Ultraprocessed Foods in Colombia

April 7, 2026 updated by: University of North Carolina, Chapel Hill
The study seeks to examine how characters on packaging and warning labels affect purchase intentions and risk perception among children aged 12 to 17 in Colombia and, examine whether characters' presence weakens or reduces the perceived message effectiveness of the warning labels' impact. This will be a 2x2 between-subjects experiment manipulating presence or absence of characters and presence or absence of warning labels. Participants will be randomly assigned to 1 of 4 conditions in an online survey programmed in Qualtrics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

This study will employ a 2x2 between-subjects experimental design to investigate the independent and combined effects of characters and front-of-package warning labels on children's risk perceptions, purchase intentions and perceived message effectiveness regarding ultra-processed foods.

After parents or legal guardians provide informed consent and the children assent to participate, the survey platform (Qualtrics) will randomly assign each child to one of four experimental conditions:

  1. Warning label + Character
  2. Warning label only
  3. Barcode control label + Character
  4. Barcode control label only

Participants will complete the study online through a self-administered survey programmed in Qualtrics. This survey has a duration of approximately 15 minutes. Each child will be exposed to three fictional ultra-processed food products (cookies package, juice bottle, and chip bag), displayed in random order. The stimuli were developed to resemble common products in Colombia but without using real brands to avoid brand loyalty bias. Each product will be displayed with a label consistent with the child's assigned experimental condition.

Children will respond to a series of questions for each product individually. These questions will assess:

  • Risk perception
  • Purchase intention
  • Perceived message effectiveness

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 (Estimated)

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.
1960

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Maria Parra-Murillo
  • Phone Number: 9843220948
  • Email: mparram@unc.edu

Study Locations

  • Colombia
      • Bogotá, Colombia
        • Online panel
        • Contact:
        • Principal Investigator:
          • Luis Fernando Gómez Guitierrez, MD

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children and adolescents between 12 and 17 years old
  • Colombian residents

Exclusion Criteria:

  • Children with legal blindness, partial blindness, or total blindness, since the study involves viewing images and reading questions.

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: Factorial 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.
Experimental: Warning label + Character
Behavioral: Warning label
Participants will view images of three products containing octagonal warning labels.
Behavioral: Character
Participants will view images of three products containing characters.
Experimental: Barcode control label + Character
Behavioral: Character
Participants will view images of three products containing characters.
Behavioral: Barcode control label
Participants will view images of three products containing Barcode control label.
Experimental: Warning label only
Behavioral: Warning label
Participants will view images of three products containing octagonal warning labels.
Behavioral: Without character
Participants will view images of three products without characters.
Other: Barcode control label only
Behavioral: Barcode control label
Participants will view images of three products containing Barcode control label.
Behavioral: Without character
Participants will view images of three products without characters.

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
Purchase intention
Time Frame: During ~15 minute online survey
Purchase intention will be assessed using 1 item: "How likely are you to consume this product?" Responses will be recorded on a 5-point Likert-style scale ranging from 1 ("Not at all likely") to 5 ("Very likely"). Because this is a single-item measure, the total score ranges from 1 to 5. Higher scores indicate greater purchase intention, whereas lower scores indicate lower purchase intention.
During ~15 minute online survey
Risk perception
Time Frame: During ~15 minute online survey
Risk perception will be assessed using 1 item: "How healthy do you think this product is?" Responses will be recorded on a 5-point Likert-style scale ranging from 1 ("Not healthy at all") to 5 ("Very healthy"). Because this is a single-item measure, the total score ranges from 1 to 5. Higher scores indicate that the product is perceived as healthier (i.e., lower perceived risk), whereas lower scores indicate that the product is perceived as less healthy (i.e., higher perceived risk).
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 will be assessed using 3 items, each measured on a 5-point Likert-style scale (1-5):

"How much does this label make you worry about what consuming this product will do to you?" (1 = Not at all worried; 5 = Extremely worried) "How much does this label make you think consuming this product is a bad idea?" (1 = Makes me think it's a very good idea to consume it; 5 = Makes me think it's a very bad idea to consume it) "How much does this label discourage you from consuming this product?"

(1 = Doesn't discourage me at all; 5 = Completely discourages me) For each product evaluated, a perceived message effectiveness score will be calculated as the mean of the 3 items, resulting in a score ranging from 1 to 5. Higher scores indicate greater perceived message effectiveness, whereas lower scores indicate lower perceived message effectiveness.
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.
Pontificia Universidad Javeriana
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: Maria Parra-Murillo, University of North Carolina, Chapel Hill
  • Study Director: Marissa Hall, PhD, University of North Carolina, Chapel Hill

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 (Estimated)

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.
May 1, 2026

Primary Completion (Estimated)

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.
September 30, 2026

Study Completion (Estimated)

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.
September 30, 2026

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).
April 7, 2026

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.
April 7, 2026

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.
April 14, 2026

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.
April 14, 2026

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.
April 7, 2026

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.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 24-2935

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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