Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000165088
Ethics application status
Approved
Date submitted
2/02/2010
Date registered
19/02/2010
Date last updated
10/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prescribed physical Activity for people with Type 2 Diabetes: kanohi-ki-te-kanohi-support.
Scientific title
New Zealand Green Prescription by face-to-face vs telephone intervention, Maori vs European for people with type 2 diabetes: effect on body weight.
Secondary ID [1] 1404 0
None
Universal Trial Number (UTN)
U1111-1113-5419
Trial acronym
GRX kanohi ki te kanohi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 256542 0
Condition category
Condition code
Metabolic and Endocrine 256715 256715 0 0
Diabetes
Public Health 256878 256878 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Green Prescription (GrX) programme is designed to increase the uptake of physical activity among individuals with physically-limiting medical conditions. A script (GrX) prepared by general practitioners or practice nurses is faxed to Regional Sports Trust GrX teams to typically provide advice and support around increasing physical activity and improving nutrition. In this research the GrX is delivered by a GrX kaiwhakahaere/support person based at Sport Waikato. This person helps and supports the participant to set and achieve small achieveable goals with the GrX kaiwhakahaere through contact once a month for six months. The contact time is typically less than a hour.
Intervention code [1] 255946 0
Lifestyle
Intervention code [2] 255955 0
Behaviour
Comparator / control treatment
Participants will be randomised within ethnicity and sex (Maori or European; male or female) to receive either the kanohi-ki-te-kanohi (face-to-face) or telephone intervention. At baseline, six month and one year measurements will be made. Effectiveness of each intervention will be measured by reported uptake of physical activity, fitness, reduction in waist circumference and weight loss as well as glucose homeostasis. The outcomes will be examined in terms of treatment, ethnicity and sex. Qualitative information will undergo thematic analysis and explore attitudes, behaviours and motivational factors to physical activity uptake by ethnicity and gender in the context of quantitative outcomes. Case studies and testimonials will be used to enrich the information and triangulate the findings.
Control group
Active

Outcomes
Primary outcome [1] 257748 0
Weight loss and reduction in waist measurement. Measurements of weight (calibrated electronic scales) and waist (non-stretch tape measure)
Timepoint [1] 257748 0
At 6 and 12 months from baseline
Primary outcome [2] 257758 0
Increased time and intensity of physical activity by questionnaire
Timepoint [2] 257758 0
At 6 and 12 months from baseline
Secondary outcome [1] 263124 0
Identify which GRx delivery programme (kanohi-ki-te-kanohi (n=70) or telephone(n=70)) results in:
greater weight and waist circumference (cm) loss
Timepoint [1] 263124 0
At 6 and 12 months from baseline
Secondary outcome [2] 263296 0
Identify which GRx delivery programme (kanohi-ki-te-kanohi or telephone) results in:
greater increase in time and daily intensity of physical activity and fitness levels
Timepoint [2] 263296 0
At 6 and 12 months from baseline
Secondary outcome [3] 263297 0
Identify the strengths and weakness of the two GRx delivery programmes
Timepoint [3] 263297 0
At 6 and 12 months from baseline qualitative interviews
Secondary outcome [4] 263298 0
Identify differences in response to the approach between Maori (n=70) & NZ Europeans (n=70)
Timepoint [4] 263298 0
At 6 and 12 months from baseline qualitative interviews

Eligibility
Key inclusion criteria
Maori and New Zealand European aged 18 or more diagnosed with Type 2 Diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insulin therapy within next 12 months
At risk feet including past lower limb amputations
End stage renal failure
Significant vascular disease
People already engaging in more than 2 ½ hours of moderate activity per week or at least 30 minutes of exercise per day

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed through central randomisation by computer of scripts through the GrX team administrator. This person is not responsibile for the delivery modes of GrX or any interaction with participants in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are stratified to either kanohi-ki-te-kanohi or telephone intervention by gender and ethnicity (50% Maori and 50% New Zealand Europeans).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Qualitative information will undergo thematic analysis and explore attitudes, behaviours and motivational factors to physical activity uptake by ethnicity and gender in the context of quantitative outcomes. Case studies and testimonials will be used to enrich the information and triangulate the findings.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2008
Actual
13/08/2008
Date of last participant enrolment
Anticipated
28/11/2009
Actual
15/02/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
152
Recruitment outside Australia
Country [1] 2406 0
New Zealand
State/province [1] 2406 0
Waikato

Funding & Sponsors
Funding source category [1] 256451 0
Government body
Name [1] 256451 0
Ministry of Health (formerly Sport and Recreation New Zealand (SPARC)
Country [1] 256451 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland1142
Country
New Zealand
Secondary sponsor category [1] 255759 0
Charities/Societies/Foundations
Name [1] 255759 0
Sport Waikato
Address [1] 255759 0
Brian Perry Sports House
Avalon Drive
PO Box 46
HAMILTON 3240
Country [1] 255759 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258504 0
Northern Y Ethics Committee
Ethics committee address [1] 258504 0
Ethics committee country [1] 258504 0
New Zealand
Date submitted for ethics approval [1] 258504 0
Approval date [1] 258504 0
08/05/2008
Ethics approval number [1] 258504 0
NTY/07/12/137

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30703 0
Dr Margaret H. Williams
Address 30703 0
Margaret H. Williams (PhD)
Research Officer
School of Sport and Recreation
Health & Environmental Sciences Faculty Office
Auckland University of Technology
Country 30703 0
New Zealand
Phone 30703 0
+64 (0) 27 658 4801
Fax 30703 0
Email 30703 0
[email protected]
Contact person for public queries
Name 13950 0
Margaret H Williams
Address 13950 0
6 Atuaroa Ave
TE PUKE
3119
Country 13950 0
New Zealand
Phone 13950 0
64 7 5737966
Fax 13950 0
64 7 5737966
Email 13950 0
[email protected]
Contact person for scientific queries
Name 4878 0
Margaret H. Williams
Address 4878 0
6 Atuaroa Ave
TE PUKE
3119
Country 4878 0
New Zealand
Phone 4878 0
64 7 5737966
Fax 4878 0
64 7 5737966
Email 4878 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.