Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001594213
Ethics application status
Approved
Date submitted
18/09/2018
Date registered
26/09/2018
Date last updated
14/06/2024
Date data sharing statement initially provided
25/09/2019
Date results provided
21/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian lifestyle change program to prevent or delay type 2 diabetes (AUS2PREVENT)
Scientific title
Australian lifestyle change program to prevent or delay type 2 diabetes amongst high risk population (AUS2PREVENT)
Secondary ID [1] 296113 0
Nil
Universal Trial Number (UTN)
U1111-1220-5636
Trial acronym
AUS2PREVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 309693 0
Condition category
Condition code
Metabolic and Endocrine 308497 308497 0 0
Diabetes
Public Health 308577 308577 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The AUS2PREVENT is an evidence-based study which was developed based on the Finnish Diabetes Prevention Study (DPS) and the US Diabetes Prevention Program (DPP).

The AUS2PREVENT program incorporates the relevant guidelines including Australian Healthy Eating Guidelines, Australia's Physical Activity and Sedentary Behaviour Guidelines, Fitness Australia’s Exercise Guidelines. The AUS2PREVENT program is a year-long program with 14 face-to-face, 1-hour group sessions delivered over 12-months. In the first six months, there will be weekly sessions in the first 10 weeks followed by a further 2 sessions, each separated by 5 weeks. During the last six months, the final 2 face-to-face sessions will be separated by 10-week intervals.

Between each face-to-face session, and for additional support to set and progress the goals they are setting, participants in the AUS2PREVENT group will be encouraged to connect with their peers and coach from within their group session. They will also be provided with text message reminders before each education session to maximise attendance rates.

The main components of the program involve education and demonstration of practical skills in the areas of physical activity, diet, and behaviour change motivation (goal setting, sleep and stress management, coping strategies, and support). The demonstration of practical skills may include a simple physical activity such as marching in place whereas the demonstration of simple stress management activities may include meditation yoga and relaxation techniques. The physical activity group sessions have been developed based on the Australian physical activity and sedentary behaviour guidelines (Department of Health 2014) and the diet sessions have been developed based on the Australian Dietary guidelines (National Health and Medical Research Council 2013) and Australian Guide to Healthy Eating (Australian Government 2017).

Coaches are experienced credentialed diabetes educators, accredited practicing dietitians, or exercise physiologists. All coaches must complete training provided by Diabetes SA. In line with evidence-based practice, the ratio of coaches to participants will be 1:40 at a maximum rate, and maximum group size will be 15 participants.

The mode of delivery is face to face with text message reminders. The prevention program will be held at 10 community centres within the study areas.
Intervention code [1] 312444 0
Prevention
Comparator / control treatment
Participants allocated to the usual care group will remain under the supervision of their GP and receive an educational brochure explaining which lifestyle factors can be changed to reduce disease risk factors and prevent diabetes. It also includes practical tips to help make the required lifestyle changes. At the completion of the 2 year trial, participants in the usual care group will have the opportunity to access relevant and free Diabetes SA resources (i.e. The Good Health Guide available from Diabetes SA) and services designed for risk management.
Control group
Active

Outcomes
Primary outcome [1] 307481 0
A composite of biometric variables that indicate type 2 diabetes risk including HbA1c; blood lipids; blood pressure, weight; waist circumference; and hip circumference.

The composite variables are HbA1c and lipids (as measured from blood drawn and evaluated in an accredited clinical pathology lab); blood pressure (measured by the GP/ GP practitioner using a digital sphygmomanometer); body weight (measured by the GP/GP practitioner using calibrated balance scales); waist circumference (measured by the GP/GP practitioner using a tape measure and at the level of the navel); and hip circumference (measured using a tape measure at the hip).
Timepoint [1] 307481 0
This primary outcome will be collected at the beginning of the program and at 6, 12 and 24 months after commencing the trial. A GP will measure these clinical variables and data will be entered into the participants' case record form.
Primary outcome [2] 330462 0
The feasibility, acceptability and cost-effectiveness of the trial intervention will be measured using a composite of quantitative and qualitative questions adapted from previous Diabetes Prevention Studies including The US Diabetes Prevention Program Research Group (Diabetes Care. 1999;22:623–634; N Engl J Med. 2002;346:393–403). The composite questions focus on overall participant satisfaction with the intervention and also the enabling and challenging factors that influenced the participants' and coaches' acceptance of the interventions. The composite question will also be supplemented by information gained from a face-to-face interview (approximately 15 minutes, not recorded) completed at the end of the 12-month intervention period. In addition, information to derive the cost-effectiveness of the intervention will be gained from medical records including data from the Medicare Benefits Schedule (MBS), the Pharmaceutical Benefits Scheme (PBS), Admitted Patient Care (APC), the Emergency Department Data Collection (EDDC), and the National Hospital Cost Data Collection (NHCDC).
Timepoint [2] 330462 0
These outcomes will be assessed by questionnaires at 3, 6, 12, 24, 36, 52, and 104 weeks post-intervention commencement.
Primary outcome [3] 330463 0
A composite of psychosocial factors that influence behaviours will be measured from a series of validated questions that incorporate questions addressing each of the following:
1) demographic information (measured using questions adapted from the ABS Census (Census of Population and Housing: Understanding the Census and Census Data, Australia (cat. no. 2900.0)); 2) health status (measured using questions adapted from the ABS Census, the Australian National Health Survey (https://www.abs.gov.au/statistics/health/health-conditions-and-risks/national-health-survey-first-results/latest-release), and the Brief Illness Perception questionnaire (Broadbent E et al. Journal of Psychosomatic Research 60 (2006) 631 – 637)); 3) smoking history (measured using questions adapted from the National Health Survey (https://www.abs.gov.au/statistics/health/health-conditions-and-risks/national-health-survey-first-results/latest-release); 4) alcohol consumption (measured using questions adapted from the Australian National Health Survey (https://www.abs.gov.au/statistics/health/health-conditions-and-risks/national-health-survey-first-results/latest-release); 5) exercise and other physical activity (measured using questions adapted from the Active Australia questionnaire(https://www.aihw.gov.au/reports/physical-activity/active-australia-survey/summary)); 6) nutrition (measured using questions adapted from the Australian National Nutrition Survey (https://www.abs.gov.au/statistics/health/health-conditions-and-risks/national-health-survey-first-results/latest-release); 7) stage of behavioural change (measured using the Partners in Health Survey, Flinders Chronic condition Management Program, 2020 (Kephart et al. 2019); 8) Quality of life (measured using the EQ-5D-5L questionnaire (EuroQol Research Foundation. EQ-5D-5L User Guide, 2019. Available from: https://euroqol.org/publications/user-guides)).
Timepoint [3] 330463 0
The primary outcome will be collected at the beginning of the program and at 6, 12 and 24 months after commencing the trial. Participants will complete a series of questions from validated questionnaires with an online AUS2PREVENT Data Collection Form.
Secondary outcome [1] 352027 0
A cumulative incidence (cumulative incidence as the probability of developing type 2 diabetes over a stated period of time) of type 2 diabetes will be determined from medical records including data from the Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), Admitted Patient Care (APC), Emergency Department Data Collection (EDDC) and National Hospital Cost Data Collection (NHCDC).
Timepoint [1] 352027 0
This outcome will be measured 52 weeks and 104-weeks after the intervention commences.
Secondary outcome [2] 352028 0
An economic analysis (i.e. health-related costs of type 2 diabetes) of the AUS2PREVENT program based on the following data and datasets:
• Medicare item codes and costs for general practice, specialist and allied health services from the Medicare Benefits Schedule (MBS)
• Pharmaceutical item codes and costs from the Pharmaceutical Benefits Scheme (PBS)
• Emergency department presentations (e.g. date and time, triage category, arrival mode, presenting problem) from the Emergency Department Data Collection (EDDC)
• Public hospital admissions (e.g. length of hospital stay, principal diagnosis, diagnosis-related group, pre-existing medical conditions, complications, procedures) from the Admitted Patient Care (APC)
• Costs for each emergency department presentation and public hospital admission from the National Hospital Cost Data Collection.
Timepoint [2] 352028 0
This outcome will be measured 104-weeks after the intervention commences.

Eligibility
Key inclusion criteria
1. aged greater than or equal to 18 years;
2. reside or work in the Cities of West Torrens, Marion, Campbelltown, or Tea Tree Gully;
3. score greater than or equal to 12 assessed by AUSDRISK tool;
4. have impaired fasting blood glucose values of greater than or equal to 6.1 to less than 6.9 mmol/L and/or HbA1c greater than or equal to 5.7 to less than 6.4 %;
5. have at least one other cardiovascular risk marker (i.e., are overweight or obese as indicated by a body mass index greater than 27 kg/m2 for Caucasian Australians or greater than 23 kg/m2 for Asian Australians; have high blood pressure or high blood lipid(s)).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. diagnosed with diabetes (i.e. 2-hr BG greater than or equal to 11.1 mmol/L and/or FBG greater than or equal to 7.0 mmol/L and/or HbA1c greater than or equal to 6.4%) at the recruitment phase or any stages during the program other than at the end of the program;
2. previously diagnosed with diabetes mellitus other than gestational diabetes mellitus at screening;
3. currently pregnant or become pregnant during the program other than at the end of the program;
4. currently involved in a regular and vigorous exercise regime;
5. receiving treatment to lower blood glucose levels, other than routine dietary and health advice; have been diagnosed with severe organ damage, disability, cognitive impairment and/or other life-threatening disease; and
6. are not able, and/or are unwilling, to attend group sessions and undertake clinical assessments.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer with blocked randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified permuted block randomisation sequence generation of treatments will be used. Age (ie less than equal to 54 years, or greater than equal to 55 years), gender (ie male or female), and local council areas (ie North-East suburbs of Adelaide, or South-West suburbs of Adelaide) represent the strata. A block size of 4 will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming an attrition rate of up to 20% and based on the knowledge that the difference in HbA1c is the critical primary outcome and the difference in diabetes incidence is the critical secondary outcome that we must see to claim prevention of type diabetes, we will require n=300 participants per group, total n=600. It is feasible to recruit these numbers within 6 to 12 months since we know from our correspondence with the Adelaide PHN that each of the 4 sites has approximately 1000 people with prediabetes and many more who are at high risk of type diabetes.

