Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001585415
Ethics application status
Approved
Date submitted
11/11/2016
Date registered
16/11/2016
Date last updated
16/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of reducing salt in bread on sales and total salt intake in remote Indigenous Australian community stores
Scientific title
A trial to assess the effect of reducing salt in bread on sales and overall salt intake in remote Indigenous Australian communities
Secondary ID [1] 290523 0
Nil known
Universal Trial Number (UTN)
U1111-1189-7328
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excess salt intake 300941 0
Condition category
Condition code
Diet and Nutrition 300741 300741 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention stores will receive salt-reduced white bread (300mg/100g) on their store shelves for 12 weeks.

The bread packaging will not be distinguishable from the control bread, however the markings on the carton the bread is packed in will differ to reduce the risk of the reduced salt bread being delivered to the control community or vice versa. In addition the price look up code (PLU) differed between the breads, to allow us to ensure that the correct bread is being sold in control and intervention stores.
Intervention code [1] 296373 0
Other interventions
Comparator / control treatment
Control stores will receive regular salt white bread (400mg/100g) on store shelves for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 300155 0
Change in market share of study bread: change in % total dollars spent on study bread compared to dollars spent on all food and drink (%$) assessed through collecting data on all sales of food and drinks over the study period.
Timepoint [1] 300155 0
Weekly reports of all sales over entire study period
Primary outcome [2] 300156 0
Change in total dollars spent on study bread ($) assessed using sales data collected throughout the entire study period
Timepoint [2] 300156 0
Weekly reports of all sales over entire study period
Secondary outcome [1] 329204 0
Change in total sodium density of purchases (sodium per megajoule of energy) assessed using sales data on all foods and drinks purchased linked to nutrition data.
Timepoint [1] 329204 0
Weekly reports of all sales over entire study period

Eligibility
Key inclusion criteria
Remote Indigenous Australian community stores that meet the following criteria will be included:
- Community store managed by one of the two participating store associations (ALPA and OBS).
- Community located within the Northern Territory (NT), Western Australia (WA) or South Australia (SA)
- Study bread represents >=45% of the market share for bread (i.e: >=45% of total dollars spent on bread is on study bread)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Store does not meet inclusion criteria or does not provide consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The study will include four periods in 2015: baseline (23 weeks, February-July), wash-in (six weeks, July-August), follow-up (12 weeks, August-November) and wash-out (six weeks, November-December).

This study was originally planned as a randomised controlled trial however changes to the baking location and supply route of the bread during the baseline period meant that many of the participating communities were unable to receive the reduced salt bread. For this reason, the study was adapted to a non-randomised controlled design, with allocation to intervention or control mostly determined by supply route of study bread for participating stores. Stores were blinded to their allocation.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/02/2015
Date of last participant enrolment
Anticipated
Actual
15/06/2015
Date of last data collection
Anticipated
Actual
3/01/2016
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NT,SA,WA

Funding & Sponsors
Funding source category [1] 294939 0
University
Name [1] 294939 0
University of South Australia
Country [1] 294939 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Menzies School of Health Research
Address
Royal Hospital Campus, 105 Rocklands Dr, Tiwi NT Australia 0810
Country
Australia
Secondary sponsor category [1] 293776 0
None
Name [1] 293776 0
Address [1] 293776 0
Country [1] 293776 0
Other collaborator category [1] 279301 0
Commercial sector/Industry
Name [1] 279301 0
The Arnhem Land Progress Aboriginal Corporation
Address [1] 279301 0
70 O’Sullivan Circuit, East Arm NT 0822
Country [1] 279301 0
Australia
Other collaborator category [2] 279302 0
Commercial sector/Industry
Name [2] 279302 0
Outback Stores
Address [2] 279302 0
67 Pruen Road, Darwin NT 0828
Country [2] 279302 0
Australia
Other collaborator category [3] 279303 0
Other
Name [3] 279303 0
The George Institute for Global Health
Address [3] 279303 0
Level 13, 321 Kent Street Sydney NSW 2000
Country [3] 279303 0
Australia
Other collaborator category [4] 279304 0
Commercial sector/Industry
Name [4] 279304 0
Goodman Fielder Limited
Address [4] 279304 0
39 Delhi Road, North Ryde Nsw 2113
Country [4] 279304 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296314 0
Human Research Ethics Committee of the NT Department of Health and the Menzies School of Health Research
Ethics committee address [1] 296314 0
John Mathews Building (Bldg 58)
Royal Darwin Hospital Campus
Rocklands Drv Casuarina NT 0810 Australia
Ethics committee country [1] 296314 0
Australia
Date submitted for ethics approval [1] 296314 0
Approval date [1] 296314 0
20/01/2015
Ethics approval number [1] 296314 0
HREC-2014-2311
Ethics committee name [2] 296315 0
Central Australian HREC
Ethics committee address [2] 296315 0
Ethics committee country [2] 296315 0
Australia
Date submitted for ethics approval [2] 296315 0
Approval date [2] 296315 0
05/01/2014
Ethics approval number [2] 296315 0
HREC-14-275
Ethics committee name [3] 296316 0
Aboriginal Health Research Ethics Committee of SA
Ethics committee address [3] 296316 0
Ethics committee country [3] 296316 0
Australia
Date submitted for ethics approval [3] 296316 0
Approval date [3] 296316 0
04/12/2014
Ethics approval number [3] 296316 0
HREC 04-14-595
Ethics committee name [4] 296317 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [4] 296317 0
Ethics committee country [4] 296317 0
Date submitted for ethics approval [4] 296317 0
Approval date [4] 296317 0
09/03/2015
Ethics approval number [4] 296317 0
HREC-599
Ethics committee name [5] 296318 0
University of South Australia HREC
Ethics committee address [5] 296318 0
Ethics committee country [5] 296318 0
Date submitted for ethics approval [5] 296318 0
Approval date [5] 296318 0
09/02/2015
Ethics approval number [5] 296318 0
0000033947

Summary
Brief summary
Aim: To investigate the effects of a reduced sodium bread on sales and overall sodium intake in remote Indigenous communities.

Study design: Communities stores will receive salt-reduced study bread (300mg/100g) (intervention communities) or regular salt study bread (400mg/100g) (control communities) to stock on store shelves for 12 weeks.

Population: Remote Indigenous communities serviced by Arnhemland Progress Aboriginal Corporation (ALPA) or Outback Stores (OBS) in Northern Territory, Western Australia or South Australia and where Study bread represents >=45% of the market share for bread sales will be invited to the study (29 communities meet this criteria).

Outcomes:
- Change in sales (market share and total dollars)
- Change in total sodium of all food and drink purchases
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70398 0
Dr Emma McMahon
Address 70398 0
Menzies School of Health Research
PO Box 10639, Brisbane Qld 4000
Country 70398 0
Australia
Phone 70398 0
+61731694212
Fax 70398 0
Email 70398 0
Emma.McMahon@menzies.edu.au
Contact person for public queries
Name 70399 0
Emma McMahon
Address 70399 0
Menzies School of Health Research
PO Box 10639, Brisbane Qld 4000
Country 70399 0
Australia
Phone 70399 0
+61731694212
Fax 70399 0
Email 70399 0
Emma.McMahon@menzies.edu.au
Contact person for scientific queries
Name 70400 0
Emma McMahon
Address 70400 0
Menzies School of Health Research
PO Box 10639, Brisbane Qld 4000
Country 70400 0
Australia
Phone 70400 0
+61731694212
Fax 70400 0
Email 70400 0
Emma.McMahon@menzies.edu.au

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No Supporting Document Provided



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