Cancer of ColonNCT04716010
Developing and Evaluating Product Messaging
A study testing Warning Labels, Tax and Combined Warning Labels and Tax in people with Cancer of Colon and Cancer of Rectum, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To assess the impact of taxes, warnings, and a combination of taxes and warnings on US adults' decisions to purchase products that contain red meat in an online grocery store. Procedures (methods): Participants will be recruited from Prime Panels (an online panel research company). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer of Colon, Cancer of Rectum
- What is being tested?
- Warning Labels, Tax and Combined Warning Labels and Tax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,160 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 28 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Consumes red meat at least once per week.
- Responsible for at least 50% of grocery shopping for the household.
- Lives in the United States
Who cannot join
- Individuals who have participated in research studies from previous aims of this research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Population Center
Chapel Hill, North Carolina, 27516
About this study
Purpose: To assess the impact of taxes, warnings, and a combination of taxes and warnings on US adults' decisions to purchase products that contain red meat in an online grocery store.
Procedures (methods): Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be assigned to one of four trial arms: 1) Control (no warning and no tax), 2) Warnings (all products that contain red meat have a health warning and environmental warning), 3) Tax (30% tax on products that contain red meat), and 4) Combined warning and tax (all products that contain red meat will have the two warnings and a 30% tax). Then, participant will enter an online grocery store reflecting their assigned arm. The participant will be instructed to complete a shopping task in the online grocery store. After completing the shopping task, participants will be redirected to an online survey and answer a series of questions about the shopping task, labels (excluding tax and control groups), and taxes (excluding warning and control groups). Questions will also include standard demographic and health related variables.
Read the detailed description
Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be randomly assigned to one of four trial arms affecting the appearance of an online grocery store. Once in the online grocery store, participants will complete a shopping task. The participants will have 9 specified items to add to their shopping cart (1 pizza, 1 burrito, Burger patties [meat or vegetarian], Breakfast sausages [meat or vegetarian], 1 frozen individual meal, 1 loaf of bread, 1 sandwich filling [for example, ham, turkey, or peanut butter], 1 pack of tortillas, 1 taco filling [for example, steak, chicken, or beans]). Participants will be informed that they will not be spending any of their own money to complete the shopping task. After completing the shopping task, participants will be redirected to a survey. They will provide self-reported responses to survey questions (e.g. perceived healthfulness from eating red meat, perceived risk of cancer from eating red meat, thinking about the health/environmental harms of food products). Participants will also answer demographic and health related questions.
- Conditions
- Cancer of Colon, Cancer of Rectum
- Being tested
- Control, Warning Labels, Tax, Combined Warning Labels and Tax
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Participants will complete a shopping task in the online grocery store, and the products that contain red meat will not have warning labels or a 30% increase in price.
Warning LabelsOther
While completing the shopping task in the online grocery store, the health and environmental warning labels will appear next to the image of every product that contains red meat.
TaxOther
While completing the shopping task in the online grocery store, all products containing red meat will have a 30% increase in price.
Combined Warning Labels and TaxOther
While completing the shopping task in the online grocery store, all products containing red meat will have the health and environmental warning labels appear next to the product image and a 30% increase in price.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Products that contain red meat will not have warning labels or an increase in price. Receives: Other: Control |
| Warning Labels | Experimental | The warning labels are black octagons with white text that appear next to images of products that contain red meat. One label says "WARNING: Eating red meat contributes to colon and rectal cancer" and the other label says "WARNING: Eating red meat harms the environment." Receives: Other: Warning Labels |
| Tax | Experimental | The tax is a 30% increase in the price of products that contain red meat. Receives: Other: Tax |
| Combined Warning Labels and Tax | Experimental | The Combined Warning Labels and Tax arm features both the warning labels and tax. The warning labels are black octagons with white text that appear next to images of products that contain red meat. One label says "WARNING: Eating red meat contributes to colon and rectal cancer" and the other label says "WARNING: Eating red meat harms the environment." The tax is a 30% increase in the price of red meat products. Receives: Other: Combined Warning Labels and Tax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Products That Contain Red Meat
The number of products in a participant's shopping basket that contain red meat.
Measured: At completion of ~15 minute shopping task
Percentage of Red Meat Containing Products
The percentage of products in a participant's shopping basket that contain red meat.
Measured: At completion of ~15 minute shopping task
Secondary outcomes (15)
Total Saturated Fat
Total grams of saturated fat of products in a participant's shopping basket. This will be calculated by adding together the total saturated fat from each product in the participant's shopping basket. Saturated fat for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Measured: At completion of ~15 minute shopping task
Total Sodium
Total grams of sodium of products in a participant's shopping basket. This will be calculated by adding together the total sodium from each product in the participant's shopping basket. Sodium for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Measured: At completion of ~15 minute shopping task
Total Calories
Total calories of products in a participant's shopping basket. This will be calculated by adding together the total calories from each product in the participant's shopping basket. Calories for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.
