Developing and Evaluating Product Messaging
Phase: NA
Conditions: Cancer of Colon, Cancer of Rectum
Sponsor: University of North Carolina, Chapel Hill

 
Developing and Evaluating Product Messaging 
 
Protocol 
# NCT04716010 
Version Date: 4/30/21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE:  
Developing and Evaluating Product Messaging 
Lead Investigator: 
Lindsey Smith Taillie, PhD  
 University of North Carolina at Chapel Hill 
 
 
I confirm that I have read this protocol and understand it.    
 
Principal Investigator Name:   
 
 
Lindsey Smith Taillie  
 
Principal Investigator Signature:  
 
  
 
 
Date:   
 
 
 
 
 
 
4/30/21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

TABLE OF CONTENTS 
Table of Contents ..................................................................................................................... 3 
Protocol Synopsis ..................................................................................................................... 4 
BACKGROUND AND RATIONALE .................................................................................................................................. 6 
STUDY OBJECTIVE ......................................................................................................................................................... 6 
INVESTIGATIONAL PLAN (BRIEF OVERVIEW) .............................................................................................................. 7 
STUDY PROCEDURES (WHAT WILL BE DONE) ............................................................................................................. 9 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS (HOW MEASUREMENTS WILL BE MADE)10 
STATISTICAL CONSIDERATION ................................................................................................................................... 13 
SAFETY MANAGEMENT .............................................................................................................................................. 15 
DATA COLLECTION AND MANAGMENT .................................................................................................................... 15 
RECRUITMENT STRATEGY .......................................................................................................................................... 15 
CONSENT PROCESS .................................................................................................................................................... 15 
PLANS FOR PUBLICATION .......................................................................................................................................... 16 
REFERENCES ............................................................................................................................................................... 17 
 
 
 

PROTOCOL SYNOPSIS 
 
Study Title 
Developing and Evaluating Product Messaging 
Funder 
Wellcome Trust 
NIH National Heart, Lung, and Blood Institute 
Study Rationale 
High intake of red and processed meat is associated with both 
health harms, such as cancer, diabetes, and cardiovascular disease, 
and environmental harms, such as greenhouse gas emissions and 
climate change. Two potential policies to lower consumption of red 
and processed meat are the addition of warning labels that 
communicate these harms and a tax on these products. This study 
examines the impact of health and environmental warning labels 
and a red meat tax on the purchasing decisions of US meat 
consumers.  
Study Objective(s) 
Primary 
• To determine the impact of a tax, warnings, and a 
combination of a tax and warnings on the count of products 
that contain red meat and the percent of products that 
contain red meat selected for purchase in an online grocery 
store. 
Secondary 
• 
To determine the impact of a tax, warnings, and a 
combination of a tax and warnings on behavioral and 
psychological outcomes related to red meat products in an 
online grocery store. 
Study Design 
 
Participants will electronically acknowledge their consent to 
participate in the study. The study platform (Gorilla Experiment 
Builder) will randomize each participant to one of four versions of 
the online grocery store (Lola’s Grocery). The participants will 
complete a shopping task in the store based on an assigned 
shopping list. After completing the shopping task, the participant 
will complete a survey in Qualtrics. The survey will ask a series of 
questions about the red meat products (e.g., thinking about 
health/environmental harms, perceived healthfulness, perceived 
cost). Questions will also include standard demographic and health 
related variables. 
Subject Population 
key criteria for Inclusion 
and Exclusion: 
Inclusion Criteria 
1. 18 years old or older 
2. Currently reside in the United States  

3. Red meat consumer (1 or more times per week) 
4. Does at least half of the grocery shopping for their 
household 
Exclusion Criteria 
        1. Participated in previous studies linked to this study 
Number Of Subjects  
 
