Optimizing Hookah Tobacco Public Education Messages to Reduce Young Adult Use
Phase: NA
Conditions: Hookah Tobacco Smoking
Sponsor: Georgetown University

Official Title: Optimizing hookah tobacco public education messages to reduce young adult use 
 
NCT Number: NCT004242014 
 
Study Protocol 
 
Initial Approval: March 4, 2019 

Page 1 of 2
APPROVAL
March 5, 2019
Darren Mays
dmm239@georgetown.edu
Dear Darren Mays:
On 3/4/2019, the IRB reviewed the following submission:
Type of Review: STUDY
Title: Randomized Trial Testing the Efficacy of Hookah 
Tobacco Public Education Messages among Young 
Adults 
Investigator: Darren Mays
IRB ID: STUDY00000277
Review Type: Non-Committee
Review Level: Expedited
Review Category: (7)(a) Behavioral research
(7)(b) Social science methods
Funding: Name: National Cancer Institute (NCI), Funding 
Source ID: R01 CA229082 01
Grant Title:
Grant ID:
IND, IDE, or HDE: None
Documents Reviewed: • FDA R01 Online ICF 021219.pdf, Category: 
Consent Form; • AmeriSpeak Email Invitation.pdf, 
Category: Recruitment Materials; • Hookah Education 
Messages.docx, Category: Any Other Study Related 
Documents; • Sun Education Messages.pptx, 
Category: Any Other Study Related Documents; 
The IRB has approved the submission. You can begin research activities. The approval 
is valid from 3/4/2019. Any modifications to the IRB-approved protocol and other 
supporting documents must be reviewed and approved by the IRB prior to 
implementation.

Page 2 of 2
If the study will continue beyond , please submit a continuation request form at least 
thirty (30) days prior to to allow the IRB sufficient time to review and approve the 
request.
In conducting this protocol, you are required to follow the requirements listed in the 
Investigator Manual (HRP-103), which can be found by navigating to the IRB Library 
within the IRB system.
Sincerely,
Michael Orquiza

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 1 of 17 
Revised: October 30, 2018 
PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults  
 
PRINCIPAL INVESTIGATOR: 
Dr. Darren Mays 
Department of Oncology  
(202) 687-8937 
Darren.Mays@georgetown.edu 
VERSION NUMBER/DATE: Version 1; January 31, 2019 
Version 2; December 2, 2019 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
12/02/2019 
Modify informed consent process 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 2 of 17 
Revised: October 30, 2018 
Table of Contents 
 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 7 
6.0 
Procedures Involved*............................................................................................... 7 
7.0 
Data and Specimen Banking* ................................................................................ 10 
8.0 
Sharing of Results with Subjects* ......................................................................... 10 
9.0 
Study Timelines ..................................................................................................... 10 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 10 
11.0 Vulnerable Populations* ........................................................................................ 10 
12.0 Local Number of Subjects ..................................................................................... 11 
13.0 Recruitment Methods ............................................................................................. 11 
14.0 Withdrawal of Subjects* ........................................................................................ 11 
15.0 Risks to Subjects* .................................................................................................. 12 
16.0 Potential Benefits to Subjects* .............................................................................. 12 
17.0 Data Management* and Confidentiality ................................................................ 12 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 15 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 15 
20.0 Compensation for Research-Related Injury ........................................................... 16 
21.0 Economic Burden to Subjects ................................................................................ 16 
22.0 Consent Process ..................................................................................................... 16 
23.0 Process to Document Consent in Writing .............................................................. 16 
24.0 Setting .................................................................................................................... 17 
25.0 Resources Available............................................................................................... 17 
26.0 Multi-Site Research* ............................................................................................. 17 
 
 
 
GHUCCTS Questions  
 
GHUCCTS is the Georgetown-Howard Universities Center for Clinical and Translational 
Science. 
 
Is this study a GHUCCTS Study?   ____Yes 
__X__No 
 
Is the project being sponsored or funded by GHUCCTS?  ____Yes 
__X__No 
 
Does the project utilize GHUCCTS services or facilities?  ____Yes 
__X__No 
(e.g., is the study conducted on the Clinical Research Unit (CRU), is the study supported 
by a GHUCCTS biostatistician, etc.) 
 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 3 of 17 
Revised: October 30, 2018 
1.0 
Study Summary 
 
Study Title 
Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
Study Design 
Two-group randomized trial study design to test message effects 
prospectively on young adults who are susceptible non-users of 
hookah tobacco and current users. 
Primary Objective 
To examine the efficacy of public education messages that target 
young adults’ beliefs about hookah tobacco use in 4 domains: 
health harms, addiction, social use, and flavoring for preventing 
and reducing hookah tobacco use.   
Secondary 
Objective(s) 
NA 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Education messages about the health harms, addictiveness, social 
use, and flavoring of hookah tobacco use. 
 
IND/IDE #  
NA 
Study Population 
Young adults between the ages 18 to 30, including young adults 
who are susceptible non-users of hookah tobacco and current 
users.  
Sample Size 
n = 1100 participants 
Study Duration for 
individual 
participants 
Approximately seven (7) months. 
Study Specific 
Abbreviations/ 
Definitions  
NA 
 
 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
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Revised: October 30, 2018 
2.0 
Objectives* 
2.1 
The purpose of this study is to examine the efficacy of hookah 
tobacco public health education messages among young adults between 
the ages 18 to 30, including young adults who are susceptible non-users of 
hookah tobacco and current users.   
2.2 
Hypothesis 1: Messages will decrease hookah initiation among 
susceptible non-users and increase cessation among hookah users. 
Hypothesis 2a: Message effects will be mediated by greater message 
engagement, message receptivity, and perceived harms of hookah tobacco.  
Hypothesis 2b: Message effects will be greater among susceptible non-
users versus hookah users and among those who do not use other tobacco 
products versus those who do. 
3.0 
Background* 
3.1 
The prevalence of regular (i.e., daily) and intermittent (i.e., some 
days, rarely) hookah tobacco use among US young adults rivals that of 
cigarette smoking and surpasses products such as electronic cigarettes.1,2 
Our previous work indicates nearly 30% of US young adults who do not 
use hookah are also at risk of initiation.3 A typical hookah smoking 
session can last 1 hour or more and exposes users to harmful chemicals 
including at least 8 classes of carcinogens linked to lung, bladder, larynx, 
oral cavity, and esophageal cancer.4-6 Long-term use increases the risks of 
cancer, lung disease, and other health outcomes, and hookah smoke 
exposure precipitates carcinogenesis in-vitro.7,8 Hookah use among young 
people can also promote addiction: users report dependence symptoms, 
withdrawal, and difficulty quitting.9, 10  Young adulthood is generally a 
vulnerable period for tobacco initiation,11 a time when addictions unfold 
and transitions to regular tobacco use occur,11 and there is growing 
evidence this occurs with hookah tobacco.12-14 Young adults’ hookah use 
is a critically important problem for tobacco control.15  
 
The 2009 Family Smoking Prevention and Tobacco Control Act 
authorized the Food and Drug Administration (FDA) to regulate the 
marketing, sale, and manufacture of cigarettes, smokeless, and roll-your-
own tobacco.16 In 2016, FDA finalized the “deeming” rule bringing all 
tobacco products under its regulatory jurisdiction, including hookah 
tobacco.17, 18 This rule subjects newly deemed products to regulatory 
measures of the Tobacco Control Act and also positions FDA to engage in 
public education to ensure consumers are informed of the risks of 
regulated products as required by the Tobacco Control Act.16 FDA has 
launched mass media campaigns targeting youth cigarette smoking and 
evidence indicates they are positively affecting smoking behavior in target 
populations.19 With the deeming rule finalized, FDA has announced plans 
to expand public education efforts to newly regulated products such as e-
cigarettes,20 and is positioned to do so for hookah as well. Importantly, 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 5 of 17 
Revised: October 30, 2018 
any FDA tobacco regulatory measures must be guided by the public health 
standard of the Tobacco Control Act: FDA must consider evidence of their 
impact on users and non-users, and especially young people. This study 
fills an important gap in the research guiding FDA public education efforts 
surrounding the risks associated with hookah tobacco use by testing the 
efficacy of messages among young adults, the primary population where 
hookah use occurs. 
3.2 
Hookah Tobacco Message Development. We have carefully 
developed and studied the effects of public education messages delivered 
online conveying harms and addictiveness of hookah tobacco use among 
young adult non-users who are susceptible to initiation and current hookah 
users. Our first step was to update message content from previous 
research21 based on the recent literature. Then, we pretested revised 
messages with 46 young adults (Mean age 24.1, 41% female, 24% non-
white) using online crowdsourcing. Participants rated revised message 
content highly (1 to 7 scale) on relevance (Mean 5.5), believability (Mean 
5.2), applicability (Mean 5.4), accuracy (Mean 5.6), understandability 
(Mean 5.6), and importance (Mean 5.2). In a separate sample of 44 young 
adult hookah users (Mean age 25.3, 53% female, 20% non-white), we also 
assessed message content preferences, finding messages conveying risks 
of harm and addiction resonate with this group.22 The proposed approach 
builds directly for our prior work to carefully develop education messages 
targeting young adults’ hookah use. 
Message Effects: Susceptible Non-Users. We experimentally examined 
effects of the revised messages in 508 young adults who never used 
hookah tobacco (M age 25.3, 50.1% female, 199% non-white) recruited 
online, 248 (49%) of whom were susceptible to initiation.23 Participants 
exposed to the messages responded favorably on measures of engagement, 
and those who were susceptible to using hookah tobacco indicated 
message content was more personally relevant than those who were not 
susceptible (p <.001). Overall, compared to young adults receiving no 
message content, those viewing study messages reported greater perceived 
harm and addictiveness (d = .89) of hookah tobacco, greater worry about 
harm and addiction (d = .30), and more negative attitudes toward hookah 
(d = .30). Among susceptible young adults, those viewing messages 
reported less intention to try hookah tobacco in the future compared to 
those not exposed to messages (d = .34, p = .035); there was no significant 
effect of messages on hookah use intentions in non-susceptible young 
adults. These data support our objective to test message efficacy among 
young adults who are susceptible non-users of hookah tobacco. 
 
