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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05783726
Other study ID # 20-0401b
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2023
Est. completion date June 22, 2023

Study information

Verified date May 2023
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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: 1. Guideline Daily Amount label 2. Nutriscore label 3. Adapted Peruvian nutrient warning label (high in sugar, high in saturated fat, high in salt/sodium)


Recruitment information / eligibility

Status Completed
Enrollment 8086
Est. completion date June 22, 2023
Est. primary completion date June 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Control
Participants will be shown images of juice, bread, yogurt, cookies, and cereal without any added front-of-package labels.
Behavioral:
Nutriscore Label
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.
Adapted Peruvian Nutrient Label
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.
Guideline Daily Amount Label
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.

Locations

Country Name City State
United States UNC Carolina Population Center Chapel Hill North Carolina

Sponsors (3)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill The Bloomberg Family Foundation, Inc., Universidad Nacional de Colombia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Selection of Product Higher in Sugar Percentage of participants who select the less healthy product in a set of two products as the product the consumer most wants to buy. During ~15 minute online survey
Primary Correct Identification of the Product Higher in Sugar Percentage of participants who correctly select the product higher in sugar (between two products) During ~15 minute online survey
Secondary Perceived Message Effectiveness 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...
make you concerned about the health effect of consuming an unhealthy product? discourage you from wanting to eat an unhealthy product? make eating an unhealthy product seem unpleasant to you? Only asked of the label arms, not control.
During ~15 minute online survey
Secondary Purchase Likelihood 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
Secondary Identify Less Healthy Product Percentage of participants that correctly identify the less healthy product when selecting between two products. During ~15 minute online survey
Secondary Ability to Identify Product as Having Excess of Sugar/Saturated Fat/Sodium Percentage of participants who correctly identify that the product contains excess sugar, saturated fat, or sodium. During ~15 minute online survey
Secondary Most Discouraging Label Percentage of participants selecting each nutrient label as most discouraging them from consuming the product. During ~15 minute online survey
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