Exploring Reactions to Health Warnings on Waterpipe Tobacco Ads
Phase: NA
Conditions: Reactions to Warnings, Hookah Smoking
Sponsor: Duke University

Protocol Pro00092330 
NCT03723616 
Document Date: May 7, 2018 
 
 
Application Information 
Full Study Title: Exploring Reactions to Health Warnings on Waterpipe Tobacco Ads 
Short Title: Reactions to Warnings on Hookah Ads 
PI: Isaac Lipkus 
 
Summary: 
Waterpipe tobacco smoking (WTS) is increasing in the U.S. among young adults exposing them 
to its many health risks. This increase is partly to due to waterpipe tobacco product and social 
allure ads that manufacturers, waterpipe bars and cafés use to portray WTS as a fun, social 
activity while masking its harmful effects. The positive feelings these ads likely elicit may reduce 
worry and perceived health risks and increase the appeal of WTS. Ad appeal may be curbed by 
placing health warnings. Thus, we address the extent to which the addition of text only and text 
+ graphic (i.e., pictorial) health warnings influence reactions to waterpipe tobacco ads as well as 
risk appraisals, attitudes toward WTS, and intention to engage in WTS. 
 
Purpose of the Project: 
We propose to explore the efficacy of varied health warnings (text only vs. text plus graphic 
warnings) to decrease ad appeal on desire to engage in WTS and examine potential cognitive 
and emotional mediators, such as perceived risks of WTS and attitudes toward WTS.  
 
Study Design: 
This research will be done in three phases involving young adults, ages 18-34, susceptible to 
WTS (i.e., nonusers who do not oppose trying WTS)27 or engage in WTS at least monthly. Phase 
1 concerns selecting text and graphic health warnings that can strongly influence beliefs and 
feelings about personal risk and intention to quit or try WTS. We will create, refine, and select 
text and graphic health warnings in four domains: 1) longer-term health effects, 2) shorter-term 
health effects, 3) addictiveness, and 4) types and levels of toxicant exposures. We will also 
select the most appealing waterpipe product and social allure ads themes that entice young 
adults to engage in WTS. The top two text and graphic health warnings in each domain and the 
top two product and social allure ads within each theme will be used for Phase 2. In Phase 2, 
using the online consumer crowdsourcing platform Turkprime28, susceptible nonsmokers and 
smokers (N=1000 per group) will be randomized to review ads with: 1) no health warnings, 2) 
text only health warnings, or 3) text + graphic health warnings. Nested within Arms 2 and 3 is 
health warning domain and ad theme. Reactions to ads will include ability to grab attention, 
cognitive and affective beliefs and attitudes toward each ad and ad appeal to engage in WTS. 
Main outcomes will include perceived risk and worry about harms (i.e., risk appraisal), attitudes 

toward WTS, and intention to try or quit WTS. At a two-week follow-up, we will reassess these 
main outcomes, WTS, and recall of ad content. In Phase 3, using a new sample of susceptible 
nonsmokers and waterpipe tobacco smokers (N=100 per group), we will conduct an eye-
tracking laboratory study to examine whether warnings evoke changes in attention that 
mediate changes in risk attitudes. The primary aims are to: 
AIM 1 (Phase 1): Develop, pilot test, and select text and graphic health warnings in four 
domains (i.e., long/short-term health effects, addiction, type and level of toxicant exposures) 
that most dissuade WTS as well as select waterpipe tobacco product ads (themes of flavored 
tobacco, waterpipe apparatus) and social allure ads (four themes of eroticism, exoticism, social 
acceptance, and occasion appropriate) that most entice WTS. 
AIM 2 (Phase 2): Using a RCT, examine how waterpipe tobacco product and social allure ads 
with or without text/graphic health warnings influence: 1) reactions to ads (e.g., beliefs and 
attitudes, ad appeal to engage in WTS); and 2) risk appraisals, cognitive and affective beliefs 
and attitudes about WTS, and intention to quit or try WTS. We explore how domain of health 
warning, ad theme, and population influence these outcomes. 
AIM 3 (Phase 2): Explore whether health warnings’ effects on risk appraisals, cognitive and 
affective beliefs and attitudes about WTS, and intentions to quit or try WTS are mediated by 
reactions to ads. 
AIM 4 (Phase 3): Using eye-tracking measures, examine how attentional outcomes mediate 
reactions to ads (e.g., beliefs and attitudes, ad appeal to engage in WTS) with and without 
health warnings. 
 
Phase 1 (In-Person Panel) Activities: 
We will recruit two panels of 10 waterpipe tobacco smokers and 10 susceptible nonsmokers (5 
men, 20% minority for both), respectively. Panels will help refine health warnings and identify 
product and social allure ads to be tested further. Panel input should enhance relevance and 
impact of warnings. Panel members will be recruited from central North Carolina using varied 
approaches (newspapers, flyers, Facebook) during the first two months of the Year 1. They will 
be asked to meet every two weeks for up to four sessions, led by Drs. Lipkus (PI) and Griffiths 
(Co-I), lasting about one hour. Participants will receive $50/session. We will also recruit 5-10 
more members to each panel as back-up; they will attend a session if, upon reminder calls, 
original panel members cannot attend a session or drop-out.  
 
After reviewing the purpose of the panel and learning about harms of WTS, the panels will 
engage in two main guided activities: 
 
•  Review product and social allure ads: Each panel will select through discussion four ads 
that exemplify best product and social allure themes (6 total, see B.2., D.3.3). Ads will 
include those we piloted and from WTS entities (bars, cafés, manufacturers/distributers) 
accessible via social media, websites, and distribution sources (e.g., yelp.com, Divine 
Hookah, iHookah). Conversations will also cover placement of warnings. 
 

•  Help create, refine and select health warnings. We will introduce WTS health warnings 
from prior studies including our WTS harm messages. Cigarette text and graphic 
warnings will be shown that could be adapted to WTS. Warnings will be grouped into 
four domains with illustrations. Using a protocol to evaluate health warnings, the panel 
will discuss strengths and weaknesses of each text and graphic warning (e.g., credibility, 
effects of perceived harm, desire to quit), what to keep and change (e.g., wording, 
content, graphics). Their goal will be to select the best four examples of persuasive text 
and graphic warnings for each health domain (16 examples total for text and 16 
examples for graphic). As with the FDA’s proposed use of graphic cigarettes warnings, 
WTS warnings will cover at least 20% of ad space. 
 
All panel sessions will be recorded which will be explained to participants prior to obtaining 
their consent to participate in the panel sessions. Participants will be asked not to use names or 
identifiers during discussions but if these do occur during the panel sessions, the identifying 
information will be stripped from the recordings. The recordings will only be reviewed by team 
members, and once the necessary information regarding the ads is extracted, the recordings 
will be destroyed.  
 
 
Phase 1 (Pilot) Procedures: 
Pilot testing of warnings. Using Turkprime, we will pilot test warnings online using 400 
waterpipe tobacco smokers and 400 susceptible nonsmokers ($2.00 payments). The text and 
graphic warnings will be pilot tested separately (N = 200 for each from each population). As a 
between-subjects design, participants will be randomized to one of the four warning domains 
and then asked to review – either text or graphic – the four warnings within the domain chosen 
by each panel counterbalanced in a Latin-square design. As suggested by Hammond and Reid 71, 
each warning will be rated on such outcomes as: grabbing attention96, clarity, credibility97, 
relevance, fear appeal (e.g., not fearful at all/fearful)98, graphicity99, extent warning influenced 
cognitions and affective beliefs (e.g., harmful/beneficial, safe/unsafe, nice/nasty)100and global 
attitude about warning (negative/positive)99 and efficacy to deter WTS (average of 3-item 
measure, e.g., “Overall, how effective is the warning?” α > .90)97. They will rate the extent each 
warning represents each health domain (1=not at all to 7= a great deal). The main outcome 
among both populations is warning efficacy to deter WTS, a rating shown to influence quit 
intentions and cessation101. Responses will be averaged for each warning and within each 
domain. The top two text and graphic warnings within each domain (8 for text and 8 for graphic 
total) with the highest mean score on warning efficacy by smoking status (smoker or 
susceptible) will be chosen for testing in Phase 2. All text and graphic warnings will be used as 
stimuli in Phase 3. 
 
Pilot testing of ads. Using Turkprime, we will pilot test ads online using 400 waterpipe tobacco 
smokers as well as 400 susceptible nonusers ($2.00 payment). The social allure and product ads 
will be tested separately (N = 200 for each). As a between-subjects design, participants will be 
randomized to one of the four social allure ad themes and asked to review the top four ads per 

theme selected by each panel. Ads will be counterbalanced in a Latin-square design. For 
waterpipe product ads, participants will be randomized to review either the four tobacco- or 
four waterpipe apparatus-themed ads counterbalanced in a Latin-square design. Reactions to 
the social allure and waterpipe product ads will mirror those of the warnings. These will 
include: extent ad grabbed attention96, credibility, relevance, fear appeal, extent ad influenced 
cognitive and affective beliefs about WTS100, global attitude about ad99, effort reviewing the ad, 
and extent ad enticed them to want to smoke (average of 2 items about ad making WTS more 
appealing and making them want to smoke 1=none at all, to 7=a great deal). They will rate 
extent each ad captured the social allure/product themes. Responses will be averaged for each 
ad within theme. The top two ads within each social allure theme (8 total), and the top two 
within each product ad theme (4 total), with the highest mean score on enticing them to “want 
to smoke” waterpipe will be chosen for Phase 2. All 24 ads will be used as stimuli for Phase 3. 
 
Phase 2 Procedures: 
Tests of ads with or without health warnings.  Using Turkprime, we will recruit online 1000 
waterpipe tobacco smokers and 1000 susceptible nonsmokers ($2.00 payment). After screening 
and collecting baseline demographic and tobacco use data (e.g., cigarettes), participants will be 
stratified and randomized to review ads with or without health warnings. After obtaining 
participants’ reactions to ads, we will assess key study constructs. All participants will complete 
a two-week follow-up.  
Interventions. Participants will be stratified by sex and use of other tobacco products (no/yes) 
and then randomized in a 1:2:2 ratio to one of three arms: 1) no health warnings (i.e., review 
ads only – control); 2) text health warnings only; or 3) text + graphic health warnings. Nested 
within Arm 2 and 3 will be both ad themes (six total) and health warning domains (four total). 
Each arm is discussed below. 
• Control arm (N = 200). Participants will be randomized with equal probability to one 
of the six ad themes (2 from product, 4 from social allure). They will view in 
counterbalanced order the two ads chosen for that theme from Phase 1 – no order 
effects are expected. They will not receive any warnings. (N ≈ 33 per cell). 
• Text only health warnings (N = 400). Ad theme selection will occur as with the 
control arm. Nested also as a between-subjects factor will be warning domain. 
Participants will see two text warnings from the same domain randomly assigned to 
the two ads within the same theme with ad order counterbalanced. Hence, this arm 
is primarily a 4 (warning domain: long-/short-term health effects, addiction, toxins) X 
6 (ad theme: eroticism, exoticism, social acceptance, occasion appropriate, 
(flavored) tobacco, waterpipe apparatus) X 2 (ad order: A1A2 vs A2A1) between-
subjects factorial design. Expecting no order effects, there are 24 main cells (N ≈ 32 
per cell combining populations). 
• Text plus graphic health warnings (N = 400). This arm is procedurally identical to the 
text only arm. The exception is that the two graphic warnings would be randomly 
added to the text warning in the same domain; thus, graphs are matched to the text 
warnings by health domain. (N ≈ 32 per cell combining populations). 

Post intervention assessments. We will assess participants’ reactions to each ad. We will not 
assess reactions to warnings specifically; doing so may unduly bring attention to them. 
Reactions to warnings will have been obtained from Phase 1 and 3. After responding to the last 
ad, and aligned with the Message Impact Framework72, we will assess participants’ knowledge 
of harms102, risk appraisals16, cognitive and affective beliefs and attitudes about WTS100, and 
intentions to quit/willingness to try WTS (4-item scale)14. We’ve used versions of these 
measures with αs > .70. 
Two-week follow-up. Using Turkprime, all participants will be asked to take an online survey 
two weeks later ($2.00 payment). As secondary aims, the goal of the follow-up is to assess WTS 
and recall of ad content, both reactions to warnings72, and sustainability of earlier effects. A 
two-week time frame aligns with other studies on recall of warning labels57. Participants will be 
asked first about their risk appraisals, cognitive and affective beliefs and attitudes about WTS, 
intention to quit/willingness to try WTS, and among smokers, frequency of WTS during the last 
two weeks. If a participant has not quit, they will be asked why. If a susceptible engaged in 
WTS, we will ask why. We will ask all if they saw and responded to WTS ads during the last two 
weeks (if yes, where), attended social events involving WTS or bought any WTS products – all 
no/yes. All will be asked to recall content of the two ads they viewed earlier. Analyses of recall 
will follow the steps by Strasser et al. on cigarette warnings103. Based on an MTurk study that 
used similar methods as proposed104, we expect 60% - 70% of participants will complete follow-
up. We predict stronger sustainability of earlier effects and a higher percent of recall accuracy 
for warnings in the text + graphic arm than text only arm. 
 
Phase 3 Procedures: 
Participants will be stratified by sex and use of other tobacco products (no/yes) and then 
randomized in a 1:2:2 ratio to the three arms as Phase 2 (control, ads with text warnings, ads 
with text + graphic warnings). Tasks will be presented (and eye position sampled) using a Tobii 
T60XL eye tracker, which uses an unobtrusive infrared camera system to sample gaze position 
at 60 Hz (and with resolution <1 degree of visual angle) while allowing participants free head 
movement. Each image will be displayed for a fixed time of 10 seconds, during which 
participants move their head and eyes naturally while looking at the image. The images will 
consist of the 24 ads, 16 text and 16 graphic warnings from Phase 1. Details of each arm 
follows. 
• Control arm: Participants will view the 24 ads from Phase 1 twice in random order 
without warnings. Further, 16 control non-tobacco ads matched for graphical content, 
presence of text, people, and other factors will be randomly distributed among these 
ads. 
• Text only: Participants will view at random the 24 ads twice. Each ad will have a different 
text warning chosen at random from the 16 from Phase 1 with the caveat that each text 
warning would be seen three times. The 16 control ads will have text disclaimers to 
control for physical features of the ads. 
• Text + graphic: This arm is identical to the text only arm except that a graphic from 
Phase 1 will be added to a text warning. Thus, each ad will be seen twice; the text + 

graphic warnings will be seen three times. The 16 control ads will have text disclaimers 
and logos or other images to control for physical features of ads.  
 
Rationale and Justification: 
In the United States, WTS among young adults is not trivial. For example, during 2013- 
2014 among 18-24-year-olds prevalence of daily, weekly, and usually monthly use was about 
18% nationally17,18. Many young adults face health risks due to WTS. The amount of smoke 
inhaled by a single one-hour waterpipe session lasting 30-60 minutes can equal that produced 
by > 100 cigarettes32. Waterpipe smoke contains heavy metals (arsenic, lead), carcinogenic 
polycyclic aromatic hydrocarbons33, pulmonary disease-causing volatile aldehydes34, carbon 
monoxide35-38, and nicotine38,39. Inhaling these toxins is likely why WTS is associated with 
cancers, poor pulmonary function, and heart disease29,40-44. WTS is also addictive45, with data 
suggesting nicotine dependence occurs faster than from cigarettes46. WTS is not safe. 
 
Waterpipe product manufacturers and waterpipe cafés often fail to mention harms of WTS22,23. 
Rather, they entice WTS in young adults via appealing product (e.g., flavored tobacco, 
aesthetically pleasing waterpipes) and social allure ads portraying WTS as a pleasant, relaxing 
and sociable activity. Social allure ads capture themes of eroticism, exoticism, social 
acceptance, and holiday gatherings20 to persuade the audience to partake in WTS. This strategy 
is working based on the growing use and spread of waterpipe cafés.47-50 Waterpipe product and 
social allure ads may mislead young adults to believe that WTS is safe, a common belief that 
can encourage WTS in this age group19,24. 
 
Inclusion Criteria: 
Eligible participants will be young adults ages 18 to 34 years old who are susceptible to, or who 
are current hookah tobacco smokers (defined as using hookah tobacco at least once in the past 
month and now using hookah tobacco on at least a monthly basis). Participants in Phases 1 and 
2 must have Internet access and a TurkPrime account. 
 
