Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers
Phase: NA
Conditions: Smoking Cessation
Sponsor: University of South Carolina

 
 
STUDY PROTOCOL 
 
 
 
 
National Clinical Trial Number: 
NCT04075682 
 
 
Principal Investigator: 
 
James F. Thrasher, MA, MS, PhD 
Professor, Department of Health Promotion Education & 
Behavior 
 
 
 
 
 
Arnold School of Public Health 
 
 
 
 
 
University of South Carolina 
 
 
 
 
 
Columbia, SC, USA 
 
 
Grant Title: 
Evaluation of cigarette package inserts for enhanced 
communication with smokers 
 
 
Grant Number: 
 
 
R01 CA215466 
 
 
Funding:   
 
 
 
National Cancer Institute/National Institutes of Health 
 
 
Version: 
 
 
 
June 23, 2022 
  
 
 

2 
 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes 
agreement by the recipient that no unpublished information contained herein will be published 
or disclosed without prior approval of the Principal Investigator or other participating study 
leadership and as consistent with the NIH terms of award.  
 

3 
 
INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary 
assurances that this study was conducted according to all stipulations of the protocol, including 
all statements regarding confidentiality, and according to local legal and regulatory 
requirements and applicable US federal regulations and ICH guidelines, as described in the 
Statement of Compliance. 
 
 
Principle Investigator                _____
_________ 
 
 
 
 
 
James F. Thrasher (06/23/2022) 
 
 
Investigator Contact Information 
 
Address: 
Department of Health Promotion, Education & Behavior 
Discovery I, 915 Greene St, Room 529 
University of South Carolina 
Columbia, SC  29208 
 
Telephone:  803.777.4862 
 
Email:  thrasher@mailbox.sc.edu 
 
 

4 
 
Table of Contents 
 
Protocol Summary …………………………………………………………………………………………………………...4 
Introduction …………………………………………………………………………………………………..………………...7 
Study Design …………………………………………………………………………………………………………………...11 
Study Population ……………………………………………………………………………………………………..……...11 
Study Intervention …………………………………………………………………………………………………..……...14 
Participant Discontinuation/Withdrawal ………………………………………………………………………...16 
Study Assessments and Procedures………………………………………………………………………………....11 
Supporting Documentation and Operational Considerations…………………………………….….....11 
References ………………………………………………………………………………………………………………..……..21 
Baseline & Ecological Momentary Assessment Surveys ……………………………………………..…….28 
 
 
 
 
 
 

5 
 
1 
PROTOCOL SUMMARY 
 
Title: 
 
Evaluation of cigarette package inserts for enhanced 
communication with smokers 
 
 
Grant Number: 
R01 CA215466 
 
 
Study Description: 
 
 
 
 
 
 
 
 
 
 
 
A randomized controlled trial was conducted to assess the 
influence of cigarette package inserts with messages about the 
benefits of cessation and tips for quitting on smoking cessation-
related psychosocial and behavioral outcomes.  We 
hypothesized that inserts would promote these outcomes and 
that these effects would be enhanced when cigarette packages 
included both inserts and pictorial warning labels.  In this 2X2 
between-subject trial (i.e., inserts with efficacy messages vs. no 
inserts; pictorial warnings vs. text-only warnings), participants 
received a 2-week supply of their preferred cigarette brand 
variety, with labeling to reflect their experimental condition. 
 
Objectives: 
 
 
 
To evaluate the impact of inserts on smoking cessation-related 
outcomes using a randomized controlled trial among adult 
smokers.  
 
Endpoints: 
Data were collected over 14 days using a study smartphone.  
Participants were instructed to log every cigarette they smoked 
during this period. Approximately 4-5 times a day, participants 
were prompted to complete a brief, 1-3 minute survey 
immediately after they indicated that they had smoked, with 
cigarette logs sampled using an algorithm based on self-
reported baseline smoking frequency.  Each evening, between 7 
and midnight, participants were instructed to respond to an 
evening survey using the smartphone app, which took 1-3 
minutes to complete.  
Primary Endpoints:  Self-efficacy to Quit Smoking; Self-efficacy 
to Cut Down on Smoking; Worry About Harms from Smoking; 
Strength of Feeling About Smoking; Extent of Motivation to 
Quit; Talk About Smoking Cessation or Harms; Foregoing or 
stubbing out a Cigarette 
Secondary Endpoints:  Strength of Hopefulness About Quitting; 
Satisfaction From Smoking; Cognitive Elaboration of Smoking 
Benefits; Cognitive Elaboration of Smoking Harms; Cognitive 
Elaboration of Cessation Benefits; Response Efficacy; Perceived 
Susceptibility to Smoking Harms; Cigarettes Per Day 

6 
 
Study Population: 
Adult smokers in South Carolina and New York were recruited, 
with efforts to recruit people from lower socioeconomic status 
groups.  Of 1818 people screened, 602 were ineligible, 773 
either declined to participate or were unable to be scheduled 
for orientation, and 443 were eligible and randomized.  Of 
these, 56 did not attend the study orientation, and 20 did not 
complete minimum criteria to be included in the analytic 
sample.  The final analytic sample involved 367 people. 
  
Description of Study 
Intervention/Experimental 
Manipulation: 
The 2X2 between subject intervention involved randomization 
to one of four groups:  a) control; b) inserts only; c) pictorial 
warnings only; d) inserts and pictorial warnings.  Insert 
conditions included four rotating messages, two about 
cessation benefits and two with cessation tips.  Warning text 
for all conditions included four rotating messages, with the 
text-only “control” condition used the current warning size and 
placement (i.e., 50% of one pack side), whereas pictorial 
warnings covered approximately 50% of the lower half of both 
the front and back of packs. 
 
 
Study Duration: 
June 28, 2019 to June 29, 2021 
 
 
Participant Duration: 
Study participation involved a 45-minute study orientation 
where potential participants completed a baseline survey, 
received training in the 14-day study, and were provided the 
study materials (i.e., smartphone, cigarette packs).  After the 
14-day observation period, participants completed a final 
survey and interview and received compensation. 
 
 
 

7 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
Smoking is the leading cause of preventable disease in the US, killing 480,000 people a 
year.1 Cigarette package labeling is a fundamental tobacco control policy2 3 that specifies how 
health messages are communicated to the 40 million people who smoke in the US.4 5 Smokers 
are exposed to their packs thousands of times a year, which makes packaging the most reliable, 
cost-effective vehicle for governments and industry to communicate with smokers. Reflecting 
this principle, the World Health Organization’s Framework Convention on Tobacco Control 
(FCTC) recommends large, pictorial health warning labels (HWLs) printed on the exterior of 
cigarette packs to communicate about smoking-related risks.6 More than 100 countries have 
adopted pictorial HWLs,7 but only Canada uses inserts to enhance HWL effectiveness. 
“Inserts” and “onserts” (hereafter “inserts”) are small, 
printed leaflets that are removable material found inside or 
attached to the outside of product packaging (Figure 1). Tobacco 
companies have long used inserts to reach smokers with 
promotional materials and messaging (e.g., coupons, contests, 
product information).8-10 Smokers are exposed to inserts every 
time they open a new pack, which is much more often than 
inserts for pharmaceutical drugs that are purchased much less 
frequently than cigarettes. Because of their high exposure 
frequency, cigarette inserts need not include all pertinent 
information, allowing for rotating messages that address key limitations of drug inserts (e.g., 
concise, legible, use of imagery).11-13 For example, Canada currently includes 8 different inserts 
that rotate across packs. One-third of Canadian smokers report reading inserts in the prior 
month,14 which would be equal to 12 million US smokers engaging with insert content each 
month. The US Food and Drug Administration (FDA) has regulatory authority to use inserts for 
communication with consumers15 and is developing pictorial HWL content for implementation 
in 4-5 years.16 17 The FDA can change its labeling policy to reflect scientific understanding, 
whether for upcoming or subsequent labels.18 
Studies of cigarette labeling have focused almost exclusively on HWLs about the 
negative consequences of smoking, generally finding that large pictorial HWLs promote 
smoking cessation.5 19 20 These studies have identified the central role of negative affect in 
mediating HWL effects on cessation-related intentions and behaviors.21-26 However, some 
research and theory cautions that “fear appeals” – like HWLs that graphically portray negative 
health consequences from smoking – may be ineffective when people are scared but do not see 
an effective way to avoid the danger that the message highlights.27-36 Rather than quit smoking, 
smokers could deny the relevance of the message (denial), not attend to it (avoidance), or lash 

