Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000613606
Ethics application status
Approved
Date submitted
24/05/2023
Date registered
5/06/2023
Date last updated
5/06/2023
Date data sharing statement initially provided
5/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Incentivising adults and young people to use public transport for physical activity gain
Scientific title
A single-blinded randomised controlled trial evaluating the impact of incentivising public transport use for physical activity among adults and young people
Secondary ID [1] 309627 0
Nil known
Universal Trial Number (UTN)
U1111-1292-3414
Trial acronym
Linked study record
Related to ACTRN12619001136190, trips4health: A single-blinded randomised controlled trial incentivising adults to use public transport for physical activity gain.
trips4health was abandoned in 2020 due to the substantial impacts of the COVID-19 pandemic. Responding to trips4heatlh preliminary outcome and process evaluation findings, inclusion criteria, recruitment, and outcome and data collection methods have been refined, and co-design processes are embedded to support study participation.

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 329951 0
Condition category
Condition code
Public Health 326856 326856 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study has a 14 week intervention phase followed by a 24 week maintenance phase. The 14 week intervention phase allows 10 weeks for behaviour change to reach automaticity and 4 weeks for maintenance or ‘tapering off’, where contact and support is gradually withdrawn in preparation for intervention cessation.Using a ‘gain-framed’ approach (i.e. rewarding positive behaviours), participants in the intervention group will have bus trip use targets from weeks 1-14 which escalate over the course of the intervention so that targets become more difficult to reach but incentive values increase (weekly bus trip targets are: weeks 1-3, one bus trip; weeks 4-6, two bus trips; weeks 7-9, three bus trips; week 10, four bus trips; weeks 11-12, 3 bus trips, week 13, three bus trips, week 14, three bus trips). If the bus trip target is met, participants receive bus trip credit (through their public transport smartcard). The credit received will be commensurate with the participant’s default fare type that they were required to set when applying for their smartcard. The price range of the different fare types is $1.52 to $5.76 (a child/student fare through to an adult fare with travel across multiple zones). The maximum credit a participant can receive by the end of the 14 week intervention phase is $48.64 if travelling on a child/student fare and if travelling as an adult $184.32 as per their default fare type. Participants will be aiming to achieve a minimum of three bus trips per week by the end of the intervention. Participants will be notified by a weekly email whether they have met or have not met their target (this data is provided by the transport company, Metro, after downloading weekly trip data from the participants' smartcard), the smartcard credit they have received (if any) and the following week’s target. There are no set targets for the distance walked to or from a bus stop. To assist participants to achieve the weekly targets and, consistent with best practice, incentives will be supported by other behaviour change techniques (e.g. information on consequences of behaviour to the individual, setting graded tasks, goal setting, social support), delivered via weekly mobile text messages (2 messages per week from weeks 1-12, 1 message per week, weeks 13-14). Development of the text messages was underpinned by the Behaviour Change Technique Taxonomy, informed by our previous qualitative work on transport behaviour and physical activity and from an incentive-based study designed to increase weekly leisure-time physical activity and reduce sitting time (Michie et al 2013, Ball et al 2017). Participants in the intervention group will also receive a printed version of Australia’s Physical Activity and Sedentary Behaviour Guidelines. All intervention support will be provided by an unblinded member of the research team.
Intervention code [1] 326055 0
Behaviour
Intervention code [2] 326056 0
Lifestyle
Comparator / control treatment
Participants in the control group will receive a printed version of Australia’s Physical Activity and Sedentary Behaviour Guidelines only. Educational materials have been selected as an active control to help engage and retain the control group.
Control group
Active

Outcomes
Primary outcome [1] 334710 0
Change in average daily step count measured by accelerometer over seven days.
Timepoint [1] 334710 0
T1 (Baseline), T2, Primary endpoint, (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post-start of intervention at study end).
Secondary outcome [1] 421821 0
Change in perspectives on travel behaviour (e.g. enablers and barriers), using a study specific questionnaire.
Timepoint [1] 421821 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [2] 421822 0
Change in self-reported out of pocket transport-related expenses, using a study specific questionnaire.
Timepoint [2] 421822 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [3] 421824 0
Change in self-reported work productivity, using a study specific questionnaire.
Timepoint [3] 421824 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [4] 421825 0
Change in self-reported commute time to work/ study location, using a study specific questionnaire.
Timepoint [4] 421825 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [5] 422087 0
Change in self-reported commute time by different transport modes, using a study specific questionnaire.
Timepoint [5] 422087 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [6] 422088 0
Change in self-reported physical activity (transport, leisure, occupational, domestic, total) (mins/week) using the International Physical Activity Questionnaire – Long form (IPAQ – L) supplemented with additional questions in the study-specific survey
Timepoint [6] 422088 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [7] 422089 0
Change in accelerometer measured minutes/week of physical activity.
Timepoint [7] 422089 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [8] 422090 0
Change in body mass index calculated from self-measured height and weight, using standard measures.
Timepoint [8] 422090 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [9] 422091 0
Change in self-reported health, using Tasmanian Population Health Survey items.
Timepoint [9] 422091 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [10] 422092 0
Change in minutes/week of transport-related physical activity derived from a simplified single-item version of the IPAQ-L.
Timepoint [10] 422092 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end), and at weekly intervals through text message during the 14-week intervention phase (T1-T2).
Secondary outcome [11] 422093 0
Costs incurred by the public transport provider to implement the intervention will be measured by Smartcard data and data supplied by the provider.
Timepoint [11] 422093 0
At trial completion.
Secondary outcome [12] 422448 0
Change in accelerometer measured minutes/week of sedentary behaviour.
Timepoint [12] 422448 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [13] 422449 0
Change in accelerometer measured minutes/week of physical activity intensity.
Timepoint [13] 422449 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [14] 422450 0
Change in self-reported (via a travel diary over seven days ) travel behaviour (e.g. mode (e.g. motor vehicle), frequency and duration)
Timepoint [14] 422450 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [15] 422451 0
Change in measured (via Smartcard data) travel behaviour (e.g. mode (i.e.,bus), frequency and duration).
Timepoint [15] 422451 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).
Secondary outcome [16] 422456 0
Change in self-reported sedentary behaviour (sitting, mins/week) using the International Physical Activity Questionnaire – Long form (IPAQ – L) supplemented with additional questions in the study-specific survey
Timepoint [16] 422456 0
T1 (Baseline), T2 (14 weeks post-start of intervention, at intervention end), T3 (38 weeks post start of intervention at study end).

Eligibility
Key inclusion criteria
Age 15+ years; resident of Tasmania; sufficient English proficiency to provide informed consent; possession of a mobile phone and active email address; ownership of or willingness to obtain a Metro Smartcard); willingness to give permission for the researchers to access Metro Smartcard data; currently making no more than five Metro bus trips/week; able to reasonably access a Metro bus service; currently making trips by motor vehicle (including motorcycle) that could be made by bus.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Intending to move house or work location within the study period whereby a Metro bus service will be inaccessible; currently engaged in or planning to engage in other public transport incentives program; pregnancy; a health condition that prevents walking; a health condition that prevents bus use; a planned activity that would prevent bus use for greater than four weeks during the 14- week intervention phase of the 38-week study period (e.g., surgery, extended holiday

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)
The allocation sequence will be generated by the Data Manager using Stata and group allocation will be performed through Research Electronic Data Capture (REDCap, Version 8.5.19, Nashville, Tennessee, USA) software by research team members not involved in allocation sequence generation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation on a 1:1 (intervention:control) ratio will be conducted in blocks of four, the details of which will be unavailable to research team members who enrol participants in the respective study arms and randomise participants to groups to ensure allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative evaluation: Descriptive statistics will characterise participants, acceptability, and outcomes according to group allocation. Primary intention-to-treat analyses will focus on comparing daily steps at baseline (T1) and 14 weeks (T2). A random-intercepts linear regression model with covariates for T1 steps, time (1=T2, 0=T1), baseline steps x time, and group (1=intervention, 0=control) x time will be estimated. The efficacy of intervention at T2 will be assessed from the coefficient of group × time (equivalent to an analysis of covariance, and to a change scores method when a T1 steps covariate is included, though standard errors may differ slightly). This model can be readily extended to analysis of a third time-point to test whether intervention efficacy is maintained at 38 weeks (T3). Prior to analysis, right-skewed PA data will be transformed using a logarithmic transformation. All models will be estimated without and with adjustment for T1 participant characteristics that differ materially between groups.

Economic Evaluation: Non-research related resources associated with the implementation of the intervention will be documented and the comparative costs and benefits of the intervention relative to the control group will be assessed. Modelled analyses will be undertaken to assess the financial implications of broader implementation rollout and upscaling of the intervention. We will also consider personal time (e.g. more/less time spent commuting), productivity and outlay (e.g. walking equipment, fuel, parking) costs.

Process evaluation: This will assess the fidelity and quality of implementation, clarify causal mechanisms and identify contextual factors associated with outcome variation. The Medical Research Council UK’s framework will underpin the process evaluation as it is designed to examine complex public health interventions. The co-design processes adopted to maximise recruitment reach, intervention acceptability, and meeting of bus trip targets will be evaluated through face-to-face or telephone/video interviews (n=10) with intervention participants (who did and did not reach targets). Participants will have the opportunity to review/edit their responses. Process evaluation items will also be included in post-intervention surveys for all participants. Administrative and research data may be used in process evaluation analysis. Qualitative process evaluation data will be analysed thematically using NVIVO software.

Statistical power calculation; A suitable number of contacts will be screened to ensure that at least 345 subjects are randomly allocated across both study arms. Allowing for up to 15% attrition (based conservatively on the abandoned trips4health trial and the relevant ACHIEVE study),this will ensure at least 300 participants. That number will provide 80% power (two-sided a=0.05) to detect a 34% increase (~2,500 steps/day) in daily steps in the intervention group relative to controls, and meaningful increases (13- 29%) in secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
345
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 313808 0
Government body
Name [1] 313808 0
Department of Health - Medical Research Future Fund (MRFF)
Country [1] 313808 0
Australia
Funding source category [2] 313809 0
Government body
Name [2] 313809 0
Department of Health
Country [2] 313809 0
Australia
Funding source category [3] 313810 0
Government body
Name [3] 313810 0
Metro Tasmania
Country [3] 313810 0
Australia
Funding source category [4] 313811 0
Government body
Name [4] 313811 0
Local Government Association of Tasmania
Country [4] 313811 0
Australia
Funding source category [5] 313873 0
Government body
Name [5] 313873 0
Tasmanian Collaboration for Health Improvement
Country [5] 313873 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue, Sandy Bay, Tasmania 7005
Country
Australia
Secondary sponsor category [1] 315645 0
None
Name [1] 315645 0
Address [1] 315645 0
Country [1] 315645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312972 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 312972 0
Ethics committee country [1] 312972 0
Australia
Date submitted for ethics approval [1] 312972 0
28/02/2023
Approval date [1] 312972 0
02/05/2023
Ethics approval number [1] 312972 0
27961

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

Contacts
Principal investigator
Name 126538 0
A/Prof Verity Cleland
Address 126538 0
Menzies Institute for Medical Research, Private Bag 23, Hobart, TAS 7001
Country 126538 0
Australia
Phone 126538 0
+61 3 6226 4603
Fax 126538 0
Email 126538 0
[email protected]
Contact person for public queries
Name 126539 0
Verity Cleland
Address 126539 0
Menzies Institute for Medical Research, Private Bag 23, Hobart, TAS 7001
Country 126539 0
Australia
Phone 126539 0
+61 3 6226 4603
Fax 126539 0
Email 126539 0
[email protected]
Contact person for scientific queries
Name 126540 0
Verity Cleland
Address 126540 0
Menzies Institute for Medical Research, Private Bag 23, Hobart, TAS 7001
Country 126540 0
Australia
Phone 126540 0
+61 3 6226 4603
Fax 126540 0
Email 126540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in articles, after de-identification
When will data be available (start and end dates)?
Beginning three months after the first publication, with no end date
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose with the approval of an ethics committee.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Proposals should be directed to [email protected] . To gain access, requestors will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19129Study protocol  [email protected]
19130Informed consent form  [email protected]
19131Ethical approval  [email protected]
19132Other  [email protected] Study questionnaires



Results publications and other study-related documents

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