Testing Product Messages for Colombia

March 14, 2023 updated by: University of North Carolina, Chapel Hill

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8071

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Carolina Population Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
The control arm will show the products with no label.
Other: Control
Participants will be shown images of juice, bread, yogurt, cookies, and cereal without any added front-of-package labels.
Experimental: Nutriscore Label
The Nutriscore label applies a letter grade (A, B, C, D or E) to a product based on certain nutrient criteria.
Other: 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.
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"
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Selection of Product Higher in Sugar
Time Frame: During ~15 minute online survey
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
Correct Identification of the Product Higher in Sugar
Time Frame: During ~15 minute online survey
Percentage of participants who correctly select the product higher in sugar (between two products)
During ~15 minute online survey

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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...

  • 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
Purchase Likelihood
Time Frame: During ~15 minute online survey
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
Identify Less Healthy Product
Time Frame: During ~15 minute online survey
Percentage of participants that correctly identify the less healthy product when selecting between two products.
During ~15 minute online survey
Ability to Identify Product as Having Excess of Sugar/Saturated Fat/Sodium
Time Frame: During ~15 minute online survey
Percentage of participants who correctly identify that the product contains excess sugar, saturated fat, or sodium.
During ~15 minute online survey
Most Discouraging Label
Time Frame: During ~15 minute online survey
Percentage of participants selecting each nutrient label as most discouraging them from consuming the product.
During ~15 minute online survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Bloomberg Family Foundation, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lindsey S Taillie, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-0401a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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