Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000379718
Ethics application status
Approved
Date submitted
25/02/2022
Date registered
4/03/2022
Date last updated
22/02/2024
Date data sharing statement initially provided
4/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility, safety, and efficacy of GRoup Exercise for people with type 2 diAbetes using Telehealth: The GREAT Study
Scientific title
The feasibility, safety, and efficacy of GRoup Exercise for people with type 2 diAbetes using Telehealth: The GREAT Study
Secondary ID [1] 306531 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GREAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 325414 0
Condition category
Condition code
Metabolic and Endocrine 322806 322806 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potential participants will initially make content via email or phone if they are willing to volunteer to take part in the study. Potential participants will initially be screened to ensure they meet all eligibility criteria. After providing written informed consent, the participants will attend the baseline assessment session at the University. Within 72 hours of this session, they will be asked to repeat tests in their home environment, while being supervised by an Accredited Exercise Physiologist via telehealth.

The 8-week telehealth exercise program will be delivered in groups of five by an Accredited Exercise Physiologist using Zoom, including two-way audio-visual communication. Each session will be 1 hour and will occur once weekly – 45 minutes will be dedicated to the exercise program and 15 minutes to education. Each 45-minute exercise program will include both aerobic and resistance training, following the Exercise and Sports Science Australia guidelines for people with type 2 diabetes (i.e., moderate to vigorous intensity, assessed by Borg RPE scale). The exercises will be selected based on the availability of equipment/space and individual participant needs within the group; examples may include squats, push-ups, banded rows, and/or balance exercises. Adherence will be monitored through attendance checklists. The sessions will occur once weekly, though participants will be provided with additional resources for completing self-directed exercise external to the supervised sessions (e.g., Exercise and Sports Science Australia Exercise Right at Home website). The frequency, intensity, duration and mode of self-directed exercise will be at the discretion of the participants, and will not be monitored.

In addition to the structured exercise component, the program will also include 15 minutes of education to help participants transition to self-management. These will be delivered by electronic slide presentations at the end of each session, and will cover such topics as health behaviour change, exercise guidelines for T2D, goal setting, medications, and dietary guidelines. To enhance the likelihood of long-term behaviour change, the education sessions will target key constructs from Bandura’s Social Cognitive Theory (i.e., self-efficacy, goals, beliefs, and social support).

After the 8-week program, all participants will attend the University for a final assessment session.
Intervention code [1] 322959 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330588 0
Feasibility of delivering group exercise interventions via telehealth (recruitment rate, retention rate, reasons for attrition, participant acceptability, practicality). This will be assessed via audits of study records, attendance lists, and semi-structured, individual interviews at the conclusion of the program.
Timepoint [1] 330588 0
The total duration of the study will be 10 weeks – this includes two baseline assessment visits in week 1, eight weeks of supervised telehealth-delivered exercise in weeks 2-9, and a final assessment visit in week 10
Secondary outcome [1] 406811 0
Glycated haemoglobin (HbA1c; blood test)
Timepoint [1] 406811 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [2] 406812 0
Fasting blood glucose (blood test)
Timepoint [2] 406812 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [3] 406813 0
Cholesterol profile (blood test)
Timepoint [3] 406813 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [4] 406814 0
Waist and hip girths (tape measure)
Timepoint [4] 406814 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [5] 406815 0
Blood pressure (automatic sphygmomanometer)
Timepoint [5] 406815 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [6] 406816 0
Physical activity levels (International Physical Activity Questionnaire, Accelerometer)
Timepoint [6] 406816 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [7] 406817 0
Diet (24 hour recall)
Timepoint [7] 406817 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [8] 406818 0
Lower body muscular endurance (2-minute step test)
Timepoint [8] 406818 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [9] 406819 0
Upper body functional strength (30sec bicep curl test)
Timepoint [9] 406819 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [10] 406820 0
Submaximal exercise capacity (6 minute walk test)
Timepoint [10] 406820 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.
Secondary outcome [11] 406821 0
Safety - participants will be instructed to report to the research team any adverse events that occur during the study period. The type, incidence, and severity of adverse events will be determined based on the Common Terminology Criteria for Adverse Events.
Timepoint [11] 406821 0
Participants will be assessed face-to-face and via telehealth at baseline, and face-to-face only following the 8-week intervention.

Eligibility
Key inclusion criteria
Participants will require a glycated haemoglobin (HbA1c) level of greater than or equal to 7.0% at baseline, and access to a device with a camera (e.g., computer/laptop/tablet). Potential participants will be screened using the Adult Pre-Exercise Screening System to ensure safety.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be ineligible if they have any condition as per the absolute contraindications to exercise outlined by the American College of Sports Medicine8 including, but not limited to: unstable angina; recent (within the past four weeks) myocardial infarction; coronary artery disease; uncompensated heart failure; New York Heart Association functional classification II-IV; severe valvular illness; pulmonary disease; uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg); renal failure (chronic kidney disease stages IV-V); cardiomyopathy. People will also be ineligible for: having type 1 diabetes, meeting the physical activity guidelines (150minutes/week moderate intensity or 75minutes/week vigorous intensity exercise), planned medical operations during the research period, a physical condition whereby exercise training would be inappropriate, pregnant or expecting to be pregnant during the study period, non-English speaking, and cognitive impairment that limits the ability to understand verbal instructions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2022
Actual
22/04/2022
Date of last participant enrolment
Anticipated
2/10/2023
Actual
29/09/2023
Date of last data collection
Anticipated
31/12/2023
Actual
7/12/2023
Sample size
Target
25
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310873 0
University
Name [1] 310873 0
University of Newcastle
Country [1] 310873 0
Australia
Primary sponsor type
Individual
Name
Dr Emily Cox
Address
University of Newcastle
10 Chittaway Road
Ourimbah NSW 2258
Country
Australia
Secondary sponsor category [1] 312137 0
Individual
Name [1] 312137 0
Professor Ronald Plotnikoff
Address [1] 312137 0
University of Newcastle University Dr Callaghan NSW 2308
Country [1] 312137 0
Australia
Secondary sponsor category [2] 312141 0
Individual
Name [2] 312141 0
Dr Myles Young
Address [2] 312141 0
University of Newcastle University Dr Callaghan NSW 2308
Country [2] 312141 0
Australia
Secondary sponsor category [3] 312142 0
Individual
Name [3] 312142 0
Dr Shelley Keating
Address [3] 312142 0
The University of Queensland Blair Drive St Lucia QLD 4072
Country [3] 312142 0
Australia
Secondary sponsor category [4] 312143 0
Individual
Name [4] 312143 0
Ryan Drew
Address [4] 312143 0
University of Newcastle 10 Chittaway Road Ourimbah NSW 2258
Country [4] 312143 0
Australia
Secondary sponsor category [5] 312144 0
Individual
Name [5] 312144 0
Dr Kim Edmunds
Address [5] 312144 0
The University of Queensland Corner of Campbell Rd and University Drive St Lucia QLD 4072
Country [5] 312144 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310434 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 310434 0
Ethics committee country [1] 310434 0
Australia
Date submitted for ethics approval [1] 310434 0
Approval date [1] 310434 0
23/07/2021
Ethics approval number [1] 310434 0
H-2021-0204

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117654 0
Dr Emily Cox
Address 117654 0
School of Environmental and Life Sciences University of Newcastle 10 Chittaway Road Ourimbah NSW 2258
Country 117654 0
Australia
Phone 117654 0
+61 2 4985 4515
Fax 117654 0
Email 117654 0
[email protected]
Contact person for public queries
Name 117655 0
Emily Cox
Address 117655 0
School of Environmental and Life Sciences University of Newcastle 10 Chittaway Road Ourimbah NSW 2258
Country 117655 0
Australia
Phone 117655 0
+61 2 4985 4515
Fax 117655 0
Email 117655 0
[email protected]
Contact person for scientific queries
Name 117656 0
Emily Cox
Address 117656 0
School of Environmental and Life Sciences University of Newcastle 10 Chittaway Road Ourimbah NSW 2258
Country 117656 0
Australia
Phone 117656 0
+61 2 4985 4515
Fax 117656 0
Email 117656 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• People from credentialed institutions upon request by email to PI- Dr Emily Cox

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial in a non-identifiable form. If the participant has given extended consent, group mean and standard deviations for all outcome data will be shared on request to the PI. For example for the purpose of meta analysis where data not reported in suitable format in the publication.

Data that will be shared are clinical outcome data.

What types of analyses could be done with individual participant data?
• Meta-analysis or other pooled analysis of raw data. All data to be shared will be de-identified.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of results (estimated to be Jan 2023) and will be available for 15 years (Jan 2038).

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Upon request by email to PI - Dr Emily Cox
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.