Contact information
Type
Scientific
Primary contact
Prof James Dunbar
ORCID ID
Contact details
PO Box 423
Warrnambool
3280
Australia
+61 (0)355 633 315
director@greaterhealth.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GGT DPP
Study hypothesis
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.
Ethics approval
Approval received from the Flinders Clinical Research Ethics Committee on the 8th March 2004 (ref: 105/034).
Study design
Non-randomised intervention study (intervention group only) [added 07/10/2008] with a randomised controlled trial follow-up
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Type two diabetes
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
1. Measures of psychological distress and general health outcomes
2. Lifestyle habits
Overall trial start date
01/08/2004
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males and females 40 to 75 years of age
2. Have a high risk of developing type two diabetes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
345
Participant exclusion criteria
1. Cancer
2. Recent myocardial infarction or stroke
3. Cognitive impairment
4. Substance abuse
5. Pregnancy
6. A previous type two diabetes diagnosis
Recruitment start date
01/08/2004
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Australia
Trial participating centre
PO Box 423
Warrnambool
3280
Australia
Sponsor information
Organisation
The Australian Government Department of Health and Ageing (Australia)
Sponsor details
Diabetes and Evidence Based Strategies
Health Services Improvement Division
MDP 23
GPO Box 9848
Canberra
2601
Australia
+61 (0)262 898 801
DPP@health.gov.au
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Australian Government Department of Health and Ageing (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Interim results
Kilkkinen A, Heistaro S, Laatikainen T, Janus E, Chapman A, Absetz P, Dunbar J, Prevention of type 2 diabetes in a primary health care setting. Interim results from the Greater Green Triangle (GGT) Diabetes Prevention Project., Diabetes Res. Clin. Pract., 2007, 76, 3, 460-462, doi: 10.1016/j.diabres.2006.09.027.
-
Final results
Laatikainen T, Dunbar JA, Chapman A, Kilkkinen A, Vartiainen E, Heistaro S, Philpot B, Absetz P, Bunker S, O'Neil A, Reddy P, Best JD, Janus ED, Prevention of type 2 diabetes by lifestyle intervention in an Australian primary health care setting: Greater Green Triangle (GGT) Diabetes Prevention Project., BMC Public Health, 2007, 7, 249, doi: 10.1186/1471-2458-7-249.