Approximately 3,144 
Study Duration 
Each subject’s participation will last approximately 20-30 minutes. 
The entire study is expected to last 3 months. 
Study Phases 
Screening 
RCT 
(1) Screening: screening for eligibility and obtaining consent  
(2) Randomization: Randomly assigning participants to one of four 
conditions 
(3) Shopping task: Instruct participants to complete shopping task in 
an online grocery store (Lola’s Grocery) 
(4) Survey: Direct participants to a Qualtrics survey measuring 
perceptions and reactions to red meat warnings and a red meat tax 
as well as standard demographics.  
Statistical And Analytic 
Plan 
We will descriptively report unadjusted values for all primary, 
secondary, and other outcomes. We will examine differences 
between each intervention arm and the control. For primary 
outcomes only, we will also examine the difference between the 
intervention arms. In exploratory analyses, we will examine whether 
predetermined participant characteristics moderate the 
intervention effects on the primary outcomes by fitting a series of 
regression models, with trial arm, the moderator (specified as 
dummy variables), and their interaction as predictors. 
DATA AND SAFETY 
MONITORING PLAN 
The study survey will be programmed to not collect IP addresses. 
The research study will collect the email of every 10th participant in 
order to distribute a $40 gift card. However, email will be collected 
in a separate survey, and a randomly generated id will connect the 
email survey and study survey. Researchers will store the study data 
on a remote terminal server, and only research investigators and 
staff will have access to the data. Participants’ emails will be shared 
with the panel vendor in order to distribute the $40 gift card, 
however study staff will not provide the panel vendor with 
participants’ other survey responses. 
 
 
 

BACKGROUND AND RATIONALE 
Introduction 
Public policy is a critical tool for improving population health. In particular, taxes and 
warning labels are common strategies to address unhealthy diets. For example, more 
than 35 countries and seven US cities now tax sugar-sweetened beverages (SSBs), and 
four countries have implemented nutrition warning labels on packaging, with five US 
states proposing similar policies.1 These efforts have been largely successful. For 
example, we found that Berkeley, California, Chile, and Mexico’s SSB and junk food taxes 
led to reductions of up to 10% in taxed product purchases, and Chile’s SSB warning 
labels led to a 25% reduction in SSB purchases.2-8 These SSB-focused studies show that 
policies like taxes and warning labels have the potential to change behavior. However, 
few studies have examined whether similar policies could reduce purchases of red meat 
in the United States, a top meat-consuming country. Given the strong associations 
between meat consumption and both greenhouse gas emissions and non-
communicable diseases (NCDs) such as cancer, diabetes, and cardiovascular disease,9-14 
reducing meat intake in the United States is critical for mitigating climate change and 
preventing NCDs.  
 
In our study, we define “red meat” as any unprocessed or processed mammalian muscle 
meat (e.g., beef, veal, pork, lamb, mutton, and goat).  
 
Our proposed project aims to evaluate the effect of health and environmental warning 
labels and a tax on purchases of products containing red meat in an online grocery store 
designed to resemble a major US supermarket. Consumer behavior in virtual 
supermarket settings emulates shopping behavior in supermarkets,15-18 and participants 
report that virtual supermarket purchases resemble regular grocery purchases.15  
 
Randomized controlled trials (RCTs) are needed to test the causal impact of warnings 
and taxes on decisions to purchase products containing red meat. This project will 
address a major gap by evaluating the effect of warning labels and a tax on purchasing 
products containing red meat in a realistic online retail environment. 
 
STUDY OBJECTIVE  
The purpose of this study is to determine whether warning labels, a tax, or a 
combination of warning labels and a tax decrease purchases of products containing red 
meat for adult US meat consumers. 
 
Primary Outcomes  
o Percent of products purchased containing red meat 
o Count of products purchased containing red meat 
Secondary Outcomes  

We hypothesize that the tax condition, warnings condition, and tax and warnings 
condition will lead to: 
o Decrease in total saturated fat of products purchased 
o Decrease in total sodium of products purchased 
o Decrease in total calories of products purchased 
o Decrease in perceived healthfulness of eating red meat  
o Increase in perceived risk of cancer from eating red meat 
o Increase in perceived environmental harms of eating red meat  
o Increase in thinking about the health harms of food products  
o Increase in thinking about the environmental harms of food products 
o Increase in thinking about the price of food products 
o Decrease in perceived healthfulness of specific red meat products  
o Increase in perceived environmental harm of specific red meat products 
o Increase in perceived cost of specific red meat products 
o Increase in intention to reduce red meat consumption 
Other Outcomes  
We hypothesize that the tax condition, warnings condition, and tax and warnings 
condition will lead to: 
o Increase in policy support of health and environmental warnings and taxes 
We will also measure: 
o Acceptability of the online grocery store  
o Ease of use of the online grocery store  
 
INVESTIGATIONAL PLAN (brief overview) 
Study Design 
The study design is a between-subjects randomized controlled trial. Gorilla Experiment 
Builder will randomly assign participants to one of four study arms in the online grocery 
store (Lola’s Grocery). Participants will have an equal chance of being randomized to any 
of the trial arms. 
 
Study Arms: 
1. Control Arm: no warning labels and no tax 
2. Warning Labels Arm: one black, octagonal warning label with the text: “WARNING: 
Eating red meat increases your risk of colon cancer and rectal cancer,” and another 
black, octagonal warning label with the text “WARNING: Eating red meat harms the 
environment” on all products containing red meat (see below) 

 
3. Tax Arm: a 30% tax on all products containing red meat 
4. Combination Arm: one black, octagonal warning label with the text: “WARNING: 
Eating red meat increases your risk of colon cancer and rectal cancer,” one black, 
octagonal warning label with the text “WARNING: Eating red meat harms the 
environment,” and a 30% tax on all products containing red meat 
 
In Lola’s Grocery, participants will be asked to complete a shopping task using a pre-
determined shopping list. The products containing red meat in Lola’s Grocery will have a 
tax, warning labels, both a tax and warning labels, or neither a tax nor warning labels, 
depending on which arm the participant has been randomized to.  
 
The text of the warning labels was developed through a literature review of the health 
and environmental harms associated with red meat consumption. The text of the 
warnings was narrowed down using two online experiments that tested perceived 
message effectiveness, level of evidence regarding the relationship between red meat 
consumption and harm, simplicity, and potential political feasibility. The marker word 
“WARNING” was included, as prior research indicates that it may increase message 
effectiveness. The warnings were designed to have an octagonal shape, as another study 
found that octagonal shapes are perceived to be more effective than rectangular labels.19 
The labels are black with white text, as this is a commonly tested color scheme for 
warning labels,20 and a similar design is being used in several countries with mandated 
nutrient warnings, including Chile, Mexico, Peru, and Uruguay. The tax level of 30% was 
determined through a review of the literature for red meat tax levels that would reduce 
health21-24 and environmental harms.24,25 
 
After completing the shopping task, participants will complete a Qualtrics survey 
measuring reactions to and perceptions of red meat as well as standard demographics. 
Upon completion, participants will receive a pre-specified incentive from Prime Panels. 
Additionally, prior to entering the store, participants will be informed that 10% of 
participants will be randomly selected to receive the groceries they select during the 
shopping task and the remainder of their budget ($40) in cash. In reality, 10% of 
participants will be randomly selected to receive a $40 gift card. This deception is being 

used to incentivize participants to select products that they would actually consume in 
real life. 
 
Study Duration, Enrollment and Number of Subjects 
Participation in the study will last approximately 20-30 minutes. The entire study is 
expected to last three months. 
 
Study Population 
Inclusion Criteria 
1. 18 years old or older 
2. Currently reside in the United States  
3. Red meat consumer (1 or more times per week) 
4. Does at least half of the grocery shopping for their household 
 
Exclusion Criteria 
1. Participation in previous studies linked to this study 
STUDY PROCEDURES (what will be done) 
Study Steps 
Participants will be recruited through Prime Panels, a survey research firm we have 
worked with previously. If interested, panel members will complete a screener in the 
Gorilla Experiment Builder to see if they are eligible. If they are not eligible, panel 
members will be redirected to a termination page indicating they are not eligible to 
participate. If they are eligible, panel members will be redirected to a consent form. If 
they agree to the consent form, they will acknowledge their consent by clicking an arrow 
to proceed to the study. 
 
