Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000527662
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
19/05/2014
Date last updated
24/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sedentary behaviour in people with cardiovascular disease: a pilot randomised controlled trial
Scientific title
Does a goal setting intervention combined with cardiac rehabilitation reduce sitting time in people with cardiovascular disease compared to cardiac rehabilitation alone?
Secondary ID [1] 284595 0
Nil known
Universal Trial Number (UTN)
U1111-1156-7987
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour (sitting) in people with cardiovascular disease undergoing an outpatient cardiac rehabilitation program 291891 0
Condition category
Condition code
Cardiovascular 292233 292233 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 292272 292272 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention – the ‘Stand up for heart health’ program:
Intervention: In week 2 of the 6 week cardiac rehabiliation (CR) program, participants in the intervention group will attend a one hour individual session in addition to the `standard' CR sessions. The intervention will consist of a one on one face to face session where participants are guided through three activities: 1) review of their assessed sedentary time; 2) normative feedback on sedentary time, using percentiles to compare an average Australian of similar age; and 3) guided goal setting to reduce sedentary time and increase the number of breaks in prolonged sitting time. The guided goal setting will involve a 'small steps' approach, whereby each participant will choose 5 to 6 ways to decrease their sitting time from a list which combines pre-specified behavioural items with suggestions of their own arising from the interview. One goal will be integrated into the participant's habitual behaviour each week for six weeks (e.g. Week 1 goal 'I am going to stand up during the ad breaks on TV, Week 2 goal 'I am going to stand up while I talk on the phone'). Each step is designed to be easily achievable and to reduce sitting time by about 10 to 15 minutes per day. A summary of the specific goal setting plan will be mailed to participants following the face to face session. Participants will be required to self-monitor their goals daily with the completion of a simple checklist (e.g. 'Today, did you achieve your goal of standing up during the TV ad breaks? Yes/No. If not, why not?'). Weekly phone calls will be completed to provide support, and remind participants to build on their previous week's goal.

The intervention has been informed by constructs from self-determination theory (Ryan and Deci 2000) which argues that enduring behaviour change arises from universal and innate human needs for competence (i.e. mastery of one’s activities and environments), autonomy (i.e. choicefully endorsing one’s actions), and psychological relatedness (i.e. interacting with and being cared for by others). The program captures each of these needs, for example:
* Competence: the ‘small steps’ are incremental, modest and easily achievable, which would be expected to support the progressive development of participants’ perceptions of competence,
* Autonomy: participants suggest and choose their own weekly small steps, which would align with increased perceptions of autonomy related to behaviour, and
* Relatedness: phone calls with the research team will be completed weekly to promote regular interaction. The phone calls will be provided in a need-supportive way, with participants who do not achieve their goals being supported with a non-judgemental and empathetic approach, rather than focussing on controlling behaviours. This approach would be expected to promote participants’ feelings of being cared for (relatedness), making it more likely that participants will internalise the views of others (Ryan and Deci 2000).
Intervention code [1] 289365 0
Treatment: Other
Intervention code [2] 289390 0
Rehabilitation
Intervention code [3] 289391 0
Behaviour
Comparator / control treatment
Participants randomised to the control group will complete usual care (outpatient CR program). In the second week of the CR program, participants in the control group will be provided with a one hour 'heart health' DVD to watch. Weekly phone calls for the duration of the 6 week CR program will also be completed for participants in the control group.
Control group
Active

Outcomes
Primary outcome [1] 292105 0
The total duration and bouts of sitting as measured by two activity monitors: the ActivPAL3 activity monitor, the gold standard for postural allocation, and the GENEActiv to measure intensity of activity.
Timepoint [1] 292105 0
Baseline, and 6 weeks (post intervention assessment).
Primary outcome [2] 292106 0
The total duration of sitting and the types and context of sedentary behaviours as measured by the Multimedia Activity Recall for Children and Adults (MARCA).
Timepoint [2] 292106 0
Baseline and 6 weeks (post intervention assessment).
Secondary outcome [1] 308211 0
Feasibility of the goal setting intervention as assessed by a project evaluation form. The form will contain a series of 5 point Likert scale questions to determine participants’ satisfaction with the program including; the materials, feedback, phone calls, support, wearing of the monitors, and overall burden relating to the program. Participants will also be invited to provide further comments. The feasibility of the participant recruitment and management processes will also be assessed by evaluating uptake of the program (% of eligible participants who enrol in the study) and retention (% of enrolled participants completing the post-intervention assessment).
Timepoint [1] 308211 0
6 weeks (post intervention assessment)

