Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001310550
Ethics application status
Not required
Date submitted
24/11/2015
Date registered
30/11/2015
Date last updated
15/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the Stepathlon pedometer program on physical activity, weight and well-being.
Scientific title
Assessment of physical activity, weight and well-being in healthy participants in the Stepathlon mobile/web delivered workplace-based pedometer program.
Secondary ID [1] 287826 0
Nil known
Universal Trial Number (UTN)
U1111-1176-3027
Trial acronym
Not Applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 296711 0
Sedentary Activity 296712 0
Wellness 296713 0
Weight 296865 0
Condition category
Condition code
Cardiovascular 296946 296946 0 0
Other cardiovascular diseases
Diet and Nutrition 296947 296947 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
100
Target follow-up type
Days
Description of intervention(s) / exposure
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] 293215 0
Not applicable
Comparator / control treatment
There is no control group of participants. Paired analyses of participant outcomes prior to and following the Stepathlon participation will be compared.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296553 0
Step-count - assessed by self-report questionnaire designed for Stepathlon
Timepoint [1] 296553 0
At completion of Stepathlon 100-day program
Primary outcome [2] 296709 0
Exercise duration- assessed by Stepathlon self-report questionnaire
Timepoint [2] 296709 0
At completion of Stepathlon 100-day program
Primary outcome [3] 296710 0
Sitting duration - assessed by Stepathlon self-report questionnaire
Timepoint [3] 296710 0
At completion of 100-day Stepathlon Program
Secondary outcome [1] 318744 0
Weight change/BMI change (as a percentage of initial participant weight/BMI)-assessed by Stepathlon self-report questionnaire.
Timepoint [1] 318744 0
At the completion of each 100-day Stepathlon event
Secondary outcome [2] 319156 0
Dietary change-assessed by Stepathlon self-report questionnaire
Timepoint [2] 319156 0
At completion of 100-day Stepathlon program

Eligibility
Key inclusion criteria
The key inclusion criteria will be participants in the Stepathlon who are able to complete pre-event and/or post-event questionnaires. The event is a community-based workplace intervention, Therefore no specific limitations are placed for inclusion in the registry study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No key exclusion criteria.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
The project will be conducted as analysis study of de-identified questionnaire data collected by Stepathlon organizers from their registry.

There is no pre-specified sample size or limits on the study. The expectation is that Stepathlon will make participant questionnaire data available on an annual basis at the completion of surveys. The anticipated sample over the 3 years may be approximately 50,000 participants. However, this is indicative only. The sample size may be larger or smaller, as this is an analysis of the Stepathlon intervention.

Generalized linear mixed effects models (GLMM) with analysis for repeated measures will be conducted for continous variables. Ordinal variables will be compared with ordinal logistic regression.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 7297 0
India
State/province [1] 7297 0
Country [2] 7298 0
New Zealand
State/province [2] 7298 0
Country [3] 7299 0
Singapore
State/province [3] 7299 0

Funding & Sponsors
Funding source category [1] 292348 0
Self funded/Unfunded
Name [1] 292348 0
Dr Anand Ganesan
Country [1] 292348 0
Australia
Primary sponsor type
Individual
Name
Dr Anand Ganesan
Address
Dr Anand Ganesan
University of Adelaide
231 North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 291025 0
None
Name [1] 291025 0
None
Address [1] 291025 0
None
Country [1] 291025 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
The purpose of the Stepathlon study is to determine the impact of Stepathlon on lifestyle and health outcomes including step count, sitting duration, exercise duration and weight.
Trial website
Not applicable
Trial related presentations / publications
Public notes
The registry study is an analysis of non-identifiable data collected by Stepathlon. Ethics review of the proposal has been sought from the University of Adelaide Human Research Ethics Committee, who advised that this project is exempt from Human Ethics review.

Contacts
Principal investigator
Name 61414 0
Dr Anand Ganesan
Address 61414 0
Level 2 Elizabeth House
231 North Terrace
University of Adelaide SA 5000
Australia
Country 61414 0
Australia
Phone 61414 0
+61883135208
Fax 61414 0
Email 61414 0
[email protected]
Contact person for public queries
Name 61415 0
Dr Anand Ganesan
Address 61415 0
Level 2 Elizabeth House
231 North Terrace
University of Adelaide SA 5000
Australia
Country 61415 0
Australia
Phone 61415 0
+61883135208
Fax 61415 0
Email 61415 0
[email protected]
Contact person for scientific queries
Name 61416 0
Dr Anand Ganesan
Address 61416 0
Level 2 Elizabeth House
231 North Terrace
University of Adelaide SA 5000
Australia
Country 61416 0
Australia
Phone 61416 0
+61883135208
Fax 61416 0
Email 61416 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.