Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000007437
Ethics application status
Approved
Date submitted
20/12/2006
Date registered
8/01/2007
Date last updated
24/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Supermarket Healthy Options Project : Strategies to Promote Healthier Food Purchases : A Supermarket Intervention Trial. The Effect of tailored nutrition education and price discounts on the nutrient content of supermarket foods purchased by main household shoppers
Scientific title
Supermarket Healthy Options Project : Strategies to Promote Healthier Food Purchases : A Supermarket Intervention Trial. The Effect of tailored nutrition education and price discounts on the nutrient content of supermarket foods purchased by main household shoppers
Secondary ID [1] 273459 0
HRC
Universal Trial Number (UTN)
Trial acronym
SHOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition-related disease
Healthier food purchases 1510 0
Condition category
Condition code
Public Health 1608 1608 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Price Discounts on Healthy Food: participants allocated to the price discounts group received a list of 'healthier' foods that were eligible for a 12.5% discount. The list was sent by mail monthly during the six month intervention period. Discounts were electronically loaded onto participants Shop N Go cards so that when they purchased discounted foods at participating supermarkets, the discount was automatically applied at point of sale. 2. Culturally Appropriate Tailored Nutrition Education: promoted and supported the purchase of 'healthier' food options. Education was targeted by ethnicity and tailored by usual food purchases. Participants were sent seven nutrition education packages by mail over the six month intervention period (weeks 1, 4, 8, 12, 16, 20 and 24). Each package focused on a staple food category. 3. Price discounts plus tailored nutrition education.
Intervention code [1] 1480 0
Behaviour
Comparator / control treatment
4. Control (no intervention)
Control group
Active

Outcomes
Primary outcome [1] 2217 0
Change from baseline in percent energy from saturated fat of supermarket food purchases at completion of the six-month trial intervention phase.
Timepoint [1] 2217 0
Six months post intervention (9 months into the trial following 3 months of baseline data collection)
Secondary outcome [1] 3870 0
Change from baseline in saturated fat at 12 months post-randomisation
Timepoint [1] 3870 0
12 months post-randomisation (15 months at trial conclusion following 3 months of baseline data collection, 6 months of trial intervention, and 6 months of follow-up)
Secondary outcome [2] 3871 0
Change from baseline in other key nutrients - total fat (percentage energy), protein (percentage energy), carbohydrate (percentage energy), energy density (MJ/kg), sodium (mg/MJ), and sugars (g/MJ) at six and 12 months
Timepoint [2] 3871 0
6 and 12 months post intervention (at 9 and 15 months respectively, following 3 months baseline data collection)
Secondary outcome [3] 257183 0
Change from baseline in quantities of healthier foods purchased (by weight) of all healthier foods, cereal and cereal products, fats and oils, fruit and vegetables, meat and alternatives, and milk and milk products, at six and 12 months
Timepoint [3] 257183 0
6 and 12 months post intervention (at 9 and 15 months respectively, following 3 months baseline data collection)

Eligibility
Key inclusion criteria
(1) primary household food shopper, (2) shop regularly at one of the eight participating PAK ‘n SAVE stores in the Wellington region (where a regular shopper is defined as one that shops at least once every 2 weeks and spends a minimum of $150 per month), (3) registered users of Shop ‘n Go (self-scanning) system, or willing to sign up to the system for the period of the study, (4) able to give written informed consent to participate in the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) another member of the household is already included in the study.

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)
Web-based central randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
JAVA software used to generate the study randomisation sequence. Minimization for ethnicity and household income using pre-set allocation probabilities
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment outside Australia
Country [1] 438 0
New Zealand
State/province [1] 438 0
Wellington region

Funding & Sponsors
Funding source category [1] 1752 0
Government body
Name [1] 1752 0
The Health Research Council of New Zealand
Country [1] 1752 0
New Zealand
Funding source category [2] 237489 0
Charities/Societies/Foundations
Name [2] 237489 0
The Research Fellow is supported by a Heart Foundation of New Zealand postgraduate scholarship
Country [2] 237489 0
New Zealand
Primary sponsor type
University
Name
Clinical Trials Research Unit, University of Auckland
Address
Level 4, School of Population Health,
Tamaki Campus
University of Auckland
Country
New Zealand
Secondary sponsor category [1] 1553 0
None
Name [1] 1553 0
N/A
Address [1] 1553 0
Country [1] 1553 0
Other collaborator category [1] 816 0
Other Collaborative groups
Name [1] 816 0
Te Hotu Manawa Maori
Address [1] 816 0
72 Dominion Road
Mt Eden
Auckland
Country [1] 816 0
New Zealand
Other collaborator category [2] 817 0
Other Collaborative groups
Name [2] 817 0
Pacific Heartbeat
Address [2] 817 0
c/- The Heart Foundation of New Zealand
9 Kalmia Street
Ellerslie
Auckland
Country [2] 817 0
New Zealand
Other collaborator category [3] 818 0
Commercial sector/Industry
Name [3] 818 0
Foodstuffs Wellington Co-operative Society Ltd
Address [3] 818 0
57 Kiln Street
Silverstream, Upper Hutt
Wellington
Country [3] 818 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3277 0
Wellington-University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 3277 0
Ethics committee country [1] 3277 0
New Zealand
Date submitted for ethics approval [1] 3277 0
Approval date [1] 3277 0
13/12/2006
Ethics approval number [1] 3277 0
2006/4602

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

Contacts
Principal investigator
Name 27414 0
Address 27414 0
Country 27414 0
Phone 27414 0
Fax 27414 0
Email 27414 0
Contact person for public queries
Name 10669 0
Dr Cliona Ni Mhurchu
Address 10669 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
Country 10669 0
New Zealand
Phone 10669 0
+64 9 373 7599 48650
Fax 10669 0
+64 9 373 1710
Email 10669 0
[email protected]
Contact person for scientific queries
Name 1597 0
Dr Cliona Ni Mhurchu
Address 1597 0
Clinical Trials Research Unit University of Auckland Private Bag 92019 Auckland
and
MRC Human Nutrition Research
Cambridge
United Kindom
Country 1597 0
New Zealand
Phone 1597 0
+64 9 373 7599 ext 84494
Fax 1597 0
+64 9 373 1710
Email 1597 0
[email protected]

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
No additional documents have been identified.