Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001567213p
Ethics application status
Submitted, not yet approved
Date submitted
28/08/2018
Date registered
19/09/2018
Date last updated
19/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A physical activity and healthy eating program to enhance school staff health.
Scientific title
Addressing the health risk behaviours of the education workforce: A program to enhance the wellbeing of primary school staff.
Secondary ID [1] 295933 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 309434 0
Unhealthy dietary intake 309435 0
Condition category
Condition code
Public Health 308282 308282 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The six month intervention is guided by social-influence and cognitive-behavioural theories and utilizes the Get Healthy@Work framework to support school’s implementation of the following existing two programs;
(i) Premier’s Sporting Challenge (PSC): To support school staff to increase their physical activity, schools will be supported to implement the NSW Department of Education’s Premiers Sporting Challenge. This 10 week program encourages staff both at an individual and school level to meet physical activity guidelines by monitoring and recording their own activity through the “PSC Tracker App”. The program provides school staff with pedometers and access to on-line resources to help achieve their physical activity goals. The PSC encourages participants to increase activity levels and tracks their progress through the app and an e-wall chart. Award levels for the 10 week challenge reflect a daily activity time commitment - either as part of team or as an individual. Once the Challenge has begun, data entry should be maintained on a week-to-week basis to effectively monitor physical activity progress. All types of moderate to vigorous physical activities can count toward an award. Awards are based on the amount of time spent being physically active. For example, Bronze 30 minutes per day, Silver 45 minutes per day, Gold 60 minutes per day, Diamond 80 minutes per day. The school communication platform app will also be used to send messages and reminders to school staff regarding physical activity.
(ii) Healthy eating program: To support school staff to increase their consumption of vegetables, fruit and water and decrease their consumption of discretionary foods and sugary drinks, schools will be supported to implement a healthy eating program that will provide school staff with advice and resources on how to make simple healthier swaps to their lunches, snacks and catering for staff gatherings etc. from ‘less healthy’ foods for ‘healthier’ everyday items whilst at school. In addition school staff will be encouraged to use existing, reputable websites and apps such as those promoted on the Teachers Health Fund website to support their changes. Part of the program involves messaging to school staff through a communication platform app currently used by the school. App analytics will be used to monitor receiving of these messages by school staff. Support officer contact with the in-school champion throughout the intervention duration will be used to monitor staff progress with the healthy eating program.

To increase the extent of schools’ implementation of these programs, strategies recommended by the NSW Governments Get Healthy@Work Framework as well as those that have previously been utilised by the research team to successfully change the health promoting policies and practices of schools and other organisations will be implemented. This includes;

(i) Program implementation support- Intervention schools will have access to a support officer, an experienced health promotion practitioner with training in physical education or nutrition, to support implementation of the programs in the school by working directly with school champions and committees to overcome barriers, and provide on-going support.
(ii) Obtaining school executive support- Support officers will meet with principals to gain their support for the initiative. Principals and the executive will be asked to demonstrate support for the implementation of the programs through their usual communications with staff.
(iii) In-school Champion- each school will nominate an in-school champion who are existing staff members at the school, and who (with assistance of support officers) will lead and promote implementation of the programs in schools and chair the school committee. Champions will complete a 1-day face-to-face workshop conducted by dietitians and physical educaiton teachers on the project team. In-school champions will then have ongoing contact with support officers across the intervention duration.
(iv) Provision of tools and resources- in-school champions will receive various printed and electronic instructional materials to implement the programs (posters, templates, power point presentations). Existing tools and resources from the Get Healthy@Work program will be adapted and tailored to the school work setting.
(v) Implementation feedback- the support officer will work with in-school champions and committees to develop an action plan to identify key tasks to implementing the programs. Support officers will monitor implementation of the action plans and provide tailored feedback to in-school champions.
Intervention code [1] 312255 0
Prevention
Intervention code [2] 312256 0
Behaviour
Intervention code [3] 312257 0
Lifestyle
Comparator / control treatment
Schools allocated to the control group will participate in the measurement components of the study only. As schools are free to implement any of the recommended programs any potential exposure to the existing services will be collected through surveys with school staff at follow-up data collection.
Control group
Active

