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Melbourne Diabetes Prevention Study: A randomised control trial of the effectiveness and cost-effectiveness of a diabetes prevention program.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000507280
Enrollment
1100
Registered
2009-06-25
Start date
2011-07-13
Completion date
2013-03-06
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 preventi

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.

Sponsors

Professor James Dunbar
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

Pre-diabetes

Exclusion criteria

Diabetes, pregnancy, cancer, severe mental illness, substance abuse, recent myocardial infarction, difficulty with the english language

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 25, 2026