Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000507280
Ethics application status
Approved
Date submitted
22/06/2009
Date registered
25/06/2009
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Melbourne Diabetes Prevention Study: A randomised control trial of the effectiveness and cost-effectiveness of a diabetes prevention program.
Scientific title
An investigation of the effectiveness and cost-effectiveness of a diabetes prevention program in people aged 50-75 years at high-risk of Type 2 Diabetes.
Secondary ID [1] 283834 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-diabetes 236975 0
Condition category
Condition code
Public Health 237319 237319 0 0
Other public health
Metabolic and Endocrine 237367 237367 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have a blood sample taken to measure blood fats and cholesterol. Participants will then ingest a sugar solution to raise their blood sugar level over two hours, and a further blood sample will be taken. A series of physical measurements will be taken and participants will complete questionnaires about their demographics, health behaviour, health status, use of health services and usual care. Participants in the intervention arm will then attend 6 sessions of a diabetes prevention program (diet and lifestyle modification) with an accredited provider. Session 1 is a 45-60 minute individual session with the program facilitator, Sessions 2-4 are 1.5 hour group sessions held at 2 week intervals, and Session 5 is a 1.5 hour group session held at 8 months after Session 1.
Intervention code [1] 236745 0
Prevention
Intervention code [2] 236746 0
Lifestyle
Comparator / control treatment
Participants will have a blood sample taken to measure blood fats and cholesterol. Participants will then ingest a sugar solution to raise their blood sugar level over two hours, and a further blood sample will be taken. A series of physical measurements will be taken and participants will complete questionnaires about their demographics, health behaviour, health status, use of health services and usual care.Control participants will be placed on a 12 month waiting lst for the Life! program and receive usual care normally provided by their doctor
Control group
Active

Outcomes
Primary outcome [1] 238176 0
The estimation of reduction in the risk of diabetes imputed from the outcomes of clinical trials, using extrapolation of the changes in weight and waist circumference.
Timepoint [1] 238176 0
Baseline, 3 months (intervention group only) and 12 months
Secondary outcome [1] 242472 0
Comparative information from clinical measures (blood pressure, hip measurements, and blood lipids/fats/glucose) from intervention and control participants. More specifically, blood pressure will be assessed using a simple mercury sphygmomanometer; hip measurements will be taken using a plastic tailors measuring tape; and blood lipids/fats and glucose will be assessed by blood analysis of blood taken from the vein in the antecubital fossa.
Timepoint [1] 242472 0
Baseline, 3 months (intervention group only) and 12 months
Secondary outcome [2] 242473 0
Comparative information from behavioural measures (as assessed by validated clinical tools) from intervention and control participants
Timepoint [2] 242473 0
Baseline, 3 months (intervention group only) and 12 months
Secondary outcome [3] 242475 0
Health economic information about the diabetes prevention program (and comparison with usual care) will be assessed by combining the cost data with the clinical and behavioural data to produce a range of incremental cost-effectiveness ratios (ICER). This ICER will be comapred to a reference threshold (i.e $50,000 per quality-adjusted life years (QALY) to determine 'value for money'. The modelled evaluation will use a Markov approach to estimate the health impacts of changes in diabetes risk status over the lifetime of participants.
Timepoint [3] 242475 0
12 months

Eligibility
Key inclusion criteria
Pre-diabetes
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diabetes, pregnancy, cancer, severe mental illness, substance abuse, recent myocardial infarction, difficulty with the english language

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)
Participants will be recruited by members of the study team, mainly by approaching people in pharmacies and invitng them to complete a diabetes risk test. Those who score within the 'high risk' range will be invited to participate in study. Participants will be randomly allocated to either the intervention or control group after they have been screened for diabetes. Randomisation will be conducted by the project manager.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be generated by a random number table and placed in individual, numbered and sealed, opaque envelopes; this will be conducted by the trial Biostatistician. Once a participant has consented and meet the eligibility criteria, the study team member will contact the Project Manager who will select the next sequential envelope, open it in front of an independent witness, and inform the study participant of the randomisation group. A randomisation log will be kept which will contain the participant number, treatment group, envelope number and signatures from both the Project Manager and the independent witness.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
13/07/2011
Date of last participant enrolment
Anticipated
Actual
6/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237167 0
Government body
Name [1] 237167 0
National Health & Medical Research Council (NHMRC)
Country [1] 237167 0
Australia
Primary sponsor type
Individual
Name
Professor James Dunbar
Address
Greater Green Triangle University Department of Rural Health, Flinders and Deakin Universities
PO Box 423
Warrnambool, Victoria 3280
Country
Australia
Secondary sponsor category [1] 4662 0
Individual
Name [1] 4662 0
Rob Carter
Address [1] 4662 0
Deakin University
Public Health, Research, Evaluation and Policy Cluster
Faculty of Health, Medicine, Nursing and Behavioural Sciences
221 Burwood Hwy
Burwood VIC 3125
Country [1] 4662 0
Australia
Secondary sponsor category [2] 4663 0
Individual
Name [2] 4663 0
Professor Edward Janus
Address [2] 4663 0
Department of Medicine
The University of Melbourne
Western Hospital
Gordon St
Footsgray 3011
Country [2] 4663 0
Australia
Secondary sponsor category [3] 4664 0
Individual
Name [3] 4664 0
Professor Catherine Bennett
Address [3] 4664 0
Deakin University, Research, Faculty of Health, School of Health and Social Development, 221 Burwood Hwy Burwood VIC 3125
Country [3] 4664 0
Australia
Secondary sponsor category [4] 287193 0
Individual
Name [4] 287193 0
Dr Sharleen O'Reilly
Address [4] 287193 0
Deakin University, School of Exercise and Nutrition Sciences, 221 Burwood Hwy, Burwood Vic 3125
Country [4] 287193 0
Australia
Secondary sponsor category [5] 287194 0
Individual
Name [5] 287194 0
Professor Erkki Vartiainen
Address [5] 287194 0
National Institute of Health and Welfare, Department of Health Promotion and Chronic Disease Prevention, P.O. Box 30, FI-00271 Helsinki, Finland
Country [5] 287194 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239259 0
Deakin Univeristy Human Research Ethics Committee
Ethics committee address [1] 239259 0
Office of Research Integrity
Research Services Division
Burwood Highway
Deakin University, Burwood VIC 3125
Ethics committee country [1] 239259 0
Australia
Date submitted for ethics approval [1] 239259 0
Approval date [1] 239259 0
17/06/2009
Ethics approval number [1] 239259 0
EC-66-2009

Summary
Brief summary
The aims of this NH&MRC funded project are to evaluate the efficacy, effectiveness, and cost-effectiveness of a structured primary care based diabetes prevention program (Life!) being implemented in Victoria for people of the age over 50 years who are at high risk of type 2 diabetes.
This will be achieved by monitoring clinical and behavioural outcomes of participants of the Life! program before and after completion (particularly any reduction in diabetes risk, weight and central body obesity, and changes in quality of life) and by comparing these with another group receiving usual care at the same time. Economic assessment will be performed by
evaluating whether the program is ‘value-for-money’ using economic analysis, modelling of longer term impacts, and evaluating of any efficiency issues.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29731 0
Prof James Dunbar
Address 29731 0
Greater Green Triangle University Department of Rural Health Flinders and DeakinUniversities PO Box 423 Warrnambool VIC 3280
Country 29731 0
Australia
Phone 29731 0
61 3 5563 3504
Fax 29731 0
Email 29731 0
Director@greaterhealth.org
Contact person for public queries
Name 12978 0
Prof Professor James Dunbar
Address 12978 0
Greater Green Triangle University
Department of Rural Health
Flinders and DeakinUniversities
PO Box 423
Warrnambool VIC 3280
Country 12978 0
Australia
Phone 12978 0
61 3 5563 3504
Fax 12978 0
Email 12978 0
Director@greaterhealth.org
Contact person for scientific queries
Name 3906 0
Prof Professor James Dunbar
Address 3906 0
Greater Green Triangle University
Department of Rural Health
Flinders and DeakinUniversities
PO Box 423
Warrnambool VIC 3280
Country 3906 0
Australia
Phone 3906 0
61 3 5563 3504
Fax 3906 0
Email 3906 0
Director@greaterhealth.org

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIScaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study2012https://doi.org/10.1186/1745-6215-13-152
N.B. These documents automatically identified may not have been verified by the study sponsor.