Eligibility
Key inclusion criteria
This study involves two groups of participants. A total sample of 60 male and females will be recruited prior to commencing a CR program at the Royal Adelaide Hospital. For inclusion, participants will communicate effectively in English, live in the metropolitan area, and be enrolled in an outpatient CR program at the Royal Adelaide Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they have one or more significant co-morbidities that affect physical mobility, are unable to walk independently or have a significant cognitive impairment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through the CR program at the Royal Adelaide Hospital. The CR program at the RAH is led by a CR nurse and a physiotherapist. Potential participants will be approached and provided with information about the study by the CR nurse at the same time they are referred to the outpatient CR program. A flyer with information about the study will be provided to potential participants at this time. Potential participants will be asked to contact the principal investigator or research staff if they are interested in participating in the study. They will then be asked a series of questions to determine their suitability for the study. Potential participants will be asked to contact the principal investigator either by phone or email to register their interest in the study. The principal investigator will then make contact with potential participants via a phone call or email, depending on the contact details provided by the potential participant. Participants will be randomised to the intervention or control group via a computer-generated randomisation procedure using a secure web-based system to ensure allocation concealment. Participants will not be aware of the intervention of interest.

This study involves a control group who will receive usual care in the form of an outpatient CR program at the RAH. Participants in the intervention group will receive the usual outpatient CR program as well as a goal setting intervention aimed to decrease their sitting time. Participants will not be informed which intervention ('usual CR' or 'usual CR + intervention to decrease sitting time') is the intervention of interest. The study will be known to participants as the 'Stand up for Heart health' study. Both participants in the control and intervention groups will receive weekly supportive phone calls from the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to the intervention or control group via a computer-generated randomisation procedure using a secure web-based system to ensure allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a single group pre-post study involving community-dwelling older adults, daily sitting time was reduced by 30.7 (+/- 85.4) minutes per day; representing an effect size of 0.35 (Gardiner et al 2011). In a two groups random effects mixed model, with alpha at 0.05, a total sample of 54 is required to detect an effect size of 0.35. While we are unlikely to demonstrate a similar effect size in an RCT, our target sample size of 60 will be sufficient to detect trends in sedentary time changes.

Demographic data will be descriptively analysed. Ordinal data from the participants' feedback will be analysed in terms of frequency of responses. Open-ended data (such as comments regarding aspects of the program) will be compiled, and common themes identified. All participants will be analysed in the groups they were initially randomised into (intention to treat analysis). Changes in the overall sedentary time (ActivPAL/GENEActiv) in the intervention group relative to the control group at post-intervention will be compared using random effects mixed modelling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/06/2014
Actual
9/06/2014
Date of last participant enrolment
Anticipated
Actual
3/06/2015
Date of last data collection
Anticipated
Actual
27/07/2015
Sample size
Target
60
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2460 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8117 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289227 0
Charities/Societies/Foundations
Name [1] 289227 0
Physiotherapy Research Foundation
Country [1] 289227 0
Australia
Primary sponsor type
Individual
Name
Dr Lucy Lewis
Address
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 287899 0
Individual
Name [1] 287899 0
Professor Tim Olds
Address [1] 287899 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country [1] 287899 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290995 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 290995 0
Ethics committee country [1] 290995 0
Australia
Date submitted for ethics approval [1] 290995 0
Approval date [1] 290995 0
27/03/2014
Ethics approval number [1] 290995 0
0000032170
Ethics committee name [2] 290996 0
Royal Adelaide Research Ethics Committee
Ethics committee address [2] 290996 0
Ethics committee country [2] 290996 0
Australia
Date submitted for ethics approval [2] 290996 0
27/03/2014
Approval date [2] 290996 0
Ethics approval number [2] 290996 0

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

Contacts
Principal investigator
Name 48346 0
Dr Lucy Lewis
Address 48346 0
Flinders University
Physiotherapy
GPO Box 2100
Adelaide SA 5001
Australia
Country 48346 0
Australia
Phone 48346 0
+61 8 72218261
Fax 48346 0
Email 48346 0
[email protected]
Contact person for public queries
Name 48347 0
Emily Vaughton
Address 48347 0
University of South Australia
School of Health Sciences
GPO Box 2471
Adelaide SA 5001
Country 48347 0
Australia
Phone 48347 0
+61 8 83026558
Fax 48347 0
Email 48347 0
[email protected]
Contact person for scientific queries
Name 48348 0
Lucy Lewis
Address 48348 0
Flinders University
Physiotherapy
GPO Box 2100
Adelaide SA 5001
Australia
Country 48348 0
Australia
Phone 48348 0
+61 8 72218261
Fax 48348 0
Email 48348 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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