Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000694718
Ethics application status
Approved
Date submitted
4/06/2013
Date registered
25/06/2013
Date last updated
19/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stores Healthy Options Project in Remote Indigenous Communities (SHOP@RIC): A randomised trial assessing the impact of a price reduction with and without an in-store nutrition education strategy on purchasing of fruit, vegetables, water and diet soft-drinks in remote Northern Territory Aboriginal communities
Scientific title
A randomised trial to assess the impact of a price reduction with and without an in-store nutrition education strategy on purchasing of fruit, vegetables, water and diet soft-drinks in remote Northern Territory Aboriginal communities
Secondary ID [1] 281191 0
Nil
Universal Trial Number (UTN)
Trial acronym
SHOP@RIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dietary intake of remote Northern Territory Aboriginal communities 287371 0
Condition category
Condition code
Diet and Nutrition 287704 287704 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 interventions:
1. A 20% discount on sell price of fresh and frozen fruit, vegetables, water and diet soft-drinks for six months;
2. A combined price discount (as described above) with an in-store nutrition education strategy. The in-store nutrition education strategy is based on social-cognitive theory and best available evidence of determinants of diet in remote Aboriginal communities. The reduced cost and benefits of consuming more of the healthy foods will be promoted through the nutrition education strategy, and suggestions and activities provided on how to increase fruit and vegetable intake and substitute water or diet soft-drinks for sugar-sweetened soft-drinks. Six themes have been developed with a supporting set of activities to be implemented over the six-month intervention period including posters, activity sheets, cooking demonstrations and taste-testing activities and competitions.
Intervention code [1] 285652 0
Behaviour
Comparator / control treatment
usual practice - no discount on fresh and frozen fruit and vegetables, water and diet soft-drinks, and no in-store nutrition education strategy
Control group
Active

Outcomes
Primary outcome [1] 287946 0
store level average quantity (grams) of fruit and vegetables sold per capita per day though the community stores participating in this trial using electronic point-of-sale data and Australian Bureau of Statistics population census data
Timepoint [1] 287946 0
at baseline, in the last month of the 6 month intervention and 6 months post intervention
Secondary outcome [1] 299103 0
store level average quantity (grams) of water and diet soft drinks sold per capita per day though the community stores participating in this trial using community level electronic point-of-sale data and Australian Bureau of Statistics population census data
Timepoint [1] 299103 0
at baseline, in the last month of the 6 month intervention and 6 months post intervention
Secondary outcome [2] 299104 0
Percent (%) total sugar to total energy purchased through the community stores participating in this trial using community level electronic point-of-sale data
Timepoint [2] 299104 0
at baseline, in the last month of the 6 month intervention and 6 months post intervention
Secondary outcome [3] 299105 0
Sodium (mg) per 1000kJ of energy purchased through the community stores participating in this trial using community level electronic point-of-sale data
Timepoint [3] 299105 0
at baseline, in the last month of the 6 month intervention and 6 months post intervention
Secondary outcome [4] 299106 0
Proportion of total sugar sweetened soft-drinks (kg) to total combined fruit and vegetable (kg) purchased though the community stores participating in this trial using electronic point-of-sale data
Timepoint [4] 299106 0
at baseline, in the last month of the 6 month intervention and 6 months post intervention
Secondary outcome [5] 303110 0
Proportion of healthy foods to unhealthy foods purchased through the community stores participating in this trial using community level electronic point-of-sale data
Timepoint [5] 303110 0
at baseline, in the last month of the 6 month intervention and 6 months post intervention
Secondary outcome [6] 303114 0
Store level average quantity (grams) of each of water, diet soft drinks, fruit, and vegetables sold per capita per day though the community stores participating in this trial using electronic point-of-sale data and Australian Bureau of Statistics population census data
Timepoint [6] 303114 0
at baseline, in the last month of the 6 month intervention and 6 months post intervention

Eligibility
Key inclusion criteria
Community store managed by either the Arnhem land progress Aboriginal Corporation (ALPA) or Outback Stores (OBS).
Community located within the Northern Territory
Store is located more than 20 kilometres from its nearest competitor
Community population of 100 residents or greater
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Community store not managed by either ALPA or OBS
Community located outside the Northern Territory
Store is located 20 kilometres or less from its nearest competitor
Community population of less than 100 residents

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)
There are 38 stores in the Northern Territory managed by ALPA or OBS. Twenty of these stores that met the study criteria and were invited to participate in the study agreed to participate. We predetermined that there would be five administrative sets of four stores and that each of the store sets would consist of mostly two ALPA stores (of which one would be randomly allocated to receive the nutrition education strategy) and two OBS stores (of which one would be randomly allocated to receive the nutrition education strategy). Using two opaque envelopes with the ALPA store names in one envelope and the OBS stores in the other, we randomly selected a store from each of the envelopes in turn and continued to consecutively allocate stores to the fixed store set framework until all stores had been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We firstly fixed the framework of five sets of four stores with around 2 ALPA stores and 2 OBS stores in each set and with 1 ALPA store and 1 OBS store in each set to receive the combined price discount/ nutrition education strategy. Using two opaque envelopes with the ALPA store names in one envelope and the OBS stores in the other, we randomly selected a store from each of the envelopes in turn and continued to consecutively allocate stores to the fixed store set framework, starting with the first store in the first store set, until all stores had been allocated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This study is a parallel group RCT with respect to the nutrition education aspect of the intervention and is a staggered concurrent before / after study with respect to the price discount intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed models will be used to analyse the store point-of-sale data; random effects will include the store; fixed effects will include the step (of 8 weeks in length which corresponds to the “lag” in the roll-out of the intervention across sets of stores), the phase (baseline, intervention, post-intervention) and the in-store nutrition education strategy. Additional covariates (the contextual factors - such as distance to competing food outlet, community level income, population size) will be described and tested and may be introduced as additional fixed effects. It is expected that there will be some additional correlation within each store and a variance-covariance model (VCVM) for this will be identified prior to the formal testing of the fixed effects and other covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 285972 0
Government body
Name [1] 285972 0
National Health and Medical Research Council
Country [1] 285972 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina
NT 0811
Country
Australia
Secondary sponsor category [1] 284794 0
None
Name [1] 284794 0
Address [1] 284794 0
Country [1] 284794 0
Other collaborator category [1] 277060 0
University
Name [1] 277060 0
Deakin University
Address [1] 277060 0
Deakin Health Economics
Population Health Strategic Research Centre
Faculty of Health
Deakin University
221 Burwood Road
Burwood, VIC 3121
Country [1] 277060 0
Australia
Other collaborator category [2] 277061 0
University
Name [2] 277061 0
The University of Auckland
Address [2] 277061 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
NEW ZEALAND
Country [2] 277061 0
New Zealand
Other collaborator category [3] 277062 0
Commercial sector/Industry
Name [3] 277062 0
Outback Stores
Address [3] 277062 0
PO Box 1953
Berrimah
NORTHERN TERRITORY 0828
Country [3] 277062 0
Australia
Other collaborator category [4] 277063 0
Commercial sector/Industry
Name [4] 277063 0
The Arnhem Land Progress Aboriginal Corporation
Address [4] 277063 0
70 O'Sullivan Circuit,
East Arm NT 0828
Country [4] 277063 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288003 0
Human Research Ethics Committee of Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 288003 0
PO Box 41096
Casuarina NT 0811
Ethics committee country [1] 288003 0
Australia
Date submitted for ethics approval [1] 288003 0
Approval date [1] 288003 0
26/03/2012
Ethics approval number [1] 288003 0
HREC-2012-1711
Ethics committee name [2] 288004 0
Central Australian Human Ethics Committee
Ethics committee address [2] 288004 0
PO Box 4066
Alice Springs
NT
0871
Ethics committee country [2] 288004 0
Australia
Date submitted for ethics approval [2] 288004 0
Approval date [2] 288004 0
22/02/2012
Ethics approval number [2] 288004 0
HREC-12-13
Ethics committee name [3] 289479 0
Deakin University Human Research Ethics Committee
Ethics committee address [3] 289479 0
Deakin Research Integrity
70 Elgar Road Burwood Victoria
Postal: 221 Burwood Highway
Burwood Victoria 3125 Australia
Ethics committee country [3] 289479 0
Australia
Date submitted for ethics approval [3] 289479 0
Approval date [3] 289479 0
23/08/2012
Ethics approval number [3] 289479 0
2012-243

Summary
Brief summary
Background: Indigenous Australians suffer a disproportionate burden of preventable chronic disease compared to their non-Indigenous counterparts – much of it diet-related. Increasing fruit and vegetable intakes and reducing sugar-sweetened soft-drink consumption can reduce the risk of preventable chronic disease. There is evidence from some general population studies that subsidising healthier foods can modify dietary behaviour. There is little such evidence relating specifically to socio-economically disadvantaged populations, even though dietary behaviour in such populations is arguably more likely to be susceptible to such interventions.
Aim: This study aims to assess the impact and cost-effectiveness of a price discount intervention with or without an in-store nutrition education intervention on purchases of fruit, vegetables, water and diet soft-drinks among remote Indigenous communities.
Methods/ Design: We will utilise a randomised multiple baseline (stepped wedge) design involving 20 communities in remote Indigenous Australia. The study will be conducted in partnership with two store associations and twenty Indigenous store boards. Communities will be randomised to either i) a 20% price discount on fruit, vegetables, water and diet soft-drinks; or ii) a combined price discount and in-store nutrition education strategy. These interventions will be initiated, at one of five possible time-points, spaced two-months apart. Weekly point-of-sale data will be collected from each community store before, during, and for six months after the six-month intervention period to measure impact on purchasing of discounted food and drinks. Data on physical, social and economic factors influencing weekly store sales will be collected in order to identify important covariates. Intervention fidelity and mediators of behaviour change will also be assessed.
Discussion: This study will provide original evidence on the effectiveness and cost-effectiveness of price discounts with or without an in-store nutrition education intervention on food and drink purchasing among a socio-economically disadvantaged population in a real-life setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34688 0
Dr Julie Brimblecombe
Address 34688 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 34688 0
Australia
Phone 34688 0
+61 08 89228577
Fax 34688 0
Email 34688 0
julie.brimblecombe@menzies.edu.au
Contact person for public queries
Name 17935 0
Mr Anthony Gunther
Address 17935 0
Menzies School of Health Research
PO Box 41096
Casuarina
NT 0811
Country 17935 0
Australia
Phone 17935 0
+61 08 89226523
Fax 17935 0
+61 08 89275187
Email 17935 0
anthony.gunther@menzies.edu.au
Contact person for scientific queries
Name 8863 0
Dr Julie Brimblecombe
Address 8863 0
Menzies School of Health Research
PO Box 41096
Casuarina
NT 0811
Country 8863 0
Australia
Phone 8863 0
+61 08 89228577
Fax 8863 0
+61 08 89275187
Email 8863 0
julie.brimblecombe@menzies.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffect of a price discount and consumer education strategy on food and beverage purchases in remote Indigenous Australia: a stepped-wedge randomised controlled trial.2017https://dx.doi.org/10.1016/S2468-2667%2816%2930043-3
EmbaseDietary sodium and iodine in remote Indigenous Australian communities: will salt-reduction strategies increase risk of iodine deficiency? A cross-sectional analysis and simulation study.2015https://dx.doi.org/10.1186/s12889-015-2686-1
N.B. These documents automatically identified may not have been verified by the study sponsor.