Trial Review

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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] 259933 0
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 265529 0
Impaired glucose tolerance 265530 0
Impaired fasting glucose 265531 0
Insulin resistance 265532 0
Type 2 diabetes 265533 0
Overweight/obesity 268120 0
Condition category
Condition code
Metabolic and Endocrine 265690 265690 0 0
Diabetes
Cardiovascular 268268 268268 0 0
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] 264346 0
Behaviour
Intervention code [2] 266804 0
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] 268986 0
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] 268986 0
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] 268987 0
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] 268987 0
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] 268988 0
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] 268988 0
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] 276758 0
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] 276758 0
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?
No
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
24
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267277 0
Charities/Societies/Foundations
Name [1] 267277 0
National Heart Foundation
Country [1] 267277 0
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] 266337 0
None
Name [1] 266337 0
Address [1] 266337 0
Country [1] 266337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269263 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 269263 0
Ethics committee country [1] 269263 0
Australia
Date submitted for ethics approval [1] 269263 0
26/08/2010
Approval date [1] 269263 0
18/10/2010
Ethics approval number [1] 269263 0
240/10/2010

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

Contacts
Principal investigator
Name 32442 0
A/Prof David Dunstan
Address 32442 0
Baker IDI Heart and Diabetes Institute. 99 Commercial Rd
Prahran, Vic 3004
Country 32442 0
Australia
Phone 32442 0
+61 3 8532 1873
Fax 32442 0
Email 32442 0
[email protected]
Contact person for public queries
Name 15689 0
Associate Professor David Dunstan
Address 15689 0
Baker IDI Heart and Diabetes Institute
Alfred Centre, Level 4 99 Commercial Road, Melbourne, Victoria 3004
Country 15689 0
Australia
Phone 15689 0
+61 3 8532 1873
Fax 15689 0
Email 15689 0
[email protected]
Contact person for scientific queries
Name 6617 0
Associate Professor David Dunstan
Address 6617 0
Baker IDI Heart and Diabetes Institute
Alfred Centre, Level 4 99 Commercial Road, Melbourne, Victoria 3004
Country 6617 0
Australia
Phone 6617 0
+61 3 8532 1873
Fax 6617 0
Email 6617 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
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
SourceTitleYear of PublicationDOI
EmbaseAlternating Sitting and Standing Increases the Workplace Energy Expenditure of Overweight Adults.2016https://dx.doi.org/10.1123/jpah.2014-0420
N.B. These documents automatically identified may not have been verified by the study sponsor.