme and Counselling	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).
mHealth Technology	Polar Ignite and App	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).
Exercise Counselling	Exercise Programme and 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.

Primary Outcome Measures

Name	Time	Method
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial	0-12 months	Information will be collected on: - The number of patients approached and reasons for not joining the study
The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial	0-12 months	Information will be collected on: - Patient gender, age, and how patients are currently treating their T2D
The number of these adults with newly diagnosed T2D who would be willing to take part in this trial	0-12 months	Information will be collected on: - The number of patients who actually enroll
The number and percentage of participants retained at 12-months.	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

Name	Time	Method
Diabetes related quality of life	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
Behavioural regulation in exercise	0 months, 0-6 months, 0-12 months	Assessed using the Behavioural Regulation in Exercise Questionnaire
Change in glycaemic control	0 months, 0-6 months, 0-12 months	Glycated hemoglobin (HbA1c), flash glucose monitoring
Adherence to exercise	0 months, 0-6 months, 0-12 months	Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)
Change in body composition	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)
Change in weight	0 months, 0-6 months, 0-12 months	Weight (kilograms)
Change in waist circumference	0 months, 0-6 months, 0-12 months	Waist circumference (centimeters)
Change in blood pressure	0 months, 0-6 months, 0-12 months	Blood pressure taken with a cuff
Change in blood lipids	0 months, 0-6 months, 0-12 months	Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein
Patient rapport with counsellor	0 months, 0-6 months, 0-12 months	Assessed using the Patient Rapport with Counsellor Questionnaire

Locations (1): University of British Columbia
🇨🇦
Kelowna, British Columbia, Canada