Women's Lifestyle Study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12605000490673
• Date of registration: 23/09/2005
• Prospective Registration: No
• Primary sponsor: National Heart Foundation of NZ
• 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
• Date of first enrolment: 24/11/2004
• Target sample size: 1080
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12605000490673.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Single group;Type of endpoint: Efficacy;

Countries of recruitment

New Zealand

Contacts

• Name: Dr Beverley Lawton

• Name: Dr Sally Rose

Key inclusion & exclusion criteria

Inclusion criteria: Able to participate in moderate intensity physical activity.
Exclusion criteria: Blood pressure >=200/110; deemed ineligible for participation in moderate intensity physical activity by GP (e.g. acutely unwell or injured).

Age minimum: 40 Years
Age maximum: 75 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Cardiovascular - Coronary heart disease

Risk factors associated with type 2 diabetes and heart disease;
Risk factors associated with type 2 diabetes and heart disease

Intervention(s)

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.

Primary Outcome(s)

Cost-effectiveness ratios[]

Adherence to physical activity[At 12 and 24 months]

Secondary Outcome(s)

Fasting bloods including glucose[Measured at baseline and repeated at 12 and 24 months.]

HBA1c and insulin[Measured at baseline and repeated at 12 and 24 months.]

Blood pressure[Measured at baseline and repeated at 12 and 24 months.]

Lipids[Measured at baseline and repeated at 12 and 24 months.]

Weight[Measured at baseline and repeated at 12 and 24 months.]

Physical fitness[Measured at baseline and repeated at 12 and 24 months.]

Waist circumference[Measured at baseline and repeated at 12 and 24 months.]

Source(s) of Monetary Support

National Heart Foundation of NZ

Hutt Valley District Health Board

Lottery Health Research Grants Board

Secondary Sponsor(s)

Hutt Valley District Health Board

Lottery Health Research Grants Board

Ethics review

Status: Not approved
Approval date:
Contact:

the Wellington Ethics Committee (now known as the Central Regional Ethics Committee)