- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567004
Testing Product Messages for Colombia
Purpose: To better understand the impact of different front-of-package labels (FOPLs) on consumer purchasing intentions and ability to identify unhealthy foods.
Participants: ~8,000 Colombians, recruited from Offerwise, that are 18 years or older.
Procedures (methods): Participants will be randomly assigned to view images of food and drink products with either a nutrient warning label, Guideline Daily Amount label, Nutriscore label, or no-label control. They will be asked a series of questions about the products and the labels (excluding control group) on them. Questions will also include standard demographic and health related variables.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be recruited from Offerwise (an online panel research company). Following online consent, participants will be randomly assigned to view different labels (explained below) on food and drink packaging. Participants will answer self-reported responses to the content (e.g., elaboration, beliefs, perceived healthfulness). After being randomized to one of the four groups and answering questions (e.g. which product is healthier, which product would you buy), the participant will see all three labels and select which is most dissuading from consuming a product high in a nutrient. At the end, the participant will answer demographic questions.
Participants will be randomized to see either a no-label control or 1 of 3 nutrient labels. The participants will see 5 types of products with the labels (fruit drinks, yogurt, sliced bread, cookies, and breakfast cereal).
Nutrient labels:
- Guideline Daily Amount label
- Nutriscore label
- Adapted Peruvian nutrient warning label (high in sugar, high in saturated fat, high in salt/sodium)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Carolina Population Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-64 years old
- Resident of Colombia
- Offerwise panel member (recruitment platform)
Exclusion Criteria:
- <18 years old or >64 years old
- Not a resident of Colombia
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 |
---|---|
Other: Control
The control arm will show the products with no label.
|
Participants will be shown images of juice, bread, yogurt, cookies, and cereal without any added front-of-package labels.
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Experimental: Nutriscore Label
The Nutriscore label applies a letter grade (A, B, C, D or E) to a product based on certain nutrient criteria.
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A front-of-package Nutriscore label will be applied to images of juice, bread, yogurt, cookies, and cereal.
This label applies a score of A, B, C, D, or E based on the product's nutrition profile.
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Experimental: Adapted Peruvian Nutrient Label
The adapted label is a black octagon with the words in Spanish saying "Excess of sugar,"Excess of saturated fat," or "Excess of salt/sodium" depending on the nutrition contents of the product.
Below the octagon is a box with words in Spanish saying "Avoid high consumption"
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A front-of-package octagonal nutrient label will be applied to images of juice, bread, yogurt, cookies, and cereal.
The label text informs consumers if a product is high in sugar, saturated fat, or salt/sodium.
These labels were developed by the Peruvian government and adapted by investigators.
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Experimental: Guideline Daily Amount Label
The Guideline Daily Amount label highlights the nutrient contents of the product by serving.
It lists the calories, total fat, saturated fat, sugar, and sodium, as well are their % of the daily value.
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A front-of-package Guideline Daily Amount label will be applied to images of juice, bread, yogurt, cookies, and cereal.
The label shows the amount and percent of daily value of calories, total fat, saturated fat, sugar, and sodium in one serving of a product.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Selection of Product Higher in Sugar
Time Frame: During ~15 minute online survey
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Percentage of participants who select the less healthy product in a set of two products as the product the consumer most wants to buy.
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During ~15 minute online survey
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Correct Identification of the Product Higher in Sugar
Time Frame: During ~15 minute online survey
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Percentage of participants who correctly select the product higher in sugar (between two products)
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During ~15 minute online survey
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Message Effectiveness
Time Frame: During ~15 minute online survey
|
Perceived message effectiveness of the study labels. Response options are on a 1 to 5 scale, with lower scores representing a higher amount of the construct. Perceived message effectiveness is measured using 3 items adapted from Baig et al. (2018): concern, unpleasantness, and discouragement. Responses to the 3 items will be averaged to create a perceived message effectiveness score. Question: How much does this message...
Only asked of the label arms, not control. |
During ~15 minute online survey
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Purchase Likelihood
Time Frame: During ~15 minute online survey
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Likelihood that participants would purchase this product in the next week if it were available.
Response options are on a 1 to 5 scale, with lower scores representing a higher amount of the construct
|
During ~15 minute online survey
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Identify Less Healthy Product
Time Frame: During ~15 minute online survey
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Percentage of participants that correctly identify the less healthy product when selecting between two products.
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During ~15 minute online survey
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Ability to Identify Product as Having Excess of Sugar/Saturated Fat/Sodium
Time Frame: During ~15 minute online survey
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Percentage of participants who correctly identify that the product contains excess sugar, saturated fat, or sodium.
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During ~15 minute online survey
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Most Discouraging Label
Time Frame: During ~15 minute online survey
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Percentage of participants selecting each nutrient label as most discouraging them from consuming the product.
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During ~15 minute online survey
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lindsey S Taillie, PhD, University of North Carolina, Chapel Hill
Publications and helpful links
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
- 20-0401a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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