Mobile Health to Enhance Exercise in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial

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

Intervention / Treatment
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* Behavioral: Exercise Programme and Counselling
* Device: Polar Ignite and App


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth Technology<br>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). | Behavioral: Exercise Programme and Counselling<br>* A 6 month exercise and physical activity programme supported by an exercise specialist<br>Device: Polar Ignite and App<br>* 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<br>* Other names: Polar Flow;|
| Active Comparator: Exercise Counselling<br>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. | Behavioral: Exercise Programme and Counselling<br>* A 6 month exercise and physical activity programme supported by an exercise specialist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0-12 months | 
| 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 | 0-12 months | 
| 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 | 0-12 months | 
| 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. | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to exercise | Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ) | 0 months, 0-6 months, 0-12 months | 
| Change in glycaemic control | Glycated hemoglobin (HbA1c), flash glucose monitoring | 0 months, 0-6 months, 0-12 months | 
| Change in body composition | Height (meters) and weight (kilograms) will be aggregated to arrive at one reported BMI value (kg/m^2) | 0 months, 0-6 months, 0-12 months | 
| Change in weight | Weight (kilograms) | 0 months, 0-6 months, 0-12 months | 
| Change in waist circumference | Waist circumference (centimeters) | 0 months, 0-6 months, 0-12 months | 
| Change in blood pressure | Blood pressure taken with a cuff | 0 months, 0-6 months, 0-12 months | 
| Change in blood lipids | Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein | 0 months, 0-6 months, 0-12 months | 
| Diabetes related quality of life | SF-12 Health Survey and Diabetes Treatment Satisfaction Questionnaire used to assess diabetes related quality of life | 0 months, 0-6 months, 0-12 months | 
| Behavioural regulation in exercise | Assessed using the Behavioural Regulation in Exercise Questionnaire | 0 months, 0-6 months, 0-12 months | 
| Patient rapport with counsellor | Assessed using the Patient Rapport with Counsellor Questionnaire | 0 months, 0-6 months, 0-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humans, Blood Glucose, Exercise, Life Style, Counseling, Biomedical Technology