Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000622606
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
10/10/2005
Date last updated
11/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Te Wai o Rona: Diabetes Prevention Strategy
Scientific title
Te Wai o Rona: Diabetes Prevention Strategy: A randomised cluster controlled trial to prevent Type 2 diabetes by 35% through lifestyle change
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 749 0
Condition category
Condition code
Metabolic and Endocrine 825 825 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: medium level coaching supported by community action and ecological change

Intervention duration: minimum 4 years
Comparator / control treatment
Control group: leaflet
Control group
Active

Outcomes
Primary outcome [1] 1057 0
35% reduction in incident diabetes over a minimum of 4 years
Timepoint [1] 1057 0
Secondary outcome [1] 1969 0
Reduction in HBA1c, blood pressure, LDL, triglycerides, cholesterol/HDL, weight, waist, bioimpedance, food items associated with obesity Increase in HDL, fitness, food items, physical activity Rural vs urban, male vs female, older vs younger, "connected" vs less connected Cost-effectiveness over a minimum of 4 years.
Timepoint [1] 1969 0

Eligibility
Key inclusion criteria
Maori aged 28 or more or living in same household as Maori and non Maori aged 28 years or more by 30/9/2005Maori women with past gestational diabetesMaori aged 23 and over by 30/9/2005 with 2 parents with diabetes.
Minimum age
23 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
DiabetesInability to provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clusters for intervention concealed until participants allocated where possible, but coaches based in larger clusters, so deducible by some.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Electronic randomisation to cluster within 5 ⿿size of cluster⿝ strata rurally and within 2 urban areas and using SPSS v13.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
12/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment outside Australia
Country [1] 150 0
New Zealand
State/province [1] 150 0

Funding & Sponsors
Funding source category [1] 913 0
Other
Name [1] 913 0
Country [1] 913 0
Primary sponsor type
Government body
Name
Health Research Council, Waikato District Health Board
Address
Country
New Zealand
Secondary sponsor category [1] 772 0
Government body
Name [1] 772 0
Ministry of Health, Lakes District Health Board, Local Diabetes team, SPARC many others in kind
Address [1] 772 0
Country [1] 772 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2199 0
Waikato Ethics committee
Ethics committee address [1] 2199 0
Ethics committee country [1] 2199 0
New Zealand
Date submitted for ethics approval [1] 2199 0
Approval date [1] 2199 0
Ethics approval number [1] 2199 0

Summary
Brief summary
Randomised cluster controlled trial of the impact of lifestyle change on new cases of Type 2 diabetes across whole Maori communities
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36363 0
Address 36363 0
Country 36363 0
Phone 36363 0
Fax 36363 0
Email 36363 0
Contact person for public queries
Name 9487 0
Professor David Simmons
Address 9487 0
Waikato Clinical School
Hockin Building
Waikato Hospital
University of Auckland
PO Box 934
Pembroke St
Hamilton 0
Country 9487 0
New Zealand
Phone 9487 0
+64 7 8398899
Fax 9487 0
+64 7 8343615
Email 9487 0
[email protected]
Contact person for scientific queries
Name 415 0
Professor David Simmons
Address 415 0
Waikato Clinical School
Hockin Building
Waikato Hospital
University of Auckland
PO Box 934
Pembroke St
Hamilton 0
Country 415 0
New Zealand
Phone 415 0
+64 7 8398899
Fax 415 0
+64 7 8343615
Email 415 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.