Recruiting

Mobile Health

Sponsor:

University of British Columbia

Code:

NCT04653532

Conditions

Diabetes Mellitus, Type 2

Telemedicine

Mobile Applications

Exercise Therapy

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise Programme and Counselling

Polar Ignite and App

Study Details

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.

Conditions

Diabetes Mellitus, Type 2

Telemedicine

Mobile Applications

Exercise Therapy

Study ID

NCT04653532

Start date

Feb 1, 2021

Status verified date

Apr, 2021

Completion date

May 1, 2023

Anticipated

Primary completion date

Dec 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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.

Interventions

Exercise Programme and Counselling

A 6 month exercise and physical activity programme supported by an exercise specialist

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

Primary outcome measure

  • Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial [ Time Frame: 0-12 months ]
  • The number of these adults with newly diagnosed T2D who would be willing to take part in this trial [ Time Frame: 0-12 months ]
  • The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial [ Time Frame: 0-12 months ]
  • The number and percentage of participants retained at 12-months. [ Time Frame: 0-12 months ]

Central Contacts and Locations

Central contacts

Ali McManus, PhD

250-807-8192ali.mcmanus@ubc.ca

Matthew S Cocks, PhD

0151 904 6243M.S.Cocks@ljmu.ac.uk

Locations

University of British Columbia

Recruiting

Kelowna, British Columbia, Canada, V1V1V7

More Information

Sponsor

University of British Columbia

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Keywords

  • Humans
  • Blood Glucose
  • Exercise
  • Life Style
  • Counseling
  • Biomedical Technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2021-04-28.