Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001488392
Ethics application status
Approved
Date submitted
2/10/2017
Date registered
20/10/2017
Date last updated
9/06/2021
Date data sharing statement initially provided
9/06/2021
Date results information initially provided
9/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise via e-Health for a Lifestyle Exchange in Type 2 Diabetes
Scientific title
Effects of an e-Health Program on Exercise Adherence in Type 2 Diabetes
Secondary ID [1] 293042 0
Nil
Universal Trial Number (UTN)
Trial acronym
PAIforDIABETES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 304947 0
Condition category
Condition code
Metabolic and Endocrine 304275 304275 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an eHealth Program that consists of participants being provided with a device and undertaking 4x2 hour sessions that will educate them on how to use the device and how to reach the physical activity goals. The device is called a Mio Fuse wristband. It uses an LED light to illuminate the capillaries around the participants wrist, tracking the velocity of the blood flow and thus, heart rate. Physical Activity Intelligence (PAI) is calculated by an algorithm in the device that uses the participant's heart rate, awarding them with a number of PAI depending on the intensity of the exercise with the goal of reaching 100 PAI per week. The intervention will be delivered by a research assistant with a minimum 2 years' experience in clinical exercise physiology. The sessions will be face to face in a group environment and held at The University of Queensland, St.Lucia weekly for 4 weeks. The participants will be expected to wear the device continuously (except for when it needs to be removed for charging) for the purposes of this study for 12 months. During the first session, 1-hour will be used to introduce participants to the concept of self monitoring for physical activity and PAI, including how to use the PAI App on their smartphone, activate the heart rate recording on the wristband, connect with activity buddies and to interpret PAI data. Thereafter, 1-hour “PAI-playtime” will be undertaken; the research assistant will introduce participants to different modalities of endurance exercises (such as walking, swimming, running, cycling, strength training etc.) in short bouts of 5-10 minutes at different intensities demonstrating different ways to “earn” PAI. Between each weekly session, participants will explore and practice using the PAI App aiming to earn 100 PAI before the next group session. The following 3 group sessions will each follow this format, 1-hour will be used for “interpretative assistance” to make sure they have correctly understood the PAI concept, share experiences using the PAI App, and problem solving; and 1 hour for “PAI-playtime”. At end of Stage 1 participants will be given a booklet describing examples of exercise sessions that they experienced at Stage 1.
Intervention code [1] 299268 0
Lifestyle
Intervention code [2] 299371 0
Treatment: Devices
Comparator / control treatment
The control group will receive standard care from their GP and/or other healthcare providers. Standard care consists of being provided with advice on how to increase physical activity levels to meet the guidelines of 150 min/week of moderate intensity activity.
Control group
Active

Outcomes
Primary outcome [1] 303550 0
The number of weeks per year that participants are able to adherence to meeting 100 PAI/week (e.g. 48/52 weeks). This will be measured on the PAI Fuse wristband and communicated to smartphone and then MIO Database.
Timepoint [1] 303550 0
12 months post intervention commencement
Secondary outcome [1] 339333 0
Cardiorespiratory fitness (VO2max) assessed by measuring oxygen consumption during a graded exercise test to exhaustion.
Timepoint [1] 339333 0
12 months post intervention commencement
Secondary outcome [2] 339334 0
Glycemic control (HbA1c) using serum samples
Timepoint [2] 339334 0
12 months post intervention commencement
Secondary outcome [3] 339335 0
Blood lipids from serun
Timepoint [3] 339335 0
12 months post intervention commencement
Secondary outcome [4] 339336 0
Blood pressure at the brachial artery with a sphygmomanometer
Timepoint [4] 339336 0
12 months post intervention commencement
Secondary outcome [5] 339337 0
Medications (type and dosage) used for the treatment of type 2 diabetes assessed by participant reporting
Timepoint [5] 339337 0
12 months post intervention commencement

Eligibility
Key inclusion criteria
Diagnosis of type 2 diabetes
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any medical condition whereby higher intensity exercise is contraindicated
Does not have regular access to a smartphone

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with blocks created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome: The number of weeks per year attaining 100 PAI will be compared between the two groups using a Chi squared statistical test.
Secondary outcomes: VO2peak and HbA1c will be compared between the two groups using a 2 way repeated measures ANOVA..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2017
Actual
1/03/2019
Date of last participant enrolment
Anticipated
31/10/2018
Actual
31/08/2019
Date of last data collection
Anticipated
31/10/2019
Actual
18/09/2020
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297654 0
University
Name [1] 297654 0
University of Queensland Consultancy Account of PI
Country [1] 297654 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Human Movement and Nutrition Sciences
The University of Queensland
Human Movement Studies Building (#26B)
St Lucia, 4072
Queensland, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 296679 0
None
Name [1] 296679 0
Address [1] 296679 0
Country [1] 296679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298739 0
University of Queensland
Ethics committee address [1] 298739 0
Human Ethics Committee
Research Road
The University of Queensland
St Lucia, 4072
Queensland
Ethics committee country [1] 298739 0
Australia
Date submitted for ethics approval [1] 298739 0
30/10/2017
Approval date [1] 298739 0
04/01/2019
Ethics approval number [1] 298739 0
2018002281
Ethics committee name [2] 308717 0
Griffith University
Ethics committee address [2] 308717 0
Office for Research
Griffith University
Nathan
QLD 4111
Ethics committee country [2] 308717 0
Australia
Date submitted for ethics approval [2] 308717 0
21/01/2019
Approval date [2] 308717 0
12/02/2019
Ethics approval number [2] 308717 0
2019/099

Summary
Brief summary
The aim of the EXHALE pilot project is to test whether the Personal Activity Intelligence (PAI) e-Health program improves adherence to exercise targets over a twelve month period in people withType 2 Diabetes. Sixty participants with Type 2 Diabetes will be randomised into the PAI e-Health Program or usual care. Those in the intervention group will receive a MIO Fuse wristband, which uses their heart rate to calculate PAI, the goal being to achieve 100PAI per week. Participants will attend group sessions to learn how to use the technology, and how exercise accumulates PAI. The control group will receive standard care from their GP and/or other healthcare providers. The primary outcome will be the ability to accumulate 100 PAI per week over twelve months. In addition, cardiorespiratory fitness, glycemic control and various physical measures will be assessed at baseline and follow-up. It is expected that the PAI e-Health program will be associated with superior adherence to physical activity compared to usual care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78070 0
Prof Jeff Coombes
Address 78070 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Blair Drive
Rm 535, Human Movement Studies Building (#26B)
St Lucia, 4072
Queensland
Country 78070 0
Australia
Phone 78070 0
+61733656767
Fax 78070 0
Email 78070 0
jcoombes@uq.edu.au
Contact person for public queries
Name 78071 0
Prof Jeff Coombes
Address 78071 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Rm 535, Human Movement Studies Building (#26B)
Blair Drive
St Lucia, 4072
Queensland
Country 78071 0
Australia
Phone 78071 0
+61733656767
Fax 78071 0
Email 78071 0
jcoombes@uq.edu.au
Contact person for scientific queries
Name 78072 0
Prof Jeff Coombes
Address 78072 0
School of Human Movement and Nutrition Sciences
The University of Queensland
Rm 535, Human Movement Studies Building (#26B)
Blair Drive
St Lucia, 4072
Queensland
Country 78072 0
Australia
Phone 78072 0
+61733656767
Fax 78072 0
Email 78072 0
jcoombes@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.