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Trial registered on ANZCTR


Registration number
ACTRN12612001290886
Ethics application status
Approved
Date submitted
6/12/2012
Date registered
13/12/2012
Date last updated
17/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of the 10,000 Steps workplace challenge in increasing health outcomes for employees at Rockhampton Regional Council.
Scientific title
The effectiveness of the 10,000 Steps workplace challenge in increasing health outcomes for employees at Rockhampton Regional Council.
Secondary ID [1] 281169 0
Nil
Universal Trial Number (UTN)
U1111-1134-3331
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 287477 0
Sedentary behaviour 287504 0
Condition category
Condition code
Mental Health 287831 287831 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To examine the effectiveness of the 10,000 Steps workplace challenge in increasing physical activity of employees and volunteers of the Rockhampton Regional Council using a clustered randomised crossover trial of the 10,000 Steps workplace challenge.

Employees of the council will be randomised into 2 groups: the intervention group will receive the 10,000 steps program first for a period of 6-weeks, and the waitlist control group will receive the 10,000 steps program once the intervention group has finished the challenge, followup measurements and questionaires. Everyone who participates in the study will be asked to complete questionnaires about the length of time they sit, their physical activity, their mood, and quality of life at the beginning of the study. Measurements such as height and weight, and hip and waist circumference will also be taken at the beginning of the study, in a private area at each workplace by one of the researchers. At the beginning of the 10,000 steps workplace challenge pedometers will be issued for the participants to keep. Participants will be asked to wear the pedometer each day during the 6-week challenge and to record the number of steps they have taken each day on the Central Queensland University 10,000 Steps web site (www.10000steps.org.au).

This website also allows monitoring team progress and provides weekly updates on the team step count- the sharing of individual's step is used as a motivational strategy. Each site will have a ‘champion’ who will guide and facilitate the workplace challenge to co-workers.
Both groups will be asked to repeat the questionnaires and measurements at 6-weeks and 12-weeks after the commencement of the study and 6-months after the end of the 10,000 steps program the study. The measurements and questionnaires are expected to take 45 minutes each time they are completed. On completion of the 10, 000 steps challenge, there will be a short evaluation of how the participants found the challenge.
Intervention code [1] 285839 0
Behaviour
Comparator / control treatment
The randomisation of participants will involve half of the sites receiving the intervention immediately (intervention group), whilst the other half of the sites (waitlist control) are assessed but do not receive the intervention until after a waiting period of 6 weeks. All participants will be assessed immediately prior to the 10,000 steps workplace challenge, post-test after 6 weeks of participating in the challenge, and 6 months post intervention.
Control group
Active

Outcomes
Primary outcome [1] 287920 0
Total steps of physical activity measured using the Yamax Digiwalker DW-150 pedomenter.
Timepoint [1] 287920 0
Cumulatively steps are logged on the 10,000 Steps website weekly and over the 6 week intervention for the waitlist control and intervention groups.
Secondary outcome [1] 299057 0
Total minutes of sitting time at work measured using the Adapted Workforce Sitting Questionnaire and Occupational Physical Activity Questionnaire
Timepoint [1] 299057 0
Measured at baseline (both groups), after intervention (6 or 12 weeks depending on group) and 6-months after completing the intervention for both groups.
Secondary outcome [2] 299483 0
Health-related quality of life measured using the Australian Quality of Life Scale: AQoL-15
Timepoint [2] 299483 0
Measured at baseline (both groups), after intervention (6 or 12 weeks depending on group) and 6-months after completing the intervention for both groups.
Secondary outcome [3] 299484 0
Mood measured using Depression Anxiety Stress Scales (DASS-21).
Timepoint [3] 299484 0
Measured at baseline (both groups), after intervention (6 or 12 weeks depending on group) and 6-months after completing the intervention for both groups.
Secondary outcome [4] 299485 0
Physical activity measured using self reported Active Australia Questionairre
Timepoint [4] 299485 0
Measured at baseline (both groups), after intervention (6 or 13 weeks depending on group) and 6-months after completing the intervention for both groups.
Secondary outcome [5] 299486 0
Body Mass Index: Researcher will measure in a private area height, weight, waist and hip measurements. Height will be measured using a Seca 213 Portable Height Measuring Instrument, weight will be measured using Tanita HD351 scales and waist and hip using Seca 203 Circumference Measuring Tape.
Timepoint [5] 299486 0
Measured at baseline (both groups), after intervention (6 or 12 weeks depending on group) and 6-months after completing the intervention for both groups.
Secondary outcome [6] 300112 0
Demographics
Timepoint [6] 300112 0
Measured at baseline (both groups), after intervention (6 or 12 weeks depending on group) and 6-months after completing the intervention for both groups.

Eligibility
Key inclusion criteria
Male and female employees of Rockhampton Regional Council will be recruited as participants for this study. Volunteers will be eligible to participate if they work at the Rockhampton Regional Council, either full-time or part-time.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Employees will be excluded if they:
Currently meet the physical activity guidelines (150 min of moderate intensity physical activity in the last week);
Have a mobility impairment; severe communication disability that compromises the ability to participate in the 10,000 steps workplace challenge or complete the outcome measures; or a cognitive deficit that impairs the ability to read and write;
Are pregnant women or women who have had a baby in the 3-months prior to the study as their BMI is likely to vary as a result of pregnancy or recent pregnancy;
Are current users of the 10,000 Steps program;
If they cannot safely increase their physical activity;
If they do not speak 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)
Randomisation will be conducted using central randomisation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a randomisation list (i.e. randomisation.com)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Active- waitlist control design ( no intervention given)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2013
Actual
Date of last participant enrolment
Anticipated
31/01/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 6108 0
4700 - Rockhampton

Funding & Sponsors
Funding source category [1] 286056 0
Government body
Name [1] 286056 0
Health Practitioner Novice Research Scheme 2012-2013, Queensland Health.
Country [1] 286056 0
Australia
Primary sponsor type
Government body
Name
Central Queensland Hospital and Health Service
Address
Rockhampton Hospital, Canning St, Rockhampton, QLD 4700.
Country
Australia
Secondary sponsor category [1] 284779 0
None
Name [1] 284779 0
Address [1] 284779 0
Country [1] 284779 0
Other collaborator category [1] 277079 0
University
Name [1] 277079 0
CQUniversity
Address [1] 277079 0
Central Queensland University
Centre for Physical Activity Studies
Bld 18 Central Queensland University,
Bruce Highway
Rockhampton 4702
Queensland
Country [1] 277079 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288107 0
Central Queensland Human Research Ethics Committee
Ethics committee address [1] 288107 0
Ethics committee country [1] 288107 0
Australia
Date submitted for ethics approval [1] 288107 0
19/07/2012
Approval date [1] 288107 0
17/09/2012
Ethics approval number [1] 288107 0
HREC/12/QCQ/23
Ethics committee name [2] 288452 0
CQUniversity HREC
Ethics committee address [2] 288452 0
Ethics committee country [2] 288452 0
Australia
Date submitted for ethics approval [2] 288452 0
Approval date [2] 288452 0
17/09/2012
Ethics approval number [2] 288452 0
H12/10-191

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

Contacts
Principal investigator
Name 34668 0
Mrs Karen Toms
Address 34668 0
Rockhampton Community Health
86 Bolsover Street
Rockhampton 4700
Queensland
Country 34668 0
Australia
Phone 34668 0
+61 7 49206900
Fax 34668 0
Email 34668 0
karen_toms@health.qld.gov.au
Contact person for public queries
Name 17915 0
Karen Toms
Address 17915 0
Queensland Health
Rockhampton Community Health
86 Bolsover Street
Rockhampton 4700
Queensland
Country 17915 0
Australia
Phone 17915 0
+61 7 49206900
Fax 17915 0
Email 17915 0
karen_toms@health.qld.gov.au
Contact person for scientific queries
Name 8843 0
Mitch Duncan Senior Post-Doctoral Research Fellow
Address 8843 0
Physical Activity and Health,
10,000 Steps Project Leader
Bld 18 Central Queensland University,
Bruce Highway
Rockhampton 4702
Queensland
Country 8843 0
Australia
Phone 8843 0
+61 07 49306977
Fax 8843 0
Email 8843 0
m.duncan@cqu.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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