ANZCTR - Registration

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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

Secondary ID [1]

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

Condition category

Condition code

Public Health

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]

Behaviour

Comparator / control treatment

4. Control (no intervention)

Control group

Active

Outcomes

Primary outcome [1]

Change from baseline in percent energy from saturated fat of supermarket food purchases at completion of the six-month trial intervention phase.

Timepoint [1]

Six months post intervention (9 months into the trial following 3 months of baseline data collection)

Secondary outcome [1]

Change from baseline in saturated fat at 12 months post-randomisation

Timepoint [1]

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]

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]

6 and 12 months post intervention (at 9 and 15 months respectively, following 3 months baseline data collection)

Secondary outcome [3]

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]

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?

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]

New Zealand

State/province [1]

Wellington region

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The Health Research Council of New Zealand

Address [1]

Grafton Mews Grafton Auckland, New Zealand

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Research Fellow is supported by a Heart Foundation of New Zealand postgraduate scholarship

Address [2]

9 Kalmia Street Ellerslie Auckland

Country [2]

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]

None

Name [1]

N/A

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Te Hotu Manawa Maori

Address [1]

72 Dominion Road Mt Eden Auckland

Country [1]

New Zealand

Other collaborator category [2]

Other Collaborative groups

Name [2]

Pacific Heartbeat

Address [2]

c/- The Heart Foundation of New Zealand 9 Kalmia Street Ellerslie Auckland

Country [2]

New Zealand

Other collaborator category [3]

Commercial sector/Industry

Name [3]

Foodstuffs Wellington Co-operative Society Ltd

Address [3]

57 Kiln Street Silverstream, Upper Hutt Wellington

Country [3]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Wellington-University of Auckland Human Participants Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

13/12/2006

Ethics approval number [1]

2006/4602

Summary

Brief summary

Unhealthy diet plays a role in 11,000 deaths every year in New Zealand and healthier diets are important in preventing common diseases including heart disease, stroke, cancer, and diabetes. Most of our food is bought at supermarkets so choosing healthier foods at supermarkets is likely to have important health benefits. The Supermarket Healthy Options Project (SHOP) assessed two ways of promoting healthier food purchases in supermarkets: price discounts and tailored nutrition education. 1,104 PAK ’n SAVE customers were randomised to one of four groups: (1) price discounts on specified 'healthier' food products, (2) culturally appropriate tailored nutrition education based on usual supermarket food purchases, (3) both price discounts and tailored education, and (4) control (no intervention). Effects on shopping habits were measured using individulised barcode scanner data. This research provides important information about two promising ways to improve our population’s diet.

Trial website

Trial related presentations / publications

KRUSE, K., BLAKELY, T., EYLES, H.C.  'Lessons learned from co-ordinating a group health education workshop for Pacific people', Health Promotion Journal of Australia, 19, (3), p232-232, 2008

EYLES, H.C., NI MHURCHU, C., WHAREMATE, L., FUNAKI, M. and 2 others 'Developing Nutrition Education Resources for a Multi-ethnic Population in New Zealand', Health Education Research, 2009, 24 (4), p558-574, doi: 10.1093/her/cyn057  

NI MHURCHU, C., BLAKELY, T., FUNAKI-TAHIFOTE, M., MCKERCHAR, C. and 3 others. ‘Inclusion of indigenous and ethnic minority populations in intervention trials:  challenges and strategies in a New Zealand supermarket study.  Journal of Epidemiology and Community Health, 2009, doi:10.1136/jech.2008.081109   

EYLES, H.C., JIANG, Y., NI MHURCHU, C.  'Use of household supermarket sales data to estimate nutrient intakes: a comparison with repeat 24-hour dietary recalls', Journal of the American Dietetic Association, In press, 2009  

EYLES, H.C., NI MHURCHU, C. 'Does tailoring matter? A systematic review of the long-term effectiveness of tailored nutrition education for adults, including priority population groups', Review in Nutrition Reviews, 67 (8), p464-480, 2009 doi:10.1111/j.1753-4887.2009.00219.x  

EYLES, H.C., NI MHURCHU, C., RODGERS, A.  'Using electronic sales data to tailor nutrition education resources for an ethnically diverse population of supermarket shoppers: Developing the methodology'., Journal of Human Nutrition and Dietetics, In press, 2009

NI MHURCHU, C., BLAKELY, T., JIANG, Y., EYLES, H.C., and 3 others 'Effects of price discounts and tailored nutrition education on supermarket food purchases:  A randomised, controlled trial (Submitted)

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Cliona Ni Mhurchu

Address

Clinical Trials Research Unit University of Auckland Private Bag 92019 Auckland

Country

New Zealand

Phone

+64 9 373 7599 48650

Fax

+64 9 373 1710

[email protected]

Contact person for scientific queries

Name

Dr Cliona Ni Mhurchu

Address

Clinical Trials Research Unit University of Auckland Private Bag 92019 Auckland and MRC Human Nutrition Research Cambridge United Kindom

Country

New Zealand

Phone

+64 9 373 7599 ext 84494

Fax

+64 9 373 1710

[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.

Trial Review

Documents added manually

Documents added automatically