Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000645651
Ethics application status
Approved
Date submitted
23/05/2023
Date registered
15/06/2023
Date last updated
15/06/2023
Date data sharing statement initially provided
15/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and effectiveness of a 12-week lifestyle program on HbA1c for Aboriginal and/or Torres Strait Islander peoples with type 2 diabetes
Scientific title
Feasibility and effectiveness of the Too Deadly program, a 12-week lifestyle program, on HbA1c for Aboriginal and/or Torres Strait Islander peoples with type 2 diabetes
Secondary ID [1] 309723 0
Sponsor: University of Melbourne
UoM CT ID: 24533
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 330114 0
Condition category
Condition code
Metabolic and Endocrine 326998 326998 0 0
Diabetes
Public Health 327086 327086 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial plans to assess the effectiveness of the Too Deadly for Diabetes 12-week lifestyle program on HbA1c for Aboriginal and/or Torres Strait Islander peoples with type 2 diabetes. The intervention will be provided in the primary care setting at 2 local Aboriginal medical service in regional and remote NSW. The control arm will continue to be provided with the usual cycle of care for that Aboriginal medical service.
Information for participants will be provided via the smartphone app titled, ‘Ray Kelly's Weight Loss Plan’. It will provide recipes, exercise programs and daily motivational videos that have been co-designed with 16 Aboriginal communities to ensure a culturally safe and supportive format for the study. Those without access to a smartphone or data will be provided with printed copies of recipes and exercise programs. Recipes and exercise programs will be further individualised by the local health professionals. They will also receive a commercially available actigraphy tracker. The starting exercise program is 20-30 minutes of walking each day. Patients will then be encouraged to participate in additional physical activity formats that they find enjoyable (eg. Swimming, netball, group exercise classes, touch football). They will also be provided with a body weight program that can be completed at home and can be adapted for a range of fitness levels.
Some sample workouts are:
1. Squats x 10-15 reps (Partial squats for those with limited strength/range of movement)
2. Walk/Jog on the spot x 60 seconds
3. Push ups x maximum (Wall push up for those with limited strength)
4. Walk/Jog on the spot x 60 seconds
5. Sit ups x 10-15 reps
Another workout for those seeking to improve their cardiovascular fitness is:
1. Walk for 5 minutes
2. Slow jog for 10 seconds, then walk for 1 minute and 50 seconds
3. Repeat step 2 for 10 intervals
4. Walk for 5 minutes
Intensity for this program is increased every week by lengthening the jog time by 5-10 seconds, and reducing the corresponding walking time by the same amount.

Training for health staff will be provided in a 4 hour face-to-face seminar by Ray Kelly. This will be provided 2 weeks prior to recruitment. The training will cover: Recent research on remission of type 2 diabetes; Identifying the obstacles and facilitators in your local community; A strengths-based approach to supporting participants; What to expect across the 12 weeks.

Participants will have a Flash blinded glucose monitor attached to their upper arm for 2 weeks prior to commencing the intervention, and in the final 2 week of the intervention to measure change in time-in-range.
Participants will undergo initial baseline testing prior to commencing the intervention as well as at the completion of the intervention. HbA1c will also be measured at 12 weeks post-intervention.
Participants will attend a weekly individual consult (12 in total; 20 minutes each) where blood sugar levels, blood pressure and weight will be measured and recorded. During these weekly consultations participant questions will be answered and the diet and exercise program may be further personalised. Participants will also have contact through a 5-10 minute phone consult between each weekly consultation. This will be completed by the chronic care nurse and the participant will be asked how they are progressing with the program since their last visit. Having regular contact over the phone may make it easier for some participants to discuss how they are feeling.

Intervention adherence will be assessed via attendance, daily step count, and food diary.

The intervention will be delivered by the staff at the Aboriginal medical service, which includes the GP, chronic care nurse, diabetes educator and other allied health professionals.
Intervention code [1] 326163 0
Lifestyle
Comparator / control treatment
Participants in the Standard Care group will undergo the standard treatment provided by the local Aboriginal Health Service, for patients with type 2 diabetes. This will include a 715 Aboriginal Health Check, a GP Management Plan and TCA. Participants will be referred to local allied health professionals for treatment and support where required. This could include referral to a dietician and/or exercise physiologist or physiotherapist. There will be no added cost caused by participation in the study as this is part of the standard care provided at the medical centre. Visits to allied health can be subsidised through Medicare and often the GP will refer a patient to an allied health professional who does not charge a gap fee. In this instance there would be no added cost to the participant. They will also receive a commercially available actigraphy tracker.
Those in the Standard Care group will be offered the intervention at 6 months post intervention completion.
Control group
Active

Outcomes
Primary outcome [1] 334852 0
Change in HbA1c level. HbA1c assessed using serum assay
Timepoint [1] 334852 0
From baseline to 12 weeks post intervention commencement. HbA1c will also be measured from baseline to 3 months.
Secondary outcome [1] 422251 0
Efficacy: Percentage (%) of time spent in target glucose range. Information obtained from the blinded sensor at -2 weeks to baseline, then weeks 10-12 post intervention commencement.
Timepoint [1] 422251 0
The assessment will be made between the 2 weeks prior to the commencement of the intervention, then weeks 10 to 12 post intervention commencement.
Secondary outcome [2] 422252 0
Safety: Number of events of severe hypoglycaemia (ADA, 2019), defined as a severe event characterised by altered mental and/or physical status requiring third-party assistance (ADA, 2019), ambulance call out or hospital presentations.
Timepoint [2] 422252 0
From baseline to 12 weeks post intervention commencement.
Secondary outcome [3] 422253 0
Percentage of individuals who achieve remission of type 2 diabetes as defined by a HbA1c of <6.5% and requiring no medication for 3 months as described in the consensus statement by the Endocrine Society, European Association for the Study of Diabetes, Diabetes UK, and American Diabetes Association (Riddle et al., 2021); and by the position statement by Diabetes Australia. HbA1c will be assessed using serum assay and medication use from patient medical records.
Timepoint [3] 422253 0
From final assessment at Week 12 post intervention commencement and 12 weeks post-intervention completion.
Secondary outcome [4] 422254 0
Physical activity levels as measured in ‘steps per day’. This will be measured by the physical activity actigraphy tracker supplied to each participant
Timepoint [4] 422254 0
From baseline to 12 weeks post intervention commencement.
Secondary outcome [5] 422710 0
Change in medications. Medication change use will be informed from patient medical records
Timepoint [5] 422710 0
From baseline to 12 weeks post intervention commencement, and 12 weeks post-intervention completion.
Secondary outcome [6] 422711 0
Feasibility of a 12-week lifestyle program on improving health outcomes for Indigenous Australians with type 2 diabetes will be assessed through attendance to weekly meetings, which will be determined from clinical records.
Timepoint [6] 422711 0
From baseline to 12 weeks post intervention commencement.
Secondary outcome [7] 422715 0
Efficacy: Percentage (%) of time spent in low glucose range. Information obtained from the blinded sensor at -2 weeks to baseline, then weeks 10-12 post intervention commencement.
Timepoint [7] 422715 0
The assessment will be made between the 2 weeks prior to the commencement of the intervention, then weeks 10 to 12 post intervention commencement.
Secondary outcome [8] 422718 0
Efficacy: Percentage (%) of time spent in high glucose range. Information obtained from the blinded sensor at -2 weeks to baseline, then weeks 10-12 post intervention commencement.
Timepoint [8] 422718 0
The assessment will be made between the 2 weeks prior to the commencement of the intervention, then weeks 10 to 12 post intervention commencement.
Secondary outcome [9] 422963 0
Feasibility of a 12-week lifestyle program on improving health outcomes for Indigenous Australians with type 2 diabetes will be assessed through change in HbA1c, which will be determined from blood assays.
Timepoint [9] 422963 0
From baseline to 12 weeks post intervention completion.
Secondary outcome [10] 422964 0
Feasibility of a 12-week lifestyle program on improving health outcomes for Indigenous Australians with type 2 diabetes will be assessed through change in quality of life, which will be determined from the EQ-5D-5L assessment form.
Timepoint [10] 422964 0
From baseline to 12 weeks post intervention commencement.

Eligibility
Key inclusion criteria
1. Indigenous Australian
2. Confirmed diagnosis of type 2 diabetes
3. Aged 18-65 years
4. HbA1c >7.5% (58 mmol/mol) from either a recent test (12 weeks) or sample at screening
5. Written informed consent
6. Able to complete a 6-minute walk test
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Being pregnant or considering pregnancy;
2. Recent hospitalisation within past 3 months;
3. Myocardial infarction within past 6 months;
4. Severe medical conditions such as unstable heart failure;
5. eGFR <30 mls/min/1.73 m2;
6. Recent positive COVID-19 test;
7. History of eating disorder;
8. Unstable mental health conditions;
9. Recent history (6 months) of substance abuse
10. Recent history of respiratory issues,
11. Recent cancer treatment;
12. Previous bariatric surgery
13. Severe retinopathy or maculopathy;
14. Inability to receive a medical clearance from their doctor.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation occurs within the RedCap system
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A convenience sample of 56 participants (Intervention: N=28; Standard Care: N=28) will be recruited by two Aboriginal Medical Services in rural New South Wales.
Sample size was calculated based on the number of participants required to test the primary hypothesis at 90% power and at a 0.05 significance level. We based our estimates on the results of the LOOK AHEAD (Action for Health in Diabetes) trial (Unick et al., 2011) and DIADEM-I (Diabetes Intervention Accentuating Diet and Enhancing Metabolism-I) (Taheri et al., 2020) and our pilot data.
We hypothesise that 65% of participants in our study will achieve the favourable outcome as defined above. Although there is no evidence that the participants in the control group will achieve any reduction, we conservatively assume a potential of up to 15% will achieve this reduction in the control group.
Recruiting 23 participants per arm would yield 90% power to observe the difference in favourable outcome between the two arms as described above using type 1 threshold of 0.05.
The final sample size for this study is 56 participants (28 per arm) in order to account for potential dropouts or non-evaluable participants which is found to be approximately 20% in this population (Lean et al., 2018).
Participants with no follow up data will be imputed as no change.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/06/2023
Actual
Date of last participant enrolment
Anticipated
24/06/2024
Actual
Date of last data collection
Anticipated
14/10/2024
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40429 0
2829 - Coonamble
Recruitment postcode(s) [2] 40428 0
2830 - Dubbo

Funding & Sponsors
Funding source category [1] 313915 0
University
Name [1] 313915 0
University of Melbourne
Country [1] 313915 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan Street, Parkville, Victoria 3010
Country
Australia
Secondary sponsor category [1] 315775 0
None
Name [1] 315775 0
Address [1] 315775 0
Country [1] 315775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313061 0
St Vincents Hospital
Ethics committee address [1] 313061 0
41 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 313061 0
Australia
Date submitted for ethics approval [1] 313061 0
12/09/2022
Approval date [1] 313061 0
07/10/2022
Ethics approval number [1] 313061 0
St Vincent’s HREC Ref: HREC 110/22
Ethics committee name [2] 313062 0
Aboriginal Health and Medical Research Council
Ethics committee address [2] 313062 0
Level 4, 280 Pitt Street, Sydney NSW 2000
Ethics committee country [2] 313062 0
Australia
Date submitted for ethics approval [2] 313062 0
09/12/2021
Approval date [2] 313062 0
19/01/2022
Ethics approval number [2] 313062 0
1883/21

Summary
Brief summary
The aim of the study is to determine the feasibility of a 12-week lifestyle program on type 2 diabetes in the Indigenous community in Australia. Feasibility is defined as achieving an attendance rate over 70%. It is hypothesised that the Too Deadly program can lead to an improvement in HbA1c and/or a reduction in glucose lowering medications for Indigenous Australians with type 2 diabetes and can be achieved safely.
Secondary hypotheses include:

1. Efficacy: The Too Deadly program is superior to standard care after 12 weeks in assisting participants to:
(a) increase in percentage (%) of time in range (target) for blood glucose levels (3.9–10 mmol/L),
(b) reduce percentage (%) of below range for blood glucose levels, defined as <3.9 mmol/L.
(c) reduce percentage (%) of time below range for blood glucose levels, defined as <3.0 mmol/L.
(d) reduce percentage(%) of time above range for blood glucose levels, defined by >10.0 mmol/L
(e) reduce percentage(%) of time above range for blood glucose levels, defined by >13.9 mmol/L.

2. Safety: Too Deadly program will not lead to increased number of severe hypoglycaemia (ADA, 2019), defined as a severe event characterised by altered mental and/or physical status requiring third-party assistance (ADA, 2019), ambulance call out or hospital presentations from baseline to 3 months.

3. The Too Deadly program will lead to improvements in glucose time in range as determined by the Flash Libre Pro.
4. The Too Deadly program will lead to a reduction in medication dose for some individuals.
5. The Too Deadly program will lead to improvements in quality of life as measured by the EQ-5D-5L questionnaire.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126858 0
Mr Ray Kelly
Address 126858 0
University of Melbourne
Grattan Street, Parkville Victoria 3010
Country 126858 0
Australia
Phone 126858 0
+61403797923
Fax 126858 0
Email 126858 0
ray.kelly@unimelb.edu.au
Contact person for public queries
Name 126859 0
Mr Ray Kelly
Address 126859 0
University of Melbourne
Grattan Street, Parkville Victoria 3010
Country 126859 0
Australia
Phone 126859 0
+61403797923
Fax 126859 0
Email 126859 0
ray.kelly@unimelb.edu.au
Contact person for scientific queries
Name 126860 0
Mr Ray Kelly
Address 126860 0
University of Melbourne
Grattan Street, Parkville Victoria 3010
Country 126860 0
Australia
Phone 126860 0
+61403797923
Fax 126860 0
Email 126860 0
ray.kelly@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is currently undecided as further discussion is to be had with the local Indigenous communities.


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.