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Developing and Evaluating Product Messaging

Primary Purpose

Cancer of Colon, Cancer of Rectum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Warning Labels
Tax
Combined Warning Labels and Tax
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer of Colon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Carolina Population Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

Control

Warning Labels

Tax

Combined Warning Labels and Tax

Arm Description

Products that contain red meat will not have warning labels or an increase in price.

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 products that contain red meat.

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.

Outcomes

Primary Outcome Measures

Count of Products That Contain Red Meat
The number of products in a participant's shopping basket that contain red meat.
Percentage of Red Meat Containing Products
The percentage of products in a participant's shopping basket that contain red meat.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 14, 2021
Last Updated
August 3, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Wellcome Trust, University of Edinburgh, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04716010
Brief Title
Developing and Evaluating Product Messaging
Official Title
Developing and Evaluating Product Messaging
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Wellcome Trust, University of Edinburgh, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon, Cancer of Rectum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Products that contain red meat will not have warning labels or an increase in price.
Arm Title
Warning Labels
Arm Type
Experimental
Arm Description
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."
Arm Title
Tax
Arm Type
Experimental
Arm Description
The tax is a 30% increase in the price of products that contain red meat.
Arm Title
Combined Warning Labels and Tax
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Warning Labels
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tax
Intervention Description
While completing the shopping task in the online grocery store, all products containing red meat will have a 30% increase in price.
Intervention Type
Other
Intervention Name(s)
Combined Warning Labels and Tax
Intervention Description
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.
Primary Outcome Measure Information:
Title
Count of Products That Contain Red Meat
Description
The number of products in a participant's shopping basket that contain red meat.
Time Frame
At completion of ~15 minute shopping task
Title
Percentage of Red Meat Containing Products
Description
The percentage of products in a participant's shopping basket that contain red meat.
Time Frame
At completion of ~15 minute shopping task
Secondary Outcome Measure Information:
Title
Total Saturated Fat
Description
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.
Time Frame
At completion of ~15 minute shopping task
Title
Total Sodium
Description
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.
Time Frame
At completion of ~15 minute shopping task
Title
Total Calories
Description
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.
Time Frame
At completion of ~15 minute shopping task
Title
Perceived Healthfulness
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Perceived Cancer Risk
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Perceived Environmental Risk
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Cognitive Elaboration (Health)
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Cognitive Elaboration (Environment)
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Cognitive Elaboration (Price)
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Specific Perceived Healthfulness
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Specific Perceived Environmental Risk
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Perceived Cost of the Burger Product.
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Perceived Cost of the Pizza Product.
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Perceived Cost of the Ham Product.
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Intention to Reduce
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Other Pre-specified Outcome Measures:
Title
Percentage of Participants Who Support Tax
Description
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'.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Percentage of Participants Who Support Health Warning Label
Description
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'.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Percentage of Participants Who Support Environmental Warning Label
Description
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'.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Mean Modified Waterlander Acceptability Scale Score
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task
Title
Ease of Store Use
Description
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.
Time Frame
~15 minutes post-test computer survey following the ~15 minute shopping task

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey S Taillie, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lindsay Jaacks, PhD
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Population Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://dataverse.harvard.edu/

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Developing and Evaluating Product Messaging

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