Message Effects: Hookah Users. We also tested message effects in 327 
young adult hookah tobacco users (Mean age 24.8, 38% female, 22% non-
white) recruited online.24 Participants completed pre-exposure measures 
and were randomized to a control condition receiving no messages (n = 
108), a condition receiving messages about hookah tobacco harms (n = 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 6 of 17 
Revised: October 30, 2018 
107), or a condition receiving messages about hookah tobacco harms and 
addictiveness (n = 112). Post-exposure measures captured hookah tobacco 
perceptions and motivation to quit. Main effects for study condition were 
statistically significant for all outcomes (p ≤ .001) except perceived risk of 
addiction (p = .051). Pair-wise mean comparisons showed participants in 
conditions receiving study messages endorsed stronger perceived harm 
(d’s .74-.79) and addictiveness (d’s .47-.80), greater worry about harm 
(d’s .42-.44) and addiction (d’s .31-.47), and stronger motivation to quit 
(d’s .22-.47). Message effects on motivation to quit were mediated by 
greater worry about harm and addiction.35 These findings demonstrate the 
potential for public education messages to affect relevant cognitive and 
behavioral outcomes in young adult hookah tobacco users. 
3.3 
There is extremely limited research on optimal message content for 
hookah tobacco, particularly research addressing the evidentiary standard 
set forth in the law. The FDA and NCI have for this reason identified 
young adults as a priority population for studies of non-cigarette product 
use such as hookah and communication interventions.25, 26 Our study 
addresses a critical research need in FDA’s priority area of 
Communications by rigorously and comprehensively identifying optimal 
content for hookah tobacco public education messages and determining 
effects on behavioral outcomes in susceptible young adult non-users and 
current hookah users. 
Evidence-based public education messaging is a recommended component 
of comprehensive tobacco control efforts.27 For cigarette smoking, 
strategies such as mass media campaigns and warning labels on product 
packaging are effective for preventing smoking uptake and promoting 
cessation.28-30 Young adults’ hookah use is characterized by unique 
perceptions and beliefs about the harms and addictiveness of hookah 
tobacco, beliefs that social use poses little risk, and is fueled by the wide 
array of appealing flavors that are commonly used by young people.31-42 
Messages aimed at these factors are needed to dissuade initiation among 
non-users and motivate users to quit.43 However, hookah tobacco use 
predominantly occurs in cafés and other social settings, limiting users’ 
exposure to regulatory communications such as warning labels on product 
packaging.18, 31 Our research indicates public education messages 
conveying health harms and addictive potential of hookah use resonate 
with young adults, decrease intentions to use hookah among susceptible 
non-users, and increase motivation to quit among current users.23, 24 Our 
preliminary findings described above on hookah message effects are 
promising, but research examining strategies to optimize message impact 
is sorely needed. 
4.0 
Study Endpoints* 
4.1 
The primary study endpoints among susceptible non-users are 
changes in susceptibility to use hookah tobacco, curiosity (i.e., intentions) 
to use hookah tobacco, and hookah tobacco initiation. The primary end 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 7 of 17 
Revised: October 30, 2018 
points among current hookah users are motivation to quit using hookah 
tobacco, frequency of hookah use, and cessation.  
4.2 
Secondary end points include perceived harm & addictiveness of 
hookah tobacco, perceived risk and worry about harm & addictiveness, 
and message-related outcomes including message receptivity, emotional 
response, and content recall. These will be examined as mediators of 
message effects. There are no safety outcomes in this trial. 
5.0 
Study Intervention/Investigational Agent 
1.1 
The study intervention is public health education messages that 
convey the health harms, addiction, social use, and/flavorings associated 
with hookah tobacco use.   
6.0 
Procedures Involved* 
6.1 
This study is a two arm prospective randomized trial to test the 
efficacy of public health messages about hookah tobacco use. All study 
procedures will be conducted by NORC staff in direct collaboration with 
the study team and investigators. Study participants will be anonymous to 
the study team and investigators, and all data collected as part of the study 
will de-identified.  
 
