ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000461594

Ethics application status

Approved

Date submitted

30/01/2024

Date registered

15/04/2024

Date last updated

13/10/2024

Date data sharing statement initially provided

15/04/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating the ability of Systems Thinking with Active Implementation (STAIR) to create healthy school environments: an effectiveness-implementation trial

Scientific title

Investigating the ability of Systems Thinking with Active Implementation (STAIR) to create healthy school environments: an effectiveness-implementation trial with weight status and implementation effectiveness as primary outcomes.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1296-9156

Trial acronym

STAIR

Linked study record

Health condition

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

Childhood obesity

Physical Inactivity

Poor diet

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Primary Schools randomly selected for the intervention will receive a multistage process undertaken by each school community.

Prior to the intervention, the research team will collect data on obesity prevalence, quality of life, dietary and physical activity behaviours, sleep, and the school environment.

This information will be provided to the school and, through a series of three 2-3 hour face-to-face or online Group Model Building (GMB) workshops conducted over a week, the causes of childhood obesity will be described and visualised using causal loop diagrams. The workshops will be led by a member of the research team and they will mark the start of the intervention. Participants will be from each school community (student leaders, principal, teachers, parents and friends, committee members, school canteen staff, health promotion officers, GPs, health reporters, food retailers) and we will use Systems Thinking In Community Knowledge Exchange (STICKE) software to help communities visualise the causes of obesity and to standardise the intervention design process across schools. Opportunities for obesity prevention will be identified that build on existing actions and align with evidence of best practice. Children in Years 5 and 6 will help design intervention actions (action formulation) with the school principal, teachers, parents and friends, committee members, school canteen staff, and community leaders (e.g. health promotion officers, GPs, health reporters, food retailers).

Intervention actions (typically 20 to 30) will then be implemented by the school and $6000 ($2000/year) will be provided to each intervention school to help implement the actions. Examples of specific actions include banning sweetened beverages and establishing walking and cycling zones around school premises.

After identifying the intervention actions, a fourth GMB workshop, GMB4, will be conducted a week or two later to link these actions to school readiness and implementation support (community infrastructure and resources) using Active Implementation functions. This implementation process aims to strengthen the prevention support system for healthy eating and physical activity in schools.

Follow-up GMB sessions will be conducted approximately every 6 months to update actions and strengthen implementation.

Intervention code [1]

Prevention

Comparator / control treatment

Primary schools randomly selected to the comparison condition will receive usual support as well as $6000 ($2000/year) for promoting student wellbeing during the intervention period at the discretion of the school. This may include providing health promotion materials or linking with Victoria's Achievement Program. Control schools will also be provided with a written report summarizing obesity prevalence, quality of life, dietary, oral health and physical activity behaviours, and the school environment at baseline, after each wave of data collection (1 year post-baseline, 2 years post baseline), and at the end of the trial (3 years post baseline). At the end of the trial, they will also receive a report on the overall results of the STAIR trial and, should they wish to design their own intervention, access to the Systems Thinking in Community Knowledge Exchange (STICKE) training modules and software.

Control group

Active

Outcomes

Primary outcome [1]

Change in childhood z-BMI score in cross sections of students at Victorian primary schools. Weight will be measured using electronic scales, height using stadiometers and body mass index (BMI) will be calculated.

Timepoint [1]

Repeat cross-sections at baseline, Year 1, Year 2 and year 3 post intervention commencement

Primary outcome [2]

Change in acceptability of STAIR implementation support as assessed by intervention school staff via a study-specific online survey, semi-structured interviews with a member of the research team and an action register (logbook and causal loop diagrams).

Timepoint [2]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Primary outcome [3]

Adoption of STAIR intervention actions and implementation support as assessed by intervention school staff via a study-specific online survey, semi-structured interviews with a member of the research team and an action register (logbook and causal loop diagrams).

