Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/02/2018
Date assigned
23/03/2018
Last edited
20/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Poor diet is a risk factor for heart disease. Saturated fat (SFA) in food increases the type of cholesterol (LDL-cholesterol) that increases the chances of heart disease. Cutting down on food containing SFA, e.g. swapping butter for plant-based spreads, could help lower the risk of heart disease. Researchers are currently investigating new ways of reducing SFA in the population's diet. This study is an online shopping experiment to find out which are the best food swaps which achieve the greatest impact on SFA, and also the swaps which are most acceptable to people. The researchers are also interested in whether they can change purchases by changing the way foods choices are presented online.

Who can participate?
Healthy volunteers aged 18 and over

What does the study involve?
Participants do a 'pretend' shop in an online supermarket specially designed to conduct this kind of experiment. They are randomly allocated to one of for groups. One group is offered lower SFA swaps to the products they first select. In a second group the position of foods in the list which appears on screen is changed so that lower SFA options are positioned higher up. In the third group both of these interventions are applied together. The fourth group see the default version of the website with no swaps offered and a random order of the foods displayed in response to each search. The amount of SFA in the final basket is calculated for the four groups.

What are the possible benefits and risks of participating?
If successful, these strategies can be delivered at scale supporting current efforts to help people make lifestyle changes to lower their risk of chronic diseases. There are no direct benefits or risks involved in participating in this study, but the participants are reimbursed for their effort.

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
February 2018 to February 2019

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Dimitrios Koutoukidis
dimitrios.koutoukidis@phc.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dimitrios Koutoukidis

ORCID ID

http://orcid.org/0000-0002-1955-7234

Contact details

Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 (0)1865617767
dimitrios.koutoukidis@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1.0

Study information

Scientific title

The effectiveness of individual-level and environmental-level interventions on food choices: an experimental online supermarket study

Acronym

OLS

Study hypothesis

To investigate the magnitude of saturated fat change achieved in the shopping basket in response to an individual-level intervention and an environmental-level intervention, separately and in combination, compared to control (no intervention).

Ethics approval

University of Oxford, Medical Sciences Interdivisional Research Ethics Committee, 08/02/2018, ref: R55722/RE001

Study design

Randomised controlled trial with a 2x2 factorial design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

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

Condition

Food choices

Intervention

This study uses a bespoke virtual online supermarket shopping (OLS) platform, hosted by The University of Oxford, which emulates a real online supermarket for research purposes relating to food purchasing interventions. Participants will be randomly allocated to one of the following groups when shopping online:

1. Individual-level intervention: offering a swap to a product with less saturated fat (SFA)
Swaps will be offered at point of selection i.e. when a participant selects an item to put in their shopping basket, if an alternative product exists that is lower in SFA within the same food category, the participant will be offered the chance to swap the item. Products offered as swaps will be within the same general price and weight range as the original item.

2. Environmental-level intervention: prominent positioning of lower SFA options
This will apply to each list of foods offered to participants when searching for products.

3. A combination of individual- and environmental-level interventions
This group will receive both interventions as described above.

4. Control
Participants in this group will see the default version of the website with no swaps offered and a random order of the foods displayed in response to each search.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Current primary outcome measure as of 20/07/2018:
The difference in the saturated fat content of the final basket (measured in % of total energy) between each of the four trial arms

Previous primary outcome measure:
Difference in the saturated fat change of the final basket (measured in % of total energy) between each single intervention group and control; between combined intervention groups and each single intervention group; and between combined intervention groups and control

Secondary outcome measures

Current secondary outcome measures as of 20/07/2018:
The following outcomes will be compared between each of the four trial arms:
1. Difference in the proportion of products with lower saturated fat in the final basket (%)
2. Difference in the overall cost of the final shopping basket (£) weighted for the size of the basket (g)
3. Difference in the total energy, energy density, sugars (% energy), and salt (g/100g) content of the shopping basket
The following outcomes will be compared between the single individual-level intervention (swaps only) and the combined intervention arms:
4. Difference in % saturated fat content per swap accepted (% energy intake)
5. Difference in the proportion of swaps accepted out of those offered (%)
6. Difference in the proportion of swaps accepted out of those offered (%) by median observed change in saturated fat
7. Difference in the proportion of swaps accepted out of those offered (%) for (a) butter, margarine, and spreads, (b) cheese, (c) milk, (d) meat, and (e) sweets and desserts
8. Difference in the proportion of accepted swaps out of total shopping basket items (%)

Previous secondary outcome measures:
Difference between intervention vs control:
1. The proportion of products with lower saturated fat in the final basket (%)
2. % saturated fat content per swap accepted (% energy intake)
3. The proportion of swaps accepted out of those offered (%)
4. The proportion of accepted swaps out of total shopping basket items (%)
5. The overall cost of the final shopping basket (£) weighted for the size of the basket
6. The total energy, energy density, sugars (% energy) and salt (g/100g) content of the shopping basket

Overall trial start date

08/02/2018

Overall trial end date

07/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. UK adults, aged ≥18 years
2. Able to speak and read English
3. Willing and able to give informed consent for participation in the study
4. Being the main (or shared) grocery shopper for their household
5. Having access to a computer and Internet

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

1240

Participant exclusion criteria

Having any dietary restriction

Recruitment start date

26/03/2018

Recruitment end date

29/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Radcliffe Observatory Quarter Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Research Services
Joint Research Office
Block 60
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol will become available. The statistical analysis plan created prior to running the statistical analysis is available. Planned publication of the study results in a high-impact peer reviewed journal.

IPD sharing statement
The current data sharing plans for the study are unknown and will be made available at a later date.

Intention to publish date

07/02/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/07/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 12/06/2018 to 29/06/2018. 2. The primary and secondary outcome measures were updated. 3. Uploaded statistical analysis plan. 16/04/2018: The target number of participants was changed from 500 to 1240.