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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
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Scientific title
A cognitive-behavioural intervention for midlife and older women to manage chronic disease risk factors compared to usual care.
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type II diabetes
3775
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Cardiovascular disease
3776
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Condition category
Condition code
Diet and Nutrition
3949
3949
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
3488
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Levels of physical activity: this is measured using the International Physical Activity Questionnaire (IPAQ)
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Assessment method [1]
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Timepoint [1]
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0 weeks, 12 weeks, 6 months
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Primary outcome [2]
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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).
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Assessment method [2]
4849
0
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Timepoint [2]
4849
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0 weeks, 12 weeks, 6 months
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Secondary outcome [1]
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Health related quality of life measured using the SF-36
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Assessment method [1]
8190
0
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Timepoint [1]
8190
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0 weeks, 12 weeks, 6 months
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Secondary outcome [2]
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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.
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Assessment method [2]
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0
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Timepoint [2]
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0 weeks, 12 weeks, 6 months
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Secondary outcome [3]
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Depressive symptoms measured using the Hopsital & Anxiety Symptoms Scale
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Assessment method [3]
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Timepoint [3]
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0 weeks, 12 weeks, 6 months
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Secondary outcome [4]
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Anxiety symptoms measured using the Hopsital & Anxiety Symptoms Scale
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Assessment method [4]
8193
0
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Timepoint [4]
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0 weeks, 12 weeks, 6 months
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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
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Diagnosed with breast cancer
Treating medical professional indicates that it is not safe for patient to be involved.
Receiving pallitative care
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
352
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
1182
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4032
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Recruitment postcode(s) [2]
1183
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4020
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Recruitment postcode(s) [3]
1184
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4500
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Recruitment postcode(s) [4]
1185
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4510
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Australian Research Council (ARC)
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Address [1]
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1st Floor, 8 Brindabella Circuit
Brindabella Business Park
CANBERRA AIRPORT ACT 2609
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Queensland University of Technology
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Address
Victoria Park Rd
Kelvin Grove QLD 4059
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Queensland Health
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Address [1]
3543
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490 Hamilton Rd
Chermside QLD 4032
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Country [1]
3543
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6015
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HREC The Prince Charles Hospital Health Service District
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Ethics committee address [1]
6015
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Rode Rd
Chermside QLD 4032
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Ethics committee country [1]
6015
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Australia
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Date submitted for ethics approval [1]
6015
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Approval date [1]
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22/11/2006
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Ethics approval number [1]
6015
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Summary
Brief summary
To examine the usefulness of a cognitive behavioural intervention to reduce chronic disease risk factors in mid-life and older women.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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A/ Prof. Debra Anderson
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Address
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School of Nursing
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
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Country
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Australia
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Phone
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+61 7 3138 3881
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/ Prof. Debra Anderson
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Address
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School of Nursing
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
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Country
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Australia
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Phone
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+61 7 3138 3881
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Fax
3077
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Email
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[email protected]
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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.
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