ISRCTN ISRCTN13729526
DOI https://doi.org/10.1186/ISRCTN13729526
Secondary identifying numbers v1.0
Submission date
26/02/2018
Registration date
23/03/2018
Last edited
10/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Dimitrios Koutoukidis
Scientific

Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

ORCiD logoORCID ID 0000-0002-1955-7234
Phone +44 (0)1865617767
Email dimitrios.koutoukidis@phc.ox.ac.uk

Study information

Study designRandomised controlled trial with a 2x2 factorial design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe effectiveness of individual-level and environmental-level interventions on food choices: an experimental online supermarket study
Study acronymOLS
Study objectivesTo 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(s)University of Oxford, Medical Sciences Interdivisional Research Ethics Committee, 08/02/2018, ref: R55722/RE001
Health condition(s) or problem(s) studiedFood choices
InterventionThis 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 typeBehavioural
Primary outcome measureCurrent 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 measuresCurrent 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 study start date08/02/2018
Completion date07/02/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1240
Total final enrolment1240
Key inclusion criteria1. 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
Key exclusion criteriaHaving any dietary restriction
Date of first enrolment26/03/2018
Date of final enrolment29/06/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University of Oxford
University/education

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

ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date07/02/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe 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 planThe current data sharing plans for the study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Statistical Analysis Plan version v1.0 13/07/2018 20/07/2018 No No
Results article results 07/06/2019 14/06/2019 Yes No
Protocol file version 3.0 13/07/2018 10/08/2022 No No

Additional files

ISRCTN13729526_SAP_v1.0_13Jul18.pdf
Uploaded 20/07/2018
ISRCTN13729526 Protocol and SAP v3.0 13Jul2018.pdf

Editorial Notes

10/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
14/06/2019: Publication reference and total final enrolment number added.
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.