Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000660280
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
4/08/2009
Date last updated
4/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lifestyle Outcomes of Absolute cardiovascular risk Feedback project
Scientific title
A randomised controlled trial to test the effect of providing absolute cardiovascular feedback, tailored lifestyle information and telephone counselling and support on lifestyle behaviours and cardiovascular risk factors in participants at risk of cardiovascular disease
Secondary ID [1] 899 0
Nil
Universal Trial Number (UTN)
Trial acronym
LOAF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 237008 0
Condition category
Condition code
Cardiovascular 237337 237337 0 0
Coronary heart disease
Cardiovascular 237338 237338 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group1. Face to face feedback (once only 45 minute session ) of absolute cardiovascular risk to patient with advice on risk factor profile and lifestyle changes to improve risk, together with individualised written materials.
Group 2. Face to face feedback (once only 45 minute session) plus telephone support and counselling (monthly phone calls for 6 months and then bi-monthly phone calls for 6 months - 9 phone calls of 10-12 minutes duration)`
Group 3. Control group - usual general practice care
Intervention code [1] 236758 0
Lifestyle
Intervention code [2] 236759 0
Prevention
Intervention code [3] 236760 0
Behaviour
Comparator / control treatment
The control group will receive their usual general practice care. General Practitioners (GP) will receive their pathology results for ethical reasons.
Control group
Active

Outcomes
Primary outcome [1] 240482 0
To measure the decrease in the proportion of their energy coming from saturated fats by asking participants to complete the Dietary Questionnaire for Epidemiological Studies (DQESv2) - Cancer Coucil of Victoria
Timepoint [1] 240482 0
baseline and 1 year after intervention
Primary outcome [2] 240483 0
Assess dietary salt intake using DQESv2
Timepoint [2] 240483 0
baseline and 1 year after intervention
Primary outcome [3] 240509 0
To monitor physical activity using The Lifescripts questionnaire and using accelerometers(Actigragh GT1M) for seven consecutive days
Timepoint [3] 240509 0
baseline and 1 year after intervention
Primary outcome [4] 240510 0
Urinary Sodium Excretion will be measured in a single, timed, overnight, non-fasting urine collection- not by 24 hour urine collection. Aliquots of each sample will be measured in duplicate for sodium and potassium using indirect ion selective electrodes and for creatinine by the Abbott Jaffe reaction, all in an Abbott Architect analyser. Urinary sodium will then be converted to daily excretion rates using the multipliers of 8 hour urinary excretion.
Timepoint [4] 240510 0
baseline and 1 year after intervention
Secondary outcome [1] 242413 0
Assess waist-hip ratio using Figure Finder Tape Measure. Measurements are to taken twice, directly over the skin and at the level of the tape. Waist measurement is taken at the level of mid-point between the inferior margin of the last rib and the iliac crest in the mid axillary plane. Hip measurement is taken at the level of the greatest posterior protuberance of the buttocks which usually corresponds anteriorly with the level of the symphysis pubis.
Timepoint [1] 242413 0
baseline and 1 year after intervention
Secondary outcome [2] 242414 0
2. Blood pressure will be measured using an OMRON office digital blood pressure HEM-907 monitor after participants have been seated for 3 minutes. Three measurements will be taken two minutes apart and an average of the last two measurements calculated.
Timepoint [2] 242414 0
baseline and 1 year after intervention
Secondary outcome [3] 242415 0
body mass index (BMI)
Timepoint [3] 242415 0
at baseline and 1 yr following randomisation
Secondary outcome [4] 242416 0
fasting blood glucose levels.
Blood samples will be collected after a 12 hour fast using Glucose List No 7D66
Timepoint [4] 242416 0
baseline and 1 year after intervention
Secondary outcome [5] 242417 0
total cholesterol to high density lipo-protein (HDL) cholesterol ratio
Blood samples will be taken after a 12 hour fast using the Abbott Architect c8000 analyser. The 3K33 Ultra HDL reagent kit will be used to analyse HDL cholesterol and the Cholesterol Kit List No. 7D62 for cholesterol.
Timepoint [5] 242417 0
at baseline and 1 yr following randomisation

Eligibility
Key inclusion criteria
Absolute cardiovascular risk(ACR) of >10%
Minimum age of females = 45yrs
Minimum age for males = 55yrs
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ACR <10%
2. A history of cardiovascular morbidity(myocardial infarction, stroke, peripheral vascular disease, angina, transient ischaemic attack, >50% carotid stenosis, carotid endarterectomy or stenting, coronary artery angioplasty or stenting, coronary artery bypass grafting)
3. Serious intercurrent illness likely to cause death within the next 2 years
4. Current participation in another clinical trial
5. Not literate in English
6. GP considers them unsuitable for the study

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)
GPs and their practices are recruited by invitational letter.
Once recruited, potential participants are identified using a data search of the GPs client database.
A list of patients is generated and given to the GP for review regarding eligibility and contraindications to participation.
Invitational letter sent to potential participant from the practice, including project description and reply slip.
On reply the participant is issued with an ID number, participant information is sent out, an appointment is made to sign consent forms and perform the baseline assessment.
If the partcipant is assessed as having a ACR of > 10% they are allocated into either the two intervention groups or the control group by cluster randomisation by general practice, based on computer generated random numbers and performed by a person not directly involved in implementation to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1799 0
7000

Funding & Sponsors
Funding source category [1] 237153 0
Charities/Societies/Foundations
Name [1] 237153 0
Heart Foundation of Australia
Country [1] 237153 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute (UTAS)
Address
Level2/199 Macquarie St
Hobart 7000
Tasmania
Country
Australia
Secondary sponsor category [1] 236917 0
None
Name [1] 236917 0
Address [1] 236917 0
Country [1] 236917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239246 0
Human Research Ethics Commitee (Tasmania) Network
Ethics committee address [1] 239246 0
HREC(Tasmania)Network
Office of Research Services
University of Tasmania
Private Bag 01
HOBART TAS 7001
Ethics committee country [1] 239246 0
Australia
Date submitted for ethics approval [1] 239246 0
25/05/2009
Approval date [1] 239246 0
04/06/2009
Ethics approval number [1] 239246 0
H0010492

Summary
Brief summary
Much cardiovascular disease could be prevented if GPs could encourage their patients to improve their diet, physical activity and smoking behaviour. Communication of risk to patients may change their behaviour but the effectiveness of individualised cardiovascular risk feedback in general practice is not yet known. This study aims determine whether feedback of their cardiovascular risk to patients in general practice can improve lifestyle behaviours associated with cardiovascular disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29743 0
Address 29743 0
Country 29743 0
Phone 29743 0
Fax 29743 0
Email 29743 0
Contact person for public queries
Name 12990 0
Helen Steane
Address 12990 0
Menzies Research Institute
Private Bag 23
Hobart 7001
Tasmania
Country 12990 0
Australia
Phone 12990 0
+61 3 62267758
Fax 12990 0
+61 3 62267704
Email 12990 0
[email protected]
Contact person for scientific queries
Name 3918 0
Tania Winzenberg
Address 3918 0
Menzies Research Institute
Private Bag 23
Hobart 7001
Tasmania
Country 3918 0
Australia
Phone 3918 0
+61 3 62267700
Fax 3918 0
+61 3 62267704
Email 3918 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

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