Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/01/2007
Date assigned
22/01/2007
Last edited
07/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.health.gov.au/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes