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ISRCTN
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ISRCTN38031372
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ClinicalTrials.gov identifier
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Public title
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The Greater Green Triangle Diabetes Prevention Project
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Scientific title
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Acronym
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GGT DPP
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Serial number at source
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N/A
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Study hypothesis
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That lifestyle intervention carried out in primary health care settings reduces the risk of type two diabetes among high risk individuals [added 07/10/2008] and that the reduction in risk can be continued through telephone support.
Please note that as of 07/10/2008 the initial anticipated end date of this trial was extended from 30/11/2006 to 31/12/2007. Other minor changes to this trial record can be found under the relevant section, with the above update date.
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Lay summary
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Ethics approval
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Approval received from the Flinders Clinical Research Ethics Committee on the 8th March 2004 (ref: 105/034).
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Study design
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Non-randomised intervention study (intervention group only) [added 07/10/2008] with a randomised controlled trial follow-up
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Type two diabetes
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Participants - inclusion criteria
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1. Males and females 40 to 75 years of age
2. Have a high risk of developing type two diabetes
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Participants - exclusion criteria
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1. Cancer
2. Recent myocardial infarction or stroke
3. Cognitive impairment
4. Substance abuse
5. Pregnancy
6. A previous type two diabetes diagnosis
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Anticipated start date
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01/08/2004
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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345
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Interventions
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During a 12-month period, participants undergo a series of tests at three points (at the start of the study, three months, and 12 months) and a series of six structured group counselling sessions. The first five sessions are carried out in two-week intervals and the final (i.e. sixth) session is carried out eight months from the beginning of the intervention.
Project nurses, dieticians and physiotherapists facilitate all group sessions and the duration of each session is 1.5 hours. The group sessions aim to motivate and support participants to change their dietary and physical activity habits and to provide them with the skills and social support to set their own goals for lifestyle change.
Added 07/10/2008:
Following the initial intervention, completing participants will be randomised into telephone support (intervention) and self-care only (control). Telephone support will consist of structured phone calls conducted by trained nurses, once a month for 6 months, then every 2 months for 12 months.
Discussions during phone calls will focus on goals for lifestyle change made by participants during the initial intervention and should take approximately 15 minutes each.
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Primary outcome measure(s)
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1. Weight
2. Height
3. Waist circumference
4. Fasting plasma glucose and lipids
5. Plasma glucose after two hours oral glucose challenge
6. Blood pressure
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Secondary outcome measure(s)
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1. Measures of psychological distress and general health outcomes
2. Lifestyle habits
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Sources of funding
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The Australian Government Department of Health and Ageing (Australia)
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Trial website
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Publications
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Results:
1. 2007 interim results: http://www.ncbi.nlm.nih.gov/pubmed/17069921
2. 2007 final results: http://www.ncbi.nlm.nih.gov/pubmed/17877832
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Contact name
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Prof
James
Dunbar
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Address
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PO Box 423
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City/town
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Warrnambool
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Zip/Postcode
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3280
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Country
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Australia
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Tel
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+61 (0)355 633 315
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Fax
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+61 (0)355 633 144
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Email
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director@greaterhealth.org
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Sponsor
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The Australian Government Department of Health and Ageing (Australia)
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Address
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Diabetes and Evidence Based Strategies
Health Services Improvement Division
MDP 23
GPO Box 9848
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City/town
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Canberra
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Zip/Postcode
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2601
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Country
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Australia
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Tel
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+61 (0)262 898 801
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Fax
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+61 (0)262 895 870
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Email
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DPP@health.gov.au
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Sponsor website:
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http://www.health.gov.au/
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Date applied
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15/01/2007
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Last edited
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07/10/2008
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Date ISRCTN assigned
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22/01/2007
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