Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/10/2020
Date assigned
21/10/2020
Last edited
21/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high. Being physically active and exercising is very important in the treatment of Type 2 diabetes (T2D), with it helping to control blood sugar and prevent complications. Nevertheless, lots of people with T2D find it hard to be physically active and/or stick to an exercise programme, even when doctors and diabetes nurses have told them to exercise as part of their treatment. Research is needed to identify more effective methods to help people with T2D increase their everyday physical activity levels, start exercising regularly and stick too the right amount of exercise to benefit their T2D management, particularly in the early stages after diagnosis.

In this project we want to see if mobile health technology (i.e. the use of smartphones, wearable technology and apps to support the delivery of interventions) when added into exercise advice makes it easier for people with T2D to begin and maintain a physically active lifestyle, which includes exercising regularly.

Who can participate?
People aged 40 - 75 years, who have been diagnosed with T2D in the last 5 - 24 months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group work with an exercise specialist to co-design a 6-month structured exercise and physical activity programme. The programme is supported by 5 meetings with the exercise specialist and regular text messages encouraging exercise and physical activity. Those in the second group (mHealth) receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants also receive a fitness watch linked to a mobile phone application (App). The fitness watch and mobile App allow the exercise specialist to provide greater support and feedback throughout the programme. Participants in both groups are sent a home testing kit to measure their own body composition, blood pressure, cholesterol and control of blood sugar before, after and 6-months following the exercise programme. The study lasts one year in total.

What are the possible benefits and risks of participating?
All participants co-design their own 6-month personalised exercise and physical activity programme, supported by 5 meetings with an exercise specialist. Participants also complete three basic health assessments. To do these assessments participants are given, to keep, a tape measure, set of scales and a blood pressure monitor.
Participants in the mHealth group are given a wrist worn fitness watch, to keep, and access to a free online training application. The fitness monitor will act as a personal trainer on participants wrist providing live feedback on how to exercise. The training app will track participants exercise and enable the exercise specialist to follow progression and provide regular personalised feedback.
Participants will collect a finger prick blood sample at three time points. Some sensitivity may be felt where the sample is taken from, but this will be short lived (normally 24h). Participants will experience fatigue during exercise sessions.

Where is the study run from?
1. Liverpool John Moores University (UK)
2. University of British Columbia (Canada)

When is the study starting and how long is it expected to run for?
April 2020 to May 2023

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
(UK contact) Dr Matthew Cocks, m.s.cocks@ljmu.ac.uk
(Canada contact) Dr Ali McManus, AliMcManus@UBC.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Matthew Cocks

ORCID ID

http://orcid.org/0000-0003-1671-8714

Contact details

Research Institute for Sport and Exercise Sciences
Tom Reilly Building
Liverpool John Moores University
Byrom Street
Liverpool
L3 3AF
United Kingdom
+44 (0)151 9046243
m.s.cocks@ljmu.ac.uk

Type

Public

Additional contact

Dr Katie Hesketh

ORCID ID

http://orcid.org/0000-0003-3409-3906

Contact details

Research Institute for Sport and Exercise Sciences
Tom Reilly Building
Liverpool John Moores University
Byrom Street
Liverpool
L3 3AF
United Kingdom
+44 (0)151 9046243
K.Hesketh@2012.LJMU.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46893, IRAS 283225

Study information

Scientific title

mHealth Biometrics for Type 2 Diabetes (MOTIVATE T2D)

Acronym

MOTIVATE T2D

Study hypothesis

The study aims to have an evidence-based exercise and PA intervention ready to evaluate in a future randomised controlled trial.

Ethics approval

Approved 20/10/2020, South East Scotland Research Ethics Committee 01 (Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG; 44+ (0)131 465 5473; Sandra.Wyllie@nhslothian.scot.nhs.uk), ref: 20/SS/0101

Study design

Pilot multicentre interventional unblinded randomized control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

See additional files

Condition

Type 2 diabetes

Intervention

Participants will be randomised to an active control (exercise counselling) or intervention (exercise counselling and mobile health (mHealth)) groups. Patients will be randomised in a 1:1 ratio using an online randomisation service administered by the Centre for Health and Evaluation and Outcome Sciences (University of British Columbia, CA).

Participants in both groups will undertake a 6-month structured exercise and physical activity intervention.

Active control (exercise counselling): Participants will have 5 exercise consultations with an exercise specialist. Exercise consultations will be supported by behaviour change text messages (weekly for first 3-months and bi-weekly for second 3-months).

