Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001018505
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
29/09/2015
Date last updated
11/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sit-Stand Protocols in a real office setting
Scientific title
Examining different sit-stand protocols in terms of health and behavioural outcomes: an office-based pilot study
Secondary ID [1] 287382 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour 296073 0
Musculoskeletal discomfort 296076 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296336 296336 0 0
Other physical medicine / rehabilitation
Musculoskeletal 296337 296337 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will seek volunteers from an office environment. Participants will be randomly allocated into one of four interventions arms for a period of 5 weeks.

The intervention groups will allocate the time spent either sitting or standing every hour they are at work.

Arm 1 - 60 minutes sitting
Arm 2 - 40 minutes sitting, 20 minutes standing
Arm 3 - 30 minutes sitting, 30 minutes standing
Arm 4 - 20 minutes sitting, 40 minutes standing

Each participant in Arms 2-4 will be provided with an adjustable sit-stand workstation (Model- Ergotron Workfit S or A; or equivalent) which will be retrofitted to their existing computer workstation or desk and personalised to each participant’s preferred sitting position and standing height. Instructions will be provided on how to adjust the sit-stand workstation between sitting and standing. Participants will receive a computer app reminder to change posture according to the postural variation group they are allocated to.

Adherence to the protocols will be assisted through the use of an App installed on participants computers. They will also receive visits from the research team and emails to remind them to follow their allocated protocol.
Intervention code [1] 292729 0
Lifestyle
Intervention code [2] 292730 0
Behaviour
Intervention code [3] 292731 0
Prevention
Comparator / control treatment
The control group will be assigned to Arm 1, where they are asked to work as normal throughout the trial. These participants would not have a desk retrofitted to their work station.
Control group
Active

Outcomes
Primary outcome [1] 295987 0
The acceptability of different sitting-standing protocols and data collection procedures.
One measure of acceptability will be response and retention rate of participants.
A study aspects questionnaire has been developed to investigate specific aspects of the study and what participants opinions of each. Qualitative measurements of the acceptability of the study will also be gauged through focus groups upon the conclusion of the study.
Timepoint [1] 295987 0
Response rates and retention will be recorded at both baseline (the end of week 1) and intervention (the end of week 5) time points when data is collected.
As participants complete the intervention(the end of week 5 of the study after 4 weeks using the sit stand desk) they will complete the Study Aspects questionnaire.
Once all intervention groups have completed their involvement in the 5 week study, focus groups will be held to further understand participants adherence and acceptability of the protocol. The focus group will be held in the week after the trial finishes.
Primary outcome [2] 295988 0
The impact of the different sitting-standing protocols on participants’ sedentary behavior.
Timepoint [2] 295988 0
Occupational Sitting and Physical Activity Questionnaire (OSPAQ) questionnaire measures time spent sitting, standing, walking and doing more physically demanding tasks at work. It will be completed at the end of baseline (week 1) data collection and at the end of the intervention (week 5) to gather self report changes in sedentary behaviour at work.

The ActivPAL will collect objective information on participnats sedentary behaviour inside and outside of work when worn on the participants thigh for 7 days during week 1 and 7 days during week 5 of the study.
Secondary outcome [1] 317112 0
Physical Activity – objective monitoring: At baseline and follow-up participants will wear a small and lightweight inclinometer/accelerometer for 7days.
Habitual physical activity: Validated questionnaire - The Active Australia Questionnaire will gather habitual physical activity data, which can be compared to the objective data from the ActivPAL.
These are composite and related outcomes which will all be compared to each other to confirm understanding of physical activity and sedentary behavior of participants.
Timepoint [1] 317112 0
During 5 week intervention. At baseline, participants will wear the ActivPAL device for 7 days continuously. Then at the completion of these 7 days, they will fill out the mentioned questionnaires. This will be repeated in the 4th week of the intervention.
Secondary outcome [2] 317113 0
Musculoskeletal: the Nordic Musculoskeletal Questionnaire will measure the 7-day prevalence of musculoskeletal discomfort.
Biomechanical strain: Kinematic sensors (Dorsavi) measuring muscle activity will be fitted on participants on two different days (2 weeks pre-intervention and on a day during the intervention). The sensors are unobtrusive, placed on the lower back and do not restrict the participants for performing their work or exercise activities.
These musculoskeletal and bio-mechanical outcomes will be used in composite to increase our understanding of the impact of the protocols on musculoskeletal discomfort in an office setting.
Timepoint [2] 317113 0
During 5 week intervention. At baseline, participants will wear the Dorsavii for 1 day at work. Then at the completion of the baseline data collection week, they will fill out the nordic musculoskeletal questionnaire. This will be repeated in the 4th week of the intervention.
Secondary outcome [3] 317114 0
Blood samples (optional): hourly blood samples will be taken during the test day to measure glucose levels which are an indicator of metabolic levels. Those providing blood samples will do so on one day at baseline and one day during the final week of the intervention. Controlled and timed meals will be provided on these days. Participants will all eat the same dinner, then fast for 10 hours before starting work. During the work day, participants will have to follow a strictly controlled diet.
Timepoint [3] 317114 0
Biological markers will be compared between baseline and intervention blood collections.
Secondary outcome [4] 317115 0
Adherence to the protocols will be measured by the activPAL devices. Perception of participants adhering to the protocol will be further gathered in the focus group discussions.
Timepoint [4] 317115 0
Qualitative data will be collected via focus group discussions once all participants have completed the intervention. Focus group discussions will be recorded, transcribed and separately analysed using a thematic analysis.

Eligibility
Key inclusion criteria
staff members must be aged over 20 years; employed at least on a 0.70FTE basis; have a primarily desk-based role; not have diabetes or other physical (acute or chronic) limitations that may prevent them from be able to complete the study protocol; be free of neurological or musculoskeletal condition which would be exacerbated by working standing-up; are not pregnant; have no planned leave during the study period and are fluent in English.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Workers would be excluded if they are aged under 20 years; employed less than 0.70FTE ; have diabetes or other physical (acute or chronic) limitations that may prevent them from be able to complete the study protocol; neurological or musculoskeletal condition which would be exacerbated by working standing-up; are pregnant; have planned leave during the study period and are not fluent in English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
For this pilot study, staff from the Division of Population Health Sydney Local Health District will be invited to volunteer. We will aim to recruit 40 staff members.
Participants will be assigned codes upon enrollment in the study and all collected data will be anonymously linked.
A central administrator allocated all participant codes to an intervention group using permuted blocks. Once assigned, a member of the research team referred to this list to inform participants which intervention group they had been assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use randomised permuted blocks to generate group allocation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2015
Actual
18/06/2015
Date of last participant enrolment
Anticipated
16/07/2015
Actual
10/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4279 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 10228 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 291948 0
University
Name [1] 291948 0
The University of Sydney, Faculty of Health Sciences Collaborative Grant 2014-16
Country [1] 291948 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Emmanuel Stamatakis
Address
C43C - C Block Cumberland Campus
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 290616 0
Government body
Name [1] 290616 0
Population Health Unit, Sydney Local Health District
Address [1] 290616 0
Level 9, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country [1] 290616 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293444 0
Ethics Review Committee (RPAH Zone) of the Sydney Local Health District
Ethics committee address [1] 293444 0
Ethics committee country [1] 293444 0
Australia
Date submitted for ethics approval [1] 293444 0
13/05/2015
Approval date [1] 293444 0
16/06/2015
Ethics approval number [1] 293444 0
RHEC/15/RPA/212

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

Contacts
Principal investigator
Name 59898 0
A/Prof Emmanuel Stamatakis
Address 59898 0
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825
AUSTRALIA
Country 59898 0
Australia
Phone 59898 0
+61 2 86271867
Fax 59898 0
Email 59898 0
[email protected]
Contact person for public queries
Name 59899 0
Alexander Voukelatos
Address 59899 0
Level 9, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country 59899 0
Australia
Phone 59899 0
+61 2 9515 9055
Fax 59899 0
02 9515 9056
Email 59899 0
[email protected]
Contact person for scientific queries
Name 59900 0
Bridget Foley
Address 59900 0
Level 6, The Hub, Charles Perkins Centre, The University of Sydney
NSW 2006
Australia
Country 59900 0
Australia
Phone 59900 0
+61 2 86271893
Fax 59900 0
Email 59900 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
SourceTitleYear of PublicationDOI
EmbaseReducing Office Workers' Sitting Time at Work Using Sit-Stand Protocols: Results From a Pilot Randomized Controlled Trial.2017https://dx.doi.org/10.1097/JOM.0000000000001018
N.B. These documents automatically identified may not have been verified by the study sponsor.