8 
 
out at it in anger (reactance). To minimize such defensive responses to HWLs and maximize 
their desirable effects, empirical evidence28 29 and diverse behavior change theories27 30 37-41 
highlight the importance of efficacy messages like those that are included on Canadian inserts. 
However, almost no research has assessed whether efficacy messages on labels can promote 
smoking cessation. Our proposed study will fill this critical gap. 
 
2.2 
BACKGROUND  
Scientific Premise & Conceptual Model 
Our central hypothesis 
is that inserts with 
efficacy messages 
promote smoking 
cessation-related 
outcomes. Other 
primary hypotheses 
(Table 1) follow from 
our conceptual model 
(Figure 2).  Figure 2 shows 
our synthesis of theory- 
and empirically-based 
propositions on which our 
study is based. We posit 
that insert exposure will 
increase efficacy beliefs 
that, in turn, increase quit 
motivation and quit 
behaviors. Prominent 
pictorial HWLs will 
increase quit motivation 
and behaviors primarily by 
generating negative affect 
around smoking, although 
some smokers will have 
defensive responses (e.g., 
avoidance, reactance) to 
HWLs. HWLs and inserts 
will interact synergistically. 
HWL-generated negative 

9 
 
affect will promote attention to and processing of insert messages (“spotlight” effect). Efficacy 
beliefs generated from inserts (or pre-existing efficacy beliefs) will reduce defensive responses 
to HWLs. Education will modify labeling effects given evidence of stronger responses to 
pictorial HWLs among smokers with lower education and literacy,42 although they face large 
barriers to cessation.43 44 Greater delayed discounting, or valuation of present rewards (e.g., 
nicotine administration) over future rewards (e.g., cessation benefits), is associated with failed 
cessation,45 46 and should reduce label effectiveness. Finally, labeling effects will vary over time, 
due to both message “wear out”47-49 and the dynamic nature of quit motivation.22 50 51  
Dual system model: We base our conceptual model in dual-system models of decision making, 
which posit that people process information using distinct but interacting modes of thinking.52-
54 The “deliberative mode” is conscious, analytical, and slow, reflecting standard cognitive 
explanations of how people engage with information and make decisions.55 By contrast, the 
“experiential mode” involves easier, more rapid and spontaneous feelings about information. 
The “affect heuristic,” wherein decision making is based on “gut” feelings, is based in this 
mode.56 57 Repeated exposures to information shape the feelings that make information 
meaningful and likely to influence people’s decisions.58 59 Deliberative and experiential modes 
are not mutually exclusive, and one may predominate over the other at any moment. In the 
context of repeated message exposures – as with cigarette labels – the relative prominence of 
either mode will vary over time because of situational and personal factors, including changes 
in motivation to process messages. 
Studies support the central role of negative affect in explaining HWL effects on 
cessation-related intentions and behaviors. Compared to text-only warnings, prominent 
pictorial HWLs elicit more negative affect, including fear, sadness, and disgust,5 60 which are 
highly correlated in HWL studies that have considered them.26 61 62 These results support 
constructionist views of emotion that emphasize emotional valence and arousal63 rather than 
differential effects of discrete emotions on intentions and behaviors.64 65 In explaining HWL 
effects on cessation-related outcomes, negative affect appears more important than cognitive 
risk perceptions.5 26 60  
Affective responses can function as: 1. information; 2. motivator; and 3. “spotlight”.22 53 
58 59 66 As information, affective responses occur in the experiential mode, involving relatively 
rapid impressions of an object or information. As a motivator, positive affect prompts pleasant 
behaviors while negative affect inhibits behaviors that feel bad or could harm oneself. This 
“approach-avoidance” function to affect is central to implicit motivation models of HWL 
effects.67 68 As a spotlight, affect can lead to deliberative decision making by promoting greater 
scrutiny of information related to the source of the affective response.22 Prior HWL studies 
have found that affect functions as “information” (e.g., risk perception), “motivator” 
(interpersonal communication about HWLs;49 69 70 reduced smoking satisfaction;71 foregoing 
cigarettes;72-77 reduced cigarettes per day78-81) and “spotlight” (e.g., frequency of thinking about 
risks72 76), all of which can independently predict subsequent cessation behavior.49 Our study 

10 
 
will provide a novel test of the “spotlight” function of negative affect, which we expect to 
promote processing of efficacy messages on inserts. This conceptualization is consistent with 
the “emotional flow” of persuasion,82 83 wherein fear appeals (e.g., HWLs encountered on the 
pack exterior) are most effective when followed by efficacy messages (e.g., inserts encountered 
after opening a pack) that generate hope about being able to escape the danger. 
Defensive responses to HWLs: Fear arousing messages can produce “defensive responses” 
(e.g., avoidance, reactance) that, according to some theories, lead to message rejection.28 31-33 35 
36 Eye-tracking research is mixed regarding whether smokers avoid HWLs by directing their 
attention more to branded parts of the pack than HWLs.84 85 Other experiments have found that 
fear arousing HWLs result in greater reactance (i.e., anger from perceived manipulation),35 36 86 
87 which can lead to message rejection.88 89 Recent RCTs find that reactance offsets the 
effectiveness of pictorial HWLs for a subgroup of smokers, but these effects do not appear to 
outweigh the effectiveness of HWLs for smokers overall.26 77 No studies have examined whether 
efficacy messages enhance the effectiveness of HWLs by dampening defensive responses, as 
suggested by theory. The strongest critics of pictorial HWLs highlight the need for this 
research.31-34 
Efficacy beliefs and messages: Behavior change theories, such as the Extended Parallel 
Processing Model (EPPM)28 41 and Protection Motivation Theory (PMT),30 posit that fear appeals 
will be most effective when message recipients believe the benefits of protective action (i.e., 
response efficacy) and are confident they can engage in this action (i.e., self-efficacy). Indeed, 
self-efficacy to quit predicts cessation behavior,14 73 77 90-94 and increasing self-efficacy to quit 
promotes smoking cessation.95-98 Fear appeals generally produce desired effects independent 
of efficacy beliefs,28 29 73 77 although HWLs can have weaker effects for smokers with lower self-
efficacy.99-101 No research, however, has examined whether including strong efficacy messages 
alongside fear-arousing HWLs will enhance desired outcomes, particularly for smokers with 
lower self-efficacy. 
HWL messages that countries have adopted and that have 
been used in experimental research minimally address efficacy 
beliefs by including information about cessation resources (e.g., 
quitlines, websites).102-107 However, most smokers quit without 
using these resources,108-111 whose inclusion on new HWLs in 
Australia did not change smokers’ self-efficacy to quit.112 To 
meaningfully change efficacy beliefs, labels likely require 
elaborated messages like those on Canadian inserts, which 
underscore cessation benefits and provide cessation tips that do 
not require cessation resource use. Our preliminary studies support this approach, including 
our post-implementation observational studies in Canada that found independent effects of 
reading inserts on subsequent sustained smoking cessation (Figure 3).14 113 No research has 
examined the conditions under which smokers are most likely to process efficacy messages 

