Lifestyle Outcomes of Absolute cardiovascular risk Feedback project

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000660280

Acronym

LOAF

Enrollment

Registered

2009-08-04

Start date

2009-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 ca

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Absolute cardiovascular risk(ACR) of >10% Minimum age of females = 45yrs Minimum age for males = 55yrs

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

Outcome results