Participants will be recruited from the National Opinion Research 
Council’s (NORC) AmeriSpeak consumer market research panel, screened 
for eligibility, and will complete a baseline assessment online. Then 
participants will be randomized in equal numbers to two arms: 1) hookah 
tobacco public education messaging or 2) control arm. On approximately a 
weekly basis for 4 weeks, participants will receive study communications 
and complete brief measures of message response online. For the hookah 
tobacco public education messaging arm, communications will consist of 
the study messages communicating about the health harms, addictiveness, 
social use, and flavorings in hookah tobacco. In response to each message, 
participants will complete measures of message response and hookah-
related outcomes detailed below. Participants in the control condition will 
receive study communications with brief messages about health behaviors 
unrelated to tobacco (sun protection) and will complete the same 
measures. Study outcomes and hypothesized mediators will be assessed 2-
, 4-, and 6-months after the message exposure period. 
6.2 
Trial participants will be 1,100 English speaking young adults ages 
18 to 30 years old who have never used hookah tobacco but are deemed 
susceptible based on four screening questions or report hookah tobacco 
use at least once within the past month on valid measures. Trial 
participants will be recruited from the AmeriSpeak national consumer 
research panel maintained and operated by NORC. Although recruitment 
and data collection procedures will be conducted by NORC and all study 
participants will be anonymous to the investigators, our team will work 
collaboratively with NORC AmeriSpeak staff to oversee recruitment, 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 8 of 17 
Revised: October 30, 2018 
enrollment, data collection, and experimental procedures.  
 
AmeriSpeak panel members who are young adults ages 18 to 30 in the US 
will be sent a standard email invitation describing the study. Potential 
participants are identified by randomly selecting households within the 
panel with a young adult within the study age range, and targeting study 
invitations based on recent study participation, and other demographic 
characteristics as needed to ensure a representative sample. This email 
invitation will introduce study procedures and eligibility criteria, and 
direct interested panel members to the eligibility screener with items to 
confirm eligibility. Procedures will ensure potential participants are adults 
ages 18 and older through two steps: 1) targeting study invitations only to 
those panel members whose age is within this range; and 2) re-assessing 
age at eligibility screening and excluding those who provide inconsistent 
information (i.e., ages differ in self-reported screening compared with 
panel-based age derived from date of birth). Panel members who are 
confirmed to meet study eligibility criteria will proceed to the online 
baseline. AmeriSpeak panel members who do not meet study eligibility 
criteria will be redirected to a concluding thank-you screen. Similar 
procedures will be followed when participants are contacted for the brief 
message exposures and  the 2-, 4-, and 6-month follow-up assessments. 
This approach is guided by similar previous tobacco research studies with 
young adults, including studies with prospective participation and 
retention rates of 70% and higher.45-46  
The online baseline assessment includes valid measures of hookah 
and other tobacco use behavior, hookah beliefs, perceptions, and other 
constructs from our conceptual framework. After completing a baseline, 
participants will be randomly assigned in approximately equal numbers to 
one of two arms: 1) hookah tobacco education messaging; 2) control arm. 
Randomization will be balanced by hookah use status (susceptible non-
user, current user) to ensure sufficient numbers of these characteristics 
across study arms. Participants in the hookah education messaging arm 
will then receive 4 study communications delivered approximately weekly 
during the exposure period. These communications will consist of: 1) the 
study hookah education messages; and 2) brief post-message 
(approximately 5 minutes) measures of hookah use behaviors, beliefs and 
perceptions, and message responses. Procedures for participants 
randomized to the control arm will be similar, however communications 
will consist of non-tobacco messages communicating about sun protection 
that we have developed on our previous work and pilot tested against 
tobacco-related messaging to ensure they are an adequate contact-matched 
control. Messages will have a similar layout and structure (e.g., amount of 
text) to the hookah public education messages and will be presented in a 
consistent order for all participants. We chose this contact-matched control 
arm to ensure groups are treated equivalently with only message content 
varying between arms. 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
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All participants will complete follow-up assessments online 2-, 4-, 
and 6-months after the message exposure period. We chose these time 
points based on our team’s prior work on young adult tobacco use 
behavior and messaging,44, 45 other research on hookah tobacco 
messaging,21 recommendations for follow-up in tobacco intervention 
research,47, 48 and because this follow-up frequency and duration will 
capture short term message effects and changes in hookah use, 
susceptibility, and mediating processes.12, 14, 21, 47, 49-52 As with the 
baseline, follow-ups will be securely administered online. Measures are 
attached in Section 14. At the conclusion of the final follow-up, all 
participants will be debriefed on the study goals and the potential risk of 
hookah and other forms of tobacco use. 
6.3 
Although the study presents minimal risks to participants, we have 
carefully developed a plan for mitigating and addressing potential risks. We will 
not collect or have access to any participant identifying information as part of the 
study; all participants will be anonymous to the investigators protecting their 
privacy and confidentiality. Due to the nature of study, the primary potential 
source of risk is the gathering of social and behavioral information about tobacco 
use. We recognize that protecting participants’ privacy and confidentiality is most 
salient and have study procedures in place to protect this information. Although 
we will not collect identifying information and all participants will be anonymous 
to the research team, we have several safeguards in place to protect participants’ 
privacy and ensure that all study data are treated as secure and confidential.   
 
