Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001107314
Ethics application status
Approved
Date submitted
11/07/2017
Date registered
28/07/2017
Date last updated
28/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of wearable activity tracker usage on participant step counts in a large scale, mobile health (mHealth) intervention.
Scientific title
Impact of wearable activity tracker usage on participant step counts in a large scale, mobile health (mHealth) intervention in healthy Stepathlon participants.
Secondary ID [1] 291191 0
Not applicable
Universal Trial Number (UTN)
U1111-1193-1033
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Physical activity 302082 0
Condition category
Condition code
Cardiovascular 301713 301713 0 0
Other cardiovascular diseases
Public Health 301714 301714 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study intends to evaluate the impact of usage of advanced consumer activity trackers (e.g. Fitbit, Goqii, Garmin etc) on physical activity outcomes in participants in the Stepathlon, an international mobile health lifestyle workplace based lifestyle intervention conducted annually.

The Stepathlon program involves recruitment of participants who are grouped into employer-based teams. Participants are provided with a pedometer, and are encouraged to measure the number of steps they take each day, with a goal of achieving 10,000 steps or more each day. The Stepathlon (https://www.stepathlon.com/) is conducted as a competition, with the objective of the event being to maximise step counts achieved by employer-based teams. The program utilises mobile/web-delivered self monitoring of step counts as a support tool.

As part of the event, individual participants have the option of completing a standardized pre- and post-event survey web-based questionnaire. The survey items include step count, weight, days exercised, hours exercised, sitting hours, as well as a series of lifestyle questions. These data have been entered by the Stepathlon organizers into a registry.

The project consists of an external analysis of these registry data. The duration of the Stepathlon program is 100 days. The study will be performed on pre- and post-event survey data.
Intervention code [1] 297191 0
Not applicable
Comparator / control treatment
Stepathlon participants who receive conventional pedometers, as part of the program intervention, will be used as an active comparator. For the purposes of the study, advanced consumer activity trackers will be defined as a named consumer fitness tracker brand identified in contemporary market report (IDC Wearable Tracker Report, March 2017). Pedometer will be defined as those users using the standard non-interactive Stepathlon Budd-E pedometer.
Control group
Active

Outcomes
Primary outcome [1] 301111 0
Physical activity as assessed by International Physical Activity Questionnaire (IPAQ) score
Timepoint [1] 301111 0
100-days (completion of Stepathlon event)
Secondary outcome [1] 331756 0
Weight change (self-report)
Timepoint [1] 331756 0
100-days
Secondary outcome [2] 336833 0
Sitting duration change (self-report sitting hours change)
Timepoint [2] 336833 0
100-days
Secondary outcome [3] 336834 0
BODY MASS INDEX change (self report)
Timepoint [3] 336834 0
100-days

Eligibility
Key inclusion criteria
Adult participants of Stepathlon, an international workplace-based mobile health lifestyle intervention/modification program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stepathlon participants less than 18 years of age.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Inverse treatment probability weighted propensity scores will be computed for treatment and control groups. The difference between treatment and control groups will be the average treatment effect on the treated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2016
Date of last participant enrolment
Anticipated
Actual
15/10/2016
Date of last data collection
Anticipated
Actual
2/02/2017
Sample size
Target
10000
Accrual to date
Final
6105
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8666 0
India
State/province [1] 8666 0
Country [2] 8667 0
New Zealand
State/province [2] 8667 0
Country [3] 8668 0
Singapore
State/province [3] 8668 0

Funding & Sponsors
Funding source category [1] 295634 0
University
Name [1] 295634 0
Flinders University of South Australia
Country [1] 295634 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Department of Cardiovascular Medicine,
Flinders Medical Centre.
1 Flinders Drive
Bedford Park 5042 SA
Country
Australia
Secondary sponsor category [1] 294491 0
None
Name [1] 294491 0
Address [1] 294491 0
Country [1] 294491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296951 0
Flinders University Human Research Ethics Committee/Southern Adelaide Local Health Network Ethics Committee
Ethics committee address [1] 296951 0
Ward 6C Room 219
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 296951 0
Australia
Date submitted for ethics approval [1] 296951 0
Approval date [1] 296951 0
17/02/2017
Ethics approval number [1] 296951 0

Summary
Brief summary
Wearable activity trackers are increasingly being utilised by consumers in daily life. It is unknown if use of these more sophisticated devices leads to improved physical activity outcomes.

The aim of the current study is to evaluate physical activity outcomes in healthy adults undertaking a health and lifestyle challenge called the Stepathlon, which is a 100-day event undertaken by adult employees in workplaces around the world.

In the current study, a propensity score weighted analysis approach will be used to compare physical activity outcomes in users of wearable trackers compared to participants in Stepathlon who do not use one of these trackers, and instead choose to use a pedometer, which is an older technology.
Trial website
Trial related presentations / publications
Public notes
The project has been approved under waiver by the Human Research Ethics Committee of the Flinders University of Australia. This was granted after completion of enrolment and data collection.
Attachments [1] 1879 1879 0 0
/AnzctrAttachments/372367-doc050918 (2).pdf (Ethics approval)

Contacts
Principal investigator
Name 72526 0
A/Prof Anand Ganesan
Address 72526 0
Department of Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive Bedford Park SA 5042
Country 72526 0
Australia
Phone 72526 0
+61882045619
Fax 72526 0
Email 72526 0
anand.ganesan@flinders.edu.au
Contact person for public queries
Name 72527 0
A/Prof Anand Ganesan
Address 72527 0
Department of Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive Bedford Park SA 5042
Country 72527 0
Australia
Phone 72527 0
+61882045619
Fax 72527 0
Email 72527 0
anand.ganesan@flinders.edu.au
Contact person for scientific queries
Name 72528 0
A/Prof Anand Ganesan
Address 72528 0
Department of Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive Bedford Park SA 5042
Country 72528 0
Australia
Phone 72528 0
+61882045619
Fax 72528 0
Email 72528 0
anand.ganesan@flinders.edu.au

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

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