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

University of British Columbia

Status: Unknown

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

Treatments: Behavioral: Exercise Programme and Counselling; Device: Polar Ignite and App

Study type: Interventional

Funder types: Other

Identifiers

NCT04653532

H20-01936

20/SS/0101 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

mHealth Technology

Experimental group

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).

Treatment:

Device: Polar Ignite and App

Behavioral: Exercise Programme and Counselling

Exercise Counselling

Active Comparator group

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.

Treatment:

Behavioral: Exercise Programme and Counselling