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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
DiabetesInability to provide informed consent.

Study design
Purpose of the study
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 913 0
Name [1] 913 0
Address [1] 913 0
Country [1] 913 0
Primary sponsor type
Government body
Health Research Council, Waikato District Health Board
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
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

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

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
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

No information has been provided regarding IPD availability
Summary results
No Results