Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000354987
Ethics application status
Approved
Date submitted
4/03/2020
Date registered
12/03/2020
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Move more at work: A Feasibility Study
Scientific title
Move more at work: A Feasibility Study of University Staff taking Opportunities to Move
Secondary ID [1] 300712 0
none
Universal Trial Number (UTN)
Trial acronym
MM@W
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behavior 316530 0
Condition category
Condition code
Public Health 314775 314775 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this intervention is for participants to perform 1-2 min of activity after every 30 min of continuous sitting throughout their work day. Once both pre-intervention assessments have taken place, all participants will have an individual consultation with a Move More @ Work Coach (a postgraduate student trained in physical activity related behaviour change techniques) lasting around 30 min. This consultation will mark the start of the intervention period. During this consultation, the coach will:
1. Briefly, discuss current evidence around sitting as a health hazard, and the health benefits associated with performing regular short bouts of movement throughout the day.
2. Discuss, and demonstrate where necessary, examples of activities that meet the intensity and duration required of an opportunity to move. These activities will also be detailed in the participant booklet that accompanies the study. Links will also be provided to videos showing the specific movements being undertaken.
3. Discuss their individual profile of the time they spent sitting and being active at work (collected from the accelerometers) during the pre-intervention assessments. The coach will highlight the discrepancies between current sedentary time and the expected behaviour if participants take an opportunity to move every 30 min.
4. Develop an individualised action and contingency plan (Bélanger-Gravel A, Godin G, Amireault S. A meta-analytic review of the effect of implementation intentions on physical activity. Health Psychology Review 2013;71:23-54). The action plan involves participants specifying exactly what activities they will perform (and would easily fit into their work context), when they will do them (e.g., may have different activities at different times of the day), and where (e.g. in the office, on the stairs). The barrier contingency plan involves participants identifying potential barriers that they may face when implementing this plan and putting strategies in place to overcome those barriers (Bélanger-Gravel A, Godin G, Amireault S. A meta-analytic review of the effect of implementation intentions on physical activity. Health Psychology Review 2013;71:23-54).
5. Provide participants with a laminated chart to record that the opportunity to move specified in their action plan was performed. This will also provide the prompt for participants to self-reflect on how they are feeling both physically and mentally at the end of each day. Participants will be asked to report the number of opportunities to move recorded on this chart back to the research team on a weekly basis by responding to the weekly study email.
6. Discuss which external electronic prompt the participant would like to use as a reminder to take their opportunities to move (an outlook calendar reminder -available on a PC or Mac, or the computer announcing the time every 30 min –Mac only). The coach will then help the participant set these prompts up on their computer.
A personalized booklet outlining these discussion points will be provided to each participant in hard copy (designed specifically for this study). Participants will also receive a laminated card on which to record their weekly action and contingency plan. Participants will be encouraged to place their action and contingency card within eyesight of their workstation to assist with self-monitoring.

At the beginning of each week of the intervention period, participants will receive an email reminding them to set weekly action and barrier plans. Participants will be asked to email a photo of this plan at the beginning of the week (to indicate they have completed their plan) to the research team.
Intervention code [1] 317035 0
Behaviour
Intervention code [2] 317079 0
Treatment: Other
Comparator / control treatment
The comparator will be usual behavior, measured at baseline
Control group
Active

Outcomes
Primary outcome [1] 323133 0
The feasibility of this intervention will be assessed by the change in number of opportunities to move that have been taken during the work day, measured via accelerometry at baseline and followup
Timepoint [1] 323133 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [1] 380897 0
total physical activity measured via accelerometry
Timepoint [1] 380897 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [2] 380898 0
total sedentary time measured via accelerometry
Timepoint [2] 380898 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [3] 380899 0
sleep, measured by accelerometry
Timepoint [3] 380899 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [4] 380900 0
Cardiometabolic risk score (made up of measurements of waist circumference; measured using a anthropomorphic measuring tape, fasting glucose;measured in plasma using the hexokinase enzymatic method, fasting triglyceride; measured in plasma using the glycerol phosphate oxidase enzymatic method and, systolic and diastolic blood pressure measured via automated sphygmomanometer)
Timepoint [4] 380900 0
Measured once at baseline (-1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [5] 380902 0
Musculoskeletal Health will be assessed using the Standardised Nordic Questionnaire
Timepoint [5] 380902 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [6] 380903 0
Psychological Well-Being will be assessed using the Positive and Negative Affect Schedule – short form (PANAS)
Timepoint [6] 380903 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [7] 380905 0
Work Engagement will be assessed using the Utrecht Work Engagement Scale 9
Timepoint [7] 380905 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [8] 380906 0
Occupational fatigue will be assessed using the 11-item Need for Recovery Scale
Timepoint [8] 380906 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)
Secondary outcome [9] 380908 0
Impact of health on work will be assessed using the Work Limitations Questionnaire – Short Form
Timepoint [9] 380908 0
Two baseline measures (-3 and -1 weeks), at the end of the intervention period (10 weeks) and the end of the followup period (20 weeks)

Eligibility
Key inclusion criteria
To be eligible for inclusion, participants must be employees of the University of Otago and based at the Dunedin campus, older than 18 years, self-report spending >5 h per day, on at least three days of the week in a seated position at work, and not be using a sit-to-stand desk.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Because this study requires participants to undertake short bouts of physical activity, participants will be excluded from participating if they have any physical or physiological impediments to participating in physical activity (all participants will be screened for contra-indications using the Physical Activity Readiness Questionnaire prior to starting the study).

To ensure participants are at work during the majority of the intervention period participants will be excluded from participating if
• they have a planned absence from work for >2 weeks during the study,
• they plan to relocate to another workplace other than the University of Otago, Dunedin campus during the 6 month study period (intervention and follow-up).

Participants will also be excluded from participation if they are pregnant as pregnancy will effect waist circumference, which is a component of the cardio-metabolic risk score.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
An interrupted time series design will be utilised in this study. In this design, baseline assessments are taken from every participant twice over a period of three weeks, and then the intervention is introduced to all participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations using the standard deviation in the number of activity breaks (in this study referred to as opportunities to move) observed in previous research (Keown M, Skeaff M, Perry T, Haszard J, Peddie M. Device Measured Sedentary Bheaviour Patterns in Office Employees. Journal of Occupational and Environmental Medicine 2018;60(12);1150-1157.) indicate that 47 participants from approximately 10 different offices will provide 90% power to detect a difference of three opportunities to move between pre-intervention and completion of the intervention, and post-intervention periods to an alpha level of 0.05. This assumes that the within person correlation in activity breaks is 0.5 and the standard deviation is 3. To account for office clusters a design effect of 4.2 was used (using an average cluster size of n=5 and a strong ICC of 0.8). Allowing for a drop of rate of ~20% 57 participants will be recruited

Statistical methods
The effect of the intervention on outcomes of interest will be assessed using mixed effects Poisson regression and linear mixed models, with 12-week and 24-week measures as outcomes and time as a fixed effect. Measurements taken during the pre-intervention period will be included as covariates (with repeated measures for the accelerometer measurements that are collected twice during the pre-intervention period) and participant as a random effect. Mean changes in outcomes with 95% CI will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2020
Actual
Date of last participant enrolment
Anticipated
9/04/2020
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
57
Accrual to date
Final
Recruitment outside Australia
Country [1] 22419 0
New Zealand
State/province [1] 22419 0
Otago

Funding & Sponsors
Funding source category [1] 305158 0
University
Name [1] 305158 0
University of Otago
Country [1] 305158 0
New Zealand
Primary sponsor type
University
Name
Department of Human Nutrition, University of Otago
Address
PO Box 56
Dunedin
New Zealand
9018
Country
New Zealand
Secondary sponsor category [1] 305520 0
University
Name [1] 305520 0
School of Physical Education, Sport and Exercise Science, University of Otago
Address [1] 305520 0
PO Box 56
Dunedin
New Zealand
9018
Country [1] 305520 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305525 0
University of Otago Human Ethics Committee
Ethics committee address [1] 305525 0
PO Box 56
Dunedin
New Zealand 9018
Ethics committee country [1] 305525 0
New Zealand
Date submitted for ethics approval [1] 305525 0
17/02/2020
Approval date [1] 305525 0
02/03/2020
Ethics approval number [1] 305525 0
H20/028

Summary
Brief summary
Sitting for long periods is associated with increased mortality and morbidity from cardio-metabolic diseases. The results of intervention studies indicate that this association is likely mediated through the effects prolonged sitting have on postprandial glucose and insulin concentrations. Particularly in healthy people, regularly interrupting periods of sitting with short bouts of physical activity in a highly controlled laboratory environment has been shown to improve postprandial glucose and insulin responses to a greater degree than either short periods, or continuous bouts of standing. However, it is not known if performing regular activity breaks (hence forth referred to as opportunities to move) outside a laboratory environment would have the same effects. Importantly, to successfully motivate adherence to this pattern of behaviour the intervention needs to incorporate strategies that support self-regulation of behaviour, provide external support and overcome work productivity and workplace culture barriers. The Move More @ Work study investigates the feasibility of an intervention designed to encourage staff to take 1 – 2 minute opportunities to move after every 30 min of continuous sitting over the work day. It will also examine adherence to the intervention and the extent to which this pattern of behaviour can improve indicators of cardio-metabolic health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100666 0
A/Prof Elaine Hargreaves
Address 100666 0
University of Otago
PO Box 56
Dunedin
New Zealand
9018
Country 100666 0
New Zealand
Phone 100666 0
+64 3 4798941
Fax 100666 0
Email 100666 0
elaine.hargreaves@otago.ac.nx
Contact person for public queries
Name 100667 0
Dr Meredith Peddie
Address 100667 0
University of Otago
PO Box 56
Dunedin
New Zealand
9018
Country 100667 0
New Zealand
Phone 100667 0
+64 3 479 8358
Fax 100667 0
Email 100667 0
meredith.peddie@otago.ac.nz
Contact person for scientific queries
Name 100668 0
Dr Meredith Peddie
Address 100668 0
University of Otago
PO Box 56
Dunedin
New Zealand
9018
Country 100668 0
New Zealand
Phone 100668 0
+64 3 479 8358
Fax 100668 0
Email 100668 0
meredith.peddie@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results
When will data be available (start and end dates)?
immediately following publication and ending 5 years following main results publication
Available to whom?
case by case basis at the discretion of the primary investigator
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
access subject to approvals by principal investigator, who can be contacted by email using the email listed on ANZCTR


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.