ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000102077

Ethics application status

Approved

Date submitted

22/01/2010

Date registered

2/02/2010

Date last updated

10/02/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

A population-based comprehensive lifestyle intervention to promote healthy weight and physical activity in people with cardiac disease

Scientific title

For people referred to cardiac rehabilitation does participation in the PANACHE (Physical Activity, Nutrition And Cardiac HEalth) Program improve physical activity levels and attainment of a healthy weight?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

PANACHE (Physical Activity, Nutrition And Cardiac HEalth) Program

Linked study record

Health condition

Health condition(s) or problem(s) studied:

acute coronary syndrome

coronary artery bypass graft surgery

myocardial infarction

percutaneous coronary intervention

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control group will receive the 6 week physical activity-only intervention used previously by Butler et al (2009) and Furber et al (2009). That intervention included a pedometer, step recording calendar, behavioural counselling and goal setting sessions (on physical activity only, and recommending 30 minutes of exercise on most days of the week) via telephone as well as two “booster” phone calls after the intervention. The control group will act as a replication study of the efficacious pedometer-based physical activity program, testing it in rural and urban settings. The advantage of having the attention-focused physical activity control group is to reduce possible Hawthorne effects for the intervention group in this study.

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 16 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).

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome 1: Proportion of participants achieving a healthy weight as defined by the National Heart Foundation of Australia. Weight will be assessed by self-report. In a sub-group, objective measures of height and weight will be completed by the researchers at baseline and at 8 months.

Timepoint [1]

Timepoint: at baseline, 8 weeks and 8 months for the intervention group. At baseline, 6 weeks and 6 months for the control group.

Secondary outcome [1]

Secondary Outcome 1: Proportion of participants achieving their targets for physical activity (30 minutes per day for weight maintenance and 60-90 minutes per day for weight loss). Self-reported physical activity will be measured using questions from the Active Australia Questionnaire. In a sub-group, physical activity will also be measured objectively using accelerometers, at baseline and at 8 months.

Timepoint [1]

Timepoint: at baseline, 8 weeks and 8 months for the intervention group. At baseline, 6 weeks and 6 months for the control group.

Secondary outcome [2]

Secondary Outcome 2: Proportion of participants reducing their sedentary activity. Self-reported sedentary time will be assessed using a question from the International Physical Activity Questionnaire.

Timepoint [2]