Timepoint [3]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [1]

Change in overweight and obesity prevalence in cross sections of students at Victorian primary schools. Weight will be measured using electronic scales, height using stadiometers and body mass index (BMI) will be calculated

Timepoint [1]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [2]

Change in appropriateness of STAIR intervention actions and implementation support as assessed by intervention school staff via a study-specific online survey, semi-structured interviews with a member of the research team and an action register (logbook and causal loop diagrams).

Timepoint [2]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [3]

Change in the feasibility of STAIR intervention actions and implementation support as assessed by intervention school staff via a study-specific online survey, semi-structured interviews with a member of the research team, an action register (logbook and causal loop diagrams) and an audit of study enrolment/withdrawal logs.

Timepoint [3]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [4]

Fidelity of STAIR intervention actions and implementation support as assessed by intervention school staff via a study-specific online survey, semi-structured interviews with a member of the research team and an action register (logbook and causal loop diagrams).

Timepoint [4]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [5]

Sustainability of STAIR intervention actions and implementation support as assessed by intervention school staff via a study-specific online survey, semi-structured interviews with a member of the research team and an action register (logbook and causal loop diagrams).

Timepoint [5]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [6]

Penetration of STAIR intervention actions and implementation support as assessed by intervention school staff via a study-specific online survey, semi-structured interviews with a member of the research team and an action register (logbook and causal loop diagrams).

Timepoint [6]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [7]

Change in moderate to vigorous physical activity as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated physical activity questions.

Timepoint [7]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [8]

Change in mode of transportation to and from school as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated physical activity questions.

Timepoint [8]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [9]

Change in frequency of teeth brushing as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated oral health questions.

Timepoint [9]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [10]

Change in rating of oral health as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated oral health questions.

Timepoint [10]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [11]

Change in dentist visits as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated oral health questions.

Timepoint [11]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [12]

Change in sleep behaviour as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated sleep questions.

Timepoint [12]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [13]

Change in serves of vegetables each day as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated food frequency questions.

Timepoint [13]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [14]

Change in serves of fruit each day as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated food frequency questions.

Timepoint [14]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [15]

Change in frequency of take-away consumption as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet and based on validated food frequency questions.

Timepoint [15]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [16]

Change in frequency and amount of savoury snacks consumed as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on validated food frequency questions. Note frequency and amount will be assessed as separate outcomes.

Timepoint [16]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [17]

Change in frequency and amount of lollies and/or chocolates consumed as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on validated food frequency questions. Note frequency and amount will be assessed as separate outcomes.

Timepoint [17]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [18]

Change in frequency and amount of cakes, sweet biscuits, pastries, and donuts consumed as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on validated food frequency questions. Note frequency and amount will be assessed as separate outcomes.

Timepoint [18]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [19]

Change in frequency and amount of sugar sweetened beverages consumed as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on validated food frequency questions. Note frequency and amount will be assessed as separate outcomes.

Timepoint [19]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [20]

Change in frequency and amount of fruit juice, fruit drink, cordial consumed as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on validated food frequency questions. Note frequency and amount will be assessed as separate outcomes.

Timepoint [20]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [21]

Change in frequency and amount of flavoured milk consumed as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on validated food frequency questions. Note frequency and amount will be assessed as separate outcomes.

Timepoint [21]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [22]

Change in amount of water consumed each day as self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on validated food frequency questions.

Timepoint [22]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [23]

Change in Global, physical and psychosocial quality of life, self-reported by grade 4-6 children in a study-specific questionnaire administered using an electronic tablet based on PedsQL

Timepoint [23]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [24]

The following outcomes will be reported by the School Principal or nominee in the electronic School Environment Audit:
- Change in effectiveness of written school policies or practices on physical activity
- Change in written school policies or practices on healthy eating
- Change in effectiveness of written school policies or practices on healthy eating
Note, each outcome will be assessed separately.

Timepoint [24]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [25]

Change in committee providing guidance on physical activity and healthy eating as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [25]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [26]

Change in awareness by teachers of policies on physical activity and healthy eating as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [26]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [27]

Change in awareness by parents of policies on physical activity and healthy eating as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [27]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [28]

Changes in public access to food and nutrition policy via website as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [28]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [29]

Changes in minutes/week devoted to formal physical education as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [29]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [30]

Changes in minutes/week devoted to organised sport as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [30]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [31]

Changes in average time children participate in physical education as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [31]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [32]

Changes in sports offered as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [32]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [33]

Changes in how physical activity is characterised as reported by the School Principal or nominee in the electronic School Environment Audit.

Timepoint [33]

Baseline, 1-year, 2-years and 3 years post intervention commencement.

Secondary outcome [34]

Changes in how physical activity is role modelled as reported by the School Principal or nominee in the electronic School Environment Audit.

Timepoint [34]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [35]

Changes in the promotion of physical activity as reported by the School Principal or nominee in the electronic School Environment Audit.

Timepoint [35]

Baseline, 1-year, 2-years and 3 years post intervention commencement.

Secondary outcome [36]

Changes in how programs/activities related to physical activity as reported by the School Principal or nominee in the electronic School Environment Audit

Timepoint [36]

Baseline, 1-year, 2-years and 3 years post intervention commencement.

Secondary outcome [37]

Changes in effectiveness of activities to promote physical activity as reported by the School Principal or nominee in the electronic School Environment Audit.

Timepoint [37]

Baseline, 1-year, 2-years and 3 years post intervention commencement.

Secondary outcome [38]

The following changes in the nutrition environment as reported by the School Principal or nominee in the electronic School Environment Audit
- Level of priority for nutrition at your school
- Extent to which teachers at your school act as role models by eating healthy foods
- Support for healthy eating provided by parents at your school
- Internal (school/volunteers) or external (commercial operator) operation of canteen service
- Allowing students to leave school grounds during the school day
- Review of canteen menu (frequency, by whom)
- Adequacy of space in the canteen for food preparation
Note, each outcome will be assessed separately.

Timepoint [38]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [39]

The following changes in the nutrition environment as reported by the School Principal or nominee in the electronic School Environment Audit
- Healthy food choices at a reasonable/subsidised price
- Daily healthy eating specials
- Healthy eating canteen program (eg traffic light labelling system)
- Routine promotion/advertisement of healthy food choices
- Review of the canteen menu on a regular basis.

- Offering healthy food choices during breakfast program
- Offering healthy food choices in the canteen
- 'Nude food' program or days
- Stopped the sale of junk foods
- Held junk food free days
- Stopped the sale of sugar-sweetened beverages
- Vic Kids Eat Well
- Achievement program
- Stephanie Alexander kitchen garden program
- Other type of garden program
- Environmental sustainability program related to food

-Use of food and/or beverage rewards in classrooms

- Sales of chocolate or lollies as part of fundraising or events for the school.
- Sales of other junk food (eg chips, popcorn) as part of fundraising or events for the school.
- Sales of soda pop or fruitdrinks that are not 100% juice as part of fundraising or events for the school.
- Sales of sport drinks as part of fundraising or events for the school.
- Sales of chocolate or lollies as part of fundraising or events for the school.
- Sales of biscuits, cakes, pastries, or other baked goods as part of fundraising or events for the school.
- Sales of fruits or vegetables as part of fundraising or events for the school.
- Sales of 100% fruit juice or vegetable juice as part of fundraising or events for the school.

- Offering cooking classes
- Offering field trips to fames/primary producers
- Offering media literacy on special topics related to healthy eating
- Offering field trips to the local grocery store/farmers markets
- Offering gardening (eg growing produce/school gardens
- Offering school breakfast program
- Offering 'other' activities
- Effectiveness of offered activities
- Barriers to offering activities

- Allowing students to drink water in the classrooms during class time
- Number of water fountains on the school grounds
- Allowing students to eat in the classrooms during class time
Note, each group of outcomes will be assessed separately.

