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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]

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

Condition category

Condition code

Public Health

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change to reach automaticity and one month for maintenance or ‘tapering off’, where contact and support is gradually withdrawn in preparation for intervention cessation.Using a ‘gain-framed’ approach (i.e. rewarding positive behaviours), participants in the intervention group will have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]

Behaviour

Intervention code [2]

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]

Change in average daily step count measured by accelerometer

Timepoint [1]

Baseline, four-months (end of intervention phase) (primary endpoint), 10-months (end of maintenance phase)

Secondary outcome [1]

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]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [2]

Change in accelerometer measured minutes/week of physical activity

Timepoint [2]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [3]

Change in blood pressure as measured by a validated automated blood pressure device

Timepoint [3]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [4]

Change in waist circumference as assessed by measurement tape

Timepoint [4]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [5]

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]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [6]

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]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [7]

Change in accelerometer measured sedentary behaviour

Timepoint [7]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [8]

Change in self-reported (through the study-specific survey) and measured (via a smartphone app and smartcard data) mode of travel behaviour

Timepoint [8]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [9]

Change in self-reported (through the study-specific survey) and measured (via a smartphone app and smartcard data) frequency of travel behaviour

Timepoint [9]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [10]

Change in self-reported (through the study-specific survey) and measured (via a smartphone app and smartcard data) duration of travel behaviour

Timepoint [10]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [11]

Change in perspectives on travel behaviour barriers as measured by the study-specific survey

Timepoint [11]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [12]

Change in perspectives on travel behaviour enablers as measured by the study-specific survey

Timepoint [12]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [13]

Change in health state utility values measured by the AQoL-8D contained within the study-specific survey

Timepoint [13]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [14]

Costs to public transport provider in implementing the intervention (data supplied by the public transport provider)

Timepoint [14]

End of trial

Secondary outcome [15]

Change in out of pocket transport-related expenses as measured by the study-specific survey

Timepoint [15]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [16]

Change in work productivity as measured by the study-specific survey

Timepoint [16]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [17]

Change in commute time to work/place of study as measured by the study-specific survey

Timepoint [17]

Baseline, four-months (end of intervention phase), 10-months (end of maintenance phase)

Secondary outcome [18]

Commute time by different transport modes as measured by the study-specific survey

Timepoint [18]

End of trial

Secondary outcome [19]

Change in accelerometer measured physical activity intensity

Timepoint [19]

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

414 La Trobe St, Melbourne, Victoria 3000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Department of Health

Address [2]

2/25 Argyle St Hobart GPO Box 125 Hobart Tasmania 7001

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Metro Tasmania

Address [3]

PO Box 61, Moonah, Tasmania 7009

Country [3]

Australia

Funding source category [4]

Government body

Name [4]

Local Government Association of Tasmania

Address [4]

326 Macquarie St, Hobart Tasmania 7000

Country [4]

Australia

Primary sponsor type

University

Name

University of Tasmania

Address

Churchill Avenue, Sandy Bay, Tasmania 7005

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Human Research Ethics Committee

Ethics committee address [1]

Office of Research Services
University of Tasmania
Private Bag 01
Hobart Tasmania 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/11/2018

Approval date [1]

27/03/2019

Ethics approval number [1]

H0017820

Summary

Brief summary

Efforts to correct the physical inactivity pandemic have focused on leisure-time physical activity (PA) with limited impact. Public transport (PT) users accumulate more PA than motor vehicle users, yet intervention studies to increase PA through transported-related behaviour are sparse. Further, incentive-based strategies have demonstrated some promise for increasing leisure-time PA, but their impact on other types of PA, such as transport-related PA, is unclear. This study aims to fill a knowledge gap by determining the impact of an incentive-based strategy to increase transport-related PA by increasing PT use in a regional Australian setting. It is hypothesised that incentivising bus use will increase bus use and reduce motor vehicle use leading to PA gain.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Verity Cleland

Address

Menzies Institute for Medical Research
University of Tasmania
17 Liverpool St
Hobart
Tasmania 7000

Country

Australia

Phone

+61362264603

Fax

[email protected]

Contact person for public queries

Name

Verity Cleland

Address

Menzies Institute for Medical Research
University of Tasmania
17 Liverpool St
Hobart
Tasmania 7000

Country

Australia

Phone

+61362264603

Fax

[email protected]

Contact person for scientific queries

Name

Verity Cleland

Address

Menzies Institute for Medical Research
University of Tasmania
17 Liverpool St
Hobart
Tasmania 7000

Country

Australia

Phone

+61362264603

Fax

[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

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.	Type	Email	Other Details
2886	Study protocol	[email protected]
2934	Informed consent form	[email protected]
2935	Ethical approval	[email protected]
2936	Other	[email protected]	Study questionnaire

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	trips4health: Protocol of a single-blinded randomised controlled trial incentivising adults to use public transport for physical activity gain.	2020	https://dx.doi.org/10.1016/j.conctc.2020.100619
Embase	Incentivising public transport use for physical activity gain: process evaluation of the COVID-19 disrupted trips4health randomised controlled trial.	2022	https://dx.doi.org/10.1186/s12966-022-01394-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically