Developing and Evaluating Product Messaging

August 3, 2023 updated by: University of North Carolina, Chapel Hill

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.

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

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 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.
4160

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 Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Individuals who have participated in research studies from previous aims of this research.

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.
Other: Control
Products that contain red meat will not have warning labels or an increase in price.
Other: Control
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.
Experimental: Warning Labels
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."
Other: Warning Labels
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.
Experimental: Tax
The tax is a 30% increase in the price of products that contain red meat.
Other: Tax
While completing the shopping task in the online grocery store, all products containing red meat will have a 30% increase in price.
Experimental: Combined Warning Labels and Tax
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.
Other: Combined Warning Labels and Tax
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.

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
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.
At completion of ~15 minute shopping task
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.
At completion of ~15 minute shopping task

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
Total Saturated Fat
Time Frame: At completion of ~15 minute shopping task
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.
At completion of ~15 minute shopping task
Total Sodium
Time Frame: At completion of ~15 minute shopping task
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.
At completion of ~15 minute shopping task
Total Calories
Time Frame: At completion of ~15 minute shopping task
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.
At completion of ~15 minute shopping task
Perceived Healthfulness
Time Frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
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.
~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 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.
~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
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.
~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
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.
~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
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.
~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
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.
~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
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.
~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 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.
~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 burger product. Likert response options are on a 1 to 5 scale, with lower scores representing less expensive and higher scores representing more expensive.
~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 pizza product. Likert response options are on a 1 to 5 scale, with lower scores representing less expensive and higher scores representing more expensive.
~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
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.
~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
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.
~15 minutes post-test computer survey following the ~15 minute shopping task

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Support Tax
Time Frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Support of policy for taxes on red meat products in the U.S. Likert response options are on a 1 to 5 scale, with higher scores representing a greater deal of support. Those who indicated '4' or '5' were assumed to more strongly agree to support a red meat product tax. This measure reports the percentage of those with a response of '4' or '5'.
~15 minutes post-test computer survey following the ~15 minute shopping task
Percentage of Participants Who Support Health Warning Label
Time Frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Support of policy for health warning labels on red meat products in the U.S. Likert response options are on a 1 to 5 scale, with higher scores representing a greater deal of support. Those who indicated '4' or '5' were assumed to more strongly agree to support a health warning label. This measure reports the percentage of those with a response of '4' or '5'.
~15 minutes post-test computer survey following the ~15 minute shopping task
Percentage of Participants Who Support Environmental Warning Label
Time Frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Support of policy for environmental warning labels on red meat products in the U.S. Likert response options are on a 1 to 5 scale, with higher scores representing a greater deal of support. Support of policy for taxes on environmental warning labels in the U.S. Likert response options are on a 1 to 5 scale, with higher scores representing a greater deal of support. Those who indicated '4' or '5' were assumed to more strongly agree to support an environmental warning label. This measure reports the percentage of participants with a response of '4' or '5'.
~15 minutes post-test computer survey following the ~15 minute shopping task
Mean Modified Waterlander Acceptability Scale Score
Time Frame: ~15 minutes post-test computer survey following the ~15 minute shopping task

Acceptability of the online grocery store. Likert response options are on a 1 to 5 scale, with higher scores representing a higher amount of agreement.

Acceptability of the online grocery store is measured using 3 items adapted from Waterlander et al., 2011. Responses to the 3 items will be averaged to create an acceptability score sum ranging from 3-15 then divided by the total number of questions asked (n = 3).

Prompt: Say whether you agree or disagree with the following statements.

I could easily find all of the food and beverages I was looking for in the online grocery store.

There were enough food and beverage options in the online grocery store.

This online grocery store felt like a real online grocery store.

Waterlander WE, Scarpa M, Lentz D, Steenhuis IHM. The virtual supermarket: an innovative research tool to study consumer food purchasing behavior. 2011;11:589. DOI: 10.1186/1471-2458-11-589.
~15 minutes post-test computer survey following the ~15 minute shopping task
Ease of Store Use
Time Frame: ~15 minutes post-test computer survey following the ~15 minute shopping task
Ease of use of the online grocery store. Likert response options are on a 1 to 5 scale, with higher scores representing more agreement that the online grocery store is easy to use.
~15 minutes post-test computer survey following the ~15 minute shopping task

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.
National Heart, Lung, and Blood Institute (NHLBI)
Wellcome Trust
University of Edinburgh

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 S Taillie, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Lindsay Jaacks, PhD, University of Edinburgh

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.
October 18, 2021

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.
October 28, 2021

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.
October 28, 2021

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).
January 14, 2021

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.
January 19, 2021

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.
January 20, 2021

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.
August 18, 2023

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.
August 3, 2023

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.
August 1, 2021

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.
  • 19-3349
  • K01HL147713 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The deidentified dataset and corresponding survey codebook will be available upon publication of study results and will remain on the Harvard Dataverse indefinitely.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Clinical Trials on Cancer of Colon

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings