Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000557639
Ethics application status
Approved
Date submitted
12/05/2023
Date registered
24/05/2023
Date last updated
2/06/2024
Date data sharing statement initially provided
24/05/2023
Date results information initially provided
2/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing tools to support the A Better Choice Strategy Implementation: the CREATE study.
Scientific title
Testing implementation tools to support healthy food environments in Queensland Hospitals: A pilot randomised controlled trial..
Secondary ID [1] 309651 0
NA
Universal Trial Number (UTN)
U1111-1289-9335
Trial acronym
CREATE (Co-designed Retail Tools for healthier food Environments)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet 329986 0
Condition category
Condition code
Diet and Nutrition 326893 326893 0 0
Other diet and nutrition disorders
Public Health 326973 326973 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-site pilot randomised controlled trial (RCT) to test implementation tools to support healthy food environments in commercial food outlets in public Queensland Hospitals.

The primary aim of this pilot study is to assess the feasibility and acceptability of conducting a RCT to evaluate the ‘CREATE’ intervention in Queensland health services, and to inform the primary outcome measures and sample size for the full RCT.

A 6-month, parallel-arm, 1:1 pilot RCT will be conducted in 7 Hospital and Health Services (HHS) in Queensland.

The proposed intervention CREATE (Co-designed Retail Tools for healthier food Environments) will support food retail outlets in healthcare facilities in improve the healthiness of the food environment through targeting: (1) retailer capability to make changes that are feasible, acceptable to customers, and financially viable; and (2) specialised support from health promotion practitioners who understand the complexities of the retail business context.

These capabilities are supported by the two key intervention components: A Retailer Toolkit and Practitioner Training which have been co-designed with end-users. The purpose of the intervention is to support the implementation of The A Better Choice Food and Drink Supply Strategy for Queensland Healthcare facilities (“A Better Choice” Strategy). A Better Choice Strategy aims to increase the provision of healthy food and drinks for staff, visitors, and patients within Queensland hospital and health services (HHS). A Better Choice Strategy uses a traffic light system to categorise food and drinks into ‘green’ (best nutritional value), ‘amber’ (some nutritional value) and ‘red’ (limited or no nutritional value). A Better Choice Strategy sets targets for the availability of each of these categories in order to create a healthier food environment. The target for food retail outlet drinks is having 0% red classified (as per the Queensland ‘A Better Choice Food and Drink Classification Guide’) drinks, a maximum of 20% amber classified drinks that are artificially sweetened, a minimum of 50% of drinks classified green and the remainder either amber (non-artificially sweetened) or green. Similarly, the targets for food are red classified foods being less than 20% of foods available, and a minimum of 50% of available foods being classified as green.

The project will be conducted in collaboration with Health and Wellbeing Queensland (HWQld), an independent statutory body of the Queensland Government who are leading the implementation of the A Better Choice Strategy.

Summary of CREATE intervention components to be delivered

A) Introduction to the Toolkit- this is an introductory phase where the retailers and practitioners are familiarised with the retailer and toolkit.
Who receives it: Retailers and Practitioners
Rationale: To provide an overview of the project and the resources to be provided.
Procedures including length of session and who will deliver: 1 hour, Research team.
Delivery (format and location): Online real time via zoom.
When and how much: Beginning of intervention (once).

B) Introduction to the Practitioner training- - this step is where the participating practitioners are provided an online training understand the toolkit and support the ABC implementation strategy. The practitioner in our study is defined as a health promotion practitioner who could be a dietitian, health promotion officer, health promotion manager, or other staff member tasked with the roll out, implementation and /or support of the A Better Choice Strategy within a Hospital and Health Service.
Who receives it: Practitioners
Rationale: Have a shared practitioner training session for above. Or could be module 1 with helpline.
Procedures including length of session and who will deliver: 1 hour, Research team.
Delivery (format and location): Online real time via zoom.
When and how much: Beginning of intervention (once).

C) Environment audit and feedback to retailers – with practitioner- this is the photo audit of participating retail outlet where the information about the healthiness of the outlet is captured. This will be done by capturing their food display, advertising or campaigns, food menu etc.
Who receives it: Retailers and Practitioners
Rationale: Understand, communicate, and make an action plan.
Material: FoodChecker Reports
Procedures including length of session and who will deliver: 1 hour, Research team.
Delivery (format and location): Over phone and FoodChecker Reports.
When and how much: Beginning of intervention and during follow-up at 6 months.

D) Retailer toolkit to retailers- This toolkit will guide retailers through the steps for success to roll out the Healthy choices’ guidelines in their food outlet, providing customers, staff, and managers with a unique food offering. Toolkit – it is an adaptation of the toolkit produced in Victoria*
Who receives it: Retailers
Rationale: Detailed step-by-step instructions tailored to retailers in QLD hospital settings on how to implement the policy.
Material: PDF toolkit including rationale and 5 key steps for changes.
Procedures including length of session and who will deliver: As required.
Delivery (format and location): Online – email or website for download.
When and how much: Beginning of intervention (once).
*Source- M, Annois B, Johnson K, Livaditis C, Blake MR, Boelsen-Robinson T, Hedley J, Rosewarne E, Hobbs V. Healthy Retail Toolkit, February 2023. Nourish Network: Melbourne, 2023

E) Practitioner training- it is an interactive training specially designed for the study to support the practitioners in assisting the retailer to implement the A Better Choices (ABC) Strategy to be compliant.
Who receives it: Practitioners
Rationale: Match practitioner training to Toolkit – steps are mirrored. Training self-paced and in modules.
Material: Teaching Practitioners how to support use of Toolkit. Procedures including length of session and who will deliver: 5-10 hours, as required.
Delivery (format and location): Online – email or website for download.
When and how much: NA

F) Newsletter- Periodic updates on the study shared in form of an online newsletter.
Who receives it: Retailers and Practitioners
Rationale: Updates on what is happening to maintain engagement.
Material: Online mail.
Procedures including length of session and who will deliver: NA
Delivery (format and location): Email update.
When and how much: Every month.
Intervention code [1] 326080 0
Behaviour
Comparator / control treatment
During the RCT, the control group will continue with usual practice and will not receive the toolkit or training. This includes access to all of the usual supports and reporting requirements the above ‘CREATE’ intervention components. provided by Health and Wellbeing Queensland but does not include at 6-months (end of RCT period). The control HHS will be offered a shortened intervention for 4-months after the 6-month RCT. Offering the control group, the intervention will likely increase participation rates. The research group only has capacity to support the intervention for 4 months, however the intervention and control group will have access to the intervention components following the study, but without the support of the research team. However, the control group will complete the baseline and 6 months survey.
Control group
Active

Outcomes
Primary outcome [1] 334732 0
Availability:

Change in percentage availability of ‘RED’ foods, in each intervention retail outlets compared to control retail outlets, from baseline (0 months) to follow-up (6 months). Photographs will be taken of the food outlet guided by an audit protocol. All food items will be matched to the FoodChecker database to identify product light classification according to the A Better Choice Guidelines.
Timepoint [1] 334732 0
Baseline (0 months) to follow-up (6 months)
Primary outcome [2] 334733 0
Acceptability of Toolkit and Training: Defined as the perception among retailers/practitioners that the toolkit is 'satisfactory’, ‘palatable’, and ‘agreeable’. These will be assessed quantitatively using the mean and standard deviation of validated items developed by Weiner et al (2017), with outcomes measured on a Likert scale.
Timepoint [2] 334733 0
Assessed at 6 months follow-up in intervention group only.
Primary outcome [3] 334734 0
Feasibility: Defined as the extent to which the toolkit can be successfully used or carried out within the retail setting.

Trial design feasibility (e.g., data collection, length of trial etc) will be assessed using questions with Likert scale responses.
Reference:
Weiner, B.J., et al., Psychometric assessment of three newly developed implementation outcome measures. Implementation Science, 2017. 12(1): p. 108.
Timepoint [3] 334734 0
At baseline (0 months) and follow-up at 6 months for intervention group. For control group it would be assessed at 6 months follow-up.
Secondary outcome [1] 421906 0
Sales data 1:
Weekly percentage of RED foods sales will be calculated from sales data collected for all weeks of the pilot study.
Timepoint [1] 421906 0
The study will measure the magnitude of change and variation between intervention and control sites for 1 year prior and over the 6 months of the pilot study in order to perform power calculations for a full-sized RCT.
Secondary outcome [2] 422149 0
Sales data 2:
Weekly percentage of RED drinks sales will be calculated from sales data collected for all weeks of the pilot study.
Timepoint [2] 422149 0
The study will measure the magnitude of change and variation between intervention and control sites for 1 year prior and over the 6 months of the pilot study in order to perform power calculations for a full-sized RCT.

Eligibility
Key inclusion criteria
Hospital-level inclusion criteria
Hospitals will be eligible if they have at least one retail outlet that sold majority food and beverages (rather than other goods or services, for example, a pharmacy that sold some chocolate bars would be excluded).
Each practitioner-retailer pairing is referred to as a “dyad”. The study aims to have 20 Health promotion practitioners-retailer dyads (10 intervention, 10 control) that have not fully implemented A Better Choice.

Health Promotion Practitioner inclusion criteria
Health promotion practitioners will be eligible for participating in the study if they 1) are responsible for supporting the implementation of the A Better Choice Strategy at their hospital site; 2) are willing to facilitate recruitment of the retailers within their site; 3) have capacity to take part in the study by supporting retailers and undertaking Practitioner Training as outlined in the consent form; and 4) intend to be employed by the health service in their current role until November 2023 to facilitate follow up data collection.

Retailer inclusion criteria
Retailers must meet the following requirements to be eligible for participating in the study: 1) are supported by a health promotion practitioner who is participating in the study; 2) are the manager, owner or operator (including franchise operator) of a predominantly-food or drink retail outlet located in a health service or hospital within the seven included HHS; 3) consents to the auditing of their food retail outlet at two time points by researchers, students or HWQld staff; 4) consents to participate in surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
At the end of recruitment, the researcher will contact the holder of the allocation schedule, an independent statistician based in the Biostatistics Unit at Deakin University, who will be blind to the names of the HHS recruited and randomise HHS to treatment groups. Due to the nature of the intervention, allocation cannot be concealed to the research teamer or to the participants. The statistician will remain blind to allocation throughout analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used to allocate pairs to intervention or waitlist control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Retailer survey and Practitioner survey
Descriptive statistics, including proportions, means and standard deviations, will be used to describe the acceptability and feasibility of the retailer and practitioner toolkits.

Audit data
The outcome measure is the percentage availability of ‘RED’ foods, as a percentage of total food products available. We will measure the magnitude of change and variation between sites in ‘RED’ food availability between baseline and end of 6-month RCT in order to perform power calculations for a full-sized RCT.

Sales data
The pilot sales data will be used to estimate the effect of the intervention on the rate of change of weekly sales of RED food and drink over the 6-month pilot RCT, which will be used to inform power calculations for a full RCT. The effect will be estimated using a GEE framework to account for autocorrelation in weekly trends over time, with the model including intervention, time and their interaction. All analyses will be performed on an intention-to-treat basis in Stata.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2023
Actual
6/09/2023
Date of last participant enrolment
Anticipated
Actual
19/09/2023
Date of last data collection
Anticipated
Actual
10/01/2024
Sample size
Target
20
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313839 0
Other Collaborative groups
Name [1] 313839 0
Australian Prevention Partnership Centre- Rapid Response Research Grant
Country [1] 313839 0
Australia
Funding source category [2] 313840 0
University
Name [2] 313840 0
Deakin University- Health ReseArch Capacity Building Grant ScHeme (Hatch) Funding
Country [2] 313840 0
Australia
Funding source category [3] 313841 0
Other Collaborative groups
Name [3] 313841 0
Health and Wellbeing Queensland
Country [3] 313841 0
Australia
Funding source category [4] 313842 0
University
Name [4] 313842 0
Deakin University, the Nourish Network
Country [4] 313842 0
Australia
Primary sponsor type
Individual
Name
Tara Boelsen-Robinson
Address
Deakin University
Locked Bag 20000, Geelong, Vic 3220
Country
Australia
Secondary sponsor category [1] 315669 0
Other Collaborative groups
Name [1] 315669 0
Health and Wellbeing Queensland
Address [1] 315669 0
139 Coronation Drive, Milton, Queensland 4064
Country [1] 315669 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312992 0
Metro North Health Human Research Ethics Committee (HREC) A (EC 00172)
Ethics committee address [1] 312992 0
Metro North Office of Research Level 7, Block 7, RBWH Campus Herston Qld 4029
Ethics committee country [1] 312992 0
Australia
Date submitted for ethics approval [1] 312992 0
28/02/2023
Approval date [1] 312992 0
11/05/2023
Ethics approval number [1] 312992 0
92364; HREC/2023/MNHA/92364; Testing Healthy Food Retail Implementation Tools in Queensland Health Services

Summary
Brief summary
The primary aim of this pilot study is to assess the feasibility and acceptability of conducting an RCT to evaluate the CREATE intervention in Queensland health services, and to inform the primary outcome measures and sample size for the full RCT. Our proposed intervention CREATE (Co-designed Retail Tools for healthier food Environments) directly addresses these factors through the provision of a Retailer Toolkit and Practitioner Training which have been co-designed with end-users to support the implementation of ‘A Better Choice’ healthy food retail targets. ‘A Better Choice’ Strategy aims to increase the provision of healthy food and drinks for staff, visitors, and patients within Queensland hospital and health services (HHS). The trial will determine the feasibility and acceptability of the implementation support tools, and that of the RCT study design, and will inform future full size RCTs.
Trial website
Trial related presentations / publications
Public notes
This study involves testing tools to support the A Better Choice Strategy Implementation at retail outlets in public hospital and health services in Queensland.

Contacts
Principal investigator
Name 126610 0
Dr Tara Boelsen-Robinson
Address 126610 0
Deakin University
Locked Bag 20000, Geelong, Vic 3220
Country 126610 0
Australia
Phone 126610 0
+61 3 9244 5426
Fax 126610 0
Email 126610 0
tara.b@deakin.edu.au
Contact person for public queries
Name 126611 0
Dr Tara Boelsen-Robinson
Address 126611 0
Deakin University
Locked Bag 20000, Geelong, Vic 3220
Country 126611 0
Australia
Phone 126611 0
+61 3 9244 5426
Fax 126611 0
Email 126611 0
tara.b@deakin.edu.au
Contact person for scientific queries
Name 126612 0
Dr Tara Boelsen-Robinson
Address 126612 0
Deakin University
Locked Bag 20000, Geelong, Vic 3220
Country 126612 0
Australia
Phone 126612 0
+61 3 9244 5426
Fax 126612 0
Email 126612 0
tara.b@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.