Outcomes
Primary outcome [1] 307249 0
Physical activity counts per minute: School staff physical activity will be assessed using ActiGraph accelerometers (Model GT3X+; and GT3X model), which are worn on the wrist much like a watch. Accelerometers are the gold standard for measuring physical activity in adults as they are small, light, acceptable and provide an objective, valid and reliable way of measuring physical activity in adults. School staff will be asked by trained research assistants, blinded to group allocation, to wear the accelerometers during waking hours for seven consecutive days.
Timepoint [1] 307249 0
Baseline and 6-months post-baseline.
Primary outcome [2] 307498 0
Staff moderate-vigorous physical activity (MVPA) will be measured as per above accelerometry.
Timepoint [2] 307498 0
Baseline and 6-months post baseline.
Secondary outcome [1] 351265 0
Dietary behaviours: Items from the NSW Population Health Survey will be used to assess school staff consumption of; i) serves of fruits and vegetables, ii) number of discretionary snacks, iii) glasses of water and iv) number of sugar sweetened beverages per day.
Timepoint [1] 351265 0
Baseline and 6-months post-baseline.
Secondary outcome [2] 351266 0
Well-being: School staff wellbeing will be assessed using Cohen’s Perceived Stress Scale which is a widely used psychological instrument for measuring the perception of stress. The 10-item tool asks participants about their feelings and thoughts during the last month.
Timepoint [2] 351266 0
Baseline and 6-months post-baseline.
Secondary outcome [3] 351267 0
Pain: School staff musculoskeletal pain will be assessed using a 5-item tool to ask participants about muscle, joint or bone pain over the last 12 months.
Timepoint [3] 351267 0
Baseline and 6-months post-baseline.
Secondary outcome [4] 351268 0
Sleep: School staff sleep patterns and satisfaction will be assessed using the 7-item composite insomnia severity index.
Timepoint [4] 351268 0
Baseline and 6-months post-baseline.
Secondary outcome [5] 352080 0
Staff sedentary behaviour will be measured via accelerometry.
Timepoint [5] 352080 0
Baseline and 6-months post baseline

Eligibility
Key inclusion criteria
NSW Government primary schools in the Hunter New England region who currently use the Skoolbag communication app.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools located outside of the Hunter New England Local Health District, with secondary students (central schools), catering exclusively for children requiring specialist care, and/or already involved in an obesity prevention intervention trial will be ineligible.

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)
Following recruitment and baseline data collection, an independent statistician will use a computerised random number function to randomise schools in a 1:1 ratio to either the intervention or a wait-list control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation to study group will be by stratified block randomisation, where a set of permuted blocks will be generated for each strata for example LHD.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on data held by the research team, the average primary school in the study region will have 10 staff members. Using a conservative estimate of a 70% response rate from school staff and assuming 20% loss-to-follow-up, a sample of 10 intervention and 10 control schools will provide a sample of approximately 357 staff (178 intervention and 178 control) at follow-up. Assuming a standard deviation of 18 mins at follow-up in the comparison group, and a conservative intra class correlation coefficient of 0.5 the sample will be sufficient to detect an absolute difference of 8 minutes, with 80% power and an alpha of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2018
Actual
Date of last participant enrolment
Anticipated
21/12/2018
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300531 0
Commercial sector/Industry
Name [1] 300531 0
Teachers Health Fund
Country [1] 300531 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 300009 0
None
Name [1] 300009 0
Address [1] 300009 0
Country [1] 300009 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301319 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301319 0
Ethics committee country [1] 301319 0
Australia
Date submitted for ethics approval [1] 301319 0
31/08/2018
Approval date [1] 301319 0
Ethics approval number [1] 301319 0

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

Contacts
Principal investigator
Name 86622 0
Dr Nicole Nathan
Address 86622 0
HNE Population Health
Longworth Ave
Wallsend NSW 2287
Country 86622 0
Australia
Phone 86622 0
+61 2 49 246 257
Fax 86622 0
Email 86622 0
[email protected]
Contact person for public queries
Name 86623 0
Nicole Nathan
Address 86623 0
HNE Population Health
Longworth Ave
Wallsend NSW 2287
Country 86623 0
Australia
Phone 86623 0
+61 2 49 246 257
Fax 86623 0
Email 86623 0
[email protected]
Contact person for scientific queries
Name 86624 0
Nicole Nathan
Address 86624 0
HNE Population Health
Longworth Ave
Wallsend NSW 2287
Country 86624 0
Australia
Phone 86624 0
+61 2 49 246 257
Fax 86624 0
Email 86624 0
[email protected]

No information has been provided regarding IPD availability


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.