First, all NORC AmeriSpeak panel members provide their consent to participate 
in research studies that NORC conducts on behalf of clients upon joining the 
panel and are provided with details of NORC’s privacy and data protection 
policies and procedures. The consent form provides contact information for 
NORC staff if participants have questions about the study or encounter any issues 
surrounding study participation. Participants may call or email NORC staff with 
any questions, concerns, or problems related to the study. This consent document 
and NORC’s policies and procedures are attached to the protocol.   
 
Second, at the beginning of all study assessments, we will emphasize the 
voluntary and confidential nature of participation and that no personally 
identifying information will be collected by or released to the investigators 
conducting this research.  
Third, in the unlikely event that a participant in the study contacts NORC 
staff with questions or to report issues, we will work with NORC staff to 
determine a resolution. Although they are unlikely and we have not 
experienced such an occurrence in our research to date, any unexpected 
adverse events will be recorded and reported to the Georgetown IRB as 
detailed below describing aspects of our Data Safety and Monitoring Plan. 
6.4 All study data will be obtained by participants’ self-report responses  

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 10 of 17 
Revised: October 30, 2018 
to anonymous online surveys. Data will be collected on hookah and other 
tobacco use behavior, hookah beliefs, perceptions, and responses to study 
messages.  
 
7.0 
Data and Specimen Banking* 
NA – No specimens are collected as part of this study. 
8.0 
Sharing of Results with Subjects* 
8.1 We will not have the ability to contact participants given the 
anonymous nature of the study. 
9.0 
Study Timelines 
9.1 The duration of an individual’s participation in the study to complete 
all procedures is approximately 7 (seven) months. We anticipate it 
will take approximately 12 months to enroll participants and 
complete data collection. We anticipate primary analyses will be 
completed by April 30, 2022. 
10.0 Inclusion and Exclusion Criteria* 
10.1 
NORC AmeriSpeak panel members will be recruited and screened for 
eligibility through a series of steps.  NORC will send an email invitation using 
their standard template to potential participants and will introduce study 
procedures and eligibility criteria to AmeriSpeak panel members. Interested panel 
members will be directed to the online eligibility screener with valid self-report 
items to confirm eligibility. Invitations will be targeted by NORC using data from 
the member panel enrollment profile (i.e., participant age) and confirmed based 
on responses to the brief online eligibility screener. 
10.2 
Eligible participants for the randomized trial will be 1) young 
adults ages 18 to 30; 2) who have never used hookah tobacco but are 
deemed susceptible based on 4 screening questions or report hookah 
tobacco use at least once within the past month based on valid measures;23, 
24 and 3) are NORC AmeriSpeak panel members residing in the US. 
Study exclusion criteria include: 1) individuals who are younger than 18 
or over 30 years of age; 2) those who do not meet self-report criteria for 
susceptibility or current use of hookah tobacco; or 3) are not registered to 
participate in research studies through the NORC AmeriSpeak panel. 
10.3 
Study participants will be Amerispeak panel members who meet 
the eligibility criteria listed above. The following special populations will 
be excluded: Adults who are unable to consent, individuals who are not 
yet adults, pregnant women, and prisoners. 
11.0 Vulnerable Populations* 
N/A 
 
 

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Education Messages among Young Adults 
 
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12.0 Local Number of Subjects 
12.1 
Our sample size is 1100 participants, including 425 young adult 
hookah users and 675 susceptible non-users. We conducted power 
analyses as described in Section 17 to determine the target sample size.  
13.0 Recruitment Methods 
13.1 
The sample will be recruited through AmeriSpeak national consumer 
market research panel maintained by NORC. Recruitment and data collection 
procedures will be conducted by NORC under Dr. Mays’s supervision; however 
all study participants will be anonymous to the investigators and NORC research 
staff will conduct all procedures using standard protocols. Participants will be 
recruited from the AmeriSpeak national panel through email invitations. This 
email invitation will introduce study procedures and eligibility criteria and 
interested panel members will be directed to the eligibility screener as described 
above. 
 
13.2 
The source of participants will be NORC’s AmeriSpeak panel. 
Participants must be AmeriSpeak panel members. All study recruitment and data 
collection will be conducted by NORC; participants will be anonymous to the 
investigators and research staff. 
 
13.3 
Potential participants through NORC are identified by randomly selecting 
households within the panel with a young adult within the study age range, and 
targeting study invitations based on recent study participation, and other 
demographic characteristics as needed to ensure a representative sample. 
13.4 
A standard email invitation will be used to recruit participants. 
NORC’s email template is attached to this application. 
13.5 
Participant incentives will be administered by NORC according to 
their standard procedures for panel members’ survey participation. Panel 
members receive incentives in the form of “points” for completing study 
milestones, which can be accumulated and redeemed for gift cards, cash, 
and other rewards. For this study, incentives will be administered by 
NORC in the form of “points” at the completion of study milestones 
including baseline, weekly surveys, and the 2-, 4-, and 6-month follow-
ups. 
14.0 Withdrawal of Subjects* 
14.1 
AmeriSpeak panel members may choose to complete study 
procedures or not. Reasons for which participants may choose to 
discontinue participation in the study may include loss of interests or lack 
of time to complete remaining procedures. There are no foreseeable 
circumstances where the investigators or research team will withdrawal 
participants without their consent; we will not have the ability to directly 
communicate with participants since all participants are anonymous to the 
research team.  

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Education Messages among Young Adults 
 
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14.2 
Participants who voluntarily withdrawal from the study will choose 
to on their own. There are no procedures for termination. 
14.3 
The only manner in which participants will withdrawal is if they 
decide to on their own. There will be no partial withdrawal with continued 
data collection in this study. 
15.0 Risks to Subjects* 
15.1 
This study does not involve drugs, devices, or medical procedures. 
The primary potential source of risks in this study is the social risk of 
gathering behavioral information about tobacco use and tobacco-related 
attitudes, perceptions, and beliefs. These include potential embarrassment 
and fear of disclosure of potentially sensitive information, and 
confidentiality concerns. 
16.0 Potential Benefits to Subjects* 
16.1 
There are no direct benefits to young adults who choose to 
participate in this research. The knowledge gained from the study will help 
us to understand how to best design hookah tobacco public education 
messages to prevent and reduce hookah use among young adults in the 
future. 
17.0 Data Management* and Confidentiality 
17.1 
 We calculated statistical power to test our study hypotheses assuming a 
two tailed α = .05 and baseline sample of 1100 participants, including 425 young 
adult hookah users and 675 susceptible non-users. We estimated the ability to 
detect effects of the messages on hookah initiation among susceptible non-users44 
and cessation among current users21 based on prior studies. Among susceptible 
non-users, we estimate 8% will initiate hookah use over the 6-month follow-up 
period based on our recent national study of US young adults.44 With susceptible 
non-users at 6-month follow-up we will have 80% power to detect percent 
differences as small as 5.3%, or initiation of 8% in the control arm and 2.7% in 
the messaging arm. This equates to an odds ratio of 0.62 comparing hookah 
initiation between the messaging and control arms in a logistic regression analysis 
including covariates. Although evidence on hookah tobacco cessation rates is 
limited, 1 prior study found that young adult hookah users exposed to risk-based 
messages were nearly 2 times more likely than those in a control condition with 
no message exposure to report cessation at 6-month follow-up (62% vs. 33%, 
odds ratio 1.89).21 Conservatively assuming a much lower overall cessation rate 
of approximately 10% (i.e., comparable to those of behavioral smoking cessation 
interventions)53 the sample of hookah users at the 6-month follow-up will have 
80% power to detect absolute differences in cessation between study arms as 
small as 8% (10% control, 18% messaging). In a logistic regression analytic 
framework with covariates, this equates to an odds ratio of 1.55. For analyses of 
continuous outcome variables, our sample will provide 80% power to detect small 
mean differences (d ≤ 0.10) between arms in the complete sample, and among 
susceptible non-users and current users separately. For testing mediating effects, 

PROTOCOL TITLE: Randomized Trial Testing the Efficacy of Hookah Tobacco Public 
Education Messages among Young Adults 
 
Page 13 of 17 
Revised: October 30, 2018 
simulation studies provide estimated power to detect mediation effects using bias-
corrected bootstrap analyses.54 The sample will provide 80% power to detect 
small- to medium- indirect (i.e., coefficients in the range of 0.20-0.30) effects. 
Similarly, for analyses of the interaction between study condition and two-level 
moderators we will have 80% power to detect moderator effects as small as 
Cohen’s f ≤ 0.10 in ANCOVA analyses (i.e., differences between susceptible 
non-users and hookah users) and odds ratios as small as 1.70 for interactions 
between non-hookah tobacco use and trial arm for binary initiation and cessation 
outcomes. 
 
The primary outcomes and analytic approach will compare differences in 6-month 
outcomes across the control and messaging arms. We will initially assess 
differences in past 30-day hookah use behavior using longitudinal mixed effects 
logistic regression in the entire sample. The model will include past 30-day 
hookah use at 6 months as the dependent variable, trial arm, and baseline 
covariates for susceptible non-user/current user and any others identified in the 
steps outlined above.55 We will then use a similar modeling strategy to assess 
differences by trial arm in hookah use initiation among participants who were 
susceptible non-users at baseline, and cessation among baseline users. These 
analyses will model dependent variables reflecting change in hookah use status 
from baseline to the 6-month follow-up separately for these two groups, a term for 
trial arm, and any covariates as identified above. Among susceptible non-users at 
baseline, we will similarly analyze changes in susceptibility status relative to trial 
arms as a secondary outcome. In both susceptible non-users and hookah users, 
will also conduct analyses to assess message effects on continuous outcome 
measures at 6 months, curiosity to use hookah tobacco and motivation to quit, 
respectively. We will use repeated measures ANCOVA to compare means of the 
continuous outcomes by trial arm at 6 months and Tukey’s adjustment method for 
the pair-wise comparisons. In exploratory analyses, we will repeat these types of 
mixed logistic and ANCOVA analyses for outcomes measured at the 1- and 3-
month time points. We will assess any potential message order effects separately 
in the education messaging arm by examining message effects by the 4x4 
Balanced Latin Square orders. If any message order effects are detected or trends 
are observed we will include order as a covariate in analyses.56 Exploratory 
analyses will also examine if responses to weekly assessments differ by message 
themes using approaches similar to those above. 
 
We will test hypotheses about potential mediation of message effects through a 
series of steps drawing from traditional mediation frameworks for preliminary 
analyses57 and applying more robust methods to formally test for mediation.58 
First, we will examine differences in means for mediating variables by trial arms 
and investigate whether each mediator at 1- and 3-month time points is correlated 
with the outcomes at 6-months using bivariate statistics and regression-based 
analysis accounting for any covariates as needed. Where these preliminary steps 
indicate potential mediation, we will formally test for mediation by estimating the 
indirect effects of candidate mediators at 1- and 3-months on study outcomes at 6-

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months via the study arms using a bias-corrected bootstrapping method with 
1,000 resamples to address non-normality of the product of the coefficients 
estimator.54, 58 This bootstrapping approach estimates an indirect (i.e., mediation) 
effect reflecting the product of the effect of trial arm on the mediator with the 
effect of the mediator on the outcome, and produces bias-corrected asymmetric 
95% confidence intervals (CIs) that correct for non-normality of the distribution 
of indirect effects.58 This method provides higher power and better control over 
the Type I error rate compared with traditional approaches for testing 
mediation.172,173 Asymmetric 95% CIs for indirect effects that do not include zero 
will indicate significant mediation effects.172 We will evaluate hypothesized 
moderators individually by introducing them one at a time and their 
corresponding interactions with trial arm into the logistic regression and 
ANCOVA models. Analyses assessing differential effects of messages among 
susceptible non-users and hookah users will primarily be ANCOVA based and 
examine mediators and outcomes measured commonly in these groups. Although 
the primary moderators of interest are those relating to hookah and other tobacco 
product use, we will also explore potential moderating effects of participant 
demographics including sex (male, female) and age (< 25, 25+) and other 
characteristics in analyses. 
 
17.2 
NORC also takes extensive measures to ensure that all panel 
members’ privacy and personal information are treated confidentially and 
kept secure. All personally identifying records are kept secured in a 
separate data servers maintained by NORC. NORC never provides any 
panel members’ personally identifying information to a research partner 
without the explicit and informed consent provided by the sampled 
members. For this study, all data will be de-identified and anonymous to 
the investigators and no personal information will be released to the 
investigators, therefore there will be no way to discern participants’ 
identities from the study data. All NORC survey response data are 
identified only by an anonymous ID number. 
17.3 
In addition to the measures put into place by NORC, our research 
team will take several additional steps to ensure data collected from 
AmeriSpeak panel members are treated as secure and confidential at 
GUMC. First, as noted above, all data will be anonymous and will not 
include personally identifying information. Any data to be transferred 
from NORC to Dr. Mays at GUMC/LCCC will use Georgetown Box. We 
will use Georgetown Box to transfer data files and documentation to Dr. 
Mays by creating a restricted access link that is password protected and 
only accessible to authorized NORC personnel. Second, once study data 
are transferred to GUMC/LCCC all electronic study data files will be 
securely stored on a GUMC/LCCC network drive. This network space is 
encrypted and directories are password-protected at the individual user 
level to ensure electronic data files are treated as secure and confidential. 
Only the GUMC/LCCC Principal Investigator and authorized study 

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personnel will be granted access to the data after appropriate permissions 
are established. 
17.4 
All study procedures use well-validated assessments with 
established psychometric properties. Quality control will be ensured by 
working with NORC to review online assessments we provide to ensure 
they function properly in terms of item performance, skip logic, and 
design. There are no other necessary quality control measures. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
 
Although all participants are anonymous to the study team and the 
procedures pose minimal risks, we have procedures in place to ensure data 
are treated as confidential and private and to protect participants.  
 
Although they are unlikely and we have not experienced such an 
occurrence in our research to date, monitoring study progress and safety of 
participants is ongoing throughout data collection.  Any unexpected 
adverse events will be recorded and reported to the Georgetown IRB. 
Despite that this study presents minimal risks for participants, the 
Principal Investigator, Dr. Mays, will actively work with NORC staff to 
monitor for any unanticipated adverse events. Dr. Mays will be 
responsible for evaluating any unanticipated problems that arise during the 
study and determining whether they affect the risk-benefit ratio of the 
study, and whether modifications to the protocol are required. Dr. Mays 
will be responsible for reporting any unexpected adverse events involving 
any aspect of the study to the Georgetown IRB per institutional guidelines. 
Unanticipated problems to be assessed include adverse events, deviations 
from the study design or protocol, and confidentiality violations. Dr. Mays 
will report unanticipated problems to the Georgetown IRB within 3 
business days of their occurrence. 
NORC panel members who participate in this research may call a NORC-
maintained and staffed telephone number with any questions or to report 
problems related to this study. This is a toll free number that is provided to 
all panel members in the privacy statement and during the informed 
consent process when they join the AmeriSpeak panel. Participants may 
similarly contact NORC via email (privacy@amerispeak.org). 
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 
The online consent form that AmeriSpeak panel members sign upon 
joining the panel emphasizes the voluntary and confidential nature of panel 
members’ participation in research conducted by NORC and that NORC does not 
share personally identifying information with clients for whom they conduct 
research. At the beginning of all study assessments we reiterate the voluntary and 
confidential nature of participation, and that participants may withdraw at any 

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time without penalty. The research team does not have access to and will not 
collect identifiable personal information. Participants are permitted to skip any 
survey questions that make them feel uncomfortable and can withdraw from the 
study at any time. 
 
19.2 
In order to protect privacy of participants, access to study data will be 
strictly controlled by the PI and will only be accessible by study personnel with 
permission and training to do so. Participants will have an anonymous ID 
associated with their survey data to ensure their privacy. The anonymous ID does 
not include any personally identifiable information. Additionally, no private 
health information will be collected or recorded in this study. All online 
questionnaires completed and gathered as part of this study will be anonymous 
and no personally identifying information will be recorded on the questionnaires. 
Furthermore, only if participants have study-related questions about their rights as 
a research participant they may contact the Georgetown University IRB and with 
other study related questions they may contact NORC. The PI will work with 
these entities to resolve any questions or issues that may arise without direct 
contact with study participants to maintain anonymity. 
 
20.0 Compensation for Research-Related Injury 
NA 
21.0 Economic Burden to Subjects 
21.1 There are no costs to participants for their participation in this 
research. 
22.0 Consent Process 
22.1 
NORC receives consent from panel members at the time the join 
the AmeriSpeak panel to participate in research they conduct on behalf of 
clients. For this study, procedures involve completing an online survey 
about tobacco use behaviors and cognitive responses to tobacco-related 
messages. All data will be de-identified and participants will be 
anonymous to the investigators. There will be no way to link individual 
participants to their answers to survey questions. These procedures present 
minimal risks to participants. Given the anonymous nature of study 
participation, and participant recruitment and data collection through 
NORC, we will use NORC’s online informed consent process that they 
have in place for panel members. Additionally, we have put into place 
rigorous procedures to treat data collected for this study as private and 
confidential in accordance with data management procedures.  
22.2 
Waiver of Consent Justification: The research presents no more than 
minimal risk of harm to participants. All study procedures will be conducted by 
NORC and participants will be anonymous to the investigators and study team. 
Therefore it would not be practicably feasible to obtain written informed consent 
from participants.  
23.0 Process to Document Consent in Writing 

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23.1 
The research presents no more than minimal risk of harm to 
participants and involves no procedures for which written documentation 
of consent is normally required outside of the research context.  
24.0 Setting 
24.1 
Study procedures will occur online and will be directly managed 
by staff at NORC in collaboration with the research team at the Lombardi 
Comprehensive Cancer Center (LCCC). No personally identifying 
information will be collected for any part of this research, and all study 
participants will be anonymous to the investigators. 
25.0 Resources Available 
25. 1 Participants will be recruited from the NORC AmeriSpeak national 
consumer market research panel maintained by NORC. NORC is an 
independent research institution that specializes in data collection for 
academic and government research. AmeriSpeak is a probability-based 
consumer research panel designed to be representative of the U.S. 
household population. Panel members participate in studies conducted by 
NORC or those conducted by NORC on behalf of government agencies, 
academic researchers, and other organizations. Through partnerships with 
academic and government researchers, NORC has been actively involved 
in public health and health sciences research. Study procedures will be 
conducted by NORC under Dr. Mays’s supervision. Dr. Mays will work 
collaboratively with NORC AmeriSpeak staff to oversee recruitment, 
enrollment, data collection, and experimental procedures. Dr. Mays has 
engaged with NORC in preparation for the NIH grant application 
supporting this study to ensure feasibility of the proposed research. Our 
research team is highly experienced in conducting online, behavioral 
studies on tobacco use and related messages to ensure the study is feasible 
and successful. 
26.0 Multi-Site Research* 
NA