Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000490673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
20/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Women's Lifestyle Study
Scientific title
Women in action: a randomised controlled trial to evaluate the effects of a physical activity intervention on risk factors for diabetes and heart disease in 40-75yr old women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factors associated with type 2 diabetes and heart disease 612 0
Condition category
Condition code
Metabolic and Endocrine 684 684 0 0
Diabetes
Cardiovascular 685 685 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Baseline measures followed by physical activity advice given by telephone over 5mths, a face-to-face visit with a research nurse at 6mths and further telephone contact at 9mths. Intervention complete at 9mths, outcomes assessed at 12 and 24mths.
Intervention code [1] 480 0
Prevention
Comparator / control treatment
Control: Baseline measures followed by reassessment at 12 and 24mths.
Control group
Placebo

Outcomes
Primary outcome [1] 835 0
Adherence to physical activity
Timepoint [1] 835 0
At 12 and 24 months
Primary outcome [2] 836 0
Cost-effectiveness ratios
Timepoint [2] 836 0
Secondary outcome [1] 1647 0
Blood pressure
Timepoint [1] 1647 0
Measured at baseline and repeated at 12 and 24 months.
Secondary outcome [2] 1648 0
Waist circumference
Timepoint [2] 1648 0
Measured at baseline and repeated at 12 and 24 months.
Secondary outcome [3] 1649 0
Weight
Timepoint [3] 1649 0
Measured at baseline and repeated at 12 and 24 months.
Secondary outcome [4] 1650 0
Fasting bloods including glucose
Timepoint [4] 1650 0
Measured at baseline and repeated at 12 and 24 months.
Secondary outcome [5] 1651 0
Lipids
Timepoint [5] 1651 0
Measured at baseline and repeated at 12 and 24 months.
Secondary outcome [6] 1652 0
HBA1c and insulin
Timepoint [6] 1652 0
Measured at baseline and repeated at 12 and 24 months.
Secondary outcome [7] 1653 0
Physical fitness
Timepoint [7] 1653 0
Measured at baseline and repeated at 12 and 24 months.

Eligibility
Key inclusion criteria
Able to participate in moderate intensity physical activity.
Minimum age
40 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Blood pressure >=200/110; deemed ineligible for participation in moderate intensity physical activity by GP (e.g. acutely unwell or injured).

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)
Sealed envelope containing group allocation opened by studynurse at completion of baseline measures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated by independent researcher using STATA in random blocks with variable block sizes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1080
Accrual to date
Final
Recruitment outside Australia
Country [1] 206 0
New Zealand
State/province [1] 206 0

Funding & Sponsors
Funding source category [1] 759 0
Charities/Societies/Foundations
Name [1] 759 0
National Heart Foundation of NZ
Country [1] 759 0
New Zealand
Funding source category [2] 760 0
Government body
Name [2] 760 0
Hutt Valley District Health Board
Country [2] 760 0
New Zealand
Funding source category [3] 761 0
Government body
Name [3] 761 0
Lottery Health Research Grants Board
Country [3] 761 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
National Heart Foundation of NZ
Address
Country
New Zealand
Secondary sponsor category [1] 627 0
Government body
Name [1] 627 0
Hutt Valley District Health Board
Address [1] 627 0
Country [1] 627 0
New Zealand
Secondary sponsor category [2] 628 0
Government body
Name [2] 628 0
Lottery Health Research Grants Board
Address [2] 628 0
Country [2] 628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2006 0
the Wellington Ethics Committee (now known as the Central Regional Ethics Committee)
Ethics committee address [1] 2006 0
Ethics committee country [1] 2006 0
New Zealand
Date submitted for ethics approval [1] 2006 0
Approval date [1] 2006 0
Ethics approval number [1] 2006 0

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

Contacts
Principal investigator
Name 36398 0
Address 36398 0
Country 36398 0
Phone 36398 0
Fax 36398 0
Email 36398 0
Contact person for public queries
Name 9669 0
Dr Sally Rose
Address 9669 0
Department of Primary Health Care and General Practice
Wellington School of Medicine & Health Sciences
University of Otago
PO Box 7343
Wellington
Country 9669 0
New Zealand
Phone 9669 0
+64 4 9186249
Fax 9669 0
+64 4 3855473
Email 9669 0
srose@wnmeds.ac.nz
Contact person for scientific queries
Name 597 0
Dr Beverley Lawton
Address 597 0
Department of Primary Health Care and General Practice
Wellington School of Medicine & Health Sciences
University of Otago
PO Box 7343
Wellington
Country 597 0
New Zealand
Phone 597 0
+64 4 3855995 ext. 4893
Fax 597 0
+64 4 3855473
Email 597 0
bevlawton@wnmeds.ac.nz

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.