Dietary ExposureNCT05842460
Testing "Ultraprocessed" Front-of-package Label Among Brazilian Consumers
A study testing Nutrient warning labels and Nutrient and ultraprocessed warning labels in people with Dietary Exposure, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this experiment is to test the effects an "ultraprocessed" warning label on foods and beverages among Brazilian consumers. The main questions it aims to answer are: Do "ultraprocessed" warnings affect Brazilian consumers' intention to purchase products? Do "ultraprocessed" warnings affect Brazilian… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Nutrient warning labels and Nutrient and ultraprocessed warning labels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,007 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 28 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older,
- residing in Brazil,
- responsible for at least 50% of the household's grocery purchases.
Who cannot join
- involvement in any pre-testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
About this study
Official title: Testing the Impact of an "Ultraprocessed" Front-of-package Warning Label Among Brazilian Consumers
The goal of this experiment is to test the effects an "ultraprocessed" warning label on foods and beverages among Brazilian consumers. The main questions it aims to answer are:
- Do "ultraprocessed" warnings affect Brazilian consumers' intention to purchase products?
- Do "ultraprocessed" warnings affect Brazilian consumers' product perceptions?
Participants will see images of four products carrying either nutrient warning labels (which are currently mandatory in Brazil) or nutrient warning labels alongside an experimental warning label informing that the product is ultraprocessed. Participants will then answer survey questions about each product. Researchers will compare responses between both arms to determine if the "ultraprocessed" warning significantly changes the effect of nutrient warnings.
- Conditions
- Dietary Exposure
- Being tested
- Nutrient warning labels, Nutrient and ultraprocessed warning labels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrient warning labelsBehavioural
Inclusion of nutrient warning labels, which are currently mandatory in Brazil, to images of food products.
Nutrient and ultraprocessed warning labelsBehavioural
Inclusion of nutrient warning labels, which are currently mandatory in Brazil, and an experimental ultraprocessed warning label to images of food products.
| Study group | Role | What they receive |
|---|---|---|
| Nutrient warnings | Active comparator | Individuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme. Receives: Behavioral: Nutrient warning labels |
| Nutrient and ultraprocessed warnings | Experimental | Individuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme and an experimental warning stating that the product is ultraprocessed. Receives: Behavioral: Nutrient and ultraprocessed warning labels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purchase intentions
How likely the participant would be to buy products will be measured by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher likelihood of buying products.
Measured: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Secondary outcomes (3)
Product healthfulness perceptions
How healthy products seem to the participant will be measured by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher perceived product healthfulness.
Measured: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Product processing status perceptions
Whether the participant believes products are ultraprocessed will be measured by survey. Responses options are "no," "yes," and "I'm not sure."
Measured: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Message effectiveness perceptions
Perceived message effectiveness of the study labels will be measured by survey through a three-item scale. Items inquire about how much the labels discourage the participant from wanting to consume the products, how much the labels make the participant concerned about the health effects of consuming the products, and how much the labels make consuming the products seem unpleasant. Response options are on a 1 to 5 scale, with higher scores representing a higher perceived message effectiveness of the study labels.
Measured: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start24 May 2023
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary ExposureStudies 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
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- The Bloomberg Family Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Lindsey Taillie, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842460
- Sponsor's protocol ID
- 23-0151
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A deidentified dataset and analytic code will be uploaded to a public repository upon publication of the study.
Publications
Cotter T, Kotov A, Wang S, Murukutla N. 'Warning: ultra-processed' - A call for warnings on foods that aren't really foods. BMJ Glob Health. 2021 Dec;6(12):e007240. doi: 10.1136/bmjgh-2021-007240. No abstract available.
PubMed 34933866Romero Ferreiro C, Lora Pablos D, Gomez de la Camara A. Two Dimensions of Nutritional Value: Nutri-Score and NOVA. Nutrients. 2021 Aug 13;13(8):2783. doi: 10.3390/nu13082783.
