Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000061235
Ethics application status
Approved
Date submitted
18/12/2017
Date registered
17/01/2018
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Date results provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Program to break up long bouts of sitting among male office workers at a public university in Saudi Arabia: SLIM trial.
Scientific title
The SLIM (Sit Less, Impress and Motivate) program targeting sedentary behaviour among male office workers at a public university in Saudi Arabia: A cluster randomised controlled trial.
Secondary ID [1] 293617 0
None
Universal Trial Number (UTN)
U1111-1206-6614
Trial acronym
SLIM (Sit Less, Impress and Motivate) trial.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary Behaviour 305878 0
Physical Inactivity 305879 0
Condition category
Condition code
Public Health 305079 305079 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An information/orientation session will be held at week zero in a place that is most convenient for participants on the University campus. In this session, the principal researcher will welcome participants to the program and explain the study objectives, benefits and risks in details. Then, he will take baseline anthropometric measurements (weight and height) and waist circumference using standardised methods. Also, participants will be asked to complete a survey of 25 questions about their sitting and standing behaviours at work and to assess demographic characteristics. At the appointment, participants will be given accelerometers, elastic belts, wearing instructions and log-sheets. The principal researcher will show participants how to wear the accelerometer and how to complete the log sheet provided. Participants will be asked to wear the accelerometer on the hip during waking hours for five consecutive days. Additionally, they will be asked to record their sleeping and non-wear time (whenever they are in water) during these five days in the log-sheet provided. During this week, participants will receive daily text-message reminders to wear the accelerometer.

Six days later, there will be another appointment with participants, where they will return the accelerometers and the log sheets. Then the principal researcher will ask participants about their physical activity and sleeping patterns during the previous week. In this appointment, the reminder software will be installed on the intervention group participants' office computers and a log-sheet to track their breaks will be provided. The principal researcher will explain how they can adjust the timing of reminders based on their own preference and how to record their breaks in the log sheet provided. This log-sheet will be collected from each participant at the end of each week during the program.

The intervention will run for 12 weeks and does NOT include any sport or fitness training.

The program includes:
1. Installing a reminder software on participants’ office computer. This software will remind them to break up the time they spend sitting at work. Reminder to break should occur every 30 minutes to one hour based on participant preference.
2. Receiving weekly text-message support. These text-messages will be provided with ideas and techniques that will help participants to break up the time they spend sitting and engaging in more healthy habits.
3- A log-sheet to record and track their active breaks.

After the 12-week program, participants will again meet with the principal researcher. Similar to the first appointment at week zero, the principal researcher will take participants’ anthropometric measurements weight and waist circumference using standardised methods. Also, participants will be asked to complete a survey of 25 questions about their sitting and standing behaviours at work. Participants will be given accelerometers, elastic belts, wearing instructions and log-sheets. Participants will be asked to wear the accelerometer on the hip during waking hours for five consecutive days. Additionally, they will be asked to record their sleeping and non-wear time (whenever they are in water) during these five days in the log-sheet provided.

Six days later, participants will have another appointment with the principal researcher. They will be asked about their physical activity and sleeping patterns during the previous week with additional process evaluation items to evaluate their program satisfaction. The appointment will be held in a place convenient for participants on the Univesity campus. Gift vouchers will be given to participants as an appreciation for participating in the data collection at this session as well.
Intervention code [1] 299873 0
Lifestyle
Intervention code [2] 299874 0
Behaviour
Comparator / control treatment
Employees from the control faculty will receive the intervention at the end of the study after 13 weeks from the beginning of the program (waiting-list control group).
Control group
Active

Outcomes
Primary outcome [1] 304254 0
Change in minutes of sedentary behaviour using ActiGraph GT3X accelerometers (ActiGraph LLC, Pensacola, FL, USA) and the 7-day Physical Activity Recall questionnaire (7-day PAR).
Sedentary behaviour is any waking behaviour characterized by an energy expenditure less than or equal to 1.5 metabolic equivalents (METs), while in a sitting, reclining or lying posture.
Timepoint [1] 304254 0
Five consecutive days at baseline (prior to intervention commencement, T0) and five consecutive days after completion of 12 week intervention (T1)
Primary outcome [2] 304255 0
Changes in self-efficacy construct from Social Cognitive Theory (SCT) using reliable questionnaire adapted from previous physical activity and sedentary behaviour literature (Hadgraft et al., 2016). The 9 items questionnaire will be measured on 1-5 Likert scales (not at all confident-very confident).

Hadgraft, N. T., Healy, G. N., Owen, N., Winkler, E. A. H., Lynch, B. M., Sethi, P., . . . Dunstan, D. W. (2016). Office workers' objectively assessed total and prolonged sitting time: Individual-level correlates and worksite variations. Preventive Medicine Reports, 4, 184-191. doi: https://doi.org/10.1016/j.pmedr.2016.06.011
Timepoint [2] 304255 0
Baseline (T0), 12 weeks after intervention commencement (T1)
Primary outcome [3] 304420 0
Changes in self-regulation construct from Social Cognitive Theory (SCT) using reliable questionnaire adapted from previous physical activity and sedentary behaviour literature (Hadgraft et al., 2016). The 10 items questionnaire will be measured on 1-5 Likert scales (never-very often).

Hadgraft, N. T., Healy, G. N., Owen, N., Winkler, E. A. H., Lynch, B. M., Sethi, P., . . . Dunstan, D. W. (2016). Office workers' objectively assessed total and prolonged sitting time: Individual-level correlates and worksite variations. Preventive Medicine Reports, 4, 184-191. doi: https://doi.org/10.1016/j.pmedr.2016.06.011
Timepoint [3] 304420 0
Baseline (T0), 12 weeks after intervention commencement (T1)
Secondary outcome [1] 341372 0
Change in minutes of Physical Activity using ActiGraph GT3X accelerometers (ActiGraph LLC, Pensacola, FL, USA) and the 7-day Physical Activity Recall questionnaire (7-day PAR). Physical Activity is any waking behaviour characterized by an energy expenditure greater than 1.5 metabolic equivalents (METs).
This is a Primary outcome.
Timepoint [1] 341372 0
Five consecutive days at baseline (prior to intervention commencement, T0) and five consecutive days after completion of 12 week intervention (T1)
Secondary outcome [2] 341373 0
Change in Body Mass Index (BMI) using standardised method (stadiometer and weight scale).
Timepoint [2] 341373 0
Baseline (T0), 12 weeks after intervention commencement (T1)
Secondary outcome [3] 341374 0
Change in waist circumference using standardised method (measuring tape).
Timepoint [3] 341374 0
Baseline (T0), 12 weeks after intervention commencement (T1)

Eligibility
Key inclusion criteria
Inclusion criteria:
Apparently healthy, adult, male academics and/or professional staff from two nominated faculties at a public university in Saudi Arabia and who own and use a mobile phone.

A “good health status” will be determined using the revised physical activity readiness questionnaire (PAR-Q) (Thomas, Reading & Shephard, 1992) by phone. PAR-Q is considered the standard physical activity screening tool for eligibility.
The recommended protocol in the PAR-Q+ will be followed. Eligible participant should answers “no” to all questions in the page 1 from the PAR-Q+. If someone answers “yes” to a question in the page 1, he will be asked the questions on pages 2 and 3. If he answers yes to a question on page 2 or 3, he will be asked to complete the specially designed online screening and exercise recommendations program - the ePARmed-X+ at www.eparmedx.com. This will inform if the participants can still participate or he should visit a qualified exercise professional or his family physician to get a clearance to participate. In this case, the researcher will ask the participant to provide the clearance in order to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Female staff; male staff who have a medical condition that prevents them from standing, walking or performing light intensity physical activity.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. The researcher will be aware of participants allocation.
To reduce the risk of contamination a cluster randomised controlled design was used. Participants will be allocated to either intervention or control group based on their cluster, which is their faculty at the main campus of a public university in Saudi Arabia. Based on the results of the previous need assessment study, two faculties within the main campus in a public university in Saudi Arabia that have a similar landscape and building structure were nominated.
These two faculties were allocated at random to either receive the intervention or to be the control group by the lead investigator witnessed by the chief investigator (using a simple randomisation (coin-toss).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As explained before a simple randomisation (coin-tossing) was performed to allocate the two faculties to control and intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
wait-list control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is change in sitting time between baseline and follow-up. A previous 12-week RCT by Schuna Jr et al. (2014) showed a reduction in sitting time of 28.8 minutes/8-h workday with a SD of 75.14. A recent systematic review and meta-analysis of workplace intervention to reduce sitting among office workers, reported average reductions in workplace sitting of 79 min/8-h workday (Chu et al., 2016). Thus, this study will be powered to detect a reasonable 60 minutes change between control and intervention groups. 26 participants per group is required to detect this difference with 95% confidence (a = 0.05) and 80% power. To account for attrition this sample size was then inflated by 25%, therefore, the final sample size is 33 per group with 66 participants in total. This calculation was performed using the package Power and Sample Size (version 3.1.2).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/01/2018
Actual
21/01/2018
Date of last participant enrolment
Anticipated
4/02/2018
Actual
30/01/2018
Date of last data collection
Anticipated
27/05/2018
Actual
10/05/2018
Sample size
Target
66
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 9440 0
Saudi Arabia
State/province [1] 9440 0
Not specified!

Funding & Sponsors
Funding source category [1] 298229 0
University
Name [1] 298229 0
Queensland University of Technology
Country [1] 298229 0
Australia
Funding source category [2] 298237 0
Government body
Name [2] 298237 0
Saudi Arabian Cultural Mission (SACM)
Country [2] 298237 0
Australia
Primary sponsor type
Individual
Name
Baraa Sami Quronfulah
Address
Faculty of Health, School - Public Health and Social Work
Queensland Univesity of Technology (QUT)
Kelvin Grove campus
Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 297347 0
Individual
Name [1] 297347 0
Kristiann Heesch
Address [1] 297347 0
Faculty of Health, School - Public Health and Social Work
Queensland Univesity of Technology (QUT)
Kelvin Grove campus
Victoria Park Rd
Kelvin Grove QLD 4059
Country [1] 297347 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299238 0
The Queensland University of Technology (QUT) Human Research Ethics Committee (UHREC)
Ethics committee address [1] 299238 0
Ethics committee country [1] 299238 0
Australia
Date submitted for ethics approval [1] 299238 0
11/10/2017
Approval date [1] 299238 0
04/12/2017
Ethics approval number [1] 299238 0
1700000964

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2273 2273 0 0
/AnzctrAttachments/374176-QUT ETHICS APPROVAL CERT 1700000964.pdf (Ethics approval)

Contacts
Principal investigator
Name 79762 0
Mr Baraa Sami Quronfulah
Address 79762 0
PhD candidate at Queensland University of Technology (QUT)

Faculty of Health, School - Public Health and Social Work
Queensland Univesity of Technology (QUT)
Kelvin Grove campus
Victoria Park Rd
Kelvin Grove QLD 4059
Country 79762 0
Australia
Phone 79762 0
+61 403 716 419
Fax 79762 0
Email 79762 0
[email protected]
Contact person for public queries
Name 79763 0
Baraa Sami Quronfulah
Address 79763 0
PhD candidate at Queensland University of Technology (QUT)

Faculty of Health, School - Public Health and Social Work
Queensland Univesity of Technology (QUT)
Kelvin Grove campus
Victoria Park Rd
Kelvin Grove QLD 4059
Country 79763 0
Australia
Phone 79763 0
+61 403 716 419
Fax 79763 0
Email 79763 0
[email protected]
Contact person for scientific queries
Name 79764 0
Baraa Sami Quronfulah
Address 79764 0
PhD candidate at Queensland University of Technology (QUT)

Faculty of Health, School - Public Health and Social Work
Queensland Univesity of Technology (QUT)
Kelvin Grove campus
Victoria Park Rd
Kelvin Grove QLD 4059
Country 79764 0
Australia
Phone 79764 0
+61 403 716 419
Fax 79764 0
Email 79764 0
[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?
Unidentifiable data of the primary and secondary outcomes.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
832Ethical approval    374176-(Uploaded-18-12-2018-15-25-54)-Study-related document.pdf



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.