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Trial registered on ANZCTR

Registration number

ACTRN12612000818831

Ethics application status

Approved

Date submitted

30/07/2012

Date registered

3/08/2012

Date last updated

23/11/2018

Date data sharing statement initially provided

23/11/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effects of increasing physical activity and reducing sedentary time in healthy, sedentary workers.

Scientific title

The effects of increasing physical activity and reducing sedentary time in healthy, sedentary workers.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Be Active @ Work

Linked study record

Health condition

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

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 study involves a two-arm parallel group randomised trial conducted over 9 months. The study involves attendance by both the gym-based exercise only group as well as the sedentary behaviour reduction group in three, one hour exercise sessions (which combine aerobic and resistance training) per week for three months.

The gym sessions run on non-consecutive days, two sessions are resistance based-exercises complimented with a cardio component. The third day comprises cardio only.

There are three (4 week) phases of the resistance training which allow for progression over time, promoting enhanced stimulus for strength and cardiovascular gains through increasing sets and weight. These three phases involve 6 strength training exercises, phase one is machine-based basic exercises, phase two encompasses bar-bell exercises, phase three increases variables
Cardio-based exercises may be performed on the participants choice of machine: bike, rowing machine, arm ergo, cross-trainer and treadmill.

The participants are guided through their new program at the introduction of each phase by qualified staff members - technique is supervised throughout each session to ensure safety and correct technique.

The intervention condition will undertake gymnasium-based exercise and sedentary behaviour reduction intervention which provides guidance and support to reduce their sedentary time during the day at work and increase their number of breaks in sedentary time (ie: changing from sitting to standing). This behavioural intervention was provided in the form of e-mails, phones calls and face to face consultations regarding behaviour change.

Post the 3 month intervention phase, participants continue to have access to the gym facilities for exercise. They are offered progression exercises by supervising staff. Attendance is monitored by staff members during the set opening hours of the gym.

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

Prevention

Comparator / control treatment

The gymnasium-based exercise group has acted as the control condition and involves participating in the gymnasium-based exercise only.

Control group

Active

Outcomes

Primary outcome [1]

Metabolic measures were obtained by a registered nurse who performed venepuncture on the participants. Fasting blood glucose, insulin and lipids were processed by Alfred Pathology.

Timepoint [1]

Conducted at baseline, at 3 months and 6 months post intervention.

Primary outcome [2]

Anthropometrics were assessed; this included resting blood pressure, resting pulse rate obtained by a sphygmomanometer. Height was collected through the use of a Livingstone mounted tape measure. Weight was also collected using a calibrated set of weighing scales and waist and hip circumference collected using a standard tape measure. From these measures, BMI and hip to waist ratio were calculated by a syntax devised by the data analyst through SPSS version 17.0.

Timepoint [2]

Conducted at baseline, at 3 months and 6 months post intervention.

Primary outcome [3]

Physical activity: Sedentary behaviour and physical activity time were assessed in the study using accelerometers (Actigraph model GT3Xplus)and inclinometers (model activPAL). An activity diary will be used in combination with the two devices to allow participants to record when they put on/took off the devices or engaged in non- ambulatory physical activities (ie. cycling, swimming) that are not able to be recorded by the accelerometer. Participants will also enter work start/finish times in the diary on those work days the devices are worn.

Timepoint [3]

The accelerometer and inclinometer will be worn for seven consecutive days at baseline and the last week of the intervention phase (Week 12). Participants will also be required to wear the devices for for five days (three workdays and two non-workdays) during week 5 and week 8 of the intervention phase

At the completion of the six month maintenance phase, participants wore and will wear the accelerometer and inclinometer again for seven consecutive days.

Secondary outcome [1]

Work productivity has been assessed through the employment of an inhouse self-reported health and work questionnaire. This questionnaire is comprised of the health and work questionnaire, the ARROL, CES_D questionnaires, the Edinburgh Claudication Scale as well as the Sf12. A Dietary questionnaire is also included (DQESv2). This eludes to data reflecting general and mental health.

Timepoint [1]

Conducted at baseline, at 3 months and 6 months post intervention.

Secondary outcome [2]

Exercise compliance has been attained through an attendance spreadsheet reflecting the time of data and frequency of attendance for each participant. Each staff member supervising the running of the gym sessions monitors and takes note of who attends the open times.

Timepoint [2]

Attendance to gym sessions will and have been monitored by staff members over 6 months following the 3 month intervention phase.

Eligibility

Key inclusion criteria

Participants will include full-time Baker IDI staff (men and women), aged 20-65 years with a BMI less than 40 kg/m2 who are characterised as being typically sedentary (sit at work for greater than or equal to 4 hours per day and watch television greater than or equal to 2 hours per day.

Minimum age

20 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Not physically active (engage in less than 150 minutes/wk of moderate-to-vigorous physical activity), not on glucose, blood pressure or lipid lowering medications, not pregnant and otherwise healthy

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)

Participants were recruited by electronic advertisements circulated to all Baker IDI staff via email and through advertisements listed on the Baker IDI staff intranet.
Willing 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. The research coordinator will also explicitly state that participation in the study is entirely voluntary and that participants may withdraw at anytime without pressure or cohesion. If the participant is suitable and willing to take part, a copy of the plain language statement will be forwarded to them by email.

