Trial from ANZCTR


Trial ID ACTRN12613000694718
Trial Status: Registered
Date Submitted: 4/06/2013
Date Registered: 25/06/2013
Retrospectively registered

Page 1

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
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
Update:
 
Reason:
 
Secondary ID [1] 281191 0
Nil
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym SHOP@RIC
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Behaviour 285652 0
Update:
 
Reason:
 
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
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: 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 287946 0
Update:
 
Reason:
 
Timepoint: at baseline, in the last month of the 6 month intervention and 6 months post intervention 287946 0
Update:
 
Reason:
 
Secondary Outcome: 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 299103 0
Update:
 
Reason:
 
Timepoint: at baseline, in the last month of the 6 month intervention and 6 months post intervention 299103 0
Update:
 
Reason:
 
Secondary Outcome: Percent (%) total sugar to total energy purchased through the community stores participating in this trial using community level electronic point-of-sale data 299104 0
Update:
 
Reason:
 
Timepoint: at baseline, in the last month of the 6 month intervention and 6 months post intervention 299104 0
Update:
 
Reason:
 
Secondary Outcome: Sodium (mg) per 1000kJ of energy purchased through the community stores participating in this trial using community level electronic point-of-sale data 299105 0
Update:
 
Reason:
 
Timepoint: at baseline, in the last month of the 6 month intervention and 6 months post intervention 299105 0
Update:
 
Reason:
 
Secondary Outcome: 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 299106 0
Update:
 
Reason:
 
Timepoint: at baseline, in the last month of the 6 month intervention and 6 months post intervention 299106 0
Update:
 
Reason:
 
Secondary Outcome: Proportion of healthy foods to unhealthy foods purchased through the community stores participating in this trial using community level electronic point-of-sale data 303110 0
Update:
 
Reason:
 
Timepoint: at baseline, in the last month of the 6 month intervention and 6 months post intervention 303110 0
Update:
 
Reason:
 
Secondary Outcome: 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 303114 0
Update:
 
Reason:
 
Timepoint: at baseline, in the last month of the 6 month intervention and 6 months post intervention 303114 0
Update:
 
Reason:
 

Page 5

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
Update:
 
Reason:
 
Minimum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
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
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Prevention
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)

The people assessing the outcomes
The people analysing the results/data
Update:
       
Reason:
 
Assignment Other
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
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.
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/07/2012
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 20
Update:
 
Reason:
 
Recruitment status Completed
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s) NT
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Government body 285972 0
Update:
 
Reason:
 
Name: National Health and Medical Research Council 285972 0
Update:
 
Reason:
 
Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
285972 0
Update:
 
Reason:
 
Country: Australia 285972 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: Menzies School of Health Research
Update:
 
Reason:
 
Address: PO Box 41096
Casuarina
NT 0811
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 284794 0
Update:
 
Reason:
 
Name: 284794 0
Update:
 
Reason:
 
Address: 284794 0
Update:
 
Reason:
 
Country: 284794 0
Update:
 
Reason:
 
Other Collaborator: University 277060 0
Update:
 
Reason:
 
Name: Deakin University 277060 0
Update:
 
Reason:
 
Address: Deakin Health Economics
Population Health Strategic Research Centre
Faculty of Health
Deakin University
221 Burwood Road
Burwood, VIC 3121
277060 0
Update:
 
Reason:
 
Country: Australia 277060 0
Update:
 
Reason:
 
Other Collaborator: University 277061 0
Update:
 
Reason:
 
Name: The University of Auckland 277061 0
Update:
 
Reason:
 
Address: National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
NEW ZEALAND

277061 0
Update:
 
Reason:
 
Country: New Zealand 277061 0
Update:
 
Reason:
 
Other Collaborator: Commercial sector/Industry 277062 0
Update:
 
Reason:
 
Name: Outback Stores 277062 0
Update:
 
Reason:
 
Address: PO Box 1953
Berrimah
NORTHERN TERRITORY 0828

277062 0
Update:
 
Reason:
 
Country: Australia 277062 0
Update:
 
Reason:
 
Other Collaborator: Commercial sector/Industry 277063 0
Update:
 
Reason:
 
Name: The Arnhem Land Progress Aboriginal Corporation 277063 0
Update:
 
Reason:
 
Address: 70 O'Sullivan Circuit,
East Arm NT 0828
277063 0
Update:
 
Reason:
 
Country: Australia 277063 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Human Research Ethics Committee of Northern Territory Department of Health and Menzies School of Health Research 288003 0
Update:
 
Reason:
 
Address: PO Box 41096
Casuarina NT 0811
288003 0
Update:
 
Reason:
 
Country: Australia 288003 0
Update:
 
Reason:
 
Approval Date: 26/03/2012 288003 0
Update:
 
Reason:
 
Submitted Date: 288003 0
Update:
 
Reason:
 
HREC: HREC-2012-1711 288003 0
Update:
 
Reason:
 
Ethics Committee name: Central Australian Human Ethics Committee 288004 0
Update:
 
Reason:
 
Address: PO Box 4066
Alice Springs
NT
0871
288004 0
Update:
 
Reason:
 
Country: Australia 288004 0
Update:
 
Reason:
 
Approval Date: 22/02/2012 288004 0
Update:
 
Reason:
 
Submitted Date: 288004 0
Update:
 
Reason:
 
HREC: HREC-12-13 288004 0
Update:
 
Reason:
 
Ethics Committee name: Deakin University Human Research Ethics Committee 289479 0
Update:
 
Reason:
 
Address: Deakin Research Integrity
70 Elgar Road Burwood Victoria
Postal: 221 Burwood Highway
Burwood Victoria 3125 Australia
289479 0
Update:
 
Reason:
 
Country: Australia 289479 0
Update:
 
Reason:
 
Approval Date: 23/08/2012 289479 0
Update:
 
Reason:
 
Submitted Date: 289479 0
Update:
 
Reason:
 
HREC: 2012-243 289479 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

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

Contact person for scientific queries
Title: Dr
Update:
 
Reason:
 
8863 0
Name: Julie Brimblecombe
Update:
 
Reason:
 
8863 0
Address: Menzies School of Health Research PO Box 41096 Casuarina NT 0811
Update:
 
Reason:
 
8863 0
Country: Australia
Update:
 
8863 0
Reason:
 
Tel: +61 08 89228577
Update:
 
Reason:
 
8863 0
Fax: +61 08 89275187
Update:
 
Reason:
 
8863 0
Email: julie.brimblecombe@menzies.edu.au
Update:
 
Reason:
 
8863 0

Contact person responsible for updating information
Title: Dr
Update:
 
Reason:
 
27007 0
Name: Julie Brimblecombe
Update:
 
Reason:
 
27007 0
Address: Menzies School of Health Research PO Box 41096 Casuarina NT 0811
Update:
 
Reason:
 
27007 0
Country: Australia
Update:
 
27007 0
Reason:
 
Tel: +61 08 89228577
Update:
 
Reason:
 
27007 0
Fax: +61 08 89275187
Update:
 
Reason:
 
27007 0
Email: julie.brimblecombe@menzies.edu.au
Update:
 
Reason:
 
27007 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: