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Trial registered on ANZCTR


Registration number
ACTRN12619001136190
Ethics application status
Approved
Date submitted
16/07/2019
Date registered
14/08/2019
Date last updated
14/08/2019
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
trips4health: Incentivising adults to use public transport for physical activity gain
Scientific title
trips4health: A single-blinded randomised controlled trial incentivising adults to use public transport for physical activity gain
Secondary ID [1] 298664 0
Nil known
Universal Trial Number (UTN)
U1111-1233-8050
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 313561 0
Condition category
Condition code
Public Health 311990 311990 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trips4health study has a four month intervention phase followed by a six month maintenance phase. The four month intervention phase allows three months for behaviour change to reach automaticity and one month for maintenance or ‘tapering off’, where contact and support is gradually withdrawn in preparation for intervention cessation.Using a ‘gain-framed’ approach (i.e. rewarding positive behaviours), participants in the intervention group will have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 1-16 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 1-2, one bus trip; weeks 3-4, two bus trips; weeks 5-8, three bus trips; weeks 9-11, four bus trips; weeks 12-16, 5 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 $1.92 to $5.76 (a concessional fare through to an adult fare with travel across multiple zones). The maximum credit a participant can receive by the end of the 16 week intervention phase is $105.60 if travelling on a concessional fare and if travelling as an adult either $154.00, $211.20 or $316.80 as per their default fare type. Participants will be aiming to achieve five 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, 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 from weeks 13-16). 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 a member of the research team
Intervention code [1] 314932 0
Behaviour
Intervention code [2] 314951 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 – alone, this type of cognitive strategy is unlikely to influence physical activity behaviour
Control group
Active

Outcomes
Primary outcome [1] 320635 0
Change in average daily step count measured by accelerometer
Timepoint [1] 320635 0
Baseline, four-months (end of intervention phase) (primary endpoint), 10-months (end of maintenance phase)
Secondary outcome [1] 372267 0
Change in self-reported physical activity (transport, leisure, occupational, domestic, total) (mins/week) and sedentary behaviour (sitting) using the International Physical Activity Questionnaire – Long
Timepoint [1] 372267 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [2] 372268 0
Change in accelerometer measured minutes/week of physical activity
Timepoint [2] 372268 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [3] 372269 0
Change in blood pressure as measured by a validated automated blood pressure device
Timepoint [3] 372269 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [4] 372270 0
Change in waist circumference as assessed by measurement tape
Timepoint [4] 372270 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [5] 372271 0
Change in body mass index calculated from measured (using a stadiometer and digital scales) or self-reported height and weight (using the study-specific survey)
Timepoint [5] 372271 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [6] 372272 0
Change in self-reported health (using the study-specific survey), with quality of life measured by the Assessment of Quality of Life-8D
Timepoint [6] 372272 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [7] 372969 0
Change in accelerometer measured sedentary behaviour
Timepoint [7] 372969 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [8] 372970 0
Change in self-reported (through the study-specific survey) and measured (via a smartphone app and smartcard data) mode of travel behaviour
Timepoint [8] 372970 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [9] 372971 0
Change in self-reported (through the study-specific survey) and measured (via a smartphone app and smartcard data) frequency of travel behaviour
Timepoint [9] 372971 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [10] 372972 0
Change in self-reported (through the study-specific survey) and measured (via a smartphone app and smartcard data) duration of travel behaviour
Timepoint [10] 372972 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [11] 372973 0
Change in perspectives on travel behaviour barriers as measured by the study-specific survey
Timepoint [11] 372973 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [12] 373106 0
Change in perspectives on travel behaviour enablers as measured by the study-specific survey
Timepoint [12] 373106 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [13] 373847 0
Change in health state utility values measured by the AQoL-8D contained within the study-specific survey
Timepoint [13] 373847 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [14] 373848 0
Costs to public transport provider in implementing the intervention (data supplied by the public transport provider)
Timepoint [14] 373848 0
End of trial
Secondary outcome [15] 373849 0
Change in out of pocket transport-related expenses as measured by the study-specific survey
Timepoint [15] 373849 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [16] 373850 0
Change in work productivity as measured by the study-specific survey
Timepoint [16] 373850 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [17] 373851 0
Change in commute time to work/place of study as measured by the study-specific survey
Timepoint [17] 373851 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)
Secondary outcome [18] 373852 0
Commute time by different transport modes as measured by the study-specific survey
Timepoint [18] 373852 0
End of trial
Secondary outcome [19] 373853 0
Change in accelerometer measured physical activity intensity
Timepoint [19] 373853 0
Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Eligibility
Key inclusion criteria
Greater than or equal to 18 years old; sufficient English proficiency to provide informed consent; living in Southern Tasmania; able to access an urban Tasmania bus service; making trips by motor vehicle that could be made by bus; current infrequent bus user (on average less than 3 trips per week in the past six months); possession or willingness to possess a public transport smartcard; willingness for the public transport provider and the researchers to access smartcard data; possession of a mobile phone
Minimum age
18 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 whereby an urban bus service in Southern Tasmania can no longer be accessed within the 10-month study period; currently engaged in or planning to engage in other incentive-based programs to enhance public transport use; pregnancy; a health condition that prevents walking; a health condition that prevents bus use; and a planned activity that would prevent bus use for greater than two weeks during the four month intervention phase of the 10 month 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)
Randomisation will be conducted centrally via computer. The research team member who creates the randomisation sequence will have no contact with participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be created using computer-generated random numbers on a 1:1 ratio without stratification. Randomisation 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.
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
Sample size calculations are based on the comparison of the primary outcome in the control versus intervention group. The calculations are based on mean and standard deviation of daily duration of steps as measured by accelerometer (8,000±3,500) based on data from a sample of participants using the same measure. The assumed correlation between baseline and at 10 months follow-up was 0.7, with a high level of stability expected between baseline and follow-up because physical activity typically tracks well over shorter periods of time (e.g. weeks and months). We expect a high level of stability between baseline and at 10 months follow-up because our unit of analysis will be based on average daily steps. A total sample of 300 participants would provide 80% power with alpha=0.05 to detect a difference of 624 steps/day (an 8% change). Allowing for expected attrition (based on a previous related PA incentives-based study), we plan to recruit 350 participants.

Quantitative Evaluation: Descriptive statistics (means and proportions) will characterise the outcomes according to group allocation. Linear mixed model (LMM) regression will compare differences in average daily step count (primary outcome) between control and intervention groups. LMM will also be used to compare differences between the control and intervention groups regarding the secondary outcomes. LMMs allow for missing outcome data and provide methods to account for correlated observations. Analyses will be undertaken on an intention-to-treat basis.

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 intervention upscaling. 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. Using the Medical Research Council UK’s framework designed for examining complex public health interventions, we will assess intervention acceptability at completion of the intervention (T2) through face-to-face or telephone interviews with intervention group participants (n=20) who did and did not reach bus trip. The recruitment and implementation impact for the public transport provider will be determined through face-to-face interviews or group discussion with key personnel (n=5) at key points during the implementation of the intervention (i.e. intervention development, mid-intervention and intervention completion). Process evaluation items will be included in all three surveys for all intervention group participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2019
Actual
Date of last participant enrolment
Anticipated
27/04/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 303202 0
Government body
Name [1] 303202 0
National Health and Medical Research Council
Country [1] 303202 0
Australia
Funding source category [2] 303203 0
Government body
Name [2] 303203 0
Department of Health
Country [2] 303203 0
Australia
Funding source category [3] 303204 0
Government body
Name [3] 303204 0
Metro Tasmania
Country [3] 303204 0
Australia
Funding source category [4] 303205 0
Government body
Name [4] 303205 0
Local Government Association of Tasmania
Country [4] 303205 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue, Sandy Bay, Tasmania 7005
Country
Australia
Secondary sponsor category [1] 303217 0
None
Name [1] 303217 0
Address [1] 303217 0
Country [1] 303217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303763 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 303763 0
Ethics committee country [1] 303763 0
Australia
Date submitted for ethics approval [1] 303763 0
30/11/2018
Approval date [1] 303763 0
27/03/2019
Ethics approval number [1] 303763 0
H0017820

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

Contacts
Principal investigator
Name 94714 0
Dr Verity Cleland
Address 94714 0
Menzies Institute for Medical Research
University of Tasmania
17 Liverpool St
Hobart
Tasmania 7000
Country 94714 0
Australia
Phone 94714 0
+61362264603
Fax 94714 0
Email 94714 0
verity.cleland@utas.edu.au
Contact person for public queries
Name 94715 0
Verity Cleland
Address 94715 0
Menzies Institute for Medical Research
University of Tasmania
17 Liverpool St
Hobart
Tasmania 7000
Country 94715 0
Australia
Phone 94715 0
+61362264603
Fax 94715 0
Email 94715 0
verity.cleland@utas.edu.au
Contact person for scientific queries
Name 94716 0
Verity Cleland
Address 94716 0
Menzies Institute for Medical Research
University of Tasmania
17 Liverpool St
Hobart
Tasmania 7000
Country 94716 0
Australia
Phone 94716 0
+61362264603
Fax 94716 0
Email 94716 0
verity.cleland@utas.edu.au

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
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Proposals should be directed to verity.cleland@utas.edu.au . To gain access, requestors will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2886Study protocol  verity.cleland@utas.edu.au
2934Informed consent form  verity.cleland@utas.edu.au
2935Ethical approval  verity.cleland@utas.edu.au
2936Other  verity.cleland@utas.edu.au Study questionnaire



Results publications and other study-related documents

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

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
Embasetrips4health: Protocol of a single-blinded randomised controlled trial incentivising adults to use public transport for physical activity gain.2020https://dx.doi.org/10.1016/j.conctc.2020.100619
EmbaseIncentivising public transport use for physical activity gain: process evaluation of the COVID-19 disrupted trips4health randomised controlled trial.2022https://dx.doi.org/10.1186/s12966-022-01394-x
N.B. These documents automatically identified may not have been verified by the study sponsor.