Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000027617
Ethics application status
Approved
Date submitted
21/12/2022
Date registered
11/01/2023
Date last updated
11/01/2023
Date data sharing statement initially provided
11/01/2023
Date results provided
11/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
TRACK & ACT: A pragmatic, one-group per-condition randomised controlled trial exploring the comparative effectiveness of pedometers and activity trackers for changing physical activity and sedentary behaviour in healthy, inactive individuals
Scientific title
TRACK & ACT: A pragmatic, one-group per-condition randomised controlled trial exploring the comparative effectiveness of pedometers and activity trackers for changing physical activity and sedentary behaviour in healthy, inactive individuals
Secondary ID [1] 308650 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 328571 0
Condition category
Condition code
Public Health 325585 325585 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly allocated to one of three groups based on their workplace. Each group randomly receives either a Fitbit ONE, Jawbone UP or Digi-Walker SW200 pedometer (PED) for 8-weeks and an orientation session to their respective device. In the first week, a one-hour group-based information session is conducted by a member of the research team to orient the participants to their devices and to provide technical support for set up. A second one-hour group-based face-to-face support session is conducted in week six to troubleshoot device issues and technical barriers to use. Participants received no education or encouragement to be more active or less sedentary in these sessions and no prescriptive instructions about how to use the device over the 8 weeks, other than that they are intended for daily wear and it was expected that participants would wear the monitors continuously for 8 weeks. Adherence was measured by tracking device analytics (e.g. steps) using either online accounts (participants in Fitbit ONE and Jawbone UP groups were asked to share their login details) or daily logs (for the Pedometer group). These data were manually extracted by a member of the research team throughout the intervention.
Intervention code [1] 325121 0
Behaviour
Comparator / control treatment
The comparison group is the pedometer group.
Control group
Active

Outcomes
Primary outcome [1] 333428 0
Steps per day using the Actigraph GT3X accelerometer. Participants are asked to wear the accelerometer for 7 days at each timepoint.
Timepoint [1] 333428 0
Participants are asked to wear the accelerometer for one week at each timepoint. Timepoints include: baseline (pre-intervention), 4- and 8- weeks, and at 16-week follow up.
Secondary outcome [1] 417043 0
Moderate to vigorous intensity physical activity using the Actigraph GT3X accelerometer. Participants are asked to wear the accelerometer for 7 days at each timepoint. Moderate to vigorous intensity physical activity (MVPA) will be defined according to accelerometer cutpoints, using the previously established cutpoint of >=2020 cpm.
Timepoint [1] 417043 0
Participants are asked to wear the accelerometer for one week at each timepoint. Timepoints include: baseline (pre-intervention), 4- and 8- weeks, and at 16-week follow up.
Secondary outcome [2] 417044 0
Sedentary behavior (h/day) using the Actigraph GT3X accelerometer. Participants are asked to wear the accelerometer for 7 days at each timepoint. Sedentary behaviour will be defined according to accelerometer cutpoints, using the previously established cutpoint of <100 cpm.
Timepoint [2] 417044 0
Participants are asked to wear the accelerometer for one week at each timepoint. Timepoints include: baseline (pre-intervention), 4- and 8- weeks, and at 16-week follow up.

Eligibility
Key inclusion criteria
Employed full-time in a desk-based role at one of three sites of a large metropolitan university, be aged between 18-65 years, own or have access to a smart phone, not be pregnant or planning pregnancy and doing less than 150 minutes of MVPA per week (i.e., below current PA recommendations), as measured by the Active Australia survey.
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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was carried out using central randomisation by a computer, by a person not involved in the study. This person then informed the study which group was allocated which device.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence was generated by simple randomisation using a randomisation table created by Microsoft Excel, by a person not involved in the study. This person then informed the study which group was allocated which device.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic characteristics will be analysed using descriptive statistics. To evaluate intervention effects, data from all eligible participants with valid baseline accelerometry data are included and analysed on an intention-to-treat basis using last observation carried forward (LOCF) to account for missing data . Waterfall plots are used to visualise the changes in the outcomes from baseline to 16-weeks for each individual participant. Linear mixed-effect regression models, one model for each outcome measure, were performed on the change in each of the outcome measures relative to baseline (i.e., for each participant, the value at week 0 was subtracted from the values at 4, 8 and 16 weeks). A group by time interaction term estimates the fixed effect of group allocation on the rate of change in the outcome measures over time. Participants were treated as a random effect, having a random slope with respect to time. A fixed intercept of zero was specified, representing the baseline value. The slopes (regression coefficients) of the group by time interaction (i.e., the slope over time for each group) were compared using one-way ANOVA, with Satterthwaite degrees of freedom approximation. Post-hoc comparisons between each of the two activity tracker groups (ONE and UP) against the PED group were conducted using Dunnett’s test. Alpha is set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/07/2014
Date of last participant enrolment
Anticipated
Actual
8/08/2014
Date of last data collection
Anticipated
Actual
12/12/2014
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312884 0
University
Name [1] 312884 0
The University of Queensland (Start-Up Grant)
Country [1] 312884 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Brisbane, QLD, 4067
Country
Australia
Secondary sponsor category [1] 314563 0
None
Name [1] 314563 0
Address [1] 314563 0
Country [1] 314563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312163 0
The University of Queensland
Ethics committee address [1] 312163 0
Ethics committee country [1] 312163 0
Australia
Date submitted for ethics approval [1] 312163 0
Approval date [1] 312163 0
03/07/2014
Ethics approval number [1] 312163 0

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

Contacts
Principal investigator
Name 123694 0
Dr Sjaan Gomersall
Address 123694 0
The University of Queensland
St Lucia
QLD 4067
Country 123694 0
Australia
Phone 123694 0
+61 413412822
Fax 123694 0
Email 123694 0
[email protected]
Contact person for public queries
Name 123695 0
Sjaan Gomersall
Address 123695 0
The University of Queensland
St Lucia
QLD 4067
Country 123695 0
Australia
Phone 123695 0
+61 413412822
Fax 123695 0
Email 123695 0
[email protected]
Contact person for scientific queries
Name 123696 0
Sjaan Gomersall
Address 123696 0
The University of Queensland
St Lucia
QLD 4067
Country 123696 0
Australia
Phone 123696 0
+61 413412822
Fax 123696 0
Email 123696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.