Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

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Trial registered on ANZCTR


Registration number
ACTRN12616001513404
Ethics application status
Approved
Date submitted
27/10/2016
Date registered
2/11/2016
Date last updated
2/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A smartphone intervention to improve health in truck drivers
Scientific title
The impact of an m-Health financial incentives program on the physical activity and diet of Australian truck drivers.
Secondary ID [1] 290401 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical activity 300737 0
Diet 300738 0
Condition category
Condition code
Public Health 300568 300568 0 0
Health promotion/education
Diet and Nutrition 300594 300594 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention used a smartphone, incentives intervention to encourage local delivery and long-haul Australian truck drivers to increase physical activity and improve diet on workdays. Drivers reviewed their health status individually with researchers, using researcher-assessed baseline physical measures of waist circumference and blood pressure, and self-reported sedentary and physical activity patterns, and diet choices. At the depot, they then participated in a workshop (around 45 minutes), led by a qualified health promotion researcher, where the health benefits of good physical activity and healthy dietary choices were presented and discussed. At this workshop, the drivers were provided with an information booklet which enabled mapping of opportunities for workday changes, and required drivers to set achievable, progressive and sustainable goals. Following the workshop, drivers were asked to implement small changes relative to these goals over 20 weeks. They were given and received training on how to use a smartphone application (app) and activity tracker (Jawbone UP) to self-monitor and regulate behaviour change; for physical activity, drivers set a workday step goal (e.g. a progressive increase of 1000 daily steps each 2 week period, with the aim of achieving and maintaining a 3000 steps/day increase above typical movement patterns) and used the app and tracker to monitor and regulate their progress relative to these goals; for diet, drivers aimed to swap food and beverages high in saturated fat and processed/refined sugar with lower or reduced fat and sugar options (e.g. fried foods with fresh wraps), entering these choices manually or through a bar code scanner in the app to monitor and self-regulate recommended daily intake; as an additional motivator, reward points and vouchers were accumulated over the duration of the intervention, relative to the number of positive physical activity and dietary changes made. For the duration of the intervention, researchers stayed connected with drivers via the app. They reviewed linked data drivers entered into the app, providing feedback and guidance on changes and progress, in the form of weekly motivational messages posted on the driver's app home page.
Intervention code [1] 296231 0
Behaviour
Intervention code [2] 296251 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299984 0
Changes in workday and non-workday sedentary behaviour and physical activity, measured using wrist worn accelerometers (GeneActiv), over 7 days, at baseline, end-intervention and two months follow-up.
Timepoint [1] 299984 0
20 weeks post commencement of the intervention, and then again at two months following completion of the intervention.
Secondary outcome [1] 328745 0
7 -day dietary questionnaire, administered by researchers.
Timepoint [1] 328745 0
20 weeks post commencement of the intervention, and then again at two months following completion of the intervention.

Eligibility
Key inclusion criteria
Local delivery and long haul drivers
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/03/2014
Date of last participant enrolment
Anticipated
Actual
30/05/2014
Date of last data collection
Anticipated
Actual
4/12/2015
Sample size
Target
60
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294804 0
Government body
Name [1] 294804 0
Workplace Health and Safety Queensland
Country [1] 294804 0
Australia
Primary sponsor type
Individual
Name
Dr Nicholas Gilson
Address
The School of Human Movement and Nutrition Sciences, Connell Building (#26A), The University of Queensland, St Lucia Campus, Brisbane, Queensland, 4072.
Country
Australia
Secondary sponsor category [1] 293648 0
None
Name [1] 293648 0
None
Address [1] 293648 0
None
Country [1] 293648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296200 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 296200 0
Human Ethics Research Management Office, Cumbrae-Stewart Building (#72), The University of Queensland, St Lucia Campus, Brisbane, Queensland, 4072.
Ethics committee country [1] 296200 0
Australia
Date submitted for ethics approval [1] 296200 0
17/06/2013
Approval date [1] 296200 0
17/07/2013
Ethics approval number [1] 296200 0
2013000750

Summary
Brief summary
Truck drivers are highly susceptible to cardiovascular disease (CVD), type 2 diabetes, obesity, high blood pressure and stress. Employees within this industry are typically older men and therefore more likely to develop CVD related conditions, compared to other occupational groups. Furthermore, inflexible and unhealthy work conditions often mean truck drivers are particularly inactive, engage in long periods of sedentary behaviour (or sitting), and have poor diets consisting of high fat convenience food, and drinks with high fat or sugar content. Effective strategies need to be developed to counter these poor lifestyle choices, but to date, no intervention study has targeted inactivity, sedentary time and diet in truck drivers; consequently, evidence is lacking on how best to empower drivers towards active living and healthy eating/drinking approaches.

This study will test the feasibility of a new intervention (termed 'Shifting Gears'), designed to promote healthy lifestyle choices, and reduce cardiovascular risk, in Australian truck drivers. The study aims to develop and implement active living and healthy eating/drinking strategies in driver breaks, and evaluate the efficacy of these strategies over a six month intervention period, using measured changes in physical activity, sedentary behaviour and healthy food/drink options, as the main study outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69962 0
Dr Nicholas Gilson
Address 69962 0
The School of Human Movement and Nutrition Sciences, Connell Building (#26A), The University of Queensland, St Lucia Campus, Brisbane, Queensland, 4072.
Country 69962 0
Australia
Phone 69962 0
+61 7 336 56114
Fax 69962 0
Email 69962 0
[email protected]
Contact person for public queries
Name 69963 0
Nicholas Gilson
Address 69963 0
The School of Human Movement and Nutrition Sciences, Connell Building (#26A), The University of Queensland, St Lucia Campus, Brisbane, Queensland, 4072.
Country 69963 0
Australia
Phone 69963 0
+61 7 336 56114
Fax 69963 0
Email 69963 0
[email protected]
Contact person for scientific queries
Name 69964 0
Nicholas Gilson
Address 69964 0
The School of Human Movement and Nutrition Sciences, Connell Building (#26A), The University of Queensland, St Lucia Campus, Brisbane, Queensland, 4072.
Country 69964 0
Australia
Phone 69964 0
+61 7 336 56114
Fax 69964 0
Email 69964 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
No additional documents have been identified.