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Trial registered on ANZCTR


Registration number
ACTRN12608000570381
Ethics application status
Approved
Date submitted
30/09/2008
Date registered
12/11/2008
Date last updated
12/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A non pharmacological intervention for managing risk factors in women with a chronic disease
Scientific title
A cognitive-behavioural intervention for midlife and older women to manage chronic disease risk factors compared to usual care.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II diabetes 3775 0
Cardiovascular disease 3776 0
Condition category
Condition code
Diet and Nutrition 3949 3949 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants receive 3 x 30 minute health education and motivational individual consultations (to encourage increased physical activity, low-fat diet, increased calcium, increased photoestrogens, increased fruit & vegetables, increased water intake and smoking cessation). These are provided 6 weeks apart (ie, week 0, week 6, week 12). These individual sessions are accompanied by a book about Managing Mid-life & Older Health Issues for Women and a Journal. The Journal facilitates/ encourages a change in health behaviour on a daily basis.
Intervention code [1] 3488 0
Lifestyle
Comparator / control treatment
Usual care: patients receive either a group education session (3 hours) + individual consultation (1 hour) OR 2 x individual consultations (2 hours). These consultations provide education about the physiology of diabetes, symptoms and complications of diabetes, self mangement and sources of support, the influence of exercise and diet on glycemic control, the healthy heart diet and changing dietary habits, and foot care and avoiding foot complications. Patients are able to come back for a follow-up appointment at 6 months if they require.
Control group
Active

Outcomes
Primary outcome [1] 4848 0
Levels of physical activity: this is measured using the International Physical Activity Questionnaire (IPAQ)
Timepoint [1] 4848 0
0 weeks, 12 weeks, 6 months
Primary outcome [2] 4849 0
A composite of changes in risk factors for chronic diseases, including reducing high blood pressure, tobacco use (self report item), alcohol use (self report item) and measures of central and general obesity (eg. body mass index, waist and hip
circumference and weight).
Timepoint [2] 4849 0
0 weeks, 12 weeks, 6 months
Secondary outcome [1] 8190 0
Health related quality of life measured using the SF-36
Timepoint [1] 8190 0
0 weeks, 12 weeks, 6 months
Secondary outcome [2] 8191 0
Self efficacy to maintain an exercise and diet program tailored for midlife and older women. This is measured using the Self-Efficacy for Managing Chronic Disease scale.
Timepoint [2] 8191 0
0 weeks, 12 weeks, 6 months
Secondary outcome [3] 8192 0
Depressive symptoms measured using the Hopsital & Anxiety Symptoms Scale
Timepoint [3] 8192 0
0 weeks, 12 weeks, 6 months
Secondary outcome [4] 8193 0
Anxiety symptoms measured using the Hopsital & Anxiety Symptoms Scale
Timepoint [4] 8193 0
0 weeks, 12 weeks, 6 months

Eligibility
Key inclusion criteria
Women aged 45 or more years of age who attend one of 4 diabetes community clinics in North Brisbane or a cardiac rehabilitation clinic in North Brisbane.
Able to understand and write in English
Minimum age
45 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with breast cancer
Treating medical professional indicates that it is not safe for patient to be involved.
Receiving pallitative care

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients of the clinics will be invited to participate. Patients who consent will post their signed consent form to university staff (off-site). Once the consent form is received, randomisation will occur off-site by a person independent of the project using permuted random blocks stratified by clinic site. A blind procedure will be used; participants will not know which condition they are receiving. Lists of patients who are allocated to the Intervention condition will be provided to the clinic staff (who deliver the intervention). The clinic staff who provide the intervention will know which patients receive the intervention; they will not be blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified by clinic site. The sequence is generated by a computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
352
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1182 0
4032
Recruitment postcode(s) [2] 1183 0
4020
Recruitment postcode(s) [3] 1184 0
4500
Recruitment postcode(s) [4] 1185 0
4510

Funding & Sponsors
Funding source category [1] 3955 0
Government body
Name [1] 3955 0
Australian Research Council (ARC)
Country [1] 3955 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 3543 0
Government body
Name [1] 3543 0
Queensland Health
Address [1] 3543 0
490 Hamilton Rd
Chermside QLD 4032
Country [1] 3543 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6015 0
HREC The Prince Charles Hospital Health Service District
Ethics committee address [1] 6015 0
Ethics committee country [1] 6015 0
Australia
Date submitted for ethics approval [1] 6015 0
Approval date [1] 6015 0
22/11/2006
Ethics approval number [1] 6015 0

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

Contacts
Principal investigator
Name 28992 0
Address 28992 0
Country 28992 0
Phone 28992 0
Fax 28992 0
Email 28992 0
Contact person for public queries
Name 12149 0
A/ Prof. Debra Anderson
Address 12149 0
School of Nursing
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 12149 0
Australia
Phone 12149 0
+61 7 3138 3881
Fax 12149 0
Email 12149 0
dj.anderson@qut.edu.au
Contact person for scientific queries
Name 3077 0
A/ Prof. Debra Anderson
Address 3077 0
School of Nursing
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 3077 0
Australia
Phone 3077 0
+61 7 3138 3881
Fax 3077 0
Email 3077 0
dj.anderson@qut.edu.au

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.