Following online consent, participants will be randomized to one of the four arms by 
Gorilla and enter into Lola’s Grocery. In this online grocery store, participants will 
complete a shopping task. They will be asked to select items using a pre-determined 
nine-item shopping list (see below), and they will be informed that their budget is $40. To 
complete the shopping task, a participant’s shopping basket must have +/- 2 items of the 
total number of items on the shopping list (7-11 items). After completing the shopping 
task, participants will be redirected to a survey. In the survey, participants will answer 
standard behavior and reaction measurement questions, as well as standard 
demographic questions. Prior to the shopping task, participants will be informed that 1 in 
10 participants will actually receive, via mail, the groceries they select and the remainder 
of their shopping budget ($40). The purpose of this is to incentivize participants to make 
purchases that reflect their real-life shopping habits. However, in reality, we will send 1 in 
10 participants a gift card of $40 (the shopping task budget). At the end of the survey, we 
will inform the 1 in 10 participants that the panel vendor will be sending them a gift card 

rather than groceries and ask for their email address. The panel vendor will email the gift 
card. 
 
Shopping List:  
1. 1 pizza 
2. 1 burrito 
3. Burger patties (meat or vegetarian) 
4. Breakfast sausages (meat or vegetarian) 
5. 1 frozen individual meal 
6. 1 loaf of bread 
7. 1 sandwich filling (for example, ham, turkey, or peanut butter) 
8. 1 pack of tortillas 
9. 1 taco filling (for example, steak, chicken, or beans) 
 
Subject Completion/Withdrawal Procedures 
A study participant is determined to have completed the study when they have finished 
and exited the study survey. To withdraw their data from the study, a participant would 
have to contact the study team or the university IRB.  
 
Screen Failure Procedures 
Prior to entering into the study, individuals will complete a survey screener. If the 
individual is younger than 18 years old, does not live in the United States, does not eat 
red meat at least one or more times per week, or does not do at least half of the grocery 
shopping for their household, they will be deemed ineligible. Such participants will be 
redirected to a screen notifying them that they are ineligible for the study. 
  
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS 
(how measurements will be made)  
Measurements will include results from the shopping task as well as subjective 
responses by participants. The online grocery store will record how many and which 
items are selected for purchase, as well as how much money is spent. Secondary 
outcomes will include a variety of measurements, including nutrition information of the 
shopping basket, 5-point Likert scale questions, and yes/no questions. 
 
 
Question 
Response Scale 
Secondary measures 
How unhealthy or healthy would it be for you 
to eat red meat? 
1=Very unhealthy 
2=Somewhat unhealthy 
3=Neither healthy nor unhealthy 

4=Somewhat healthy 
5=Very healthy 
How much would eating red meat increase 
your risk of colon and rectal cancer? 
1=Not at all 
2=Very little 
3=Somewhat 
4=Quite a bit 
5=A great deal 
How much would eating red meat harm the 
environment? 
1=Not at all 
2=Very little 
3=Somewhat 
4=Quite a bit 
5=A great deal 
How much did you think about the 
environmental harms of food products while 
you were shopping? 
1=Not at all 
2=Very little 
3=Somewhat 
4=Quite a bit 
5=A great deal 
How much did you think about the health 
harms of food products while you were 
shopping? 
1=Not at all 
2=Very little 
3=Somewhat 
4=Quite a bit 
5=A great deal 
How much did you think about the price of 
food products while you were shopping? 
1=Not at all 
2=Very little 
3=Somewhat 
4=Quite a bit 
5=A great deal 
How good or bad for your health do you think 
this product is? 
1=Very bad 
2=Somewhat bad 
3=Neither bad nor good 
4=Somewhat good 
5=Very good 
How good or bad for the environment do you 
think this product is? 
1=Very bad 
2=Somewhat bad 
3=Neither bad nor good 
4=Somewhat good 
5=Very good 
How inexpensive or expensive do you think 
this product is? 
1=Very inexpensive 
2=Somewhat inexpensive 
3=Neither inexpensive nor expensive 

4=Somewhat expensive 
5=Very expensive 
Other outcomes 
Overall, how difficult or easy was it to use the 
online grocery store? 
1=Very difficult 
2=Difficult 
3=Neither difficult nor easy 
4=Easy 
5=Very easy 
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. 
1=Strongly disagree 
2=Somewhat disagree 
3=Neither agree nor disagree 
4=Somewhat agree 
5=Strongly agree 
There were enough food and beverage 
options in the online grocery store. 
1=Strongly disagree 
2=Somewhat disagree 
3=Neither agree nor disagree 
4=Somewhat agree 
5=Strongly agree 
This online grocery store felt like a real online 
grocery store. 
1=Strongly disagree 
2=Somewhat disagree 
3=Neither agree nor disagree 
4=Somewhat agree 
5=Strongly agree 
Say how much you agree or disagree with the 
following statements. 
 
Red meat products should be labeled with 
warnings describing the link between red 
meat and diseases, such as colon cancer. 
1=Strongly disagree 
2=Somewhat disagree 
3=Neither agree nor disagree 
4=Somewhat agree 
5=Strongly agree 
Red meat products should be labeled with 
warnings describing the link between red 
meat and environmental harms. 
1=Strongly disagree 
2=Somewhat disagree 
3=Neither agree nor disagree 
4=Somewhat agree 
5=Strongly agree 

Red meat products should receive an extra 
tax to reflect the health and environmental 
harms of red meat consumption. 
1=Strongly disagree 
2=Somewhat disagree 
3=Neither agree nor disagree 
4=Somewhat agree 
5=Strongly agree 
 
STATISTICAL CONSIDERATION    
Statistical Methods 
 
We will descriptively report unadjusted values for primary, secondary, and other outcomes.  
We will use a two-sided critical alpha of 0.05 to conduct all statistical tests. Per CONSORT 
guidelines, we will not test for balance in covariates. Primary analyses will be intent-to-
treat, including all eligible participants with non-missing outcome data (e.g., complete-
case).  
 
Sensitivity Analyses 
 
We will describe dropout (defined as entering the store but not completing the 
purchasing task) by study arm and by screener characteristic (age, red meat 
consumption). If differential dropout is identified, we will consider sensitivity analyses to 
handle missing outcome data, such as inverse probability weighting.  
 
For all primary, secondary, and other outcomes, we will assess whether the outcomes 
vary by study arm with regression models, in which the referent group will be the control 
(compared to each of the three interventional study arms). For the primary outcomes, 
the regression model will be selected based on the frequency of zero purchases of 
products containing red meat.  If the frequency of zeros is high (>10% of participants), we 
will consider models to deal with the high proportion of zeros (e.g., zero-inflated Poisson 
or zero-inflated negative binomial for a count variable; fractional regression for 
percentage variable). Choice of model will also depend on whether heteroscedasticity 
exists. Model selection exercises will be reported. For secondary and other outcomes, we 
will use linear regression.   
 
For all analyses, means will be compared between each of the treatment groups and the 
control group, and for the primary outcome all pairwise comparisons of means will be 
examined. We will consider a result statistically significant at p<0.05.  
  
In exploratory analyses, we will examine whether the following participant characteristics 
moderate the intervention effects on the  primary outcomes:  
a. 
Frequency of red meat intake   
b. 
Interest in health  

i. For interest in health, we will take the average of the 3 items if 
alpha>.70. The 3 items are adapted from Hearty et al. (2006).26 If 
alpha is not above .70, we will either create a scale excluding the 
item that makes the three-item scale drop below .70, if there is 
one; or we will look at the items separately. 
c. 
Interest in sustainability  
i. For interest in sustainability, we will take the average of the 6 
items if alpha>.70. The six items are adapted from Haws et al. 
(2014).27 If alpha is not above .70, we will either create a scale 
excluding the item(s) that make(s) the six-item scale drop below 
.70, if there is one; or, we will look at the items separately.   
d. 
Household income level  
e. 
Educational attainment  
f. 
Age group  
g. 
Race/ethnicity  
h. 
Political orientation  
i. 
Gender   
  
To test whether these characteristics moderate the effect of the intervention on the 
count or percentage of products containing red meat selected, we will fit a series of 
regression models (one for each potential moderator), with trial arm, the moderator 
(specified as dummy variables), and their interaction as predictors. We will use a Wald 
chunk test to determine the joint interaction. We will quantitatively evaluate the 
presence of moderation by calculating the marginal effect of the intervention on the 
outcome at different levels of the moderating variable. If the pattern of main results is 
similar between intervention arms (warning label, tax, and warning plus tax), we will 
consider combining intervention arms for the moderation analysis.   
 
Sample Size and Power 
Sample size calculations were conducted using PASS 2019 Power Analysis and Sample 
Size Software (NCSS, Kaysville, Utah, USA). The effect size for the warning label was 
hypothesized to be the smallest effect size, and so the sample size was chosen to power 
this effect. With this sample size, the power associated with the tax and combined 
conditions will be maintained at approximately the same level or higher (better). 
For a factorial design with two factors at 2 and 2 levels, assuming a Cohen’s d of 0.1 
(considered “small”,28 and conservative relative to SSB warning label experiments which 
found 0.25),29 the sample size per arm needed to achieve 80% power at an alpha level of 
0.05 is n=786 per arm (n=3,144 total across the four arms). 
 
Outliers and Exclusions 

To complete the shopping task, a participant’s shopping basket must have +/- 2 items of 
the total number of items on the shopping list. The are 9 items total on the shopping list, 
so the participant’s basket must have 7-11 items.  
 
We will conduct sensitivity analyses excluding individuals who are in the bottom 2 
percentile of expenditures, those who complete the study unusually quickly (e.g., based 
on the distribution of time to completion as ascertained during a soft launch of the 
study), and individuals who are non-compliant with the shopping list (<50% of products 
selected comply with the shopping list).   
SAFETY MANAGEMENT 
Provided that this study is conducted completely online, and participants do not have any 
interactions with study staff there is no anticipation of adverse events. However, the 
investigators have provided an email to contact as well as the IRB contact information, on 
the consent form, should a participant be concerned about any aspects of the research 
study.  
DATA COLLECTION AND MANAGMENT  
The study survey will be programmed to not collect IP addresses. The research study will 
collect the email of every 10th participant for gift card distribution. However, email will be 
collected in a separate survey, and a randomly generated id will connect the email survey 
and study survey. Researchers will store the study data on a remote terminal server, and 
only research investigators and staff will have access to the data. Participants’ emails will 
be shared with the panel vendor in order to distribute the $40 gift card, however study 
staff will not provide the panel vendor with participants’ other survey responses. Once 
gift cards are distributed, participant emails will be deleted. 
RECRUITMENT STRATEGY 
Participants will be Prime Panels participants who have voluntarily signed up to complete 
tasks remotely, including research surveys. Our study sample will include only those who 
self-enroll in the study based on interest, availability, and meeting the inclusion criteria. 
There is no specific advertisement for this study. Rather, Prime Panels identifies users for 
the survey based on the inclusion criteria (age 18 or older, resides in United States, 
consumes red meat at least once a week, and does at least 50% of household grocery 
shopping) and informs them of the study opportunity. 
CONSENT PROCESS 
To provide consent, individuals will first complete a survey screener in Qualtrics. If they 
are eligible for the study, they will be redirected to the study consent form. If the 
participant agrees to the consent form, they are informed that by continuing to the 
study, they are consenting to participate. The consent process is completed entirely 
online, and at no point in the study do participants interact with the study team. 

PLANS FOR PUBLICATION 
The investigators plan to publish as an open-access peer-reviewed paper. They will target 
public health peer-reviewed journals for manuscript submission.  
 
 

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