Health BehaviorNCT06296355
Impacts of Warning Labels on Ultra-Processed Foods
A study testing Health Warning Label, Identity Warning Label and Barcode Label in people with Health Behavior and Diet, Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Diet, Healthy
- What is being tested?
- Health Warning Label, Identity Warning Label and Barcode Label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Identifying as Latino or Hispanic
- Ages 18-55 years old
- Currently resides in the United States
Who cannot join
- Not identifying as Latino or Hispanic
- Less than 18 or greater than 55 years old
- Not residing in the United States
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Carolina Population Center
Chapel Hill, North Carolina, 27516
About this study
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.
Read the 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.
- Conditions
- Health Behavior, Diet, Healthy
- Being tested
- Health Warning Label, Identity Warning Label, Barcode Label
- Keywords
- front-of-package labels, ultra-processed food, food and beverage purchases
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Warning LabelBehavioural
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."
Identity Warning LabelBehavioural
Message displayed on warning label is: "WARNING: Ultra-processed food".
Barcode LabelOther
Barcode is displayed.
| Study group | Role | What they receive |
|---|---|---|
| Health Warning Label | Experimental | 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. Receives: Behavioral: Health Warning Label |
| Identity Warning Label | Experimental | 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. Receives: Behavioral: Identity Warning Label |
| Barcode Label | Other | 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. Receives: Other: Barcode Label |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a product as ultra-processed
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.
Measured: Immediately after exposure to intervention, assessed during 1-time online study visit.
Secondary outcomes (3)
Perceived product healthfulness of ultra-processed products
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.
Measured: Immediately after exposure to intervention, assessed during 1-time online study visit.
Intentions to purchase ultra-processed products
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.
Measured: Immediately after exposure to intervention, assessed during 1-time online study visit.
Perceived message effectiveness
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.
Measured: Immediately after exposure to intervention, assessed during 1-time online study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start9 Aug 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Lindsey Smith Taillie, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296355
- Sponsor's protocol ID
- 24-0300d
- Status last verified
- Oct 2024
- First submitted
- 28 Feb 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Warning Labels on Ultra-Processed Foods
- ClinicalTrials.gov ID
- NCT06296355
- Acronym / sponsor ID
- 24-0300d
- Conditions
- Health Behavior, Diet, Healthy
- Keywords
- front-of-package labels, ultra-processed food, food and beverage purchases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Warning Label | Experimental | Behavioral: Health Warning LabelParticipants 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. |
| Identity Warning Label | Experimental | Behavioral: Identity Warning LabelParticipants 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. |
| Barcode Label | Other | Other: Barcode LabelParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Identifying as Latino or Hispanic
- Ages 18-55 years old
- Currently resides in the United States
Key exclusion criteria (3 listed)
- Not identifying as Latino or Hispanic
- Less than 18 or greater than 55 years old
- Not residing in the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Warning LabelMessage 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." | Behavioural | Health Warning Label |
| Identity Warning LabelMessage displayed on warning label is: "WARNING: Ultra-processed food". | Behavioural | Identity Warning Label |
| Barcode LabelBarcode is displayed. | Other | Barcode Label |
Primary outcome
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.
3 secondary outcomes
Perceived product healthfulness of ultra-processed products
Time frame: Immediately after exposure to intervention, assessed during 1-time online study visit.
Intentions to purchase ultra-processed products
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Smith Taillie, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Warning Label, Identity Warning Label and Barcode Label in people with Health Behavior and Diet, Healthy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a product as ultra-processed (time frame: Immediately after exposure to intervention, assessed during 1-time online study visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.