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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04340791
Other study ID # 803194 1B3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 13, 2020
Est. completion date May 13, 2020

Study information

Verified date November 2020
Source University of Liverpool
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Description:

See attached protocol documents.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date May 13, 2020
Est. primary completion date April 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Increased proportion of lower energy density items
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.
Labelling
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."

Locations

Country Name City State
United Kingdom University of Liverpool Liverpool Merseyside

Sponsors (1)

Lead Sponsor Collaborator
University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Validity 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)
Other Kcal influence 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)
Primary 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. 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Secondary Total energy of the food items purchased (kcal) 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)
Secondary Energy from total sugar (% of total energy) 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)
Secondary Energy from saturated fatty acids (SFA) (% of total energy) 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)
Secondary 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. 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Secondary 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 20 minutes (the time frame denotes time taken to make the food shopping task online and there is no follow up)
Secondary Cost (GPB) 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)
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