PubMed 34444941D'Angelo Campos A, Ng SW, Duran AC, Khandpur N, Taillie LS, Christon FO, Hall MG. "Warning: ultra-processed": an online experiment examining the impact of ultra-processed warning labels on consumers' product perceptions and behavioral intentions. Int J Behav Nutr Phys Act. 2024 Oct 9;21(1):115. doi: 10.1186/s12966-024-01664-w.
PubMed 39385224
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Impact of an "Ultraprocessed" Front-of-package Warning Label Among Brazilian Consumers
- ClinicalTrials.gov ID
- NCT05842460
- Acronym / sponsor ID
- 23-0151
- Conditions
- Dietary Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- The Bloomberg Family Foundation, Inc.
- Study start
- 24 May 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 6 May 2023 (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.
The goal of this experiment is to test the effects an "ultraprocessed" warning label on foods and beverages among Brazilian consumers. The main questions it aims to answer are:
- Do "ultraprocessed" warnings affect Brazilian consumers' intention to purchase products?
- Do "ultraprocessed" warnings affect Brazilian consumers' product perceptions?
Participants will see images of four products carrying either nutrient warning labels (which are currently mandatory in Brazil) or nutrient warning labels alongside an experimental warning label informing that the product is ultraprocessed. Participants will then answer survey questions about each product. Researchers will compare responses between both arms to determine if the "ultraprocessed" warning significantly changes the effect of nutrient warnings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrient warnings | Active comparator | Behavioral: Nutrient warning labelsIndividuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme. |
| Nutrient and ultraprocessed warnings | Experimental | Behavioral: Nutrient and ultraprocessed warning labelsIndividuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme and an experimental warning stating that the product is ultraprocessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older,
- residing in Brazil,
- responsible for at least 50% of the household's grocery purchases.
Key exclusion criteria (1 listed)
- involvement in any pre-testing.
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 |
|---|---|---|
| Nutrient warning labelsInclusion of nutrient warning labels, which are currently mandatory in Brazil, to images of food products. | Behavioural | Nutrient warnings |
| Nutrient and ultraprocessed warning labelsInclusion of nutrient warning labels, which are currently mandatory in Brazil, and an experimental ultraprocessed warning label to images of food products. | Behavioural | Nutrient and ultraprocessed warnings |
Primary outcome
Purchase intentions
Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
How likely the participant would be to buy products will be measured by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher likelihood of buying products.
3 secondary outcomes
Product healthfulness perceptions
Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Product processing status perceptions
Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
Message effectiveness perceptions
Time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.
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 14 Aug 2023.
- Background: PubMed 34933866Cotter T, Kotov A, Wang S, Murukutla N. 'Warning: ultra-processed' - A call for warnings on foods that aren't really foods. BMJ Glob Health. 2021 Dec;6(12):e007240. doi: 10.1136/bmjgh-2021-007240. No abstract available.
- Background: PubMed 34444941Romero Ferreiro C, Lora Pablos D, Gomez de la Camara A. Two Dimensions of Nutritional Value: Nutri-Score and NOVA. Nutrients. 2021 Aug 13;13(8):2783. doi: 10.3390/nu13082783.
- Derived from this study: PubMed 39385224D'Angelo Campos A, Ng SW, Duran AC, Khandpur N, Taillie LS, Christon FO, Hall MG. "Warning: ultra-processed": an online experiment examining the impact of ultra-processed warning labels on consumers' product perceptions and behavioral intentions. Int J Behav Nutr Phys Act. 2024 Oct 9;21(1):115. doi: 10.1186/s12966-024-01664-w.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. A deidentified dataset and analytic code will be uploaded to a public repository upon publication of the study.
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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 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 Nutrient warning labels and Nutrient and ultraprocessed warning labels in people with Dietary Exposure, 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 1 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 14 Aug 2023. 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?
Purchase intentions (time frame: Online survey within 20 minutes following completion of a ~10 minute shopping task.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842460, which also lists 3 linked publications.
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 14 Aug 2023.