Intervention (exercise counselling and mHealth): Participants will have 5 exercise consultations with an exercise specialist. Exercise consultations will be supported by 3 mHealth elements; 1) a wrist worn fitness watch, featuring a 3d accelerometer and optical heart rate monitor, 2) a smartphone app for patients, and 3) a coaching website for the exercise specialist, and behaviour change text messages influenced by patients exercise adherence (following each exercise session for the first month, weekly from month 2-3 and bi-weekly for the final 3-months).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Feasibility outcomes:
1. The number of adults with newly diagnosed T2D that are eligible to participate
2. The proportion of these who would be willing to take part in this trial (i.e. recruitment rate), and their characteristics
3. The number of participants retained at 12-months (i.e. participant drop-out)

Secondary outcome measures

1. Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT:
1.1. Adherence to structure exercise, measured using heart rate monitoring of all structured exercise sessions, measured throughout the 12-month study period
1.2. Self reported leisure-time exercise, measured using the Godin Leisure-Time Exercise Questionnaire (GLEEQ), measured monthly over 12-month study period
1.3. Device assessed physical activity, measured using a GENEActiv physical activity monitor for 14 days at baseline, post-intervention (6-months) and follow-up (12-months)
1.4. HbA1c, measured using a finger prick blood sample at baseline, post-intervention (6-months) and follow-up (12-months)
1.5. 14-day glycaemic control, measured using Flash Glucose Monitoring for 14-days at baseline, post-intervention (6-months) and follow-up (12-months)
1.6. Body composition, measured using BMI and waist circumference at baseline, post-intervention (6-months) and follow-up (12-months)
1.7. Blood pressure, measured using automated blood pressure monitor at baseline, post-intervention (6-months) and follow-up (12-months)
1.8. Blood Lipids (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides), measured using a finger prick blood sample at baseline, post-intervention (6-months) and follow-up (12-months)
1.9. Health related quality of life, measured using the SF-12 health survey at baseline, post-intervention (6-months) and follow-up (12-months)
1.10. Diabetes Treatment Satisfaction using the Diabetes Treatment Satisfaction Questionnaire status version at baseline, post-intervention (6-months) and follow-up (12-months), and Diabetes Treatment Satisfaction Questionnaire change version at post-intervention (6-months)
1.11. Exercise motivation, measured through the Behavioural Regulation in Exercise Questionnaire at baseline, post-intervention (6-months) and follow-up (12-months)
1.12. Patient rapport with counsellor, measured through the Patient Rapport with Counsellor Questionnaire at baseline, post-intervention (6-months) and follow-up (12-months)

2. Evaluate the acceptability of the intervention to patients, assessing the feasibility of implementing the intervention:
2.1. Patient experiences of the intervention, measured using semi-structured interviews post-intervention (6-months)
2.2. Continuity of physical activity after intervention the concluded, measured using semi-structured interviews at follow-up (12-months)

3. Pilot methods for collecting outcome measures and ensure that our plans for recruitment, randomisation, treatment, and follow-up all run smoothly:
3.1. Acceptability of the virtual testing procedures, measured using semi-structured interviews at baseline
3.2. Acceptability of research process, measured using semi-structured interviews post-intervention (6-months)

4. Determine availability and completeness of economic data
4.1. Health related quality of life, measured using the 5-Level EQ-5D at baseline, post-intervention (6-months) and follow-up (12-months)
4.2. Healthcare usage, measured using a study specific questionnaire assessing Healthcare Usage Over the Previous 12-weeks at baseline, post-intervention (6-months) and follow-up (12-months)

Overall trial start date

01/04/2020

Overall trial end date

01/05/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Clinical Diagnosis of T2D within the previous 5–24 months
2. Aged 40 - 75 years
3. Treating diabetes with only Metformin or lifestyle modifications (diet and exercise)
4. For those prescribed Metformin: Stable dose for 3-months or more

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 (UK arm n=60; Canadian arm n=60)

Participant exclusion criteria

1. HbA1c >10% (>86mmol/mol)
2. Blood pressure >160/100 mmHg
3. Prescription of oral antidiabetic drug other than Metformin
4. Prescription of Insulin
5. Unstable angina
6. Myocardial infarction within the previous 3 months
7. Transient ischemic attack (TIA) in the previous 6 months
8. Heart failure >= class 2
9. Inability to increase level of activity
10. Pregnancy or planning to become pregnant
11. <6 months postpartum or stopped breastfeeding <1 month before recruitment
12. Not owning a smartphone/ or having no data plan or access to WiFi
13. Currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week)

Recruitment start date

01/11/2020

Recruitment end date

01/12/2021

Locations

Countries of recruitment

Canada, United Kingdom

Trial participating centre

Liverpool John Moores University
Research Institute for Sport and Exercise Sciences Tom Reilly Building Liverpool John Moores University Byrom Street
Liverpool
L3 3AF
United Kingdom

Trial participating centre

The University of British Columbia
School of Health and Exercise Sciences Faculty of Health and Social Development ART360 (Arts Building) 1147 Research Road
Kelowna
V1V 1V7
Canada

Sponsor information

Organisation

Liverpool John Moores University

Sponsor details

Research Innovation Services
Exchange Station
Tithebarn Street
Liverpool
L2 2QP
United Kingdom
+44 (0)151 2312121
sponsor@ljmu.ac.uk

Sponsor type

University/education

Website

https://www.ljmu.ac.uk/

Funders

Funder type

Government

Funder name

Medical Research Council; Grant Codes: MR/T032189/1

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

Our intended policy is that the research team will have exclusive use of the data for a period of 12 months or until the data is published. Following this data will be publicly available through the LJMU Data Repository, published under a permissive re-use license. A CC BY NC license will be applied to openly available data, this creative commons license permits others to distribute, and build upon the work for non-commercial purposes. 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 statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository

Intention to publish date

01/06/2023

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/10/2020: The participant information sheet was uploaded as an additional file. 19/10/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)