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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] 1320 0
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 256658 0
coronary artery bypass graft surgery 256724 0
myocardial infarction 256725 0
percutaneous coronary intervention 256726 0
Condition category
Condition code
Cardiovascular 256816 256816 0 0
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] 255892 0
Prevention
Intervention code [2] 255893 0
Lifestyle
Intervention code [3] 255894 0
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] 257682 0
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] 257682 0
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] 263005 0
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] 263005 0
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] 263006 0
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] 263006 0
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 [3] 263007 0
Secondary Outcome 3: Proportion of participants meeting dietary guidelines. This will be assessed by self-report, using questions on food intake from the NSW Population Health Survey. In a sub-group, food intake will also be measured using a 3-day food diary, at baseline and at 8 months.
Timepoint [3] 263007 0
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 [4] 263008 0
Secondary Outcome 4: Changes in planning intentions for physical activity and healthy eating. This will be assessed by self-report using a questionnaire.
Timepoint [4] 263008 0
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 [5] 263009 0
Secondary Outcome 5: Changes in quality of life measures (independent living, social relationships, physical senses, psychological well-being). This will be assessed by self-report using the Assessment of Quality of Life (AQoL)Questionnaire.
Timepoint [5] 263009 0
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 [6] 263010 0
Secondary Outcome 6: Cost and cost-effectiveness for the intervention compared to the outcomes achieved. Participant's self-reported costs will be assessed using questionnaires. Investigators will establish program costs by recording and valuing program inputs.
Timepoint [6] 263010 0
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 [7] 263011 0
Secondary Outcome 7: Perceptions of cardiac rehabilitation staff and trial participants in rural and urban areas regarding usefulness and acceptability of the intervention. Experiences of trial participants will be assessed using questionnaires. Staff will be invited to participate in semi-structured interviews.
Timepoint [7] 263011 0
Timepoint: at 8 weeks and 8 months for the intervention group. At 6 weeks and 6 months for the control group. At the conclusion of the trial for staff interviews.

Eligibility
Key inclusion criteria
All people referred for cardiac rehabilitation at two urban and two regional hospitals from the commencement of the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
A letter will be mailed to people eligible to participate in the trial inviting them to participate in the study. Participants will be randomised by the researcher during the follow up telephone call when they agree to be enrolled into the study. Participants will be block randomized by site by month. The random numbers will be generated and packaged by a person external to the study so the group allocation will be concealed from the researcher until the participant has agreed to be in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Microsoft Excel will be used to generate random numbers and the Statistical Package for Interactive Data Analysis (SPIDA) will be used to randomise these numbers into sets of two letters (A and B, representing the intervention and control groups respectively) by blocks of four to ensure a balanced sample size across both study groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2010
Actual
15/04/2010
Date of last participant enrolment
Anticipated
Actual
22/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
356
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2474 0
2642
Recruitment postcode(s) [2] 2475 0
2650
Recruitment postcode(s) [3] 2476 0
2651
Recruitment postcode(s) [4] 2477 0
2652
Recruitment postcode(s) [5] 2478 0
2655
Recruitment postcode(s) [6] 2479 0
2660
Recruitment postcode(s) [7] 2480 0
2663
Recruitment postcode(s) [8] 2481 0
2665
Recruitment postcode(s) [9] 2482 0
2666
Recruitment postcode(s) [10] 2483 0
2268
Recruitment postcode(s) [11] 2484 0
2700
Recruitment postcode(s) [12] 2485 0
2701
Recruitment postcode(s) [13] 2486 0
2702
Recruitment postcode(s) [14] 2487 0
2705
Recruitment postcode(s) [15] 2488 0
2722
Recruitment postcode(s) [16] 2489 0
2580
Recruitment postcode(s) [17] 2490 0
2581
Recruitment postcode(s) [18] 2491 0
2582
Recruitment postcode(s) [19] 2492 0
2586
Recruitment postcode(s) [20] 2493 0
2227
Recruitment postcode(s) [21] 2494 0
2228
Recruitment postcode(s) [22] 2495 0
2229
Recruitment postcode(s) [23] 2496 0
2230
Recruitment postcode(s) [24] 2497 0
2232
Recruitment postcode(s) [25] 2498 0
2233
Recruitment postcode(s) [26] 2499 0
2234
Recruitment postcode(s) [27] 2500 0
2216
Recruitment postcode(s) [28] 2501 0
2217
Recruitment postcode(s) [29] 2502 0
2218
Recruitment postcode(s) [30] 2503 0
2019
Recruitment postcode(s) [31] 2504 0
2220
Recruitment postcode(s) [32] 2505 0
2221
Recruitment postcode(s) [33] 2506 0
2222
Recruitment postcode(s) [34] 2507 0
2223
Recruitment postcode(s) [35] 2508 0
2226

Funding & Sponsors
Funding source category [1] 256381 0
Government body
Name [1] 256381 0
NSW Health Promotion Demonstration Research Grant
Country [1] 256381 0
Australia
Primary sponsor type
Government body
Name
South East Sydney & Illawarra Area Health Service
Address
Division of Population Health and Planning
Locked Bag 9
Unanderra Delivery Centre
NSW 2526
Country
Australia
Secondary sponsor category [1] 251694 0
Government body
Name [1] 251694 0
Greater Southern Area Health Service
Address [1] 251694 0
Manager Health Development
PO Box 83
Braidwood
NSW 2622
Country [1] 251694 0
Australia
Other collaborator category [1] 1056 0
Individual
Name [1] 1056 0
Ms Janice Sangster
Address [1] 1056 0
Health Development
Wagga Wagga Community Health Centre
Docker St
Wagga Wagga
NSW 2650
Country [1] 1056 0
Australia
Other collaborator category [2] 1057 0
Individual
Name [2] 1057 0
Dr Susan Furber
Address [2] 1057 0
Research and Evaluation Coordinator
South East Sydney & Illawarra Area Health Service
Division of Population Health and Planning
Locked Bag 9
Unanderra Delivery Centre
NSW 2526
Country [2] 1057 0
Australia
Other collaborator category [3] 1058 0
Individual
Name [3] 1058 0
Mr Andy Mark
Address [3] 1058 0
Regional Health Promotion Coordinator Illawarra
National Heart Foundation of Australia (NSW Division)
PO Box 276 Kiama
NSW 2533
Country [3] 1058 0
Australia
Other collaborator category [4] 1059 0
Individual
Name [4] 1059 0
Professor Adrian Bauman
Address [4] 1059 0
School of Public Health , University of Sydney
Building K25, 94 Parramatta Rd, Camperdown
Sydney, NSW 2050
Country [4] 1059 0
Australia
Other collaborator category [5] 1065 0
Individual
Name [5] 1065 0
Associate Professor Margaret Allman-Farinelli
Address [5] 1065 0
Clinical Nutrition and Dietetics
University of Sydney
Sydney 2006
Country [5] 1065 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258445 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 258445 0
Ethics committee country [1] 258445 0
Australia
Date submitted for ethics approval [1] 258445 0
Approval date [1] 258445 0
25/09/2008
Ethics approval number [1] 258445 0
HE08/243
Ethics committee name [2] 258446 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee
Ethics committee address [2] 258446 0
Ethics committee country [2] 258446 0
Australia
Date submitted for ethics approval [2] 258446 0
Approval date [2] 258446 0
18/11/2008
Ethics approval number [2] 258446 0
SSA/08/STG/184 and SSA/08/STG/185
Ethics committee name [3] 258447 0
Greater Southern Area Health Services Human Research Ethics Committee
Ethics committee address [3] 258447 0
Ethics committee country [3] 258447 0
Australia
Date submitted for ethics approval [3] 258447 0
Approval date [3] 258447 0
28/11/2008
Ethics approval number [3] 258447 0
08/GSAHS/81
Ethics committee name [4] 258448 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [4] 258448 0
Ethics committee country [4] 258448 0
Australia
Date submitted for ethics approval [4] 258448 0
Approval date [4] 258448 0
15/12/2009
Ethics approval number [4] 258448 0
HREC 09403

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30754 0
Dr Susan
Address 30754 0
Health Promotion Service
Illawarra Shoalhaven Local Health District
Locked Bag 9
Wollongong NSW 2500
Country 30754 0
Australia
Phone 30754 0
+61 2 4221 6729
Fax 30754 0
Email 30754 0
susan.furber@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 14001 0
Janice Sangster
Address 14001 0
Wagga Wagga Community Health Centre
Docker St
Wagga Wagga, NSW 2650
Country 14001 0
Australia
Phone 14001 0
+61 2 6938 6476
Fax 14001 0
Email 14001 0
janice.sangster@gsahs.health.nsw.gov.au
Contact person for scientific queries
Name 4929 0
Janice Sangster
Address 4929 0
Wagga Wagga Community Health Centre
Docker St
Wagga Wagga, NSW 2650
Country 4929 0
Australia
Phone 4929 0
+61 2 6938 6476
Fax 4929 0
Email 4929 0
janice.sangster@gsahs.health.nsw.gov.au

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