Diabetes Mellitus, Type 2, Exercise Therapy, Mobile Applications, Telemedicine
Conditions
Keywords
Humans, Blood Glucose, Exercise, Life Style, Counseling, Biomedical Technology
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.
Interventions
BEHAVIORALExercise Programme and Counselling
A 6 month exercise and physical activity programme supported by an exercise specialist
DEVICEPolar 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
Sponsors
Canadian Institutes of Health Research (CIHR)
Liverpool John Moores University
University of Exeter
Medical Research Council
Lancaster University
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | 0 months, 0-6 months, 0-12 months | Waist circumference (centimeters) |
| Change in weight | 0 months, 0-6 months, 0-12 months | Weight (kilograms) |
| 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 |
| 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 |
| Patient rapport with counsellor | 0 months, 0-6 months, 0-12 months | Assessed using the Patient Rapport with Counsellor Questionnaire |
| Adherence to exercise | 0 months, 0-6 months, 0-12 months | Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ) |
| Change in glycaemic control | 0 months, 0-6 months, 0-12 months | Glycated hemoglobin (HbA1c), flash glucose monitoring |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine healthcare usage | 0 months, 0-6 months, 0-12 months | Questionnaire assessing healthcare usage in the last 12 weeks |
| Acceptability and feasibility of patients continuing the intervention on their own | 0-6 months, 0-12 months | Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention |
| Determine availability and completeness of economic data | 0 months, 0-6 months, 0-12 months | 5-level EQ-5D Questionnaire |
| Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients | 0-12 months | Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments |
| Pilot methods for collecting outcome measures | Approx. 1 month after baseline | Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use. |
| Acceptability and feasibility of the wearable intervention to patients | 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 |
Countries
Canada
Contacts
Primary ContactAli McManus, PhD
Backup ContactMatthew S Cocks, PhD
Outcome results
None listed