11 
 
and, thereby, increase their efficacy beliefs. Consistent with the “spotlight” function of affect53 
and theories of “emotional flow,”82 we hypothesize that efficacy messages on inserts will most 
influence cessation-related outcomes among smokers exposed to fear arousing pictorial HWLs 
on packs.  
3 
STUDY DESIGN 
 
This study builds on tobacco labeling research that has focused almost exclusively on fear 
arousing HWLs for cigarette pack exteriors. Our assessment of efficacy messages on package 
inserts involves a 2X2 between-subject prospective randomized controlled trial (RCT) in the US, 
in which we will evaluate: a) inserts with efficacy messages vs no inserts; and b) fear arousing 
pictorial HWLs vs text-only HWLs. 
 
4 
STUDY POPULATION 
Participant eligibility: 
• Legal age to purchase cigarettes, which started at 18 but was changed to 21 years old 
(December 20, 2019) after the federal government increased the legal age of tobacco 
purchase; 
• Smoked at least 100 cigarettes in their life; 
• Smoked at least 10 cigarettes per day, to ensure exposure to four rotating labels in each 
treatment condition; 
• Exhaled carbon monoxide of at least 8ppm to confirm smoking status, using COVITA.  
After the onset of COVID-19, this criterion was eliminated due to concerns about COVID 
transmission while using the COVITA device. 
Participant ineligibility: 
• Use of e-cigarettes, other forms of smoked tobacco (cigars, water pipe, hookah, 
cigarillos, little cigars, pipe), or smokeless tobacco products (chewing tobacco, snuff, 
dip) in the last month to minimize issues of cross-product substitution, as the study was 
not designed to address this issue; 
• Living with someone else who has participated in or was currently participating in this 
two-week study, in order to prevent exposure to the study stimuli; 
• Pregnant or considering becoming pregnant; 
• After the onset of COVID-19 data collection, participants who reported having 
experienced symptoms or having been exposed to COVID-19 in the prior 30 days.  
4.1 
STRATEGIES FOR RECRUITMENT AND RETENTION 

12 
 
Recruitment and training differed somewhat across the two recruitment sites:  
University of South Carolina (UofSC) and Cornell University.  Furthermore, after the onset of 
COVID-19, these methods changed to ensure the safety of participants and study personnel.  
The information below describes these differences by site and time period. 
To enhance protocol compliance and retention, check in calls were scheduled for three 
days after orientation and another call six days after orientation across sites and recruitment 
periods. Text reminders were set up for 24 hours before all calls and check ins. Before these 
calls, cigarette log and evening survey data were checked to assess compliance with study 
protocols.  During the calls issues with compliance were discussed, any participant questions 
were answered, and participants were reminded of the date and time of the next call and 
follow up. After the second follow up call, participants who logged less than 50% of their 
baseline cigarettes per day or who missed more than one evening report received a third check 
in call. 
Pre-COVID 
UofSC:   From June 28, 2019 to March 5, 2020, participants in Columbia, SC, were recruited 
though advertisements on social media (e.g., Facebook, Craigslist) and flyers, which directed 
participants to a screening survey hosted on RedCap. Eligible participants were called to 
confirm eligibility, interest in participating, preferred cigarette brand variety, and to schedule a 
date and time to attend an in-person study orientation at a UofSC lab.  Prior to participants’ 
arrival at the lab, packs of the participant’s preferred brand of cigarette were purchased based 
on the number of cigarettes they smoked per day. These packs were then prepared according 
to their randomized condition with appropriate labels and inserts. Additionally, all cigarette 
packs were labeled on the bottom with the number of packs (i.e., if a person received 7 packs, 
they were labeled 1-7) and placed in a Ziplock bag to maintain freshness.  
Cornell University:  From July 6, 2019 to December 3, 2019, participants were recruited through 
intercept at smoke shops in 6 locations: Binghamton, Cortland, Ithaca, Newark, Oswego, 
Syracuse. Census data (54) were used to identify areas with lower median household income 
(ranged=$34K - $44K) than the state median ($68K). Sites were selected from the list of 
candidates based the presence of smoke shops that were willing and able to host the mobile 
lab (i.e., had sufficient adjacent parking).  Flyers were posted outside of the smoke shops 
approximately one week in advance of recruitment, with onsite signage was visible to 
participants at the time of recruitment. The intercept recruitment efforts occurred on 
weekends. At these recruitment efforts, a Cornell University-branded mobile lab (i.e., Ford Van) 
with five private research stations and 4-5 research staff went to recruit participants, to 
prepare study cigarette packs, and to conduct protocol orientation.  After participants were 
screened for eligibility, they commenced with the baseline survey and study orientation inside 
the mobile lab, while study personnel purchased and prepared the cigarette packs for their 
preferred brand variety with labels reflecting their condition. We limited the number of 

13 
 
cigarette packs that participants in NY could receive to 14 packs due to the extremely high price 
of cigarettes in NY (i.e., the highest price in the US at $11.96 on average).  We were concerned 
that this high price would lead to differential participant compensation across study sites and 
potentially promote over-reporting of baseline smoking among NY participants.    
Both Sites:  At both sites, the in-person study orientation lasted approximately one hour and 
included: 
• Eligibility confirmation with a brief survey and expired CO (>=8ppm) using Covita 
• Study consent 
• Baseline survey (e.g., smoking behaviors, demographics) 
• Baseline interview (social network data, health literacy assessment) 
• Training in use of the study phone and the protocols, including how to log cigarettes, 
the timing of cigarette and evening surveys, what to do if participants missed logs and 
surveys, review of the EMA survey items, and a short quiz on the study protocol. 
Provision of packs modified to reflect experimental condition. 
• Schedule date and time for check-in calls (3 and 6 days after orientation) and 15 days 
later for the follow-up survey and study debriefing. 
Post-COVID onset 
After the onset of COVID, we adjusted the study protocols to minimize in-person contact 
with study participants.  Recruitment was done only through Facebook ads, and the eligibility 
survey integrated new questions on their availability for meeting in designated locations to 
receive study materials (i.e., study phone and cigarette packs) and about their ability to 
participate in video calls (Skype or Zoom), and COVID-19 exposures.  Calls to screen for 
eligibility and to confirm interest in participation were the same as during the pre-COVID period 
with the addition of scheduling a study material pick up date and time before the virtual 
orientation. The social network questions were also moved to this call so the study phones 
could be programmed with named network members integrated into the data collection 
platform prior to giving the participant the materials. The baseline survey and a COVID-19 
screener were also scheduled to be emailed to the participant on the morning of their materials 
pick up and orientation.  During this period, we stopped using CO levels for determining 
eligibility due to concerns about COVID transmission. To meet sampling quotas, we prioritized 
recruitment of smokers who indicated they were male or intending to quit within six months. 
UofSC:  From August 12, 2020 to June 15, 2021, participants were recruited through Facebook 
ads, expanding the ad reach to include Columbia SC, Greenville SC, and Charlotte NC.  For the 
material pick up and drop off, participants in Columbia briefly met staff on the UofSC campus.  
These participants were oriented via Zoom once home. For Greenville and Charlotte 
participants, a staff member traveled to the city to hand off materials while other staff 
conducted the Zoom orientations. Staff members wore masks and participants remained in 

14 
 
their cars and were encouraged to also wear masks. Participants from Greenville and Charlotte 
also received mailing materials to use for returning the phone after the study, whereas 
Columbia participants arranged to drop off the phone with study staff.  The final study debrief 
took place on June 29, 2021. 
Cornell University:  From December 1, 2020 to April 29, 2021, participants were recruited using 
the same protocols as for UofSC, including Facebook targeting of specific cities (i.e., 
Binghamton, Elmira, Syracuse, Rochester, Utica, and Cortland) and calling respondents to 
confirm eligibility and schedule meeting dates, times, and locations where they could pick up 
study materials. Additionally, participants at Cornell completed the orientation activities over 
Zoom prior to picking up the study materials.   
 
