None listed
Conditions
Brief summary
Cardiovascular disease (CVD) is the leading cause of death and the most expensive group of diseases treated in Australia. Maintaining a healthy weight and engaging in regular physical activity are important behaviours for the primary and secondary prevention of CVD. However, many people with CVD are overweight and insufficiently active. In addition, only 20 to 30 per cent of people requiring secondary prevention services for CVD attend traditional centre based cardiac rehabilitation (CR) groups. To improve outcomes of and access to CR services there is a need for the efficacy, effectiveness and cost-effectiveness of alternative approaches to CR to be established. This randomised control trial aims to: 1. Determine the efficacy of a telephone-delivered comprehensive lifestyle intervention on weight and physical activity in people with CVD in urban and rural settings. 2. Determine if the findings on physical activity reported by Butler et al (2009) and Furber et al (in press) are replicated in the control group of this trial. 3. Determine the costs and cost-effectiveness of the comprehensive lifestyle intervention in urban and rural settings, compared to outcomes achieved. 4. Explore the perceptions of cardiac rehabilitation staff and trial participants in rural and urban areas regarding usefulness and acceptability of the comprehensive lifestyle intervention to promote physical activity and healthy weight for people with CVD. This trial addresses a significant gap in public health practice by providing evidence of the efficacy and cost-effectiveness of a low cost, low contact, high reach intervention promoting healthy weight and physical activity among people with CVD in rural and urban areas in Australia. If effective, this population-based approach has the potential to cut health costs and improve access to secondary prevention programs, particularly for rural and disadvantaged communities. References Furber S, Butler L, Phongsavan P, Mark A, Bauman A. Randomised controlled trial of a pedometer-based telephone intervention to increase physical activity among cardiac patients not attending cardiac rehabilitation Patient Education and Counseling. Published online Dec 16th 2009. Butler L, Furber S, Phongsavan P, Mark A, Bauman A. Effects of a pedometer based intervention on physical activity levels after cardiac rehabilitation: A randomised controlled trial. Journal of Cardiopulmonary Rehabilitation and Prevention 29(2):105-114 (2009).
Interventions
The intervention group will receive an 8 week comprehensive lifestyle intervention. The intervention comprises 4 behavioural counselling and goal setting sessions on weight, nutrition and physical activity via telephone; and written materials and a pedometer via mail. The telephone counselling and goal setting sessions will be based on social cognitive theory. Participants will be taught how to self-monitor their food intake and physical activity and to set attainable nutrition and physical acti
The intervention group will receive an 8 week comprehensive lifestyle intervention. The intervention comprises 4 behavioural counselling and goal setting sessions on weight, nutrition and physical activity via telephone; and written materials and a pedometer via mail. The telephone counselling and goal setting sessions will be based on social cognitive theory. Participants will be taught how to self-monitor their food intake and physical activity and to set attainable nutrition and physical activity goals which will be reviewed at subsequent sessions. Each session will take between 10 and 15 minutes depending on the support required. Intervention participants will be asked to undertake 60-90 minutes of exercise most days of the week to lose weight. Goals will be individualized and if the participant’s body mass index is in the healthy range of 18.5-24.9 kg/m2, nutritional intake meets national dietary guidelines and physical activity reaches recommended targets, the focus will be on maintenance. The intervention group will receive two “booster” phone calls after the intervention.
Sponsors
South East Sydney & Illawarra Area Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All people referred for cardiac rehabilitation at two urban and two regional hospitals from the commencement of the trial.
Exclusion criteria
Unable to use English fluently enough to participate in the interview or telephone coaching calls. A clinical diagnosis of uncompensated, severe cardiac failure (Class IV); uncontrolled arrhythmia or angina; severe or symptomatic aortic stenosis; or persistent hypotension with systolic blood pressure (SBP) <90 mm Hg. A clinical diagnosis of a severe coexisting medical condition that would prevent participation eg. Cognitive impairment, dementia, a terminal illness, severe rheumatoid arthritis, severe arthritis, renal disease requiring dialysis, uncontrolled diabetes. Are planning to have major orthopaedic surgery within the next 6 months that is likely to affect their mobility eg. hip replacement; knee reconstruction; spinal surgery. A signed consent form is not returned. A signed clearance form is not returned from their general practitioner or specialist.
Outcome results
None listed