- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04340791
Increased Proportion of Lower Energy Density Items vs. Nutritional Labelling at an Online Supermarket
Effectiveness of Information-based Versus Structural Interventions on Food Choices by Socioeconomic Position: a Randomized Controlled Trial in an Experimental Online Supermarket
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L69 7ZA
- University of Liverpool
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Default proportion & no labelling
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. |
|
|
Experimental: Default proportion & labelling
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."
|
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."
|
|
Experimental: Increased proportion & no labelling
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.
|
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.
|
|
Experimental: Increased proportion & labelling
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." |
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."
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Calculated as the sum of the energy of the purchased items (kcal)
|
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)
|
Calculated as the percentage of total energy of the purchased items from total sugar
|
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)
|
Calculated as the percentage of total energy of the purchased items from SFA
|
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)
|
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.
|
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)
|
Lower energy density items will be defined as ≤ median of energy density distribution within a food category
|
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)
|
Calculated as the sum of the prices of the purchased items
|
20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity
Time Frame: 5 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
|
Mean of item "I would normally buy [the 10 items on the shopping list]" for all the food items coded as: 1 = Never; 2 = Very rarely; 3 = Rarely; 4 = Occasionally; 5 = Frequently; 6 = Very frequently.
|
5 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
|
|
Kcal influence
Time Frame: 5 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
|
Answer to the item "The choices I made during online shopping were influenced by how many calories I thought were in the options available."
coded as: 1 = Strongly disagree; 2 = Disagree; 3 = Slightly disagree; 4 = Neutral; 5 = Slightly agree; 6 = Agree; 7 = Strongly agree
|
5 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 803194 1B3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Study Data/Documents
- Study Protocol
- Statistical Analysis Plan
- Informed Consent Form
-
Individual Participant Data Set
Information comments: When results will be published
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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