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Trial registered on ANZCTR


Registration number
ACTRN12622000596707
Ethics application status
Approved
Date submitted
19/03/2022
Date registered
21/04/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Benchmarking for healthy stores in remote Aboriginal and Torres Strait Islander communities
Scientific title
Benchmarking for healthy stores in remote Aboriginal and Torres Strait Islander communities: Assessing the feasibility and effectiveness of an innovative benchmarking approach
Secondary ID [1] 306605 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor dietary quality 325514 0
Overweight 325515 0
Type 2 diabetes 325516 0
Condition category
Condition code
Public Health 322890 322890 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises two full benchmarking cycles (one per year) each with four segments: 1. Benchmarking assessment of i) best-practice store policy action, ii) implementation of best-practice, iii) healthiness of customer purchasing; iv) level of influence of enabling/impeding factors; 2. Benchmarking assessment visual report with recommendations provided to storeowners; 3. Report and recommendations discussed with storeowners and 4. codesign of action plan. The duration of a full benchmarking cycle is 52 weeks. Benchmarking assessment will occur for each store within the months of July/August of each year. Provision of benchmarking assessment reports and co-design of action plan will occur for each store within the months of Nov/Dec of each year. Storeowners/managers will be responsible for implementation of the action plan until Nov/Dec of the following year when a second action plan will be codesigned and implemented. Benchmarking assessment of i) best-practice store policy action, ii) implementation of best-practice, iii) healthiness of customer purchasing; iv) level of influence of enabling/impeding factors will be assessed by a dietitian or member of the research team with input from the storeowner/manager. The benchmarking visual report with recommendations will be provided to storeowners via email by a dietitian or a member of the research team. A dietitian or member of the research team will discuss the recommendations and codesign an action plan with store representative/s. The Benchmarking assessment of best-practice store policy action is anticipated to take approximately 30mins to complete using a policy action audit tool. Benchmarking assessment of implementation of best-practice is anticipated to take 40-60mins to complete by a dietitian or member of the research team using an App, called Store Scout App. Benchmarking assessment of the healthiness of customer purchasing will be done by the research team using store sales reports. Assessment of level of influence of enabling/impeding factors will be done by a store representative using an e-survey and is anticipated to take approximately 30mins. Provision and discussion of benchmarking visual report with recommendations to store representatives and codesign of action plan is anticipated to take 60-90mins.
The codesign process involves a single 60-90 min workshop either face-to-face in-store or via videoconference between a store representative and a dietitian and/or member of the research team. The strategies that may be employed as part of the action plan include 'No price promotions on discretionary food and drink products', 'Price discounts on fruit and vegetables', 'No discretionary food and drink products in highly visible/high traffic areas of the store including front-of-store, check-outs, end-of-aisle caps'. Adherence to the benchmarking intervention will be monitored via interview with the dietitian or member of the research team at the end of each benchmarking cycle.
Intervention code [1] 323036 0
Prevention
Comparator / control treatment
Control stores will receive 1. benchmarking assessment, but will not receive 2. benchmarking visual report with recommendations, 3. discussion of the visual report with recommendations or 4. co-design of action plan.
Control stores will be offered one full benchmarking cycle at the end of the randomised controlled trial.
Control group
Active

Outcomes
Primary outcome [1] 330669 0
Change from baseline in free sugars (g/MJ total energy) from all food and drinks purchased (from point-of-sale derived estimates) using electronic sales data
Timepoint [1] 330669 0
Last 6 months of Y2
Secondary outcome [1] 407142 0
Change from baseline for:
- Total weight of discretionary products sold per MJ of all products sold (g/MJ) (store sales derived estimates)
Assessed using audit of store sales data
Discretionary products are defined according to the Australian Dietary Guidelines definition:
“foods and drinks not necessary to provide the nutrients the body needs, but that may add variety. However, many of these are high in saturated fats, sugars, salt and/or alcohol, and are therefore described as energy dense. They can be included sometimes in small amounts by those who are physically active, but are not a necessary part of the diet"

The Australian Dietary Guidelines Summary lists examples of discretionary choices as including: "most sweet biscuits, cakes, desserts and pastries; processed meats and sausages; ice-cream and other ice confections; confectionary and chocolate; savoury pastries and pies; commercial burgers; commercially fried foods; potato chips, crisps and other fatty and/or salty snack foods; cream, butter and spreads which are high in saturated fats; sugar sweetened soft drinks and cordials, sports and energy drinks and alcoholic drinks".
Timepoint [1] 407142 0
Baseline, last 6 months of Y1 and last 6 months of Y2
Secondary outcome [2] 407143 0
Change in baseline for:
- Core products (g/MJ) ie total gram weight of core products sold per MJ of energy from all products sold
Assessed using audit of store sales data

Core products are defined as those food and drinks that are not classified as discretionary food/ drinks.
Timepoint [2] 407143 0
Baseline, last 6 months of Y1 and last 6 months of Y2
Secondary outcome [3] 407144 0
Change in baseline for:
- Total sodium (mg/MJ) of all products sold
Assessed using audit of store sales data
Timepoint [3] 407144 0
Baseline, last 6 months of Y1 and last 6 months of Y2
Secondary outcome [4] 407240 0
Change from baseline in free sugars (g/MJ total energy) from all food and drinks purchased (from point-of-sale derived estimates) using electronic sales data
Timepoint [4] 407240 0
Last 6 months of Y1

Eligibility
Key inclusion criteria
A food retail outlet in the Northern Territory of Australia, that is primarily a grocery store and services a remote community that has a primarily Aboriginal population, is able to be approached at the time of recruitment and has a store board/owner and/or is serviced by a retail organisation area manager who have shown interest in the study and/or engaged with nutrition initiatives, there is a public health nutrition service provided by a partner organisation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The food retail outlet is a roadhouse, cafe or club (i.e., not primarily a grocery store); food retail business reason for being unable to recruit (e.g., civil unrest, financial difficulties)

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 will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers will be used to allocate stores in near equal numbers to intervention/control. To ensure that we do not exceed capacity of the public health nutritionists to deliver the intervention, we may need to stratify randomisation by public health nutrition service area covered by each partner organisation. We cannot determine this until all stores are recruited.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Allocation of stores will occur simultaneously after the required sample of stores is reached.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sales data from each store will be aggregated into 6 monthly chunks before ratio outcomes (e.g. total weight of discretionary products sold per MJ of all products sold (g/MJ)) are calculated. The outcomes will then be log-transformed. The main analysis for an outcome will be a simple ANCOVA analysis using sales data from Jul-Dec 2021 (baseline), Jul-Dec 2022 (Y 1), Jul-Dec 2023 (Y 2) and randomisation group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/05/2022
Actual
29/07/2022
Date of last participant enrolment
Anticipated
31/05/2022
Actual
29/07/2022
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
40
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 310703 0
Government body
Name [1] 310703 0
Australian Department of Health (Medical Research Future Fund)
Country [1] 310703 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Nutrition Dietetics and Food
Faculty of Medicine Nursing and Health Sciences
Level 1, 264 Ferntree Gully Rd
Notting Hill
Monash University,
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 311923 0
Other
Name [1] 311923 0
Menzies School of Health Research
Address [1] 311923 0
Darwin (Royal Darwin Hospital Campus)
John Mathews Building (JMB)
Building 58, Royal Darwin Hospital Campus
Corner of Nightingale and Paracelsus road, Tiwi.
Northern Territory 0810
Country [1] 311923 0
Australia
Secondary sponsor category [2] 312237 0
University
Name [2] 312237 0
University of Queensland
Address [2] 312237 0
School of Public Health
288 Herston Road (corner of Herston Rd and Wyndham St)
The University of Queensland
Herston QLD 4006, Australia
Country [2] 312237 0
Australia
Secondary sponsor category [3] 312238 0
Other
Name [3] 312238 0
Indigenous Allied Health Australia
Address [3] 312238 0
9 Napier Cl, Deakin ACT 2600
Country [3] 312238 0
Australia
Secondary sponsor category [4] 312241 0
University
Name [4] 312241 0
Curtin University
Address [4] 312241 0
Kent St
Bentley
WA 6102
Country [4] 312241 0
Australia
Secondary sponsor category [5] 312242 0
Other
Name [5] 312242 0
Monash Data Futures Institute
Address [5] 312242 0
13 Rainforest Walk
Level 2
Monash University
Clayton VIC 3800
Country [5] 312242 0
Australia
Other collaborator category [1] 282185 0
Commercial sector/Industry
Name [1] 282185 0
Outback Stores
Address [1] 282185 0
67 Pruen Rd, Darwin City NT 0828
Country [1] 282185 0
Australia
Other collaborator category [2] 282186 0
Commercial sector/Industry
Name [2] 282186 0
The Arnhem Land Progress Aboriginal Corporation
Address [2] 282186 0
70 O'Sullivan Cct, East Arm NT 0822
Country [2] 282186 0
Australia
Other collaborator category [3] 282187 0
Government body
Name [3] 282187 0
NT Health Top End Health Service
Address [3] 282187 0
Top End Health Service
Royal Darwin Hospital, Rocklands Drive
Tiwi NT 0810
Country [3] 282187 0
Australia
Other collaborator category [4] 282188 0
Government body
Name [4] 282188 0
NT Health Central Australian Health Service
Address [4] 282188 0
Central Australia Health Service
Level 1 Eurilpa House
Alice Springs NT 0870
Country [4] 282188 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310286 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 310286 0
Ethics committee country [1] 310286 0
Australia
Date submitted for ethics approval [1] 310286 0
10/11/2021
Approval date [1] 310286 0
08/02/2022
Ethics approval number [1] 310286 0
HREC 2021-4212
Ethics committee name [2] 310496 0
Central Australian Human Research Ethics Committee
Ethics committee address [2] 310496 0
Ethics committee country [2] 310496 0
Australia
Date submitted for ethics approval [2] 310496 0
27/01/2022
Approval date [2] 310496 0
Ethics approval number [2] 310496 0
CA-22-4235

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

Contacts
Principal investigator
Name 117126 0
A/Prof Julie Brimblecombe
Address 117126 0
Department of Nutrition Dietetics and Food
Faculty of Medicine Nursing and Health Sciences
Monash University
Level 1
264 Ferntree Gully Rd
Notting Hill
Victoria 3168
Country 117126 0
Australia
Phone 117126 0
+61399053455
Fax 117126 0
Email 117126 0
julie.brimblecombe@monash.edu
Contact person for public queries
Name 117127 0
Julie Brimblecombe
Address 117127 0
Department of Nutrition Dietetics and Food
Faculty of Medicine Nursing and Health Sciences
Monash University
Level 1
264 Ferntree Gully Rd
NottingHill
Victoria
Country 117127 0
Australia
Phone 117127 0
+61399053455
Fax 117127 0
Email 117127 0
julie.brimblecombe@monash.edu
Contact person for scientific queries
Name 117128 0
Julie Brimblecombe
Address 117128 0
Department of Nutrition Dietetics and Food
Faculty of Medicine Nursing and Health Sciences
Monash University
Level 1
264 Ferntree Gully Rd
Notting Hill
Victoria 3168
Country 117128 0
Australia
Phone 117128 0
+61399053455
Fax 117128 0
Email 117128 0
julie.brimblecombe@monash.edu

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15315Study protocol  julie.brimblecombe@monash.edu
15316Statistical analysis plan  julie.brimblecombe@monash.edu
15317Informed consent form  julie.brimblecombe@monash.edu 383517-(Uploaded-19-03-2022-08-38-09)-Study-related document.docx
15318Ethical approval  julie.brimblecombe@monash.edu 383517-(Uploaded-19-03-2022-08-39-20)-Study-related document.pdf
15319Analytic code  julie.brimblecombe@monash.edu



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.