Impacts of Warning Labels on Ultra-Processed Foods

October 14, 2024 updated by: University of North Carolina, Chapel Hill

Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).

Participants: ~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.

Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned.

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

On the study platform (Qualtrics), participants will be randomly assigned to 1 of 3 arms with equal probability: a UPF health warning label, a UPF identity label, or a barcode control label. Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) displayed in random order, each with a label displayed on the front of package according to the participants' study arm. Participants will complete a 13-item online survey to assess each product as to a) whether the product is ultra-processed; b) perceptions of healthfulness; c) intentions to purchase the product.

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.
4000

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: Lindsey Smith Taillie, PhD
  • Phone Number: (919) 445-8313
  • Email: taillie@unc.edu

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Identifying as Latino or Hispanic
  • Ages 18-55 years old
  • Currently resides in the United States

Exclusion Criteria:

  • Not identifying as Latino or Hispanic
  • Less than 18 or greater than 55 years old
  • Not residing in the United States

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.
Experimental: Health Warning Label
Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a health warning label displayed on the front of package.
Behavioral: Health Warning Label
Message displayed on warning label is: "WARNING: Consuming ultra-processed food and drinks can cause weight gain, which increases the risk of obesity and type 2 diabetes."
Experimental: Identity Warning Label
Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with an identity warning label displayed on the front of package.
Behavioral: Identity Warning Label
Message displayed on warning label is: "WARNING: Ultra-processed food".
Other: Barcode Label
Participants will view four products (a fruit-flavored drink, pretzels, a yogurt, and a breakfast cereal) each with a barcode control label displayed on the front of package.
Other: Barcode Label
Barcode is displayed.

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
Identification of a product as ultra-processed
Time Frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Correct identification of a product as ultra-processed. Measured with the question, "Do you think this product is ultra-processed?" Response options are Yes, No, and I'm not sure.
Immediately after exposure to intervention, assessed during 1-time online study visit.

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
Intentions to purchase ultra-processed products
Time Frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Measured with the question, "How likely would you be to purchase this product in the next week, if it were available?" Likert responses are on a 1 to 5 scale, from "Not at all likely" (coded as 1) to "Extremely likely" (coded as 5), with higher scores representing a higher intention to purchase ultra-processed products.
Immediately after exposure to intervention, assessed during 1-time online study visit.
Perceived product healthfulness of ultra-processed products
Time Frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Measured with the question, "How good or bad for your health would it be to consume this product every day?" Likert responses are on a 1 to 5 scale, from "Very bad" (coded as 1) to "Very good" (coded as 5), with higher scores representing a higher perceived healthfulness.
Immediately after exposure to intervention, assessed during 1-time online study visit.
Perceived message effectiveness
Time Frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Measured with the question, "How much does this message discourage you from wanting to consume an ultra-processed food or drink?" Likert responses are on a 1 to 5 scale, from "Not at all" (coded as 1) to "Very much" (coded as 5), with higher scores representing a higher perceived message effectiveness.
Immediately after exposure to intervention, assessed during 1-time online study visit.

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.
Robert Wood Johnson Foundation

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 Smith Taillie, 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 (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.
August 9, 2024

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.
September 11, 2024

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.
September 11, 2024

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).
February 28, 2024

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.
February 28, 2024

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.
March 6, 2024

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.
October 15, 2024

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.
October 14, 2024

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, 2024

More Information

Terms related to this study

Keywords

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.
  • 24-0300d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A deidentified dataset and the corresponding survey codebook will be shared beginning 9 months and continuing for 36 months after publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. The study protocol, statistical analysis plan, and informed consent form will be published alongside as supplementary material.

IPD Sharing Time Frame

beginning 9 and continuing for 36 months following publication of study results.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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