Descriptive and inferential statistics will be produced. Categorical variables will be described as frequencies and percentages, and the Chi-square test will be used to compare differences between two groups. Continuous variables with normal distribution will be presented as mean with standard deviation (SD), and the independent t-test will be performed for comparisons. For continuous data with skewed distribution, data will be presented as median (25th,75th percentile) and using the Mann-Whitney U tests for comparisons. Multivariate mixed effect and logistic regression model will be performed to examine the independent predictors of continuous outcomes and dichotomous outcomes respectively.

As the outcome occurs for each individual with repeated time points, the mixed effect models will capture both fixed effects and random effects within the hierarchical structure of the data. The fixed effects, including group effect, time effect and group x time interaction, will be analogous to the regression coefficients. In particular, the changes in outcomes from baseline will be calculated at 6-, 12-, and 24-months. The differences in changes over time for the primary and secondary outcomes between the intervention and the usual care groups will also be assessed. The model will include participant-level random effects to account for correlation between participants. The maximum likelihood estimate procedure will be used to compare significant differences in primary and secondary outcomes over time and between groups. Univariate models will be first used, then multivariate modelling will be undertaken by adding variables considered clinically important or statistically significant from the univariate model to adjust for confounding effects between variables. A series of models will be undertaken by adding and subtracting variables, with changes in model fit assessed by log likelihood to choose the final multivariate model.

Qualitative analysis of qualitative data collected as part of questions asked in the Main and Mini Questionnaire at 3, 6, 9, 12 and 24 (e.g., influencing and motivational factors; enablers and barriers) will be performed using thematic analysis and presented as a narrative report.

A cost-effectiveness analysis will be performed from the perspective of the health care system. Direct costs for the intervention (e.g. capital costs, delivery of the lifestyle change program) and total costs associated with the use of health services for the control and intervention groups will be compared. A generalised linear regression model with the same covariate adjustments specified in the primary outcome model will be used to estimate the costs in the intervention and control groups. The mean costs and outcomes for each treatment group will then be compared.

The incremental cost-effectiveness ratio (ICER) per type 2 diabetes prevented and the 95% confidence interval will be calculated by dividing the difference in total costs by the difference in outcome between the two groups. Bootstrapping (using 5,000 resamples) will be used to represent the joint uncertainty around the differences in costs and outcomes. A cost-effectiveness plane will be generated to graphically represent the joint differences in costs and outcomes between the intervention and control groups. Cost-effectiveness acceptability curves will be generated to indicate the probability that the intervention is cost-effective compared with usual care at different monetary values for improvements in the analysed outcomes.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/03/2022
Actual
21/12/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
8/03/2023
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
600
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 36786 0
5091 - Tea Tree Gully
Recruitment postcode(s) [2] 36787 0
5074 - Campbelltown

Funding & Sponsors
Funding source category [1] 300702 0
Charities/Societies/Foundations
Name [1] 300702 0
Diabetes SA
Country [1] 300702 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Diabetes SA
Address
159 Sir Donald Bradman Drive, Hilton SA 5033
Country
Australia
Secondary sponsor category [1] 300245 0
None
Name [1] 300245 0
Address [1] 300245 0
Country [1] 300245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301486 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301486 0
Ethics committee country [1] 301486 0
Australia
Date submitted for ethics approval [1] 301486 0
03/12/2018
Approval date [1] 301486 0
16/04/2019
Ethics approval number [1] 301486 0
344.18 HREC/18/SAC/416

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

Contacts
Principal investigator
Name 87158 0
Dr Natalie Luscombe-Marsh
Address 87158 0
Diabetes SA
159 Sir Donald Bradman Drive
Hilton, SA 5033
Country 87158 0
Australia
Phone 87158 0
+61 8 8354 5803
Fax 87158 0
+61 8 8234 2013
Email 87158 0
[email protected]
Contact person for public queries
Name 87159 0
Fiona Benton
Address 87159 0
Diabetes SA
159 Sir Donald Bradman Drive
Hilton, SA 5033
Country 87159 0
Australia
Phone 87159 0
+61 8 8354 5833
Fax 87159 0
+61 8 8234 2013
Email 87159 0
[email protected]
Contact person for scientific queries
Name 87160 0
Natalie Luscombe-Marsh
Address 87160 0
Diabetes SA
159 Sir Donald Bradman Drive
Hilton, SA 5033
Country 87160 0
Australia
Phone 87160 0
+61 8 8354 5803
Fax 87160 0
+61 8 8234 2013
Email 87160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, 5 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal on the case-by-case basis.
Available for what types of analyses?
Only to achieve the aims in the approved proposal, or for IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator via email: [email protected].


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.