Allocation concealment was executed by central randomisation using the computer. Using unidentifiable data to allocate each participant into either groups.

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

The participants were block randomised stratified by age, gender and BMI.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Two arm parallel study with a 6 month maintenance phase at the conclusion of the 3 month intervention phase.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/06/2011

Actual

30/11/2011

Date of last participant enrolment

Anticipated

Actual

30/11/2012

Date of last data collection

Anticipated

Actual

30/11/2013

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]

Baker IDI Heart and Diabetes Institute

Address [1]

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

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 Pavillion,
The Alfred, 55 Commercial Road, Melbourne, 
VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/12/2010

Approval date [1]

07/01/2011

Ethics approval number [1]

1/10/0382

Summary

Brief summary

Engaging in regular physical activity is essential for maintaining good health and well-being. Because employed adults spend the majority of their workday waking hours in the workplace, offering exercise programs at work may be an efficient strategy to increase physical activity; a recent meta-analysis has shown that some workplace physical activity interventions can improve both health and important worksite outcomes. The emergence of compelling evidence linking prolonged sitting to detrimental health outcomes, including mortality, has prompted calls for new thinking within public health messages to include both being physically active and reducing time spent sitting. However, the extent to which changes in metabolic/cardiovascular and productivity outcomes arising from a workplace physical activity program may be enhanced through a combined intervention approach (physical activity + sedentary behaviour reduction) has not been investigated. The proposed study will investigate the efficacy of a gymnasium-based exercise program with and without the combination of individually tailored feedback to reduce sedentary time on cardiovascular health outcomes and productivity in healthy, sedentary adults.  
A total of 68 full-time Baker IDI staff aged 20-65 years with a BMI less than 40 kg/m2 who are typically sedentary (sit at work equal to 4 hours/d and watch television equal to 2 hours/d), are not physically active (less than 150 minutes/wk moderate-to-vigorous physical activity), not on glucose, blood pressure or lipid lowering medications, not pregnant and otherwise healthy will be recruited to participate. 
The proposed study will involve a two-arm parallel group randomised trial conducted over 9 months which includes three phases.
Phase 1: Baseline (1 week): Following initial screening for eligibility, behavioural, metabolic and physiological measurements will be performed to establish baseline values.
Phase 2: Intervention Phase (3 months): Participants will then be randomly assigned to one of two groups:

1.	Gymnasium-Based Exercise Only (n=34)
2.	Gymnasium-Based Exercise + Sedentary Behaviour 
        Reduction Intervention (n=34)

At the completion of three months, all behavioural, metabolic and physiological measurements will be reassessed. Participants will undertake three, one hour exercise sessions (which combine aerobic and resistance training) per week for three months. All sessions will be developed and supervised by an exercise physiologist or qualified personal trainer and will be conducted at the Baker IDI Healthy Lifestyle Research Centre research gymnasium. Participants assigned to the Gymnasium-Based Exercise + Sedentary Behaviour Reduction Intervention will additionally receive guidance and support to reduce their sedentary time at work and increase their number of breaks in sedentary time (ie: changing from sitting to standing). 

Phase 3: Maintenance Phase (9 months): All participants will undergo a nine month maintenance phase whereby gymnasium-based exercise will be required on at least two and up to three days per week. At the completion of the maintenance phase, all behavioural, metabolic and physiological measurements will be reassessed.Study outcomes will include:  metabolic (fasting blood glucose,insulin and lipids) and anthropometric measures, blood pressure, physical activity, sedentary time  and breaks in sedentary time (primary); and work productivity, self perceived general and mental health and exercise compliance (secondary).
Sedentary behaviour and physical activity time will be assessed in the study using accelerometers (Actigraph model GT3Xplus), worn during waking hours on selected days and positioned over the right hip via a belt. Accelerometers are similar in size and shape to pedometers and record data on physical activity duration, frequency and intensity. Breaks in sedentary time will be assessed using inclinometers (model activPAL)) worn discretely on the upper thigh area fixed with hypoallergenic, micropore tape. Inclinometers are equivalent in size to a matchbox and measure the number of postural changes from sedentary to upright (standing). An activity diary will be used in combination with the two devices to allow participants to record when they put on/took off the devices or engaged in non- ambulatory physical activities (ie. cycling, swimming) that are not able to be recorded by the accelerometer. Participants will also enter work start/finish times in the diary on those work days the devices are worn. 
 It is anticipated findings from the proposed research study will be used to inform future interventions targeting behavioural change across the “whole of day” (during exercise and non exercise time) in at risk populations eg. overweight/obese, diabetics, individuals with metabolic syndrome.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Dunstan

Address

Baker Heart and Diabetes Institute
Level 4, 99 Commercial Road
Melbourne
VIC 3004

Country

Australia

Phone

+6138532111

Fax

David.Dunstan@baker.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

Alicia Thorp

Address

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

Country

Australia

Phone

+61 3 8532 1854

Fax

Alicia.Thorp@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

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.

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