Mobile Health to Enhance Exercise in Type 2 Diabetes

NCT ID: NCT04653532

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-05-01

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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Telemedicine Mobile Applications Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Exercise Programme and Counselling

Intervention Type BEHAVIORAL

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

Polar Ignite and App

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Exercise Programme and Counselling

Intervention Type BEHAVIORAL

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

Interventions

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Exercise Programme and Counselling

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

Intervention Type BEHAVIORAL

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

Intervention Type DEVICE

Other Intervention Names

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Polar Watch Polar Flow

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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Liverpool John Moores University

OTHER

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

Lancaster University

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia

Kelowna, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ali McManus, PhD

Role: CONTACT

250-807-8192

Matthew S Cocks, PhD

Role: CONTACT

0151 904 6243

Facility Contacts

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Jonathan Low

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34836904 (View on PubMed)

Other Identifiers

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20/SS/0101

Identifier Type: OTHER

Identifier Source: secondary_id

H20-01936

Identifier Type: -

Identifier Source: org_study_id

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