Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001534471
Ethics application status
Approved
Date submitted
3/11/2016
Date registered
8/11/2016
Date last updated
29/01/2020
Date data sharing statement initially provided
1/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A behaviour-change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease
Scientific title
A behaviour-change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease: a randomised controlled trial
Secondary ID [1] 290402 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 300739 0
Sedentary behaviour 300740 0
Condition category
Condition code
Respiratory 300569 300569 0 0
Chronic obstructive pulmonary disease
Public Health 300570 300570 0 0
Health promotion/education
Mental Health 300571 300571 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The behaviour change intervention will consist of weekly sessions with a physiotherapist for six weeks. In Weeks 1, 3 and 6, participants will receive a one on one, face-to-face session in the setting of their choice (i.e., in the participants’ own home or at the pulmonary rehabilitation site) lasting approximately one hour. In the other three weeks of the intervention, participants will receive supportive phone calls of up to 30 minutes. All six sessions will be conducted by the same principal investigator, who has been trained in the use of the 'capability', 'opportunity', 'motivation' and 'behaviour' (COM-B) model and the Behaviour Change Wheel, to ensure that the intervention is delivered consistently across participants.

During the initial session, a behavioural analysis will be conducted using the COM-B model to determine what needs to change (in terms of capability, opportunity and motivation) for each individual participant to achieve the two target behaviours and reduce their sedentary time. Participants will also be asked to report their stage of readiness for change and complete the Perceived Competence Scale, which assesses their feelings of competence about engaging in a heath behaviour. These two questionnaires have been adapted for the study to assist the principal investigator in tailoring the intervention to meet the individual needs and progress of each participant.

Based on the behavioural analysis and the results of the questionnaires, appropriate behaviour change techniques will be selected to facilitate movement through the stages of readiness for change. These include:
1. Information about the health consequences of sedentary behaviour. Written and verbal education will be provided regarding the health risks associated with too much sedentary time, and how these risks can be reduced by replacing sitting and lying down with light intensity physical activity.
2. Guided goal setting to reduce sedentary time. Participants will be asked to implement one goal per week that involves replacing sitting or lying down with light intensity physical activity (e.g., “I am going to eat my breakfast standing up at the kitchen bench instead of sitting down at the table”), or standing up and moving for two minutes after 30 minutes of continuous sedentary time (e.g., “I am going to walk around the house for two minutes after 30 minutes of reading in bed”). The aim is to progress that goal over the intervention period, so that by the final week participants will have integrated six goals into their day to reduce sedentary time. Action planning will be used to specify when, where, and how participants will reduce their sedentary time. Participants will record their weekly goals and action plans in a workbook.
3. Self-monitoring and review of behaviour goals. The workbook will also contain a simple daily checklist that participants can use to self-monitor their goals (e.g., “Today, did you achieve your goal of eating breakfast standing up at the kitchen bench? Yes/No. If not, what was stopping you?”). Self-reported achievement of goals will be interpreted from this checklist.
4. Problem solving of barriers to achieving weekly goals. Participants will be prompted to identify potential barriers to reducing sedentary time, and to generate strategies to overcome these barriers. This may involve restructuring the home environment, advising on social support to enable more light intensity physical activity, or using intrinsic cues embedded in an activity to remind participants to break up prolonged bouts of sedentary time (e.g., using the television ad breaks as a prompt to stand and move up when watching television).
5. Feedback on sedentary time. The Jawbone UP3 (Jawbone, San Francisco, USA) is a commercially available accelerometer worn on the wrist that will be used to provide feedback on prolonged bouts of sedentary time. The device has a vibrating alert function and will be programmed to vibrate after 30 minutes of sustained inactivity. This real-time feedback aims to remind participants to move if they accumulate 30 minutes of sustained inactivity. Participants will be asked to wear the Jawbone during all waking hours for the six-week intervention period.
6. Motivational interviewing techniques. These will include positive reinforcement; using recollections of previous success with reducing sedentary time to inform new goals; addressing any maladaptive beliefs participants may have about COPD or about sedentary behaviour; and acknowledging any difficulties they may have and redirecting them towards a solution.

Standardised definitions of the behaviour change techniques mentioned above can be found in the Behaviour Change Taxonomy.

Compliance with the behaviour change intervention will be monitored by (1) keeping a register of attendance for face-to-face sessions and a log of call times for phone sessions, and (2) reviewing the participants’ workbook and daily checklist at each face-to-face session.
Intervention code [1] 296233 0
Behaviour
Intervention code [2] 296234 0
Lifestyle
Intervention code [3] 296325 0
Treatment: Other
Comparator / control treatment
In order to provide similar levels of attention to the intervention and control groups, participants in the control group will be given a sham intervention in addition to usual care. The sham intervention will consist of weekly “sham” phone calls during the six-week intervention period. During these phone calls, participants will only be asked if their health status has changed over the intervention period (e.g., hospitalised for an acute exacerbation). No instructions regarding sitting time or exercise will be given, and participants will be directed to contact their local GP if they have any health issues. Each phone call will last no more than 15 minutes in duration.
Control group
Placebo

Outcomes
Primary outcome [1] 299987 0
Total sedentary time per day (activPAL3 activity monitor, PAL Technologies Ltd, Glasgow, Scotland, UK). This will be calculated as the duration of all sedentary bouts each day in minutes, and will also be reported as a percentage of total waking wear time.
Timepoint [1] 299987 0
Participants will be asked to wear the activPAL3 activity monitor for seven consecutive days, 24 hours a day, at each assessment time point: Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention. The activPAL3 activity monitor is only to be removed if skin irritation occurs.
Primary outcome [2] 299988 0
Usual bout duration, i.e., the duration above and below which 50% of all sedentary time is accumulated (activPAL3 activity monitor, PAL Technologies Ltd, Glasgow, Scotland, UK).
Timepoint [2] 299988 0
Participants will be asked to wear the activPAL3 activity monitor for seven consecutive days, 24 hours a day, at each assessment time point: Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention. The activPAL3 activity monitor is only to be removed if skin irritation occurs.
Primary outcome [3] 299989 0
Feasibility of the behaviour-change intervention. This consists of four measures: (1) uptake of the behaviour-change intervention (% of eligible participants who enrolled in the study) and retention (% of enrolled participants assessed at the completion of the six-week intervention); (2) compliance with the intervention (total number of intervention sessions completed within the six-week period); (3) self-reported achievement of weekly goals; and (4) major or minor adverse events associated with the behaviour-change intervention.
Timepoint [3] 299989 0
Completion of the six-week behaviour-change intervention (six weeks following randomisation)
Secondary outcome [1] 328756 0
Functional exercise capacity (6-minute walk test)
Timepoint [1] 328756 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention
Secondary outcome [2] 328757 0
Health-related quality of life (St George’s Respiratory Questionnaire)
Timepoint [2] 328757 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention
Secondary outcome [3] 328758 0
Domain- and behaviour-specific sitting time (Sedentary Behaviour Questionnaire)
Timepoint [3] 328758 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention
Secondary outcome [4] 328759 0
Self-efficacy (Patient Activation Measure)
Timepoint [4] 328759 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention
Secondary outcome [5] 328760 0
Composite outcome for anxiety and depression (Hospital Anxiety and Depression Scale)
Timepoint [5] 328760 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention
Secondary outcome [6] 328761 0
Composite outcome for participant satisfaction and acceptance of the different components of the behaviour change intervention. This will be assessed at the completion of the behaviour change intervention using semi-structured interviews and a study-specific questionnaire consisting of a series of 5-point Likert scales and open-ended items. All participants assigned to the behaviour change intervention will be invited to participate in a semi-structured interview within one month of completing the intervention. Interview questions will explore participants’ attitudes towards the different components of the intervention, and the impact of the intervention on perceptions of sedentary behaviour and barriers to reducing sedentary behaviour. The interviews will be conducted either face-to-face or over the phone by an independent researcher who is not involved in the delivery of the intervention. Each interview will be audiotaped and will take 30-45 minutes to complete.
Timepoint [6] 328761 0
Completion of the six-week behaviour-change intervention
Secondary outcome [7] 342968 0
Number of sit-to-stand transitions per day (activPAL3 activity monitor, PAL Technologies Ltd, Glasgow, Scotland, UK)
Timepoint [7] 342968 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention
Secondary outcome [8] 342969 0
Prolonged sedentary time per day, i.e., time spent sitting or lying down continuously for more than 30 minutes (activPAL3 activity monitor, PAL Technologies Ltd, Glasgow, Scotland, UK)
Timepoint [8] 342969 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention
Secondary outcome [9] 342970 0
Number of sedentary bouts per day accumulated in bouts of longer than 30 minutes (activPAL3 activity monitor, PAL Technologies Ltd, Glasgow, Scotland, UK)
Timepoint [9] 342970 0
Baseline, completion of the six-week behaviour-change intervention (six weeks following randomisation), three months following the completion of the behaviour-change intervention

Eligibility
Key inclusion criteria
Medical diagnosis of chronic obstructive pulmonary disease (forced expiratory volume in one second (FEV1) / forced vital capacity ratio of < 0.7); Clinically stable, defined as no change in medication in the four weeks preceding recruitment; Able to mobilise independently with or without a walking aid; Expected to wait eight weeks or more on the waiting list for a pulmonary rehabilitation program.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have participated in a supervised exercise training program within the last six months; have limited spoken and/or written English which prevents them from participating in the intervention.

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 randomised in a concealed manner using a computer-generated random sequence (https://www-users.york.ac.uk/~mb55/guide/minim.htm). This will be performed by a third person independent of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a concealed manner using a computer-generated random sequence (https://www-users.york.ac.uk/~mb55/guide/minim.htm). This will be performed by a third person independent of the research team. Randomisation will be stratified according to exercise capacity (6-minute walk distance (6WMD) less than 350 metres, 6WMD greater than or equal to 350 metres) and whether the participant has completed a pulmonary rehabilitation program in the past (yes or no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative data analysis
All analyses will be performed using SPSS (Version 22 for Windows, IBM, USA). Intention-to-treat analysis will be conducted, and a p-value of < 0.05 considered significant. Analysis of covariance (ANCOVA) will be used to calculate between-group comparisons of total sedentary time and the number of bouts of sedentary time longer than 30 minutes after adjusting baseline values. Uncertainty about the size of the mean differences between groups will be quantified with 95% confidence intervals. Within-group comparisons will be examined using paired t-tests and described as mean differences with 95% confidence intervals. Functional exercise capacity, HRQoL, self-reported sedentary time according to the SBQ, patient activation, and anxiety and depression scores will be analysed similarly.

The feasibility measures and participant satisfaction will be analysed descriptively. Uptake and retention of the intervention, participant compliance, and self-reported achievement of weekly goals will be calculated as percentages. Any adverse events will be reported.

Qualitative data analysis
A sample of de-identified interview transcripts will be analysed using the 'capability', 'opportunity', 'motivation' and 'behaviour' (COM-B) model as a thematic framework. Transcripts will first be coded independently by two researchers into categories using the computer software package NVivo (Qualitative Solutions & Research Pty Ltd., Australia), and the coding compared for consistency. Categories will correspond to the six components of behaviour identified by the COM-B model: Physical capability, psychological capability, physical opportunity, social opportunity, reflective motivation, and automatic motivation. As data is refined and gaps in the data are identified, purposive sampling will be conducted to further develop emerging categories. The researchers will then meet to discuss the categories and group the categories into themes and sub-themes, until a consensus on the major themes is reached. Supporting quotations for each theme will be extracted from the transcripts. Semi-structured interviews will continue to be performed until data saturation is achieved and there are no new emerging themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2017
Actual
21/12/2016
Date of last participant enrolment
Anticipated
30/04/2019
Actual
1/05/2019
Date of last data collection
Anticipated
31/08/2019
Actual
1/09/2019
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9993 0
Mona Vale Hospital - Mona Vale
Recruitment hospital [2] 13019 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 13020 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 13021 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 18833 0
2103 - Mona Vale
Recruitment postcode(s) [2] 25505 0
2050 - Camperdown
Recruitment postcode(s) [3] 25506 0
2031 - Randwick
Recruitment postcode(s) [4] 25507 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 294810 0
Charities/Societies/Foundations
Name [1] 294810 0
The Physiotherapy Research Foundation
Country [1] 294810 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 293651 0
Charities/Societies/Foundations
Name [1] 293651 0
The Better Breathing Foundation
Address [1] 293651 0
Level 5
137-139 Bathurst Street
Sydney NSW 2000
Country [1] 293651 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296202 0
Sydney Local Health District Human Research Ethics Committee – RPAH Zone
Ethics committee address [1] 296202 0
Ethics committee country [1] 296202 0
Australia
Date submitted for ethics approval [1] 296202 0
31/07/2016
Approval date [1] 296202 0
31/10/2016
Ethics approval number [1] 296202 0
HREC/16/RPAH/400

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1218 1218 0 0
/AnzctrAttachments/371728-4_Study_protocol_Version4_01.11.2016_CLEAN.docx (Protocol)
Attachments [2] 1223 1223 0 0
/AnzctrAttachments/371728(v03-11-2016-23-17-14)-6_PIS_Version4_20.07.2016.docx (Participant information/consent)

Contacts
Principal investigator
Name 69970 0
Dr Zoe McKeough
Address 69970 0
Rm 0203, O Block
Cumberland Campus C42
75 East St
The University of Sydney
Lidcombe NSW 2141
Country 69970 0
Australia
Phone 69970 0
+61 2 9351 9269
Fax 69970 0
+61 2 9351 9278
Email 69970 0
[email protected]
Contact person for public queries
Name 69971 0
Zoe McKeough
Address 69971 0
Rm 0203, O Block
Cumberland Campus C42
75 East St
The University of Sydney
Lidcombe NSW 2141
Country 69971 0
Australia
Phone 69971 0
+61 2 9351 9269
Fax 69971 0
+61 2 9351 9278
Email 69971 0
[email protected]
Contact person for scientific queries
Name 69972 0
Zoe McKeough
Address 69972 0
Rm 0203, O Block
Cumberland Campus C42
75 East St
The University of Sydney
Lidcombe NSW 2141
Country 69972 0
Australia
Phone 69972 0
+61 2 9351 9269
Fax 69972 0
+61 2 9351 9278
Email 69972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It was previously stated in the submission of ethics for this trial that "information collected for, used in, or generated by, this project will not be used for any other purpose."


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA behaviour change intervention to reduce sedentary time in people with chronic obstructive pulmonary disease: protocol for a randomised controlled trial2017https://doi.org/10.1016/j.jphys.2017.04.001
EmbaseSix-week behaviour change intervention to reduce sedentary behaviour in people with chronic obstructive pulmonary disease: A randomised controlled trial.2022https://dx.doi.org/10.1136/thoraxjnl-2020-214885
EmbaseValidity and Accuracy of Step Count as an Indicator of a Sedentary Lifestyle in People With Chronic Obstructive Pulmonary Disease.2023https://dx.doi.org/10.1016/j.apmr.2023.01.020
N.B. These documents automatically identified may not have been verified by the study sponsor.