Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/06/2010
Date assigned
30/06/2010
Last edited
06/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diet-related diseases such as obesity, heart disease and diabetes are on the rise in Australia and internationally. Many of these diseases can be prevented by health-promoting strategies such as eating a diet high in fruits and vegetables. Recent research has shown that women who have a lower level of education and/or are living on lower incomes are less likely to consume healthy foods including fruits and vegetables than those who are more educated and/or wealthier. This may be because certain knowledge and skills in nutrition, budgeting, meal planning and preparation are lacking in this population group. The aim of this study is to test a set of skill-building materials developed to help women on low incomes plan for, purchase and consume a healthier diet on a budget.

Who can participate?
Women aged between 18 and 60 who shop regularly at one of the participating supermarkets and have a low weekly household income.

What does the study involve?
Participants are randomly allocated to either a skill-building intervention or a waiting list. The skill-building intervention is delivered over six months via regular newsletters, recipes, booklets and activities, as well as an optional face-to-face supermarket tour with qualified Dietitians. The study tests the effectiveness of these strategies for increasing the amount of fruit and vegetables purchased and eaten by the participants. This is done through collecting and analysing survey data and supermarket sales data before, after and 6 months after the intervention. Participants on the waiting list complete the assessments only until the intervention and 6-month follow-up are complete, at which point they are offered the skill-building intervention materials.

What are the possible benefits and risks of participating?
The risks to taking part in this study are very small. Participation is voluntary and participants can withdraw from the study at any time.

Where is the study run from?
Deakin University (Australia)

When is study starting and how long is it expected to run for?
January 2010 to March 2015

Who is funding the study?
Australian Research Council (ARC) (Australia)

Who is the main contact?
Prof. Kylie Ball

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kylie Ball

ORCID ID

Contact details

221 Burwood Highway
Burwood
Victoria
3125
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Improving eating behaviours in socio-economically disadvantaged communities: a randomised controlled trial

Acronym

ShopSmart 4 Health

Study hypothesis

This study aims to test the effectiveness of a skill-building nutrition promotion strategy on increasing fruit and vegetable purchasing and consumption amongst women living in socio-economically disadvantaged communities. The study also aims to test the impact of the strategy on self-efficacy for, perceived barriers to, and perceived affordability of, consuming fruits and vegetables. The contribution of self- efficacy, perceived barriers and perceived affordability as mediators of changes in fruit and vegetable purchasing and consumption behaviours will also be examined.

The study will test to see if there is a difference between the skill-building intervention participants and the controls, both immediately post-intervention and at a six-month follow-up, in:
1. Measures of fruit and vegetable purchasing or consumption
2. The proposed mediators, self-efficacy, perceived affordability and barriers of fruit and vegetable consumption

Ethics approval

Deakin University Human Research Ethics Committee - Health Medicine Nursing and Behavioural Sciences Subcommittee, 05/02/2010, ref: HEAG-H 188/09

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Supermarket-based health promotion for socio-economically disadvantaged women in the area of nutrition

Intervention

A randomised controlled trial conducted with women who shop at two randomly-selected Coles supermarkets based in low-income neighbourhoods in metropolitan Melbourne.

Control:
No treatment. Participants will complete the assessments only, until the intervention and 6-month follow-up are complete, at which point they will be offered the skill building intervention materials.

Intervention:
The skill-building intervention will be delivered over a six-month period and will incorporate a range of modes of delivery and educational and behaviour change strategies.
Participants in this intervention condition will be provided with materials and resources through printed newsletters. Newsletters will be sent every two weeks for the first two months, and then once a month for the rest of the six-month intervention. Participants will also be provided with the opportunity to undertake a supermarket tour, during which the range and potential uses of fruits and vegetables (including tinned and frozen) will be identified. Elements of the intervention to be provided will include:
1. Education- will focus on raising awareness of the health- and weight-related benefits of consuming a healthy diet, particularly recommended intakes and suggestions for how to increase fruits and vegetables. The range of fruit and vegetable options available and their relative costs compared with other less healthful foods will be highlighted.
2. Skill-building – to foster behavioural skills in budgeting; meal planning; and meal preparation strategies including provision of shopping lists linked to simple recipes. This is aimed at increasing the theoretical mediators, self-efficacy and perceived affordability.
3. Goal-setting – this is a key behaviour change activity identified as a common element of successful previous dietary interventions. e.g. women will be encouraged to increase their and their families’ vegetable consumption to meet the guidelines of five serves/day.
4. Overcoming barriers – tips will be provided on overcoming commonly-reported barriers to increased fruit and vegetable consumption, e.g. suggestions will be provided on engaging familial support, given theoretical arguments and previous literature on the importance of social influences on behaviour.

A key focus of the skill-building intervention will be on affordability and addressing perceived high costs of healthy eating.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 27/07/2011:
Data on demographic characteristics, key study outcomes and mediators will be collected pre- and immediately post-intervention, and at 6-month follow-up.
1. Demographics:
1.1. Age
1.2. Family structure (marital/cohabitation status, number and ages of dependent children, other household members)
1.3. Education level
1.4. Own and household income will be assessed
2. Outcome measures:
Data on food purchasing will be gathered using a combination of electronic sales data, which Coles have confirmed they will provide to us via linkage with their store loyalty cards (FlyBuys); and self-report survey data (to assess consumption and complement the electronic sales data). We will use previously-published measures of both fruit and vegetable purchasing and consumption. Measures of daily equivalent fruit and vegetable purchasing quantities (adjusted for household members/composition) and daily equivalent serves consumed will be calculated.