Measured: At completion of ~15 minute shopping task
Perceived Healthfulness
Perceived healthfulness of eating red meat. Likert response options are on a 1 to 5 scale, with higher scores representing a higher perceived healthfulness of eating red meat.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cancer Risk
Perceived risk of colon and rectal cancer from eating red meat. Likert response options are on a 1 to 5 scale, with higher scores representing a higher perceived risk of colon and rectal cancer from eating red meat.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Environmental Risk
Perceived risk of environmental harms from eating red meat. Likert response options are on a 1 to 5 scale, with higher scores representing a higher perceived risk of environmental harms from eating red meat.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Cognitive Elaboration (Health)
Thinking about the health harms of food products while completing the shopping task. Likert response options are on a 1 to 5 scale, with higher scores representing a higher amount of thinking about health harms of food products.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Cognitive Elaboration (Environment)
Thinking about the environmental harms of food products while completing the shopping task. Likert response options are on a 1 to 5 scale, with higher scores representing a higher amount of thinking about the environmental harms of food products.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Cognitive Elaboration (Price)
Thinking about the price of food products while completing the shopping task. Likert response options are on a 1 to 5 scale, with higher scores representing a higher amount of thinking about the price of food products.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Specific Perceived Healthfulness
Perceived healthfulness of specific red meat products (burgers, pepperoni pizza, and deli ham). Likert response options are on a 1 to 5 scale, with lower scores representing worse for health and higher scores representing better for health.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Specific Perceived Environmental Risk
Perceived environmental harm of specific red meat products (burgers, pepperoni pizza, and deli ham). Likert response options are on a 1 to 5 scale, with lower scores representing worse for the environment and higher scores representing better for the environment.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cost of the Burger Product.
Perceived cost of the burger product. Likert response options are on a 1 to 5 scale, with lower scores representing less expensive and higher scores representing more expensive.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cost of the Pizza Product.
Perceived cost of the pizza product. Likert response options are on a 1 to 5 scale, with lower scores representing less expensive and higher scores representing more expensive.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cost of the Ham Product.
Perceived cost of the ham product. Likert response options are on a 1 to 5 scale, with lower scores representing less expensive and higher scores representing more expensive.
Measured: ~15 minutes post-test computer survey following the ~15 minute shopping task
Intention to Reduce
Intention to reduce red meat consumption in the next 30 days. Likert response options are on a 1 to 5 scale, with higher scores representing a higher intention to reduce red meat consumption in the next 30 days.
Measured: ~15 minutes post-test computer survey following the ~15 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 posted20 Jan 2021
- Study start18 Oct 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- 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
- 4,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University of Edinburgh, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lindsey S Taillie, PhD, Principal investigator, University of North Carolina, Chapel HillLindsay Jaacks, PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716010
- Sponsor's protocol ID
- 19-3349
- Other IDs
- K01HL147713
- Status last verified
- Aug 2021
- First submitted
- 14 Jan 2021
- Last updated
- 18 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A deidentified dataset and the survey codebook will be published to the Harvard Dataverse. The study protocol and statistical analysis plan will be published as supporting information with the study results in a peer-reviewed journal.
Publications
Willits-Smith A, Taillie LS, Jaacks LM, Frank SM, Grummon AH. Effects of red meat taxes and warning labels on food groups selected in a randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Apr 15;21(1):39. doi: 10.1186/s12966-024-01584-9.
PubMed 38622655Taillie LS, Bercholz M, Prestemon CE, Higgins ICA, Grummon AH, Hall MG, Jaacks LM. Impact of taxes and warning labels on red meat purchases among US consumers: A randomized controlled trial. PLoS Med. 2023 Sep 18;20(9):e1004284. doi: 10.1371/journal.pmed.1004284. eCollection 2023 Sep.
PubMed 37721952
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating Product Messaging
- ClinicalTrials.gov ID
- NCT04716010
- Acronym / sponsor ID
- 19-3349
- Conditions
- Cancer of Colon, Cancer of Rectum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,160 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Wellcome Trust, University of Edinburgh, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Posted 9 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To assess the impact of taxes, warnings, and a combination of taxes and warnings on US adults' decisions to purchase products that contain red meat in an online grocery store.
Procedures (methods): Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be assigned to one of four trial arms: 1) Control (no warning and no tax), 2) Warnings (all products that contain red meat have a health warning and environmental warning), 3) Tax (30% tax on products that contain red meat), and 4) Combined warning and tax (all products that contain red meat will have the two warnings and a 30% tax). Then, participant will enter an online grocery store reflecting their assigned arm. The participant will be instructed to complete a shopping task in the online grocery store. After completing the shopping task, participants will be redirected to an online survey and answer a series of questions about the shopping task, labels (excluding tax and control groups), and taxes (excluding warning and control groups). Questions will also include standard demographic and health related variables.
Detailed description
Participants will be recruited from Prime Panels (an online panel research company). Following online consent, participants will be randomly assigned to one of four trial arms affecting the appearance of an online grocery store. Once in the online grocery store, participants will complete a shopping task. The participants will have 9 specified items to add to their shopping cart (1 pizza, 1 burrito, Burger patties [meat or vegetarian], Breakfast sausages [meat or vegetarian], 1 frozen individual meal, 1 loaf of bread, 1 sandwich filling [for example, ham, turkey, or peanut butter], 1 pack of tortillas, 1 taco filling [for example, steak, chicken, or beans]). Participants will be informed that they will not be spending any of their own money to complete the shopping task. After completing the shopping task, participants will be redirected to a survey. They will provide self-reported responses to survey questions (e.g. perceived healthfulness from eating red meat, perceived risk of cancer from eating red meat, thinking about the health/environmental harms of food products). Participants will also answer demographic and health related questions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlProducts that contain red meat will not have warning labels or an increase in price. |
| Warning Labels | Experimental | Other: Warning LabelsThe warning labels are black octagons with white text that appear next to images of products that contain red meat. One label says "WARNING: Eating red meat contributes to colon and rectal cancer" and the other label says "WARNING: Eating red meat harms the environment." |
| Tax | Experimental | Other: TaxThe tax is a 30% increase in the price of products that contain red meat. |
| Combined Warning Labels and Tax | Experimental | Other: Combined Warning Labels and TaxThe Combined Warning Labels and Tax arm features both the warning labels and tax. The warning labels are black octagons with white text that appear next to images of products that contain red meat. One label says "WARNING: Eating red meat contributes to colon and rectal cancer" and the other label says "WARNING: Eating red meat harms the environment." The tax is a 30% increase in the price of red meat products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Consumes red meat at least once per week.
- Responsible for at least 50% of grocery shopping for the household.
- Lives in the United States
Key exclusion criteria (1 listed)
- Individuals who have participated in research studies from previous aims of this research.
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 |
|---|---|---|
| ControlParticipants will complete a shopping task in the online grocery store, and the products that contain red meat will not have warning labels or a 30% increase in price. | Other | Control |
| Warning LabelsWhile completing the shopping task in the online grocery store, the health and environmental warning labels will appear next to the image of every product that contains red meat. | Other | Warning Labels |
| TaxWhile completing the shopping task in the online grocery store, all products containing red meat will have a 30% increase in price. | Other | Tax |
| Combined Warning Labels and TaxWhile completing the shopping task in the online grocery store, all products containing red meat will have the health and environmental warning labels appear next to the product image and a 30% increase in price. | Other | Combined Warning Labels and Tax |
Primary outcome
Count of Products That Contain Red Meat
Time frame: At completion of ~15 minute shopping task
The number of products in a participant's shopping basket that contain red meat.
Percentage of Red Meat Containing Products
Time frame: At completion of ~15 minute shopping task
The percentage of products in a participant's shopping basket that contain red meat.
15 secondary outcomes
Total Saturated Fat
Time frame: At completion of ~15 minute shopping task
Total Sodium
Time frame: At completion of ~15 minute shopping task
Total Calories
Time frame: At completion of ~15 minute shopping task
Perceived Healthfulness
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cancer Risk
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Environmental Risk
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Cognitive Elaboration (Health)
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Cognitive Elaboration (Environment)
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Cognitive Elaboration (Price)
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Specific Perceived Healthfulness
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Specific Perceived Environmental Risk
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cost of the Burger Product.
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cost of the Pizza Product.
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Perceived Cost of the Ham Product.
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Intention to Reduce
Time frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38622655Willits-Smith A, Taillie LS, Jaacks LM, Frank SM, Grummon AH. Effects of red meat taxes and warning labels on food groups selected in a randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Apr 15;21(1):39. doi: 10.1186/s12966-024-01584-9.
- Derived from this study: PubMed 37721952Taillie LS, Bercholz M, Prestemon CE, Higgins ICA, Grummon AH, Hall MG, Jaacks LM. Impact of taxes and warning labels on red meat purchases among US consumers: A randomized controlled trial. PLoS Med. 2023 Sep 18;20(9):e1004284. doi: 10.1371/journal.pmed.1004284. eCollection 2023 Sep.
- Individual participant dataSharing planned: Yes. A deidentified dataset and the survey codebook will be published to the Harvard Dataverse. The study protocol and statistical analysis plan will be published as supporting information with the study results in a peer-reviewed journal.
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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 S Taillie, PhD principal investigator
University of North Carolina, Chapel Hill
Lindsay Jaacks, PhD principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warning Labels, Tax and Combined Warning Labels and Tax in people with Cancer of Colon and Cancer of Rectum, 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 4 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 18 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?
Yes. Results are posted in the registry (first posted 9 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Products That Contain Red Meat (time frame: At completion of ~15 minute shopping task). The study lists 2 primary outcomes in all. 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 NCT04716010, which also lists 2 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 18 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.