Consumer Perceptions of Waterpipe Tobacco Packaging and Digital Marketing Claims
Phase: NA
Conditions: Waterpipe Tobacco Smoking
Sponsor: Wake Forest University Health Sciences

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Waterpipe Marketing Aim 3 
 
 
IRB00060111 
 
NCT05439421 
 
IRB Approved Date:  12.16.2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol 
Evaluating the Impact of Waterpipe Tobacco Marketing Claims on Young Adults 
Aim 3 Survey 
 
Principal Investigator 
Erin Sutfin, PhD 
 
Wake Forest Co-Investigators 
Beth Reboussin, PhD 
Kimberly Wagoner, DrPH, MPH 
Jennifer Cornacchione Ross, PhD 
 
External Co-Investigators 
Allison Lazard, PhD (University of North Carolina at Chapel Hill) 
Eric Soule, PhD (East Carolina University) 
 
Wake Forest Staff 
Caroline Kimes, BS 
Cynthia Suerken, MS 
Alexandra Zizzi, MSPH 
 
Sponsors 
National Cancer Institute 
FDA Center for Tobacco Products (CTP) 
 
Background, Rationale, and Context 
Waterpipe tobacco (WT) smoking in the U.S. is common among young adults, with approximately 5.5 million 
current users. WT smoking is associated with many of the same health risks as cigarette smoking, but 
consumers often erroneously believe WT smoking is less harmful and less addictive than cigarette smoking. 
Package design is an effective tool used by the tobacco industry to communicate product information to 
consumers, including information related to health risks. The Food and Drug Administration (FDA) has begun 
to prohibit certain claims on WT packaging. Under Section 911 of the Family Smoking Prevention and Tobacco 
Control Act, manufacturers and retailers are prohibited from making unauthorized modified risk tobacco 
product (MRTP) claims, including statements that the product or its smoke: (1) results in reduced harm; (2) 
contains a reduced level of a substance or presents a reduced exposure to a substance; (3) does not contain 
or is free of a substance; and (4) statements that use modified risk descriptors such as light, mild, low, or 
similar descriptors. In addition, manufacturers and retailers are also prohibited from making false and 
misleading claims on packaging and in advertising under Section 903. Some prohibited claims are easily 
identifiable, but others are more difficult to identify due to lack of specificity in the law and the implicit nature of 
some claims. Evidence is needed specific to WT packaging and marketing to determine which claims may be 
associated with consumer harm misperceptions to inform future regulatory actions. The proposed study will 
address this gap by documenting WT packaging digital marketing (websites and social media) claims and how 
such claims influence consumer perceptions and behavioral intentions. In Aim 1, we will identify WT product 
packaging and digital marketing through a comprehensive website review to identify manufacturers (who make 

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tobacco for waterpipes) and retailers (who sell WT for onsite use such as cafés and lounges). We will create a 
sample frame of WT brands and flavors and will randomly select five flavors from 30 brand for purchase. For 
digital marketing, we will use the same 30 brands of WT and a random sample of 30 US-based retailers with 
websites and social media accounts. We will capture all website content and 20 of the most recent posts from 
Facebook and Instagram, the two most popular social media platforms among young adults. In Aim 2, we will 
content analyze all of the packaging and digital marketing content captured in Aim 1. We will them use an 
expert panel to determine whether claims found on the packaging and in the digital marketing are examples of 
unauthorized claims. In Aim 3, we will conduct an online experiment with a nationally-representative sample of 
young adults to evaluate the impact of unauthorized claims present on WT packaging and digital media on 
young adults’ willingness to try the product, perceptions of harm, and product appeal. The findings will help the 
FDA determine which claims consumers interpret in ways that the law prohibits; which could prompt the FDA to 
engage in additional rulemaking so consumers are not misled.  
 
Objective(s) 
The overarching goal of this project is to evaluate the impact of unauthorized claims present on WT 
packaging and digital media on young adults’ willingness to try WT, perception of harm, and WT product 
appeal.  
 
Methods and Measures 
 
Design 
We will conduct an online experiment with a national probability-based sample (n=1,515) of young adults (ages 
18-29) recruited from the AmeriSpeak panel, funded and operated by NORC at the University of Chicago, and 
a third-party non-probability panel. All panel members aged 18-29 will be invited to be screened, and those 
who have used in the past year (current users), as well as those who have not but are susceptible to use 
(susceptible) will be invited to participate. We will measure WT susceptibility with a four-item scale, validated 
by our team. We anticipate 9% of young adults ages 18-29 will be current WT users and 40% will be 
susceptible non-users. Given the young adult sampling frame available and estimated response rate from 
NORC, we anticipate recruiting 303 current waterpipe users and 1212 susceptible non-users. AmeriSpeak 
participants will receive points, worth approximately $5, for completing the survey. Third-party participants will 
receive compensation as agreed upon with their panel. 
 
To assess eligibility, participants will be asked their age and several questions about waterpipe use and 
susceptibility. Then, participants will complete three distinct tasks. For the Packaging Task, participants be 
exposed to six different WT packages. For each package, participants will be randomly assigned to view a WT 
package with a prohibited or potentially-prohibited claim or a WT package without a potentially-prohibited 
claim. For the Digital Marketing Task, participants will view 10 digital marketing images (e.g., website or 
Instagram post). For each digital marketing images, participants will be randomly assigned to view the image 
with a prohibited or potentially-prohibited claim or without a potentially-prohibited claim. For the Claim 
Perception Task, participants will view up to four of the sixteen claims as a standalone (not on either the 
packaging or digital marketing). For all tasks, participants will complete questions while the stimuli are shown 
on the survey webpage. We will counterbalance the order of the Packaging and Digital Marketing Tasks. At the 
end of the study, participants will receive a link to electronic resources from the CDC about the harms 
associated with WT smoking. 
 
Experimental Stimuli. All packaging, social media posts, and website claims will be manipulated in Photoshop 
to appear on fictitious brand packaging or digital marketing that mimic current designs. We will create a 
fictitious manufacturer (brand) and retailer for three reasons: (1) it allows for manipulation of claims on package 
and digital marketing while keeping all other design content constant; (2) it avoids using brand or retailer 
names which could influence responses due to existing brand/retailer perceptions or loyalty; and (3) it removes 
the potential for claims and brand/retailer to be completely confounded, as would be in most cases; therefore, 
creating a new brand/retailer removes this confounder. 
 

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Setting 
Participants will complete the online survey at a computer in a location of their choosing. 
 
Subjects Selection Criteria 
We will conduct an online national probability-based survey with a sample of up to 1,515 U.S. young adults 
(18-29 years old) using the AmeriSpeak panel at NORC and a third-party non-probability sample, weighted 
with the AmeriSpeak sample to be nationally representative. 
 
 
Screener 
All interested individuals will be able to complete our screener.  Interested individuals will click on the link to the 
survey and be routed to a website to review consent language and complete the screener.  Participants will be 
consented and then complete a one-minute to determine if they are eligible for the full survey based on their 
age, waterpipe use, and susceptibility to waterpipe use.   
 
Inclusion Criteria 
• 
Adults ages 18+ 
• 
U.S. residents 
 
Exclusion Criteria 
• 
Non-U.S. residents 
 
Full Survey 
Eligible participants will be automatically invited to continue on to complete the full survey.  Eligible participants 
are U.S. residents between the ages of 18-29 years old who fit into one of the two categories numbered below.   
 
Inclusion Criteria 
• 
Adults ages 18-29  
• 
U.S. residents 
• 
Satisfies one of the following categories:  
1) Has used waterpipe tobacco within the past year (estimated 303 participants) 
2) Has not used waterpipe tobacco within the past year but is susceptible to using waterpipe 
tobacco in the future (estimated 1212 participants) 
 
Exclusion Criteria 
• 
Persons below age 18 or above age 29 
• 
Non-U.S. residents 
 
Sample Size 
• 
We estimate up to 1,515 of those screened will complete the full survey 
 
Interventions and Interactions 
Interested individuals will click on the link to the survey and be routed to a website to review consent language 
and complete the screener.  Participants will complete a one-minute screener to determine if they are eligible 
based on their age and waterpipe tobacco use & susceptibility. After completing the screener, participants who 
are not eligible will be thanked for their time but will not receive an incentive. Those who are eligible will 
automatically be invited to continue on to the full survey. The full survey will last approximately 20-25 minutes. 
After completing the survey, participants will receive a small incentive in the form they’ve agreed to with their 
panel. 
 
Outcome Measure(s) 
 
PRIMARY 

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Willingness to try hookah tobacco. The Packaging Task) will use one item to assess the extent to which young 
adults are likely to try the waterpipe tobacco product: “How likely would you be to try this specific 
product?” Response scale (1) Not at all likely to (4) Very likely.  
 
Willingness to smoke hookah 
The Digital Marketing Task  will use one item to assess the extent to which the advertisement makes young 
adults want to smoke hookah: “How much does this advertisement make you want to smoke hookah?” 
Response scale (1) Not at all to (4) A lot. 
 
 
 
SECONDARY  
None 
 
OTHER 
Absolute safety perception. The Packaging Task will use one item to assess young adults’ perceptions of how 
the packaging influences their opinion of how safe the product is: “How much does this packaging make 
you think this product is safe?” Response scale (1) Not at all to (4) A lot. The Digital Marketing Task will use 
a similar item to assess the advertisement’s impact on perception of the safety of smoking hookah: “How 
much does this advertisement make you think smoking hookah is safe?” Response scale (1) Not at all to 
(4) Very. For the first stimulus shown only, participants will be asked to provide the words or elements that led 
them to their perception; this item is descriptive. 
 
Relative safety perception. The Packaging Task will use one item to assess young adults’ perceptions of how 
safe the product pictured is as compared to other products that may be available to them: “Compared to 
other hookah tobacco on the market, how safe do you think this specific product is?” Response scale 
(1) Much less safe to (5) Much more safe. 
 
Absolute harm perception. The Packaging Task will use one item to assess young adults’ perceptions of how 
the packaging influences their opinion of how harmful the hookah tobacco pictured is: “How much does this 
packaging make you think this product is harmful?” Response scale (1) Not at all to (4) A lot. The Digital 
Marketing Task will also use one item to assess young adults’ perceptions of how harmful hookah smoking is, 
based on the advertisement pictured: “How much does this advertisement make you think smoking 
hookah is harmful?” Response scale (1) Not at all to (4) A lot. For the first stimulus shown only, participants 
will be asked to provide the words or elements that led them to their perception; this item is descriptive.  
 
Product appeal. The Packaging Task will use one item to assess young adults’ opinions of the appeal of the 
product shown: “How appealing is this specific product to you?” Response scale (1) Not at all appealing to 
(4) Very appealing. The Digital Marketing Task will use one item to assess their opinions of the appeal of 
smoking hookah, in context of the advertisement: “How appealing does this advertisement make smoking 
hookah seem to you?” Response scale (1) Not at all appealing to (4) Very appealing.  
 
Analytical Plan 
 
For the primary outcomes, linear regression analyses will examine differences in the mean outcomes between 
the two randomized conditions. This analysis will be performed for each of the 6 packages and 10 digital 
marketing images. Models will adjust for age, sex, race, ethnicity, waterpipe use status (current user, 
susceptible non-user), and use of other tobacco products The order in which the two tasks were performed will 
be included as a covariate, but if no significant order effects are detected, this covariate will be removed from 
the model. After testing for main effects, we will explore interactions with user status and sex. The same set of 
models will be fit for the secondary and other outcomes. Statistical significance will be set at p<0.05 for all 
analyses.  
 

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Human Subjects Protection 
 
Subject Recruitment Methods 
We will recruit participants using the AmeriSpeak panel at NORC. All panel members ages 18-29 will be invited 
to complete the screener to determine eligibility. Eligible participants will continue to review the informed 
consent and complete the full survey. NORC will also work with a third party non-probability sample to recruit 
participants to achieve accrual goals, if not met through AmeriSpeak.  
 
Informed Consent 
Since the study is exempt, consent is not required. However, before the survey, participants will be provided 
with a study information sheet to describe the study and participants will be asked to check a box to indicate 
that they agree to participate.  
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, minimizing to 
the fullest extent possible the collection of any information that could directly identify subjects, and maintaining 
all study information in a secure manner. Data will be collected and housed on the secure NORC server, and 
de-identified data will be provided to the Wake Forest team. 
 
Access to de-identified data will be limited to study staff.  Data and records will be kept locked and secured, 
with any computer data password protected.  No reference to any individual participant will appear in reports, 
presentations, or publications that may arise from the study. 
 
Data and Safety Monitoring 
The Principal Investigator, Dr. Sutfin will be responsible for the overall monitoring of the data and safety of 
study participants.  Dr. Sutfin will be assisted by other members of the study staff. It will also be monitored 
closely by the Wake Forest School of Medicine IRB. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes will be 
promptly reported by the principal investigator or designated member of the research team to the IRB and 
sponsor or appropriate government agency if appropriate.