Previous primary outcome measures from update on 30/06/2010:
Data on demographic characteristics, key study outcomes and mediators will be collected pre- and immediately post-intervention, and at 6-month follow-up.
1. Demographics:
1.1. Age
1.2. Family structure (marital/cohabitation status, number and ages of dependent children, other household members)
1.3. Education level
1.4. Own and household income will be assessed
2. Outcome measures:
Data on food purchasing will be gathered using a combination of electronic sales data, which Coles have confirmed they will provide to us via store loyalty cards (Fly-Buys and/ or a study card); and self-report survey data (to assess consumption and complement the electronic food purchasing data). We will use previously-published measures of both fruit and vegetable purchasing and consumption. Measures of daily equivalent fruit and vegetable purchasing quantities (adjusted for household members/composition) and daily equivalent serves consumed will be calculated.

Secondary outcome measures

Current secondary outcome measures as of 27/07/2011:
1. Mediator measures:
We will assess self-efficacy, perceived barriers and perceived affordability via validated self-report surveys.
2. Process evaluation outcomes:
We will assess subjective perceptions of the intervention components that may be useful in predicting outcomes at the completion of the intervention.
3. Economic evaluation:
A cost consequences analysis will be conducted from a societal perspective comparing incremental costs and outcomes in the intervention arm to the control arm at 12 months. Intervention resource use and costs will be prospectively recorded via project team records and Coles data, supported by interviews with the project team. Household cost impact will be determined through external (Coles) data on food purchasing combined with participant self-report data on non-Coles and Coles-non-Flybuys food purchasing over the course of the intervention and follow-up period.

Previous secondary outcome measures from update on 30/06/2010:
1. Mediator measures:
We will assess self-efficacy, perceived barriers and perceived affordability via validated self-report surveys.
2. Process evaluation outcomes:
We will assess subjective perceptions of the intervention components that may be useful in predicting outcomes at the completion of the intervention.

Overall trial start date

01/01/2010

Overall trial end date

16/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 09/11/2011:
1. Female
2. The main household shopper
3. Aged between 18 and 60 years
4. Shop regularly at one of the participating Coles supermarkets in low socio-economic areas
5. A FlyBuys (Coles store loyalty card) member OR willing to sign up to FlyBuys
7. Able to give written informed consent to participate in the study
8. Willing to give information about income and dietary and mediator behaviours at three time points (baseline, post-intervention and six-month follow-up)
9. Belong to one of the following low income groups: Have a weekly household income below $1000 per week after tax, have a health care card, or main income is from a pension or welfare benefit
10. Willing to have purchase data collected and analysed
11. Able to speak, read and write in English

Previous inclusion criteria:
1. Female
2. The main household shopper
3. Aged between 18 and 45 years
4. Shop regularly at one of the participating Coles supermarkets in low socio-economic areas
5. A FlyBuys (Coles store loyalty card) member OR willing to sign up to FlyBuys
6. Planning to continue to shop with Coles regularly over the next 12 months
7. Able to give written informed consent to participate in the study
8. Willing to give information about income and dietary and mediator behaviours at three time points (baseline, post-intervention and six-month follow-up)
9. Have an equivalised household income below AUS$------ (to be confirmed)
10. Willing to have purchase data collected and analysed
11. Able to speak, read and write in English

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

274 to allow for survey non-response, drop-outs, and measuring a low-effect size as found in a similar trial in New Zealand. 137 in each study arm, with an additional 30 in the pilot study group.

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

09/05/2011

Recruitment end date

09/06/2011

Locations

Countries of recruitment

Australia

Trial participating centre

221 Burwood Highway
Burwood, Victoria
3125
Australia

Sponsor information

Organisation

Australian Research Council (ARC) (Australia)

Sponsor details

GPO Box 2702
Canberra ACT
2601
Australia

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

Australian Research Council - Industry Linkage Grant (ref: LP0990129)

Alternative name(s)

ARC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23668896
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27413129

Publication citations

  1. Protocol

    Ball K, McNaughton SA, Le H, Andrianopoulos N, Inglis V, McNeilly B, Lichomets I, Granados A, Crawford D, ShopSmart 4 Health - protocol of a skills-based randomised controlled trial promoting fruit and vegetable consumption among socioeconomically disadvantaged women., BMC Public Health, 2013, 13, 466, doi: 10.1186/1471-2458-13-466.

  2. Results

    Ball K, McNaughton SA, Le HN, Abbott G, Stephens LD, Crawford DA, ShopSmart 4 Health: results of a randomized controlled trial of a behavioral intervention promoting fruit and vegetable consumption among socioeconomically disadvantaged women, Am J Clin Nutr, 2016, pii: ajcn133173, doi: 10.3945/ajcn.116.133173.

Additional files

Editorial Notes

06/09/2016: Plain English summary added. 02/08/2016: Publication reference added. 18/02/2016: The overall trial dates have been updated from 16/03/2010 - 16/03/2013 to 01/01/2010 - 16/03/2015 and the recruitment dates have been updated from 16/03/2010 - 16/03/2013 to 09/05/2011 - 09/06/2011.