None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
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.
Outcome results
None listed