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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Telemedicine; Mobile Applications; Exercise Therapy
• Intervention / Treatment: Behavioral: Exercise Programme and Counselling; Device: Polar Ignite and App

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali McManus, PhD; Phone Number: 250-807-8192; Email: ali.mcmanus@ubc.ca
• Study Contact Backup: Name: Matthew S Cocks, PhD; Phone Number: 0151 904 6243; Email: M.S.Cocks@ljmu.ac.uk

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V1V7
      • Recruiting
      • University of British Columbia
      • Contact: Jonathan Low

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mHealth Technology; 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; 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; Other Names: Polar Watch; Polar Flow
Active Comparator: Exercise Counselling; 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; A 6 month exercise and physical activity programme supported by an exercise specialist

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Determine availability and completeness of economic data	5-level EQ-5D Questionnaire	0 months, 0-6 months, 0-12 months
Determine healthcare usage	Questionnaire assessing healthcare usage in the last 12 weeks	0 months, 0-6 months, 0-12 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR); Medical Research Council; Liverpool John Moores University; University of Exeter; Lancaster University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Humans; Exercise; Counseling; Blood Glucose; Biomedical Technology; Life Style
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H20-01936; 20/SS/0101 (Other Identifier: South East Scotland Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pseudonymised data from this study will be made available for sharing with other investigators, after publication of the study's key papers. Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/). This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services. A DOI will be generated for datasets as they are deposited to the repository. Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
• IPD Sharing Time Frame: Data will be stored in this repository for a minimum of 10 years or for 10 years from the last date of access.
• IPD Sharing Access Criteria: Data will be shared through the LJMU Data Repository (http://opendata.ljmu.ac.uk/). This is a secure institutional data repository, which is searchable on the www, it is managed by Library Services. A DOI will be generated for datasets as they are deposited to the repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No