Clinical trial NCT04653532: Mobile Health to Enhance Exercise in Type 2 Diabetes
Official title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Telemedicine
Mobile Applications
Exercise Therapy
Keywords: Humans
Blood Glucose
Exercise
Life Style
Counseling
Biomedical Technology
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Liverpool John Moores University
name: University of Exeter
name: Medical Research Council
name: Lancaster University
First posted: 2020-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
timeFrame: 0-12 months
measure: The number of these adults with newly diagnosed T2D who would be willing to take part in this trial
timeFrame: 0-12 months
measure: The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial
timeFrame: 0-12 months
measure: The number and percentage of participants retained at 12-months.
timeFrame: 0-12 months
Secondary outcomes:
measure: Adherence to exercise
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Change in glycaemic control
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Change in body composition
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Change in weight
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Change in waist circumference
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Change in blood pressure
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Change in blood lipids
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Diabetes related quality of life
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Behavioural regulation in exercise
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Patient rapport with counsellor
timeFrame: 0 months, 0-6 months, 0-12 months
Other outcomes:
measure: Acceptability and feasibility of the wearable intervention to patients
timeFrame: 0-6 months, 0-12 months
measure: Acceptability and feasibility of patients continuing the intervention on their own
timeFrame: 0-6 months, 0-12 months
measure: Pilot methods for collecting outcome measures
timeFrame: Approx. 1 month after baseline
measure: Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients
timeFrame: 0-12 months
measure: Determine availability and completeness of economic data
timeFrame: 0 months, 0-6 months, 0-12 months
measure: Determine healthcare usage
timeFrame: 0 months, 0-6 months, 0-12 months
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
References:
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.