The Greater Green Triangle Diabetes Prevention Project
| ISRCTN | ISRCTN38031372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38031372 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/01/2007
- Registration date
- 22/01/2007
- Last edited
- 07/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof James Dunbar
Scientific
Scientific
PO Box 423
Warrnambool
3280
Australia
| Phone | +61 (0)355 633 315 |
|---|---|
| director@greaterhealth.org |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study acronym | GGT DPP |
| Study objectives | 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(s) | Approval received from the Flinders Clinical Research Ethics Committee on the 8th March 2004 (ref: 105/034). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2004 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 345 |
| Key inclusion criteria | 1. Males and females 40 to 75 years of age 2. Have a high risk of developing type two diabetes |
| Key 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 |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Australia
Study participating centre
PO Box 423
Warrnambool
3280
Australia
3280
Australia
Sponsor information
The Australian Government Department of Health and Ageing (Australia)
Government
Government
Diabetes and Evidence Based Strategies
Health Services Improvement Division
MDP 23
GPO Box 9848
Canberra
2601
Australia
| Phone | +61 (0)262 898 801 |
|---|---|
| DPP@health.gov.au | |
| Website | http://www.health.gov.au/ |
"ROR" |
https://ror.org/0314h5y94 |
Funders
Funder type
Government
The Australian Government Department of Health and Ageing (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results: | 01/06/2007 | Yes | No | |
| Results article | final results: | 19/09/2007 | Yes | No |