Exclusion Criteria: 
Study exclusion criteria include people who are younger than 18 and older than 34, those who 
are not susceptible to WTS or who are not current hookah smokers, those who do not have a 
TurkPrime account who are thus unable to complete assessments (for Phases 1 and 2), and 
those who are unable to complete the entirety of the study in English. 
 
Recruitment & Enrollment: 
Individuals in Phase 1 and 2 will be recruited online using Turkprime28, a research platform that 
supports behavioral sciences data collection through the Internet crowdsourcing platform 
Amazon Mechanical Turk (MTurk), and uses MTurk workers. MTurk workers, are individuals 
from the public who volunteer to participate in online studies with payment. Overall, Turkprime 
enhances the efficiency of implementation of experimental tasks that are difficult to conduct 
with MTurk (e.g., ability to conduct prospective studies). The investigative team will follow all 
the conditions required to use this platform for data collection. For example, the research team 

will post key words and title for the various phases of the study, indicate amount of time 
needed to complete study tasks, and amount of payment. Those interested will then be linked 
to the study consent form and study materials.  
 
We will obtain active informed consent online, with the approval of the Duke University 
Medical Center Institutional Review Board (DUMC IRB). The online consent will inform about 
the research, including confidentiality, voluntary nature of participation, and potential risks and 
benefits. It will also emphasize that no personally identifying information will be available to, or 
collected by, the investigators conducting this research. The online consent form will contain 
contact information for the DUMC IRB if participants have questions about the study or their 
rights as a research participant or experience any issues or problems participating in the study 
(see “Data Safety and Monitoring” for additional details). The voluntary and confidential nature 
of the research will be emphasized again at the beginning of the study surveys. Note that all 
studies using this platform to study waterpipe tobacco under Dr. Lipkus as the PI have been 
designated by the DUMC IRB as exempt.  
 
During Phase 1, we will create two 10-member panels, one for smokers and one for susceptible 
nonsmokers, as well as a backup panel of 5 to 10 members for each. Phase 2 will involve a 
sample of 1000 waterpipe tobacco smokers and 1000 susceptible nonsmokers who match the 
study eligibility criteria. For Phase 3, 100 waterpipe tobacco smokers and 100 susceptible 
nonsmokers ages 18-34 will be recruited from the subject pools managed by the Social Science 
Research Institute and Duke’s Department of Psychology and Neuroscience. Information about 
the study will be made available to the subject pools. Individuals who express interest will be 
asked to contact the study project coordinator. In the event we cannot readily obtain eligible 
study participants from these subject pools, we will advertise the study in central North 
Carolina using newspaper, flyers, and social media outlets (e.g., Facebook). In person written 
consent will be obtained for Phase 3. Participants who will form the first advisory panels will be 
recruited through newspapers in Central North Carolina, Craigslist, advertisements in college 
newspapers and through social media. They will be asked to review and sign a written consent 
form, of which they will receive a copy, during the first panel visit at the Duke University School 
of Nursing. The consent form will emphasize the basic elements described above (e.g., 
confidentiality, benefits, risks, etc.). 
 
Setting: 
Study procedures will take place at Duke University. 
 
Multicenter: 
No 
 
Total Participant Accrual: 
3,000 
 
Duration of Accrual: 

6 months 
 
Duration of Study: 
16 months 
 
Sample Size (power calculations) and statistical considerations: 
Power calculations were conducted on factorial MANOVAs for H2A and H2B, and 
general linear models for H3 (mediation). There are no established programs to calculate 
required sample size for multiple mediations; however, general linear models are the core 
procedures for multiple mediations. As stated, the factorial design is incomplete; to be 
conservative, this power analysis was based on a complete 3 (study arms) x 4 (health domains) 
x 6 (ad themes) X 2 (populations) design. Using G*Power109 the required total N for detecting an 
effect size (small: f = 0.10 or f2 = 0.02; medium: f = 0.25 or f2 = 0.15; large: f = 0.40 or f2 
= 0.35) with 90% power, two-tailed, with α = .01 for all main and interaction effects is 3934 for 
small, 657 for medium, and 289 for large effects. We are well-powered to detect moderate 
effect sizes. 
 
