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Trial registered on ANZCTR

Registration number

ACTRN12611000632998

Ethics application status

Approved

Date submitted

21/06/2011

Date registered

22/06/2011

Date last updated

19/11/2018

Date data sharing statement initially provided

19/11/2018

Date results provided

19/11/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Can increased standing during the workday benefit metabolic health?

Scientific title

Understanding the efficacy of reducing workplace sedentary time through increased standing on cardio-metabolic health: an experimental study in overweight, middle aged males using a simulated workplace environment.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

SOS (Sit or Stand)@ Work Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pre-diabetes

Impaired glucose tolerance

Impaired fasting glucose

Insulin resistance

Type 2 diabetes

Overweight/obesity

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This randomised, cross-over trial involves two short-term experimental conditions, separated by a two week washout period. Each experimental condition will be undertaken for 10 consecutive workdays (Monday-Friday) in a controlled research setting.

The sitting/standing (intervention) condition will require participants to undertake their usual daily occupational tasks while systematically interchanging between a seated and standing working posture every 30 minutes, with these transitions being achieved using electric, height adjustable sit-to-stand desks. Ambulation/movement will not be restricted when in the standing working posture. Participants will spend a total of four hours desk bound (seated) and four hours standing (that is, a total of eight programmed transitions between seated and standing working posture) in the simulated office environment on each day. The intervention condition is designed to represent a “viable” workplace environment where equal proportions of the working day are spent sitting and standing.

Intervention code [1]

Behaviour

Intervention code [2]

Prevention

Comparator / control treatment

The prolonged sitting condition (considered to reflect ‘usual office practice’) will act as the control condition and involve desk bound (seated) work in the simulated office environment for eight hours each day. Ambulatory movement during this period of time will be restricted to brief interruptions for meals and using the toilet only. The control experimental condition is designed to represent a “sedentary” workplace environment which mandates non-discretionary sitting time (for example, call centres).

Control group

Active

Outcomes

Primary outcome [1]

Postprandial plasma glucose levels (mean area under the curve [AUC]). Plasma glucose concentrations will be assessed using standard testing equipment at an outsourced Hospital pathology laboratory.

Timepoint [1]

Plasma glucose levels will be measured at baseline and every hour over a four hour period following consumption of a standard breakfast drink for determination of the mean area under the curve (AUC) for each experimental condition.
The mean AUC will be determined on day 1, day 12, day 29 and day 40 following study enrolment.

Primary outcome [2]

Postprandial serum insulin levels (mean area under the curve [AUC]). Serum insulin concentrations will be assessed using standard testing equipment at an outsourced Hospital pathology laboratory.

Timepoint [2]

Serum insulin levels will be measured at baseline and every hour over a four hour period following consumption of a standard breakfast drink for determination of the mean area under the curve (AUC) for each experimental condition.
The mean AUC will be determined on day 1, day 12, day 29 and day 40 following study enrolment.

Primary outcome [3]

Postprandial serum triglyceride levels (mean area under the curve [AUC]). Serum triglyceride concentrations will be assessed using standard testing equipment at an outsourced Hospital pathology laboratory.

Timepoint [3]

Serum triglyceride levels will be measured at baseline and every hour over a four hour period following consumption of a standard breakfast drink for determination of the mean area under the curve (AUC) for each experimental condition.
The mean AUC will be determined on day 1, day 12, day 29 and day 40 following study enrolment.

Secondary outcome [1]

Postprandial plasma free fatty acid levels (mean area under the curve [AUC]). Plasma free fatty acid concentrations will be assessed using standard testing equipment at an outsourced Hospital pathology laboratory.

Timepoint [1]

Plasma free fatty acid levels will be measured at baseline and every hour over a four hour period following consumption of a standard breakfast drink for determination of the mean area under the curve (AUC) for each experimental condition.
The mean AUC will be determined on day 1, day 12, day 29 and day 40 following study enrolment.

Eligibility

Key inclusion criteria

males and females, overweight/obese (BMI 25-34.9 kg/m2), aged 35 to 65 years, employed full-time in typically sedentary (desk-bound) occupation, of English-speaking background

Minimum age

35 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Key exclusion criteria: smoker, have a clinical history of cardiovascular disease, diabetes mellitus, thrombotic disease, musculoskeletal injury, regularly engage in high levels of exercise (> 300 minutes/wk of moderate-to-vigorous activity), taking prescription medications for hypertension and/or hyperlipidemia.

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)

Interested volunteers will be screened for eligibility via a telephone-administered interview with the research coordinator. During the interview, the research coordinator will explain the study details in lay terms and outline the inclusion/exclusion criteria. If the participant is suitable and willing to take part, a copy of the plain language statement will be forwarded to them by mail or email. There will be no relationship to potential participants. Once the participant has a thorough understanding of the study and procedures involved, they will be invited to attend a face to face screening visit at the Healthy Lifestyle Research Centre at Baker IDI Heart and Diabetes Institute. During the screening visit, participants will have the opportunity to raise any concerns they may have and they will be asked to either reread the plain language statement and give informed consent or decline to take part in the study. Anthropometric measurements will be obtained at this screening visit, and participants will have the opportunity to test any personal work equipment (typically a laptop computer that will be connected to the wireless internet) in the simulated office environment, in preparation for the trial. During each experimental condition, participants would be asked to wear two small lightweight devices which measure and store information regarding the frequency and duration of times spent sitting, standing and walking. These devices will be worn everyday (during waking hours) starting from your familiarisation visit to the completion of the last experimental condition. One instrument, known as an accelerometer, will be worn with a belt at hip height. The other instrument, known as the ActivPal inclinometer, will be fixed to the front of the upper thigh with Micropore tape.
Participants would also be required to wear an armband (Sensewear device) during each experimental condition (in work hours only) to measure how much energy you are expending whilst working in a standing and/or seated posture.
Once a potential subject has been deemed eligible to participate and provided their informed, consent they will be randomised to the order which they receive the two experimental conditions. The method for allocation concealment will involve a computer generated list of the order of treatments which will not be disclosed till after enrolment in the study is complete.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation allocation sequence will be generated using a online website program(http://www.randomization.com). Randomisation will be based on two treatment groups with balanced permutations, with the total number of subjects (n=24) divided into two blocks.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/05/2011

Actual

1/05/2011

Date of last participant enrolment

Anticipated

Actual

1/03/2013

Date of last data collection

Anticipated

Actual

1/05/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Heart Foundation

Address [1]

Level 12/500 Collins Street, Melbourne, VIC 3000

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Baker IDI Heart and Diabetes Institute

Address

75 Commercial Road, Melbourne, VIC 3004
(Postal address: PO Box 6492, St Kilda Road Central VIC 3008)

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Human Research Ethics Committee

Ethics committee address [1]

Alfred Ethics Office, Ground Floor, Linay Pavilion, The Alfred, 55 Commercial Road, Melbourne, Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/08/2010

Approval date [1]

18/10/2010

Ethics approval number [1]

240/10/2010

Summary

Brief summary

New epidemiological and experimental evidence, from our group and others, indicates that prolonged sitting is associated with adverse cardio-metabolic consequences, independent of time spent in moderate-to-vigorous physical activity. Furthermore, we have recently reported for the first time that breaks in sedentary time (such as standing from a seated position) are beneficially associated with several cardio-metabolic biomarkers, independent of total sedentary and moderate-to-vigorous activity time.

Our pilot research in a cohort of Australian workers indicates that office-based workers spend more than three quarters of their total work time sedentary. Combined with evidence from the USA that workplace sitting time is associated with cardiovascular disease risk, these new findings suggest that reducing prolonged periods of unbroken sitting in the workplace may offer a novel and economically viable means of improving cardio-metabolic health in the working population. No intervention study has systematically investigated the effects of reducing workplace sitting time on cardio-metabolic risk factors. Preliminary data from our laboratory indicates that brief bouts of light intensity activity during prolonged periods of sitting acutely improves postprandial glucose and insulin in older, sedentary adults during a single-day intervention. The proposed study will extend upon these findings and examine -- in a simulated office environment -- the short term (10-day) effect of reducing workplace sedentary time through systematic, sustained bouts of standing, on biomarkers of cardio-metabolic risk. 

Given the enormous societal burden associated with cardiovascular disease and its associated conditions, this is an important and timely study. Furthermore, the workplace has been identified by the National Preventative Health Taskforce as a key environment for health promotion and disease prevention. Findings from this rigorous, experimental study will determine whether reducing workplace sedentary time through increased standing is beneficial to cardio-metabolic health.  This novel experimental investigation will provide a key element of the evidence base to underpin the development of future workplace innovations, programs and policy strategies which aim to reduce sedentary behaviour.

Trial website

http://www.bakeridi.edu.au/SOSAtWork/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof David Dunstan

Address

Baker IDI Heart and Diabetes Institute. 99 Commercial Rd
Prahran, Vic 3004

Country

Australia

Phone

+61 3 8532 1873

Fax

david.dunstan@bakeridi.edu.au

Contact person for public queries

Name

Associate Professor David Dunstan

Address

Baker IDI Heart and Diabetes Institute
Alfred Centre, Level 4 99 Commercial Road, Melbourne, Victoria 3004

Country

Australia

Phone

+61 3 8532 1873

Fax

David.Dunstan@bakeridi.edu.au

Contact person for scientific queries

Name

Associate Professor David Dunstan

Address

Baker IDI Heart and Diabetes Institute
Alfred Centre, Level 4 99 Commercial Road, Melbourne, Victoria 3004

Country

Australia

Phone

+61 3 8532 1873

Fax

David.Dunstan@bakeridi.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

ethical approval not given

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

Source	Title	Year of Publication	DOI
Embase	Alternating Sitting and Standing Increases the Workplace Energy Expenditure of Overweight Adults.	2016	https://dx.doi.org/10.1123/jpah.2014-0420

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically