Mobile Health to Enhance Exercise in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— MOTIVATET2D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04653532
• Other study ID #: H20-01936
• Secondary ID: 20/SS/0101
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2021
• Source: University of British Columbia
• Contact: Ali McManus, PhD
• Phone: 250-807-8192
• Email: ali.mcmanus[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Exercise Programme and Counselling
A 6 month exercise and physical activity programme supported by an exercise specialist

Device:
• Polar 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

Locations

Country	Name	City	State
Canada	University of British Columbia	Kelowna	British Columbia

Sponsors (6)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), Lancaster University, Liverpool John Moores University, Medical Research Council, University of Exeter

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability and feasibility of the wearable intervention to patients	Post-intervention patient questionnaire that will assess the acceptability of the wearable intervention and exposure to other wearable technologies	0-6 months, 0-12 months
Other	Acceptability and feasibility of patients continuing the intervention on their own	Follow-up patient questionnaire investigating anticipated barriers and facilitators to continuing the intervention	0-6 months, 0-12 months
Other	Pilot methods for collecting outcome measures	Early acceptability questionnaire investigating the acceptability of the measurement instruments and their ease of use.	Approx. 1 month after baseline
Other	Ensure that our plans for recruitment, randomisation, treatment, and follow-up are acceptable to patients	Post intervention patient questionnaire investigating the acceptability of the recruitment and randomisation process and the measurement instruments	0-12 months
Other	Determine availability and completeness of economic data	5-level EQ-5D Questionnaire	0 months, 0-6 months, 0-12 months
Other	Determine healthcare usage	Questionnaire assessing healthcare usage in the last 12 weeks	0 months, 0-6 months, 0-12 months
Primary	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
Primary	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
Primary	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
Primary	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	Adherence to exercise	Adherence to structured exercise assessed through monthly exercise questionnaire (GLTEQ)	0 months, 0-6 months, 0-12 months
Secondary	Change in glycaemic control	Glycated hemoglobin (HbA1c), flash glucose monitoring	0 months, 0-6 months, 0-12 months
Secondary	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
Secondary	Change in weight	Weight (kilograms)	0 months, 0-6 months, 0-12 months
Secondary	Change in waist circumference	Waist circumference (centimeters)	0 months, 0-6 months, 0-12 months
Secondary	Change in blood pressure	Blood pressure taken with a cuff	0 months, 0-6 months, 0-12 months
Secondary	Change in blood lipids	Total cholesterol, high-density lipoprotein, triglycerides, low-density lipoprotein	0 months, 0-6 months, 0-12 months
Secondary	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
Secondary	Behavioural regulation in exercise	Assessed using the Behavioural Regulation in Exercise Questionnaire	0 months, 0-6 months, 0-12 months
Secondary	Patient rapport with counsellor	Assessed using the Patient Rapport with Counsellor Questionnaire	0 months, 0-6 months, 0-12 months