We will use 90% power at .01 level of significance (two-tailed) for univariate tests 
and contrasts. Possible covariates obtained within the survey will include: race, sex, education, 
use of other tobacco products and among smokers, WTS frequency and level of addiction to 
WTS. Missing data will multiply imputed105 as appropriate after checking missing 
randomness106. For H2A and H2B, factorial MANOVAs will be conducted using SAS Proc GLM 
for all outcomes simultaneously. For H2A, if the omnibus multivariate test is significant at a .05 
level, rather than .01, for the primary outcomes (risk appraisals, beliefs/feelings about WTS, 
global attitude about WTS, and intention to quit/willingness to try WTS), we will perform post-
hoc univariate tests for each outcome at a .01 level for comparisons among: (a) ads without 
health warnings (control arm), with text warning only, and with both text + graphic health 
warnings; (b) four health warning domains; (c) six ad themes; d) two study populations; and 
interactions of a-d. Noteworthy, the interactions will be incomplete due to lack of health 
warnings in the control arm. Thus, Type IV sum of squares will be used to address empty cells. 
For H2B, the same statistical methods will be conducted as with H2A, using reactions to ads as 
the main outcomes. For H3, we have several mediators (reactions to ads). We will use the SAS 
Macro by Preacher and Hayes107 to test multiple mediation effects in each study population. 
This approach address both multiple mediators simultaneously as well as multi-categorical 
variables108 such as warning domains as proposed herein. 
 
Importance / Value: 
Waterpipe tobacco smoking (WTS) is becoming widespread in the United States among young 
adults17,18. Increases in WTS are partly due to advertisements (ads) that entice young adults to 
engage in WTS19,20. Often devoid of health warnings22,23, waterpipe product and social allure 
ads likely mislead young adults to believe WTS is safe, promoting experimentation with WTS 
and reducing the desire to quit among users19,24. Thus, as shown with cigarette health 

warnings1, designing effective text and graphic (i.e., pictorial) warnings is vital to curbing the 
effects of these ads. 
 
Risks / Benefits: 
We consider this study to involve very minimal risk. Some participants may become alarmed of 
learning the potential health implications of waterpipe tobacco smoking and the potential for 
addiction. This may be especially alarming among smokers of other tobacco products (e.g., the 
perception of the compounding of health risks and potential for addiction using several 
products). For others, learning of these issues may reinforce existing knowledge. 
 
The benefits of participation, other than the fiscal compensation for completing the entire 
study (see below), are that participants gain a better understanding of health effects of WTS. 
The ultimate study goal, and hence benefit to study participants, is to equip them with 
knowledge that they can use to curb the persuasive appeal of WTS ads, prevent further 
experimentation with waterpipe tobacco, and achieve cessation to avoid future harm. The 
benefits of this study also include findings that may lead to policy changes in the regulation of 
WTS ads from commercial establishments, such as those posed by the FDA. 
 
Data Safety and Monitoring: 
This study neither involves the testing of pharmacologic agents nor therapeutic treatments. The 
primary goal of this study is to examine how the provision of text only or text + graphic health 
warnings, or lack therefore, on social allure and waterpipe tobacco product ads influence risk 
appraisals, cognitive and affective beliefs and attitudes about waterpipe tobacco smoking 
(WTS) and intentions to quit/willingness to try WTS among waterpipe tobacco smokers and 
susceptible nonsmokers, respectively. This study also examines whether any effects are 
mediated by reactions to the ads, with a subcomponent to study in more detail attentional 
factors as potential mediators through use of eye-tracking. Thus, it is classified as a Type 3 
Study (Non-therapeutic, non-physical intervention), a minimal risk level study that dictates 
annual review by the Duke Cancer Center Scientific Monitoring Subcommittee for scientific 
progress and IRB compliance (The overall Duke DSMB plan follows the specific details regarding 
DSMB procedures that will be followed by the research team). 
Adverse Event Reporting: The study consent form presented on will have a study-related email 
address and a study toll-free number. In the event a participant emails or calls the toll-free 
study number, the project manager will record all reported events in the adverse event log 
(including the subject’s name, date, and event description). The project manager will inform the 
principal investigator, Isaac Lipkus, Ph.D., who will consult with co-investigators as needed on 
the action that should be taken. This action and date of implementation also will be recorded in 
the adverse event log. The entire investigative team will participate in classifying events as 
“serious” or “non-serious (see listing below),” as well as “non-attributable,” “possibly 
attributable” or “attributable” to the intervention (unlike a pharmaceutical trial where known 
side effects exist, the classification of “expected” vs. “unexpected” is inappropriate for this 
intervention). Serious—any event or condition that is life threatening, results in a 

hospitalization, cancer or a physical or cardiac event serious enough to require medical 
attention. A brief listing follows: 
Fatal 
Life threatening 
Permanently disabling 
Required or prolonged hospitalization (Admission—not ER visit) 
Overdose 
Significant hazard to patient 
Non-Serious—all other events. 
All adverse events will be reported on an annual basis to the Duke Cancer Center Scientific 
Monitoring Subcommittee. In keeping with NIH guidelines, minority status and gender also will 
be included in these reports to allow for detection of differential effects. 
Monitoring Safety of Participants 
There will be several ongoing mechanisms for monitoring non-medical adverse events. The 
project coordinator will oversee day-to-day monitoring of the study activities. This monitoring 
will be facilitated by an email address and a toll-free number provided to participants to report 
concerns related to study participation. These ongoing progress reports will enable monitoring 
of the number of participants involved in the intervention groups, attrition rates, and other 
relevant data. 
Mechanisms for Reporting Mon-medical Adverse Events to the Study Principal Investigator 
and Institutional Review Board (IRB) 
The project coordinator or Principal Investigator will follow up with participants within 48 hours 
to ensure that the event has been resolved and will document actions taken. Participants will 
be able to call directly to the study’s toll-free number to report non-medical AEs. All non-
medical AEs will be reported to the Principal Investigator and to the IRB via annual progress 
reports. 
Mechanisms for Monitoring and Reporting Medical Adverse Events 
There are no foreseeable medical adverse events linked to this study. All research projects 
conducted at or originating from the Duke University School of Nursing are required to have 
yearly departmental and Institutional Review Board (IRB) review. Reports of AEs are required as 
part of these progress reports. Additionally, any changes to the project between review periods 
must be approved by the IRB prior to fielding. 
Plans for Assuring Compliance with Adverse Event Reporting 
Participants will be instructed to email or call a 24-hour toll-free number if they experience an 
AE. As mentioned previously, the project coordinator will then inform the Principal Investigator 
and the IRB as detailed above. All adverse events will be reported to NIDA within 3 weeks of 
occurrence. Because this study does not include the use of an investigational drug, there is no 
requirement that the AE be reported to NIDA in real-time. All AEs are reported as part of the 
progress reports in the non-competitive and competitive renewals. 
Plans for Assuring that Action Resulting in Suspension of Trial is Reported 
The Principal Investigator will be responsible for contacting NIDA grant program director if any 
action resulting in temporary or permanent suspension of the trial occurs. Because this trial 
does not involve any investigational medication, the action would be limited to an IRB- or 
investigator- initiated suspension. 

Plans for Assuring Data Accuracy and Protocol Compliance Assurance of data accuracy 
All surveys will use standardized language and procedures which will be pretested. The project 
coordinator will produce reports of recruitment and survey completion rates for study 
investigators. All programming and subsequent checking of data quality and accuracy will take 
place by project staff at Duke. To enhance the quality of these data, we will implement several 
safeguards as stipulated in section D.9. in the research plan on data quality. In addition, our 
statistician will perform a quality data check to make sure all the variables and codes are 
appropriate. 
Assurance of Protocol Compliance 
The PI and the clinical coordinator will monitor protocol compliance throughout the project. 
The investigative team will review all procedures, including methods to protect participants’ 
confidentiality and quality control of data. 
Action to protect patient confidentiality 
Before participants start to complete the online tasks (Phase 1 and Phase 2) or the eye-tracking 
laboratory component (Phase 3), they will be reminded that all their data will be confidential 
and that the research only uses study-related IDs that are not linked to any identifying 
information.  
 
Selection of Subjects: 
Age range: 18 – 34 
Sex: All sexes 
Source of subjects: Recruited locally from Durham, NC, Duke University, and from Turkprime 
which recruits people, who get paid for completing online surveys and studies, from anywhere 
in the United States. 
 
Advertisements: 
Individuals in Phase 1 and 2 will be recruited online using Turkprime28, a research platform that 
supports behavioral sciences data collection through the Internet crowdsourcing platform 
Amazon Mechanical Turk (MTurk), and uses MTurk workers. MTurk workers, are individuals 
from the public who volunteer to participate in online studies with payment. For Phase 3, the 
100 waterpipe tobacco smokers and the 100 susceptible nonsmokers ages 18-34 will be 
recruited from the subject pools managed by the Social Science Research Institute and Duke’s 
Department of Psychology and Neuroscience. In the event we cannot readily obtain eligible 
study participants from these subject pools, we will advertise the study in central North 
Carolina using newspaper, flyers, and social media outlets (e.g., Facebook). 
 
Informed Consent Process: 
Phases 1 and 2: We will obtain active informed consent online, with the approval of the Duke 
University Medical Center Institutional Review Board (DUMC IRB). The online consent will 
inform about the research, including confidentiality, voluntary nature of participation, and 
potential risks and benefits. It will also emphasize that no personally identifying information will 
be available to, or collected by, the investigators conducting this research. The online consent 
form will contain contact information for the DUMC IRB if participants have questions about 

the study or their rights as a research participant or experience any issues or problems 
participating in the study. The voluntary and confidential nature of the research will be 
emphasized again at the beginning of the study surveys. Note that all studies using this 
platform to study waterpipe tobacco under Dr. Lipkus as the PI have been designated by the 
DUMC IRB as exempt. 
Phase 3: In person written consent will be obtained. Participants who will form the first 
advisory panels will be recruited through newspapers in Central North Carolina, Craigslist, 
advertisements in college newspapers and through social media. They will be asked to review 
and sign a written consent form, of which they will receive a copy, during the first panel visit at 
the Duke University School of Nursing. The consent form will emphasize the basic elements 
described above (e.g., confidentiality, benefits, risks, etc.). 
 
Subject Compensation: 
Fiscal compensation will vary by study phase and tasks. Among panel members, they will 
receive $50 for each session they attend, with each session expected to last about an hour. For 
Phase 1 participants who review either the ads or the health warnings, they will be 
compensated with a payment of $2.00 for tasks that are expected to take 15 to 20 minutes. For 
Phase 2 participants, they will get a total of $4.00 for both reviewing the intervention materials 
and for completing the two-week post-intervention assessments. Each is expected to take 
about 15 minutes. Participants in Phase 3 will receive $25.00 for their in-person participation. 
 
Privacy and Confidentiality of Study Records: 
Data collected online will be anonymous with each participant having a unique Turkprime ID 
with no identifying information. With respect to data, all will be stored at the Duke University 
School of Nursing. Assessment completion will be monitored in Qualtrics by study personnel as 
Survey data will be downloaded by authorized personnel and stored in a password protected 
database behind Duke’s server. User-level restrictions will be in place to ensure only 
authorized, fully trained study staff have access to these data. All study related databases will 
be password-protected and accessed only by study personnel. All computerized data will be 
stored and protected as part of the Duke University School of Nursing’s data storage protocols. 
 
Will Protected Health Information (PHI) be used or accessed in this study?  
Yes 
 
PHI Sources: 
Questionnaires 
 
Will the study team need to collect PHI prior to consent (Does the study team 
need a HIPAA waiver)? 
No 
 
 

Privacy and Confidentiality of HIPAA Waiver: 
Data collected online will be anonymous with each participant having a unique Turkprime ID 
with no identifying information. With respect to data, all will be stored at the Duke University 
School of Nursing. Assessment completion will be monitored in Qualtrics by study personnel as 
Survey data will be downloaded by authorized personnel and stored in a password protected 
database behind Duke’s server. User-level restrictions will be in place to ensure only 
authorized, fully trained study staff have access to these data. All study related databases will 
be password-protected and accessed only by study personnel. All computerized data will be 
stored and protected as part of the Duke University School of Nursing’s data storage protocols. 
 
 
 
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