Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000457145
Ethics application status
Approved
Date submitted
12/03/2019
Date registered
20/03/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
20/03/2019
Date results information initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Work-HIIT: A time efficient work-place physical activity program
Scientific title
Evaluating the efficacy and feasibility of a University-based high intensity interval training program (Work-HIIT) on health and well-being in adults in the work place.
Secondary ID [1] 297221 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
Work-HIIT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Body composition 311276 0
Muscular fitness 311277 0
Cardio-respiratory fitness 311278 0
Physical activity levels 311279 0
Self-efficacy 311280 0
Job satisfaction 311281 0
Sleep patterns 311282 0
Anxiety 311283 0
Motivation 311284 0
Condition category
Condition code
Public Health 309893 309893 0 0
Health promotion/education
Mental Health 309894 309894 0 0
Anxiety
Mental Health 309895 309895 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 309896 309896 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Work-HIIT will be run as a semester long (16 weeks) work place exercise program at the University of Newcastle, Australia. Session times (before work / lunch time or after work) and locations will be adapted to suit participants (where possible), with group sizes also determined by participant preferences. Participants can become involved individually or as a small group, with multiple sessions offered throughout the week. Work-HIIT will be implemented and evaluated as a randomized controlled trial (RCT). All staff who choose to participate in the study will be randomised into either the intervention group or the wait-list control group (Receives program in Semester 2). Participants will be asked to complete 3 x 10min HIIT exercise sessions per week for the entire semester. The first eight weeks will be supervised by a member of the research team and the following weeks will be participant lead.
All HIIT sessions with include a range of body weight and aerobic exercises. Sessions are designed to enjoyable by encouraging participants to work in pairs of their choice (with one participant undertaking the ‘work’ phase while their partner rests), and as the intervention progresses participants will also be provided with additional elements of choice including: music (playlists), exercise choice during a workout, and choice of workouts. Participants will also be asked to wear a heart rate monitor during sessions so that they can monitor their exercise intensity. Importantly graded exercises to suit all fitness / skill levels will be available.

The feasibility and the effectiveness of the Work-HIIT program for improving a range of health and wellbeing outcomes in adults in the workplace will be assessed using validated measures at baseline (February 2019), 10-weeks (April 2019) and at 6-month follow-up (July 2019). Participants will also be asked to give their opinions about the program via a short evaluation survey at the completion of the program. Participation in this research is entirely your choice and only those participants who have provided explicit written consent will be included in the study. Participants may also withdraw from the study at any time without giving a reason.

Participants use of heart rate monitors and pre/post session evaluations will be used to monitor adherence.
Intervention code [1] 313473 0
Lifestyle
Intervention code [2] 313474 0
Behaviour
Intervention code [3] 313475 0
Prevention
Comparator / control treatment
The wait-list control group will receive the program in Semester 2 (after 16 weeks).
Control group
Active

Outcomes
Primary outcome [1] 318835 0
Cardio-respiratory fitness - (PACER) shuttle run/test
Timepoint [1] 318835 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [1] 366199 0
Muscular fitness - 90° push-up test & the standing long jump.
Timepoint [1] 366199 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [2] 366200 0
Body composition - Body Mass Index, BMI-z scores (using the ‘LMS’ method) will be calculated. Specifically, height and weight will be measured using both a portable digital scale and stadiometer. BMI will be calculated using the standard equation (weight [kg] / height [m]2).
Timepoint [2] 366200 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [3] 366201 0
Feelings state questionnaire
Timepoint [3] 366201 0
Before and after each exercise session
Secondary outcome [4] 366202 0
Evaluation survey (Likert scale assessment of the perceived benefits of physical activity and feelings toward health in theory resulting from Work-HIIT). This survey also provides an indication of Work-HIIT i.e., feasibility and was designed specifically for the study.
Timepoint [4] 366202 0
End of the program (6 months)
Secondary outcome [5] 366203 0
Motivation to engage in PA - (Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2))
Timepoint [5] 366203 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [6] 366204 0
HIIT self-efficacy scale
Timepoint [6] 366204 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [7] 366205 0
Wellbeing at work: Short-SWELL
Timepoint [7] 366205 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [8] 366206 0
Job satisfaction: MOAQ-JSS
Timepoint [8] 366206 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [9] 366207 0
Productivity at Work (Questionnaire that was designed specifically for the study).
Timepoint [9] 366207 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [10] 366208 0
Sleep Patterns (Questionnaire completed by participants)

Specific references:
1. Ohayon, M., et al., National Sleep Foundation's sleep quality recommendations: first report. Sleep Health, 2017. 3(1): p. 6-19.
2. Meltzer, L.J., et al., The Children's Report of Sleep Patterns--Sleepiness Scale: a self-report measure for school-aged children. Sleep Med, 2012. 13(4): p. 385-9.
Timepoint [10] 366208 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [11] 366209 0
Perceived Workplace Environment Scale (PWES)
Timepoint [11] 366209 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.
Secondary outcome [12] 366210 0
Anxiety: GAD-7
Timepoint [12] 366210 0
Baseline, 10-weeks and at 6-month follow-up after intervention commencement.

Eligibility
Key inclusion criteria
Male and female staff located at the Callaghan Campus of UoN (at the University of Newcastle, Australia) and who report that they sit often or all of the time at work will be recruited to participate in the intervention and eligible study participants will be aged 18+ years, be available to attend three sessions per week, and have no existing medical conditions or injuries preventing participation is assessments or the Work-HIIT sessions (determined via a pre-screening questionnaire).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No existing medical conditions or injuries preventing participation is assessments or the Work-HIIT sessions (determined via a pre-screening questionnaire).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2019
Actual
20/03/2019
Date of last participant enrolment
Anticipated
26/04/2019
Actual
30/04/2019
Date of last data collection
Anticipated
15/11/2019
Actual
15/11/2019
Sample size
Target
50
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301769 0
University
Name [1] 301769 0
University of Newcastle’s Women in Research Fellowship
Country [1] 301769 0
Australia
Primary sponsor type
Individual
Name
Dr Narelle Eather of the University of Newcastle
Address
Office: Room 310, HPE Building, University of Newcastle, Callaghan Campus, University Drive, Callaghan, NSW, 2308, Australia
Country
Australia
Secondary sponsor category [1] 301513 0
None
Name [1] 301513 0
Address [1] 301513 0
Country [1] 301513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302487 0
The University of Newcastle Human Research Ethics Committee.
Ethics committee address [1] 302487 0
University’s Human Ethics Committee, Research Services, NIER Precinct, The University of Newcastle, University Drive, Callaghan NSW 2308, Australia.
Ethics committee country [1] 302487 0
Australia
Date submitted for ethics approval [1] 302487 0
07/01/2019
Approval date [1] 302487 0
26/02/2019
Ethics approval number [1] 302487 0
H-2016-0407

Summary
Brief summary
Work-HIIT will be evaluated using a RCT design (N = 50 workers) to encourage staff to manage sedentary time by attending at least 3 HIIT sessions a week, for a Semester (16 weeks). All HIIT sessions include a range of body weight and aerobic exercises. A range of health and wellbeing outcomes will be assessed using validated measures. Staff at the University of Newcastle who report they are mostly sedentary at work will be recruited (aged 18+ years, and have no existing medical conditions).
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 90390 0
Dr Narelle Eather
Address 90390 0
Room:: HPE310
Building: Health and Physical Education HPE
Location: Callaghan, University Drive, Callaghan, NSW 2308, Australia
Organisation: University of Newcastle
Country 90390 0
Australia
Phone 90390 0
+61 2 4921 6232
Fax 90390 0
Email 90390 0
[email protected]
Contact person for public queries
Name 90391 0
Dr Narelle Eather
Address 90391 0
Room:: HPE310
Building: Health and Physical Education HPE
Location: Callaghan, University Drive, Callaghan, NSW 2308, Australia
Organisation: University of Newcastle
Country 90391 0
Australia
Phone 90391 0
+61 2 4921 6232
Fax 90391 0
Email 90391 0
[email protected]
Contact person for scientific queries
Name 90392 0
Dr Narelle Eather
Address 90392 0
Room:: HPE310
Building: Health and Physical Education HPE
Location: Callaghan, University Drive, Callaghan, NSW 2308, Australia
Organisation: University of Newcastle
Country 90392 0
Australia
Phone 90392 0
+61 2 4921 6232
Fax 90392 0
Email 90392 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
No IPD will not be available for privacy and security.


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.