Diet, HealthyNCT04340791
Increased Proportion of Lower Energy Density Items vs. Nutritional Labelling at an Online Supermarket
A study testing Increased proportion of lower energy density items and Labelling in people with Diet, Healthy and Food Selection, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
This study will be a 2x2 randomised controlled trial with information-based intervention (no labelling / labelling) and structural intervention (default proportion / increased proportion of lower energy density food items) as between-subject factors and energy density (kcal/g) of food purchases during an online… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Food Selection
- What is being tested?
- Increased proportion of lower energy density items and Labelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2020to 13 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- United Kingdom residents
- Aged ≥ 18 years
- Fluent in English
- Have access to a computer and Internet
- Responsible for a substantial proportion of household grocery shopping
Who cannot join
- Unable to provide informed consent and to comply with the study requirements
- Any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, dairy or lactose free, food allergy, other)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
Official title: Effectiveness of Information-based Versus Structural Interventions on Food Choices by Socioeconomic Position: a Randomized Controlled Trial in an Experimental Online Supermarket
This study will be a 2x2 randomised controlled trial with information-based intervention (no labelling / labelling) and structural intervention (default proportion / increased proportion of lower energy density food items) as between-subject factors and energy density (kcal/g) of food purchases during an online supermarket-shopping task as dependent variable. This study will use an online supermarket platform developed to mimic an online supermarket website and participants will be asked to complete a shopping task using a pre-determined shopping list of 10 items.
Read the detailed description
See attached protocol documents.
- Conditions
- Diet, Healthy, Food Selection
- Being tested
- Increased proportion of lower energy density items, Labelling
- Keywords
- availability, labelling, food choice, socio-economic position
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased proportion of lower energy density itemsBehavioural
The proportion of lower energy density vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (D and DL) (33% lower - 67% higher). Lower energy density items will be defined as lower energy density ≤ median of energy density distribution within a food category.
LabellingBehavioural
When energy density of an item ≤ median of ED distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions when logging-into the platform will introduce the badges to the participants: "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category."
| Study group | Role | What they receive |
|---|---|---|
| Default proportion & no labelling | No intervention | No intervention: Default proportion condition (33% lower energy density items - 67% higher energy density items). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category. No labelling. |
| Default proportion & labelling | Experimental | When energy density of a food item ≤ median of energy density distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions will introduce the badges to the participants as "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category." Receives: Behavioral: Labelling |
| Increased proportion & no labelling | Experimental | The proportion of lower energy density items vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (33% lower - 67% higher). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category. Receives: Behavioral: Increased proportion of lower energy density items |
| Increased proportion & labelling | Experimental | The proportion of lower energy density items vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (33% lower - 67% higher). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category.
When energy density of a food item ≤ median of energy density distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions will introduce the badges to the participants as "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category." Receives: Behavioral: Increased proportion of lower energy density items; Behavioral: Labelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ED of the food items purchased (kcal/100g)
Calculated as the sum of the energy of the purchased items (kcal) divided by the sum of their weight (g) and multiplied by 100.
Measured: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Secondary outcomes (6)
Total energy of the food items purchased (kcal)
Calculated as the sum of the energy of the purchased items (kcal)
Measured: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Energy from total sugar (% of total energy)
Calculated as the percentage of total energy of the purchased items from total sugar
Measured: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Energy from saturated fatty acids (SFA) (% of total energy)
Calculated as the percentage of total energy of the purchased items from SFA
Measured: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Salt content (g/100g)
Calculated as the sum of the salt content of the purchased items (g) divided by the sum of their weight (g) and multiplied by 100.
Measured: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Proportion of lower energy density food items in the basket of foods purchased
Lower energy density items will be defined as ≤ median of energy density distribution within a food category
Measured: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Cost (GPB)
Calculated as the sum of the prices of the purchased items
Measured: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start13 Apr 2020
- Primary completion13 Apr 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Robinson, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340791
- Sponsor's protocol ID
- 803194 1B3
- Status last verified
- Nov 2020
- First submitted
- 7 Apr 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared on the Open Science Framework
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Information-based Versus Structural Interventions on Food Choices by Socioeconomic Position: a Randomized Controlled Trial in an Experimental Online Supermarket
- ClinicalTrials.gov ID
- NCT04340791
- Acronym / sponsor ID
- 803194 1B3
- Conditions
- Diet, Healthy, Food Selection
- Keywords
- availability, labelling, food choice, socio-economic position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a 2x2 randomised controlled trial with information-based intervention (no labelling / labelling) and structural intervention (default proportion / increased proportion of lower energy density food items) as between-subject factors and energy density (kcal/g) of food purchases during an online supermarket-shopping task as dependent variable. This study will use an online supermarket platform developed to mimic an online supermarket website and participants will be asked to complete a shopping task using a pre-determined shopping list of 10 items.
Detailed description
See attached protocol documents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Default proportion & no labelling | No intervention | –No intervention: Default proportion condition (33% lower energy density items - 67% higher energy density items). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category. No labelling. |
| Default proportion & labelling | Experimental | Behavioral: LabellingWhen energy density of a food item ≤ median of energy density distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions will introduce the badges to the participants as "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category." |
| Increased proportion & no labelling | Experimental | Behavioral: Increased proportion of lower energy density itemsThe proportion of lower energy density items vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (33% lower - 67% higher). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category. |
| Increased proportion & labelling | Experimental | Behavioral: Increased proportion of lower energy density items, Behavioral: LabellingThe proportion of lower energy density items vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (33% lower - 67% higher). Lower energy density items will be defined as lower ED ≤ median of ED distribution within a food category. When energy density of a food item ≤ median of energy density distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions will introduce the badges to the participants as "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- United Kingdom residents
- Aged ≥ 18 years
- Fluent in English
- Have access to a computer and Internet
- Responsible for a substantial proportion of household grocery shopping
Key exclusion criteria (2 listed)
- Unable to provide informed consent and to comply with the study requirements
- Any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, dairy or lactose free, food allergy, other)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased proportion of lower energy density itemsThe proportion of lower energy density vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (D and DL) (33% lower - 67% higher). Lower energy density items will be defined as lower energy density ≤ median of energy density distribution within a food category. | Behavioural | Increased proportion & labelling, Increased proportion & no labelling |
| LabellingWhen energy density of an item ≤ median of ED distribution within a food category, "healthier choice" badges will be added to the food item pictures on the online supermarket. Instructions when logging-into the platform will introduce the badges to the participants: "In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category." | Behavioural | Default proportion & labelling, Increased proportion & labelling |
Primary outcome
Mean ED of the food items purchased (kcal/100g)
Time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Calculated as the sum of the energy of the purchased items (kcal) divided by the sum of their weight (g) and multiplied by 100.
6 secondary outcomes
Total energy of the food items purchased (kcal)
Time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Energy from total sugar (% of total energy)
Time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Energy from saturated fatty acids (SFA) (% of total energy)
Time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Salt content (g/100g)
Time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Proportion of lower energy density food items in the basket of foods purchased
Time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Cost (GPB)
Time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Yes. Shared on the Open Science Framework
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased proportion of lower energy density items and Labelling in people with Diet, Healthy and Food Selection, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean ED of the food items purchased (kcal/100g) (time frame: 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.