Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001588280
Ethics application status
Approved
Date submitted
7/09/2018
Date registered
25/09/2018
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Date results information initially provided
29/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Stores 2020: A randomised controlled trial to assess impact of a 12-week intervention to reduce retail merchandising of discretionary food and beverages in remote Indigenous community stores, on free sugar intake using store food and drink purchasing data.
Scientific title
Healthy Stores 2020: Reducing retail merchandising of discretionary food and beverages in remote Indigenous community stores
Secondary ID [1] 295991 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HS 2020
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 309505 0
Risk of type 2 diabetes 309670 0
Risk of cardiovascular disease 309671 0
Risk of renal disease 309672 0
Obesity 309706 0
Condition category
Condition code
Public Health 308339 308339 0 0
Other public health
Diet and Nutrition 308473 308473 0 0
Obesity
Diet and Nutrition 308474 308474 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) The intervention described below will be administered for 12 weeks in stores randomised to receive the intervention.
b) The intervention will be set-up in store by the research team and ALPA personnel and then maintained by the store manager
c) A fortnightly phone-call will be made to the store manager by a research team member to assess implementation fidelity. The store manager will be asked to provide electronic photographs of specific locations in the store and to respond to a set of questions about implementation. Where non-compliance is identified, the store manager will be informed of this and asked to comply.
Strategy detail:
On discretionary food and drink products in store:
- No visible promotional displays
- No price discounts or volume promotions
- Reduced facings of confectionery, sweet biscuits, sugar sweetened drinks, table sugar
- No beverage units >600ml of soft drink permitted in refrigerators
- Educational material showing amount of sugar in soft drinks
On core food and drink products:
- Healthy food end-cap displays
- Increased facings of core products in the proximity of discretionary product categories where the facings have been reduced
Intervention code [1] 312318 0
Behaviour
Comparator / control treatment
Usual store practice. The Arnhem Land Progress Aboriginal Corporation (ALPA) has a food and nutrition policy which is available on the ALPA website. Store managers are instructed to align their practice with this policy. No training with regards to the food and nutrition policy is provided and monitoring is adhoc and infrequent. If non-compliance is identified by visiting ALPA personnel to the store, the store manager may be asked to change their practice to comply with the policy.
Control group
Active

Outcomes
Primary outcome [1] 307321 0
Difference in free sugars (grams/MJ: store sales derived estimates) from baseline in intervention vs control stores
Timepoint [1] 307321 0
12 weeks of strategy [primary timepoint] and 24 weeks post end of strategy
Secondary outcome [1] 351459 0
Difference from baseline in intervention vs control stores for:
- Food and drink sales ($)
Assessed using audit of store sales data
Timepoint [1] 351459 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [2] 351947 0
Difference from baseline in intervention vs control stores for:
- Gross profit
Assessed using audit of store sales data, business activity statements provided by ALPA, interview with store managers and ALPA business personnel
Timepoint [2] 351947 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [3] 351948 0
Difference from baseline in intervention vs control stores for:
- Total energy (MJ) of all products sold (store sales derived estimates)
Assessed using audit of store sales data
Timepoint [3] 351948 0
12 weeks strategy and 24 weeks post end of strategy
Secondary outcome [4] 351949 0
Difference from baseline in intervention vs control stores 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 [4] 351949 0
12 weeks strategy and 24 weeks post end of strategy
Secondary outcome [5] 351950 0
Difference from baseline in intervention vs control stores 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 [5] 351950 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [6] 351951 0
Difference from baseline in intervention vs control stores for:
- Total sodium (mg/MJ) of all products sold
Assessed using audit of store sales data
Timepoint [6] 351951 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [7] 351952 0
Difference from baseline in intervention vs control stores for:
- Total weight of table sugar sold per MJ of energy from all products sold (g/MJ)
Assessed using audit of store sales data
Timepoint [7] 351952 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [8] 351953 0
Difference from baseline in intervention vs control stores for:
- Total table sugar sold (percent $ share to total food and drink $)
Assessed using audit of store sales data
Timepoint [8] 351953 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [9] 351954 0
Difference from baseline in intervention vs control stores for:
- Sweet biscuits sold (g weight as a percent of total food and drinks g weight)
Assessed using audit of store sales data
Timepoint [9] 351954 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [10] 351955 0
Difference from baseline in intervention vs control stores for:
- Total table sugar sold (g weight as a percent of total food and drinks g weight)
Assessed using audit of store sales data
Timepoint [10] 351955 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [11] 351956 0
Difference from baseline in intervention vs control stores for:
- Free sugars ($ sales as a percent of total food and drink $ sales)
Assessed using audit of store sales data
Timepoint [11] 351956 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [12] 351957 0
Difference from baseline in intervention vs control stores for:
- Total gram weight of sugar sweetened beverages sold per MJ of energy from all products (g/MJ)
Assessed using audit of store sales data

Sugar sweetened beverages includes all beverages with any added sugar
Timepoint [12] 351957 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [13] 351958 0
Difference from baseline in intervention vs control stores for:
- Total weight of sweet biscuits sold per MJ of energy from all products sold (g/MJ)
Assessed using audit of store sales data
Timepoint [13] 351958 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [14] 351959 0
Difference from baseline in intervention vs control stores for:
- Total weight of confectionery sold per MJ of energy from all products sold (g/MJ)
Assessed using audit of store sales data
Timepoint [14] 351959 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [15] 351960 0
Difference from baseline in intervention vs control stores for:
- Sugar sweetened beverages (percent $ share to total food and drink $)
Assessed using audit of store sales data
Timepoint [15] 351960 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [16] 351961 0
Difference from baseline in intervention vs control stores for:
- Sweet biscuits (percent $ share to total food and drink $)
Assessed using audit of store sales data
Timepoint [16] 351961 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [17] 351962 0
Difference from baseline in intervention vs control stores for:
- Confectionery (percent $ share to total food and drink $)
Assessed using audit of store sales data
Timepoint [17] 351962 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [18] 351963 0
Difference from baseline in intervention vs control stores for:
- Total gram weight of Sugar sweetened beverages sold as a percent of total weight of all products sold (g weight as a percent of total food and drinks g weight)
Assessed using audit of store sales data
Timepoint [18] 351963 0
12 weeks of strategy and 24 weeks post end of strategy
Secondary outcome [19] 351964 0
Difference from baseline in intervention vs control stores for:
- Total weight of confectionery sold as a percent of total gram weight of all products sold (g weight as a percent of total food and drinks g weight)
Assessed using audit of store sales data
Timepoint [19] 351964 0
12 weeks of strategy and 24 weeks post end of strategy

Eligibility
Key inclusion criteria
ALPA owned or managed store in a remote Australia Indigenous community
ALPA = Arnhem Land Progress Aboriginal Corporation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Remote Indigenous community store that is not owned and/or managed by ALPA

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 was concealed. A list of stores consenting to participate in the study were randomly allocated to control and intervention groups by a statistician via use of STATA.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) after recruitment was complete
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
Longitudinal data analysis models will be used on fortnightly store sales data. This will enable the effect of the intervention to be expressed as a relative decrease. Analysing fortnightly data reduces variation due to pay cycles, as observed in our previous analyses with sales data. All models will include random effects for the stores, and fixed effects for fortnight and intervention. Within-store residuals will be assumed to have an autoregressive structure of order 1. We will report effect sizes (and 95% CI) together with the associated p-values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/08/2018
Date of last participant enrolment
Anticipated
Actual
10/08/2018
Date of last data collection
Anticipated
31/05/2019
Actual
31/05/2019
Sample size
Target
25
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NT,QLD

Funding & Sponsors
Funding source category [1] 300585 0
Government body
Name [1] 300585 0
National Health and Medical Research Council
Country [1] 300585 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Nutrition, Dietetics and Food
BASE Facility
Level 1
264 Ferntree Gully Rd
NottingHill
VIC 3168
Country
Australia
Secondary sponsor category [1] 300080 0
None
Name [1] 300080 0
Address [1] 300080 0
Country [1] 300080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301373 0
The HREC of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 301373 0
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drv Casuarina NT 0810 Australia
Ethics committee country [1] 301373 0
Australia
Date submitted for ethics approval [1] 301373 0
01/02/2018
Approval date [1] 301373 0
01/08/2018
Ethics approval number [1] 301373 0
2018-3048
Ethics committee name [2] 301399 0
Central Australian Human Research Ethics Committee (HREC)
Ethics committee address [2] 301399 0
PO Box 4066
Alice Springs
NT 0871.
Ethics committee country [2] 301399 0
Australia
Date submitted for ethics approval [2] 301399 0
20/02/2018
Approval date [2] 301399 0
17/04/2018
Ethics approval number [2] 301399 0
CA-18-3056
Ethics committee name [3] 301400 0
Far North QLD HREC
Ethics committee address [3] 301400 0
William McCormack Place
Level 7 East,
5B Sheridan Street
Cairns QLD 4870
PO Box 902 CAIRNS
Queensland 4870 Australia
Ethics committee country [3] 301400 0
Australia
Date submitted for ethics approval [3] 301400 0
07/03/2018
Approval date [3] 301400 0
01/08/2018
Ethics approval number [3] 301400 0
HREC/18/QCH/23 – 1211 ERM Project Id: 39823

Summary
Brief summary
High intake of discretionary food and drinks contribute to the excessive burden of chronic disease experienced by Indigenous Australians living in remote Australia. In collaboration with the Arnhem Land Progress Aboriginal Corporation (ALPA; who manage 25 stores in remote Australia) we will test an intervention to reduce sales of discretionary products in remote Australian communities. Stores randomised to the intervention group will be supported by ALPA to reduce merchandising (i.e., availability and display) of four food categories (sugar, sugar sweetened beverages, sweet biscuits and confectionery) that in total provide 73% of discretionary foods and 90% of free sugars. The remaining stores (50% of total) will serve as controls. Electronic store sales data will be collected over the baseline period, 12-week intervention period and 24-week post intervention to objectively assess change in healthiness of purchases and gross store profit. This research will greatly advance our understanding of how the retail food environment can be used to improve population level dietary intake globally.
We hypothesise that intervention stores will have a significant reduction in free sugars from food and drinks purchased (measured using sales data) compared with control stores over the 12 weeks of strategy compared to the baseline and this will be sustained over the 24 weeks post end of the intervention.
Trial website
Trial related presentations / publications
Public notes
The store level outcomes are being used as a proxy of community dietary behaviours

Contacts
Principal investigator
Name 86790 0
A/Prof Julie Brimblecombe
Address 86790 0
Department of Nutrition, Dietetics and Food
Monash University
Level 1
264 Ferntree Gully Rd
Notting Hill
3168 VIC
Country 86790 0
Australia
Phone 86790 0
+61 03 99053455
Fax 86790 0
Email 86790 0
[email protected]
Contact person for public queries
Name 86791 0
A/Prof Julie Brimblecombe
Address 86791 0
Department of Nutrition, Dietetics and Food
Monash University
Level 1
264 Ferntree Gully Rd
Notting Hill
3168 VIC
Country 86791 0
Australia
Phone 86791 0
+61 03 99053455
Fax 86791 0
Email 86791 0
[email protected]
Contact person for scientific queries
Name 86792 0
A/Prof Julie Brimblecombe
Address 86792 0
Department of Nutrition, Dietetics and Food
Monash University
Level 1
264 Ferntree Gully Rd
Notting Hill
3168 VIC
Country 86792 0
Australia
Phone 86792 0
+61 03 99053455
Fax 86792 0
Email 86792 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
At this stage we are undecided


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 29/03/2019 https://www.researchprotocols.org/2019... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of restricted retail merchandising of discretionary food and beverages on population diet: a pragmatic randomised controlled trial.2020https://dx.doi.org/10.1016/S2542-5196%2820%2930202-3
N.B. These documents automatically identified may not have been verified by the study sponsor.