Timepoint [39]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Secondary outcome [40]

Cost saving ($) of diseases averted through reduced exposure to BMI as assessed by models based on change in zBMI
- We will conduct a trial based evaluation and a modelled economic evaluation using a multi-state life table Markov model to estimate the healthy beneftis (HALYS) and healthcare cost-savings of diseases averted over the lifetime of the intervention population.

Cost of implementation support captured from activity logs completed by staff in intervention schools.
- A cost-consequence analysis will present disaggregated implementation costs and outcomes.

Timepoint [40]

Baseline, 1-year, 2-years and 3 years post intervention commencement

Eligibility

Key inclusion criteria

There are two types of participants in this study, adult staff from participating schools and support organisations and children attending participating schools.

School and supporting organisational staff are eligible to participate if they are involved with healthy eating and physical activity in Schools
All children in Years 1-6 at selected primary schools will be invited to participate.

Minimum age

6 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

We will exclude schools with fewer than 120 children and schools exclusively educating children with special needs.

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)

Allocation is not concealed

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

Simple randomisation of clusters (schools) using a randomisation table created by computer software

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

Students will be the unit of analysis. All analyses will be conducted under the intention-to-treat principle. The effect of the STAIR intervention on the primary outcome (z-BMI) will be assessed using a linear mixed model with study group, time (baseline, 2-year follow-up, 3-year follow-up), and the interaction group × time as fixed effects and school. School and student will be included as random effects to account for clustering of students within schools and repeated measures in students measured more than once (e.g., students in year 1 at baseline and year 3 at the 3-year follow-up). Secondary outcomes will be analysed by fitting a generalized linear mixed model with link and distribution selected according to the outcome distribution. Multiple imputation will be used to manage missing outcomes. We will explore if age modifies the intervention effect using the same modelling approach.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

17/02/2025

Actual

Date of last participant enrolment

Anticipated

27/06/2025

Actual

Date of last data collection

Anticipated

28/06/2027

Actual

Sample size

Target

4400

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Vichealth

Address [2]

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Victorian Department of Education

Address [3]

Country [3]

Australia

Funding source category [4]

Charities/Societies/Foundations

Name [4]

Royal Flying Doctor Service

Address [4]

Country [4]

Australia

Funding source category [5]

Government body

Name [5]

Victorian Department of Health

Address [5]

Country [5]

Australia

Primary sponsor type

University

Name

Deakin University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (DUHREC)

Ethics committee address [1]

https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/02/2024

Approval date [1]

19/04/2024

Ethics approval number [1]

2024-051

Summary

Brief summary

Society asks a lot of schools, including that they protect children's health and wellbeing. This trial will work out the best way of supporting schools, teachers and school communities to create and sustain school environments that protect children's physical and mental health. We will measure the impact and return on investment of this support on children's health and education outcomes as well as on the schools themselves.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Colin Bell

Address

School of Medicine, Deakin Waurn Ponds, 75 Pigdons Road, Geelong 3216, VIC, Australia

Country

Australia

Phone

+61 3 52278043

Fax

[email protected]

Contact person for public queries

Name

Colin Bell

Address

School of Medicine, Deakin Waurn Ponds, 75 Pigdons Road, Geelong 3216, VIC Australia

Country

Australia

Phone

+61 3 52278043

Fax

[email protected]

Contact person for scientific queries

Name

Colin Bell

Address

School of Medicine, Deakin Waurn Ponds, 75 Pigdons Road, Geelong 3216, VIC Australia

Country

Australia

Phone

+61 3 52278043

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Where student numbers are sufficient, de-identified primary and secondary outcome student data and school level data with information on condition (intervention or control).

When will data be available (start and end dates)?

Data will be available from the end of the study 30/04/28 with no end date to availability.

Available to whom?

Those conducting research studies in the same general area of research

Available for what types of analyses?

Epidemiological studies.

How or where can data be obtained?

By contacting the Principal Investigator
Address: School of Medicine, Deakin Waurn Ponds, 75 Pigdons Road, Geelong 3216, Australia VIC
Ph +61 3 52278043

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.

Trial Review

Documents added manually

Documents added automatically