5 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
All labeling stimuli associated with each of the four intervention groups are shown in Table 1.  
• The text-only warnings were stickers that covered the existing Surgeon General’s 
warning on the side of cigarette packs, covering approximately 50% of one side of packs.  
Four different text messages were selected from the 2009 Family Smoking Prevention 
and Tobacco Control Act that gave FDA regulatory authority over tobacco products: 
o WARNING: Cigarettes cause fatal lung disease 
o WARNING: Cigarettes cause cancer 
o WARNING: Cigarettes cause strokes and heart disease 
o WARNING: Tobacco smoke can harm your children 
• The pictorial warnings were 2” x 1.75” stickers that covered approximately 50% of the 
bottom half of the front and back of cigarette packs.  The text was the same as for the 
text-only warnings but with accompanying imagery selected from the FDA’s originally 
proposed graphic warnings (2011) or for which prior research indicated effectiveness. 
• The four insert messages were printed on 16 pt. matte cardstock and trimmed to 2” x 
3.5”. The four different messages selected based on our prior research to identify two 
effective messages to promote self-efficacy (i.e., tips to quit) (Loud et al., 2021) and two 
messages to promote response efficacy (i.e., cessation benefits) (Thrasher et al., 2018).  
All four inserts were designed with contrasting color schemes to help increase the 
likelihood that participants would recognize that the inserts included multiple messages.  
All four inserts included the same cessation resource information on the back. Reading 
levels ranged from 3.6-6.9th grade. Word counts ranged from 25-65 words.   
• Participants assigned to groups that did not receive inserts received no inserts or 
accompanying control messages.  The control group received packs labeled with just the 
text-only warnings. 

15 
 
Table 1. Stimuli Images and Sources 
Text only warnings 
 
 
 
 
 
Pictorial warnings 
 
 
 
 
 
 
 
Inserts 
 
Grade Level: 6.7 
Word Count: 57 
 
Grade Level: 3.8 
Word Count: 58 
 
Grade Level: 3.6 
Word Count: 65 
 
Grade Level: 6.9 
Word Count: 25 
 
 
Word Count: 11 

 
16 
 
All participants were provided with a supply of their preferred cigarette brand variety with 
packs modified to reflect their experimental condition. Study personnel double-checked 
participant assignment to experimental condition at baseline.  At the end of study participation, 
all participants were asked to report on the labeling of the cigarettes that they received. 
 
6 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
Participants could discontinue participation at any time.  Clinically relevant findings were 
reported as an adverse event (AE).  We discontinued participation for the following reasons: 
• Significant study intervention non-compliance, as indicated by not logging any cigarettes 
or evening reports;  
• Unable to contact study participant during any scheduled followup calls; 
• Any event or medical condition or situation occurred such that continued collection of 
follow-up study data were not in the best interest of the participant or might have 
required an additional treatment that would confound the interpretation of the study. 
The reason for participant discontinuation or withdrawal from the study were recorded. 
Those who signed the informed consent form and were randomized but did not receive the study 
intervention were replaced.  Participants were also replaced if they signed the informed consent 
form, were randomized, received the study intervention, and subsequently withdraw, or if they 
were discontinued from the study. 
A participant was considered lost to follow-up if study personnel were unable to contact 
the participant after at least 3 attempts.  If the participant continued to be unreachable, he or 
she was considered to have withdrawn from the study with a primary reason of lost to follow-
up. 
 
7 
STUDY ASSESSMENTS AND PROCEDURES 
7.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
Participant data were collected in three phases:  the baseline survey, which included 
measurement of potential moderators of intervention effects (H5 & H6); ecological momentary 
assessments across the 2-week study period, including data collected around smoking sessions 
and through daily evening surveys; the final followup survey.  Specifics on each of these are 
provided below. 
Baseline survey: 
Participants with confirmed eligibility who consented to participate answered a baseline 
survey on sociodemographics (i.e., sex, education, income), a 1-minute validated task to assess 

 
17 
 
delay discounting,45 46 a health literacy assessment,114 and smoking-related perceptions and 
behavior (e.g., time to first cigarette; preferred brand; risk perceptions; quit intentions; 
readiness to quit; self-efficacy to quit) using validated questions.115-118  Participants were then 
trained in the EMA protocol and given a 14-day supply of their preferred brand of cigarettes 
with packs modified to reflect their experimental condition. 
Ecological Momentary Assessment (EMA) protocol: 
EMA data were collected from participants over 14 days using a study smartphone 
(Android, Samsung Galaxy J3 and Samsung Galaxy A10e) for which all functions were disabled 
except for the app used for entering data. Participants were asked to use the app to log every 
cigarette they smoked during this period. Approximately 4-5 times a day, participants were 
prompted to complete a brief, 1-3 minute survey immediately after they indicated that they 
had smoked, with cigarette logs sampled using an algorithm based on self-reported baseline 
smoking frequency to reduce participant burden.   Each day, between 7 and midnight, an 
evening survey was available in the smartphone app, which took 1-3 minutes to complete. 
Participants received an alert on the study phone to complete this report at 9pm if they had not 
already completed it by that time. The app was programmed by CoI Ferguson’s team at HBART 
and uploaded to the cloud in real time, which allowed for monitoring of participant compliance.   
Follow-up survey and study debrief: 
The conclusion of the study included a self-administered survey and study debrief, both 
which were scheduled for 15 days after the orientation. The survey took approximately 15 
minutes and assessed: smoking behaviors and beliefs measured at baseline; reactance to health 
warning labels; reactions to the inserts and labels on their packs, depending on their condition.  
After completing the survey, participants completed a 30-minute debrief, which included:  
Aided and unaided recall of warnings and inserts to which participants were exposed; 
discussion of study protocol issues and suggestions to improve them in the future.   
The location and timing of the followup survey and debrief were different between 
UofSC and Cornell University both before and after COVID-19, described as follows: 
Pre-COVID UofSC: Participants received a text reminder the morning of their scheduled follow-
up. Participants arrived at the UofSC campus and first completed the survey in a private room. 
Then, participants completed the debrief with a UofSC staff member. For the recall component 
of the debrief, participants viewed the stimuli on a computer screen. At the end, participants 
turned in their phone and charger and received their $150 VISA gift card in person.  
Pre-COVID Cornell University: Participants completed the follow up remotely with an online 
survey and debrief phone call. They received a text reminder and an email with the survey link 
the morning of their scheduled follow up. They were instructed to complete the survey on their 
own before their debrief call. Once they were on the phone, the staff member conducting the 
interview sent the participant an email with a link to an online presentation of the study stimuli 
for the recall component of the debrief and instructed to advance through the presentation 

 
18 
 
only when instructed during the call. If participants had not yet completed the follow-up 
survey, they were instructed to complete the survey and were called again once it was 
completed. At the end, participants were instructed to mail their phone and charger in the pre-
addressed and stamped envelopes they had received during orientation. Once the phone and 
charger were received, their $150 visa gift card was mailed to their home address.   
Post-COVID onset UofSC: Participants received a text reminder and email with the survey link 
the morning of their scheduled follow up. They were instructed to complete the survey on their 
own before their debrief meeting. Prior to the debrief meeting, the staff member conducting 
the interview sent the participant a Zoom link. The debrief occurred via Zoom with audio and 
video sharing when possible. For the recall component of the debrief, the staff member shared 
their screen and showed the participants the stimuli. Columbia participants returned to the USC 
campus to return their cell phone and charger and receive their $150 visa gift card. Greenville 
and Charlotte participants received a prepaid shipping envelope to mail their phone and 
charger. Once the phone and charger were received, their $150 visa gift card was mailed to 
their home address.   
Post-COVID-onset Cornell University: After the onset of COVID-19, the debrief occurred via 
Zoom with audio and video sharing when possible. For the recall component of the debrief, the 
staff member shared their screen and showed the participants the stimuli. If screen sharing was 
not possible, participants were sent the link and instructions for the online presentation of 
stimuli as was done during the pre-COVID period. All other aspects of the follow up protocol 
were the same as during the pre-COVID period.   
 
7.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
7.2.1 
DEFINITION OF ADVERSE EVENTS 
This protocol used the definition of adverse event from 21 CFR 312.32 (a): any untoward 
medical occurrence associated with the use of an intervention in humans, whether or not 
considered intervention-related. 
Study participation involved receipt of information about the harms of smoking and the 
benefits of smoking cessation via cigarette package labeling.  All participants were adults who 
smoked frequently, with their smoking status confirmed using standard protocols (COVITA 
>=8ppm).  Study personnel monitored protocol adherence in real time, and followed up with 
participants, as necessary, over the 2-week study period to trouble shoot and resolve any issues 
related to adherence.  This allowed identification of events that could be characterized as 
adverse events.  However, we did not consider these events to be intervention-related given 
that the intervention consisted of the provision of information over a brief, 2-week period.  
Because participants were established, frequent smokers, we expected that we might detect 

 
19 
 
some adverse events over the period of observation that would be potentially related to their 
history of smoking, though not to study participation, per se.   
The following guidelines were used to describe severity of events:  
• Mild – Events require minimal or no treatment and do not interfere with the 
participant’s daily activities.  
• Moderate – Events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic 
drug therapy or other treatment. Severe events are usually potentially life-threatening 
or incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
8 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
8.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
8.1.1 
INFORMED CONSENT PROCESS 
The UofSC IRB considered the study to be Expedited given that research activities were 
determined to (i) present no more than minimal risk to human subjects, and (ii) involve only 
procedures listed in one or more of the categories authorized by 45 CFR 46.110 and 21 CFR 
56.10. 
After initial screening for eligibility, potential participants were directed to a survey with 
the informed consent document that describes the study procedures and potential risks.  When 
the potential participant finished reading this document, study personnel responded to any 
questions they had about the study. Those who were still interested in participating 
electronically signed the informed consent document prior to starting study participation.  
Consent documents are submitted to clinicaltrials.gov as separate supplementary material. 
8.1.2 
CONFIDENTIALITY AND PRIVACY  
All study personnel were trained in human subjects research ethics, including the 
importance of maintaining confidentiality or research participants.  Research activities were 
conducted in settings that were as private as possible.  De-identified data from all surveys are 
stored on password-protected computers and associated with a unique identifying number, 
without any personal information attached.  In one file, participants' names were associated 
with this unique identification number. We kept this information in a locked office and on 
password protected network storage for three months after study participation has ended, in 

 
20 
 
case we had any further questions around the data a particular participant provided. After that 
period lapsed, we destroyed this file with personal information for all participants who 
indicated that they were uninterested in being contacted about opportunities to participate in 
future research studies for which they may be eligible. 
 
 

 
21 
 
9 
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1 
EMA Insert Study – Baseline Survey:  July 10, 2020 
NOTE:  After the onset of COVID-19, the questionnaire was modified to include additional questions related 
to COVID (shown below) but was otherwise the same as the survey used before COVID-19 onset.  
Part 1: Online survey (self-administered online) 
Var ID 
Eligibility  
DE01 
How old are you?   
[Enter age] ______  
[If <21, NOT ELIGIBLE] 
SB01 
Have you smoked at least 100 cigarettes in your life? 
1.  Yes 
2.  No   
SB02 
In the past 30 days, did you smoke every day, some days, or not at all? 
1. Every day 
2. Some days [NOT ELIGIBLE] 
3. Did not smoke [NOT ELIGIBLE] 
ND04 
On average, how many cigarettes do you smoke each day, including both factory-made and roll-your-
own cigarettes? 
[Enter number of cigarettes]____________ 
[If <10, NOT ELIGIBLE] 
NP01 
Vaping products (often called e-cigarettes) are devices that heat a liquid only, but do NOT contain 
any actual tobacco. The liquid often contains nicotine and may be tobacco-flavored or many other 
flavors. The liquid that the vaping device heats may be in a cartridge or pod, or it may come 
separately in a bottle. 
 Examples include: Juul, blu and NJOY]. 
 
During the past 30 days, did you use a vaping product or e-cigarette?  
1, Yes [NOT ELIGIBLE] 
2, No 
 
NP02 
During the past 30 days, did you use any form of smoked tobacco products other than cigarettes 
(e.g. cigars, water pipe, hookah, cigarillos, little cigars, pipe)? 
1. Yes [NOT ELIGIBLE] 
2. No 
NP03 
During the past 30 days, did you use any form of smokeless tobacco products (e.g. chewing tobacco, 
snuff, dip)? 
1. Yes [NOT ELIGIBLE] 

2 
2. No  
COVID-19* 
Have you or anyone in your household tested positive for COVID-19 in the last 30 days?  
1. Yes [NOT ELIGIBLE] 
2. No 
COVID-19* 
Have you or anyone in your household had any of the following symptoms in the last 30 
days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for 
unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees 
Fahrenheit? 
1. Yes [NOT ELIGIBLE] 
2. No 
COVID-19* 
Have you or anyone in your household visited or received treatment in a hospital, nursing 
home, long-term care, or other health care facility in the past 30 days 
1. Yes [NOT ELIGIBLE] 
2. No 
COVID-19* 
Have you or anyone in your household cared for an individual who is in quarantine or is 
suspected positive or has tested positive for COVID-19? 
1. Yes [NOT ELIGIBLE] 
2. No 
COVID-19* 
Do you have any reason to believe you or anyone in your household has been exposed to or 
acquired COVID-19? 
1. Yes [NOT ELIGIBLE] 
2. No 
COVID-19* 
To the best of your knowledge, have you been in close proximity to any individual who 
tested positive for COVID-19? 
1. Yes [NOT ELIGIBLE] 
2. No 
*  COVID-19 questions were originally developed by the American Medical Association (https://www.ama-
assn.org/practice-management/sustainability/use-covid-19-screening-script-when-reopening-your-practice) 
-End of eligibility section- 
WISDM (smoking dependence) 
Intro 
Below are a series of statements about cigarette smoking. Please rate your level of agreement for 
each using the following scale: 
1. Not true of me at all 
2.   
3.   
4.   
5.   
6.   

3 
7. Extremely true of me 
 
THE QUESTIONS ARE SHOWN IN A MATRIX WITH THE SAME SCALE PRESENT FOR EACH QUESTION. 
WIS1 
I often smoke without thinking about it.  
WIS2 
I smoke without deciding to.  
WIS3 
I frequently light cigarettes without thinking about it.  
WIS4 
I find myself reaching for cigarettes without thinking about it.  
WIS5 
Cigarettes control me.  
WIS6 
Sometimes I feel like cigarettes rule my life.  
WIS7 
I’m really hooked on cigarettes. 
WIS8 
My smoking is out of control. 
WIS9 
It’s hard to ignore an urge to smoke. 
WIS10 
I frequently crave cigarettes. 
WIS11 
My urges to smoke keep getting stronger if I don’t smoke.  
WIS12 
I usually want to smoke right after I wake up.  
WIS13 
Other smokers would consider me a heavy smoker.  
WIS14 
I smoke within the first 30 minutes of awakening in the morning.  
WIS15 
I consider myself a heavy smoker.  
FTND/QA (smoking dependence) 
ND01 
 How soon after waking up do you usually have your first cigarette? 
1. within the first 5 minutes 
2. 6-30 minutes 
3. 31-60 minutes 
4. more than 60 minutes 
9.    Don´t know 
ND02 
Do you find it difficult to refrain from smoking in places where it is forbidden (e.g., in church, at the 
library, in the cinema)? 
1. Yes 
2. No 
ND03 
Which cigarette would you hate most to give up? 
1. The first one in the morning 
2. Any other  
ND05 
Do you smoke more frequently during the first hours after waking than during the rest of the day? 
1. Yes 
2. No 
ND06 
Do you smoke when you are so ill that you are in bed most of the day? 
1. Yes 
2. Yes 
QA01 
 
Are you planning to quit smoking . . . 
1   Within the next month 
2   Within the next 6 months 
3   Sometime in the future, beyond 6 months 
4   Or are you not planning to quit? 
9.    Don´t know 
QA02b 
Have you made any attempts to stop smoking in the past 12 months? 
1. Yes 
2. No [Go to QA04] 
9.    Don´t know [Go to QA04] 
QA03b 
What is your best estimate of the longest time that you went without smoking during the last 12 
months? 
1. Less than 24 hours 

4 
2. Less than 30 days, but more than 24 hours 
3. Between 1 month and 4 months 
4. Between 4 months and 8 months 
5. Between 8 months and 1 year 
6. More than 1 year 
9.    Don’t know 
QA04 
How much do you want to quit smoking? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very much 
5. 
Extremely 
99. 
 Don’t know 
QA05 
If you decided to quit smoking, how likely would you be to visit a website or call a telephone number 
that provides help for people who want to quit? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. Don’t know 
Response Efficacy  
RE01 
How much do you think you would benefit from health and other gains if you were to quit smoking 
permanently? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very much 
5. 
Extremely 
99. 
 Don’t know 
RE01b 
How much would quitting smoking now reduce your chances of getting a serious disease? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very much 
5. 
Extremely 
99. 
 Don’t know 
RE02 
Please indicate how much you agree or disagree with each of the following statements. 
If you quit smoking, you are less likely to have a heart attack. 
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
RE03 
If you quit smoking, you are less likely to get lung cancer.  
1. Strongly disagree  
2.  Disagree 
3.  Neutral 

5 
4.  Agree 
5. Strongly agree 
9. Don’t know 
RE04 
If you quit smoking, you are less likely to get diabetes.  
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
RE05 
If you quit smoking, you would save a lot of money.  
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
RE06 
If you quit smoking, you are less likely to get osteoporosis. 
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
Perceived Risk 
PR02 
You will quit long before you need to worry about getting a serious disease from smoking 
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
PR01 
How worried are you, if at all, that smoking will damage your health in the future?  
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99.  Don’t know 
Experiential Perceptions 
Intro 
-The following questions (EP01, EP02, and EP04) will be asked for each of the following diseases: 
cancer, heart disease, diabetes, and lung disease. Repeat all questions for each disease before 
asking about the next disease.  

6 
EP01 
How concerned are you, if at all, about getting [disease] in your lifetime? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. Don’t know 
EP02 
How easy is it for you to imagine yourself getting [disease] in the future? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. Don’t know 
EP03 
How confident are you that you will NOT get [disease]? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. Don’t know 
Self-efficacy 
SE01 
If you decided to give up smoking completely how certain are you that you would succeed? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. 
 Don’t know 
SE02 
If you decided to quit smoking, how certain are you that you could you find the help you need to 
quit? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. Don’t know 
SE03 
Overall, how confident are you that you can stop smoking altogether right now? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. Don’t know 
SE04 
How confident are you that you can completely avoid smoking in the future? 
1. 
Not at all 

7 
2. 
A little 
3. 
Moderately 
4. 
Very 
5. 
Extremely 
99. Don’t know  
Intro 
Please indicate how much you agree or disagree with each of the following statements.  
SE05 
You know how to fight the cravings that come with quitting smoking.  
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
SE06 
If you tried to quit smoking, it would be easy to fight the cravings to smoke.  
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
SE07 
If you wanted to, you could delay a cigarette that you would normally smoke for at least two hours. 
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
SE08 
If you decided to quit smoking, you would be able to get the support from family and friends that 
you need to quit. 
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
SE09 
You are able to set a quit date to quit smoking. 
1. Strongly disagree  
2.  Disagree 
3.  Neutral 
4.  Agree 
5. Strongly agree 
9. Don’t know 
 
Var ID 
Health warnings 
 
The next set of questions asks about the health warnings on cigarette packages, which contain information 
about the health risks of smoking.  
WL01 
In the last 2 weeks, how often, if at all, have you noticed health warnings on cigarette packages? 
1. Never  
2. Rarely 
3. Sometimes 

8 
4. Often 
5. Very often 
9.    Don´t know 
WL02 
In the last 2 weeks, how often, if at all, have you read or looked closely at the health warnings on cigarette 
packages? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Very often 
9.    Don´t know 
 WL03 
In the last 2 weeks, have the health warnings stopped you from having a cigarette when you were about to 
smoke one? Would you say . . . 
1. Never 
2. Once 
3. A few times 
4. Many times 
9.    Don´t know 
 WL03A 
In the last 2 weeks, how much did the health warnings make you feel angry? 
1. No at all 
2. A little 
3. Moderately 
4. Very much 
5. Extremely 
6. Don’t know 
 WL03B 
In the last 2 weeks, how much did the health warnings make you feel annoyed? 
1. 1.  No at all 
2. A little 
3. Moderately 
4. Very much 
5. Extremely 
6. Don’t know 
 
 WL03C 
In the last 2 weeks, how much did the health warnings make you feel irritated? 
1. 1.  No at all 
2. A little 
3. Moderately 
4. Very much 
5. Extremely 
6. Don’t know 
 
 WL04 
In the last 2 weeks, how often have you talked with others about the health warnings on cigarette packs? 
1. 
Not at all 
2. 
Once 
3. 
A few times 
4. 
Often 
5. 
Very often 
9.    Don´t know 

9 
 WL05 
How much do the health warnings make you think about the health risks of smoking? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very much 
5. 
Extremely 
9.    Don´t know 
 WL06 
How much do the health warnings on cigarette packs make you more likely to quit smoking? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very much 
5. 
Extremely 
9.    Don´t know 
 WL07 
How much do the health warnings help people who want to quit? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very much 
5. 
Extremely 
99. 
 Don’t know 
 WL08 
How much do the health warnings make you feel like you would be better off without smoking? 
1. 
Not at all 
2. 
A little 
3. 
Moderately 
4. 
Very much 
5. 
Extremely 
99. 
 Don’t know 
 
Var 
ID 
Delay Discounting Task 
DD100 For the next 5 questions, you will be asked to choose between receiving different amounts of money at different 
points in time. 
 
You will see two options. You are requested to choose one of them. There are no right or wrong answers, but 
please take your time, answer thoughtfully, and pay careful attention to each of the options. 
 
We are NOT providing you with any additional money.  Instead, we are interested in your responses to these 
hypothetical questions about what you would prefer if someone was to offer you money.  
 
Would you rather have $500 now or $1000 in 3 weeks? 
0 - $500 now 
1 - $1000 in 3 weeks 
[Ask 
[If response=0, go to 396a/DD200a 
If response=1, go to 396b/DD200b] 
DD20
0a 
[Ask if 395/DD100=0.] 
Would you rather have $500 now or $1000 in 1 day? 
0 - $500 now 
1 - $1000 in 1 day 

10 
 
[If response=0, go to 397a/DD300a. 
If response=1, go to 397b/DD300b.] 
DD20
0b 
[Ask if 395/DD100=1.] 
Would you rather have $500 now or $1000 in 2 years? 
0 - $500 now 
1 - $1000 in 2 years 
 
[If response=0, go to 397c/DD300c. 
If response=1, go to 397d/DD300d.] 
DD30
0a 
[Ask if 396a/DD200a=0.] 
Would you rather have $500 now or $1000 in 4 hours? 
0 - $ 500 now 
1 - $ 1000 in 4 hours 
 
[If response=0, go to 398a/DD400a. 
If response=1, go to 398b/DD400b.] 
DD30
0b 
[Ask if 396a/DD200a=1.] 
Would you rather have $500 now or $1000 in 4 days? 
0 - $500 now 
1 - $1000 in 4 days 
 
[If response=0, go to 398c/DD400c. 
If response=1, go to 398d/DD400d.] 
DD30
0c 
[Ask if 396b/DD200b=0.] 
Would you rather have $500 now or $1000 in 4 months? 
0 - $500 now 
1 - $1000 in 4 months 
 
[If response=0, go to 398e/DD400e. 
If response=1, go to 398f/DD400f.] 
DD30
0d 
[Ask if 396b/DD200b=1.] 
Would you rather have $500 now or $1000 in 8 years? 
0 - $500 now 
1 - $1000 in 8 years 
 
[If response=0, go to 398g/DD400g. 
If response=1, go to 398h/DD400h.] 
DD40
0a 
[Ask if 397a/DD300a=0.] 
Would you rather have $500 now or $1000 in 2 hours? 
0 - $500 now 
1 - $1000 in 2 hours 
 
[If response=0, go to 399a/DD500a. 
If response=1, go to 399b/DD500b.] 
DD40
0b 
Ask if 397a/DD300a=1. 
Would you rather have $500 now or $1000 in 9 hours? 
0 - $500 now 
1 - $1000 in 9 hours 
 
[If response=0, go to 399c/DD500c. 
If response=1, go to 399d/DD500d.] 

11 
DD40
0c 
[Ask if 397b/DD300b=0.] 
Would you rather have $500 now or $1000 in 2 days? 
0 - $500 now 
1 - $1000 in 2 days 
 
[If response=0, go to 399e/DD500e. 
If response=1, go to 399f/DD500f.] 
DD40
0d 
[Ask if 397b/DD300b=1.] 
Would you rather have $500 now or $1000 in 1.5 weeks? 
0 - $500 now 
1 - $1000 in 1.5 weeks 
 
[If response=0, go to 399g/DD500g. 
If response=1, go to 399h/DD500h.] 
DD40
0e 
[Ask if 397c/DD300c=0.] 
Would you rather have $500 now or $1000 in 2 months? 
0 - $500 now 
1 - $1000 in 2 months 
 
[If response=0, go to 399i/DD500i. 
If response=1, go to 399j/DD500j.] 
DD40
0f 
[Ask if 397c/DD300c=1.] 
Would you rather have $500 now or $1000 in 8 months? 
0 - $500 now 
1 - $1000 in 8 months 
 
[If response=0, go to 399k/DD500k. 
If response=1, go to 399l/DD500l.] 
DD40
0g 
[Ask if 397d/DD300d=0.] 
Would you rather have $500 now or $1000 in 4 years? 
0 - $500 now 
1 - $1000 in 4 years 
 
[If response=0, go to 399m/DD500m. 
If response=1, go to 399n/DD500n.] 
DD40
0h 
[Ask if 397d/DD300d=1.] 
Would you rather have $500 now or $1000 in 18 years? 
0 - $500 now 
1 - $1000 in 18 years 
 
[If response=0, go to 399o/DD500o. 
If response=1, go to 399p/DD500p.] 
DD50
0a 
[Ask if 398a/DD400a=0.] 
Would you rather have $500 now or $1000 in 1 hour? 
0 - $500 now 
1 - $1000 in 1 hour 
 
[go to part 5, sociodemographics] 
DD50
0b 
[Ask if 398a/DD400a=1.] 
Would you rather have $500 now or $1000 in 3 hours? 
0 - $500 now 
1 - $1000 in 3 hours 

12 
 
[go to part 5, sociodemographics] 
DD50
0c 
[Ask if 398b/DD400b=0.] 
Would you rather have $500 now or $1000 in 6 hours? 
0 - $500 now 
1 - $1000 in 6 hours 
 
[go to part 5, sociodemographics] 
DD50
0d 
[Ask if 398b/DD400b=1.] 
Would you rather have $500 now or $1000 in 12 hours? 
0 - $500 now 
1 - $1000 in 12 hours 
 
[go to part 5, sociodemographics] 
DD50
0e 
[Ask if 398c/DD400c=0.] 
Would you rather have $500 now or $1000 in 1.5 days? 
0 - $500 now 
1 - $1000 in 1.5 days 
 
[go to part 5, sociodemographics] 
DD50
0f 
[Ask if 398c/DD400c=1.] 
 
Would you rather have $500 now or $1000 in 3 days? 
0 - $500 now 
1 - $1000 in 3 days 
[go to part 5, sociodemographics] 
DD50
0g 
[Ask if 398d/DD400d=0.] 
 
Would you rather have $500 now or $1000 in 1 week? 
0 - $500 now 
1 - $1000 in 1 week 
 
[go to part 5, sociodemographics] 
DD50
0h 
[Ask if 398d/DD400d=1.] 
Would you rather have $500 now or $1000 in 2 weeks? 
0 - $500 now 
1 - $1000 in 2 weeks 
 
[go to part 5, sociodemographics] 
DD50
0i 
[Ask if 398e/DD400e=0.] 
Would you rather have $500 now or $1000 in 1 month? 
0 - $500 now 
1 - $1000 in 1 month 
 
[go to part 5, sociodemographics] 
DD50
0j 
[Ask if 398e/DD400e=1.] 
Would you rather have $500 now or $1000 in 3 months? 
0 - $500 now 
1 - $1000 in 3 months 
 
[go to part 5, sociodemographics] 
DD50
[Ask if 398f/DD400f=0.] 

13 
0k 
Would you rather have $500 now or $1000 in 6 months? 
0 - $500 now 
1 - $1000 in 6 months 
 
[go to part 5, sociodemographics] 
DD50
0l 
[Ask if 398f/DD400f=1.] 
Would you rather have $500 now or $1000 in 1 year? 
0 - $500 now 
1 - $1000 in 1 year 
 
[go to part 5, sociodemographics] 
DD50
0m 
[Ask if 398g/DD400g=0.] 
Would you rather have $500 now or $1000 in 3 years? 
0 - $500 now 
1 - $1000 in 3 years 
 
[go to part 5, sociodemographics] 
DD50
0n 
[Ask if 398g/DD400g=1.] 
Would you rather have $500 now or $1000 in 5 years? 
0 - $500 now 
1 - $1000 in 5 years 
 
[go to part 5, sociodemographics] 
DD50
0o 
[Ask if 398h/DD400h=0.] 
Would you rather have $500 now or $1000 in 12 years? 
0 - $500 now 
1 - $1000 in 12 years 
 
[go to part 5, sociodemographics] 
DD50
0p 
[Ask if 398h/DD400h=1.] 
Would you rather have $500 now or $1000 in 25 years? 
0 - $500 now 
1 - $1000 in 25 years 
 
[go to part 5, sociodemographics] 
 
Var ID 
Socio-demographics 
DE02A 
What was your sex at birth?  
1. Male 
2. Female 
3. Intersex  
DE02B 
Do you think of yourself as…  
1. Man 
2. Woman 
3. Transgender man/trans man/female-to-male (FTM)  
4. Transgender woman/trans woman/male-to-female (MTF) 
5. Non-binary 
6. Not listed  
9. Prefer not to answer 
DE02C 
Do you think of yourself as… 
1. Straight/heterosexual 

14 
2. Lesbian/gay/homosexual 
3. Bisexual 
4. Queer 
5. Pansexual 
6. Asexual 
7. Not listed 
99.    Prefer not to answer 
DE03 
What is the highest level of formal education that you have completed? 
1. Grade school or some high school 
2. Completed high school 
3. Technical / trade school or community college 
4. Some university, no degree 
5. Completed university degree 
6. Post-graduate degree 
 
DE05 
Which racial or ethnic group best describes you? Select all that apply.  
1. White 
2. Black or African American 
3. Latino/Latina/Latinx 
4. Asian 
5. Native Hawaiian or Pacific Islander 
6. American Indian or Alaska Native 
7. Not listed (Please specify) 
 
DE06 
Are you currently … ?  
1 - employed for wages – full time 
2 - employed for wages – part time 
3 - self-employed 
4 - unemployed 
5 - homemaker 
6 - student 
7 - retired 
 8 - unable to work 
9.    Don´t know 
DE07 
Which of the following categories best describes your ANNUAL household income, that is the total income 
before taxes, or gross income, of all persons in your household combined, for one year? 
1   Under $10,000 
2   $10,000-29,999 
3   $30,000-44,999 
4   $45,000-59,999 
5   $60,000-74,999 
6   $75,000-99,999 
7   $100,000-149,999 
8   $150,000 and over 
9   Prefer not to answer 
 
End of online baseline survey. (Participants will be prompted to call staff member to complete the baseline 
interview.) 
 
 
 

15 
Part 2: Baseline interview 
These items will be interviewer-administered either in person (pre-COVID) or over the phone (post-COVID), 
immediately after the online baseline survey is completed. 
VAR ID Health literacy assessment 
 
(The staff interviewer will email the participant a link to view this image online) 
 
 
 
This next section will involve reading a nutrition label and answering questions about it. First, I will give you 
the label to look at, and you can refer back to it whenever you need to. When you are ready, I will ask 6 
questions about the nutrition label, which is printed on a pint of ice cream. Please let me know if you need me 
to repeat any of the questions, and feel free to use this pen and paper if necessary. The purpose of this 
section is to see how you interpret a nutrition label.  
[NOTE:  Do not let participant see response options] 
 
If you eat all of the ice cream in the container, how many calories will you eat? 
1  Correct response (i.e., 1000 calories) 
2.  Incorrect response 
 
If you were allowed to eat 60 grams of carbohydrates as a snack, how much ice cream could you eat? 
 
[Note: If patient answers “2 servings,” ask “How much ice cream would that be if you were to measure it into 
a bowl?”] 
 
1  Correct response (i.e., 1 cup; any amount up to 1 cup; or Half the container) 
2  Incorrect response 
 
Imagine that your doctor advises you to reduce the amount of saturated fat in your diet. You usually have 42 g 
of saturated fat each day, which includes 1 serving of ice cream. 
 
If you stop eating ice cream, how many grams of saturated fat would you be consuming each day? 
1  Correct response (i.e., 33 grams) 
2  Incorrect response 

16 
 
If you usually eat 2500 calories in a day, what percentage of your daily value of calories will you be eating if 
you eat one serving of ice cream? 
 
1  Correct response (i.e., 10%) 
2  Incorrect response 
 
 
Pretend that you are allergic to the following substances:  Penicillin, peanuts, latex gloves, and bee stings.  Is it 
safe for you to eat this ice cream? 
 
1  Correct response (i.e., No) 
2  Incorrect response (Skip to income question) 
 
[NOTE:  Ask only if the patient correctly responds “No” to the previous question]: 
 
Why would it not be safe to eat this ice cream? 
1. Correct response (i.e., because it contains peanut oil.) 
2. Incorrect response 
 
Var ID 
Social network items 
[Interviewer administered] 
Intro_S
N 
In the next section, we will ask you to name several people that you know and tell us a few things about them. 
Over the two-week study period, we will continue to ask about your interactions with these people.  
 
SN_01 
Of the people with whom you are closest, who have you spent the most time with in the past two weeks? You 
can name up to five people.  
1. (SN_01A) 
2. (SN_01B) 
3. (SN_01C) 
4. (SN_01D) 
5. (SN_01E) 
 
[PROBE: It does not have to be someone you see in person, and it cannot be a child under 3.] 
[IF THEY PROVIDE TWO ALTERS WITH THE SAME FIRST NAME, ASK THEM TO PROVIDE SOME 
ADDITIONAL DISTINGUISHING LABEL (E.G., INITIAL OF LAST NAME).] 
[ASK PARTICIPANTS TO NAME ALL ALTERS BEFORE PROBING WITH COGNITIVE INTERVIEW ITEMS] 
 
[EACH OF THE SUBSEQUENT QUESTIONS WILL BE ASKED FOR EACH ALTER (SN_01A-SN_01E) WITH THE 
PARTICIPANT’S RESPONSE APPEARING IN THE BLANK SPACES. THERE WILL ALSO BE A TEXT BOX AFTER EACH 

17 
QUESTION FOR THE INTERVIEWER TO TYPE IN ANY ADDITIONAL INFORMATION PROVIDED BY THE 
RESPONDENT.] 
SN_02 
What is your relationship with ______? 
1. Spouse 
2. Partner or significant other 
3. Child 
4. Other Family 
5. Friend 
6. Work Colleague 
7. Neighbor 
8. Acquaintance  
Other [specify] 
SN_03 
To the best of your knowledge, how old is ___________?  
 [Exclude children 3 years and younger from the EMA analysis] 
SN_04 
How close do you feel to ______?  
1. Not at all 
2. A little 
3. Moderately 
4. Very 
9. Extremely  
SN_05 
How often do you talk to ______? 
1. Every day 
2. Several times a week 
3. Once a week 
4. Once every two weeks 
5. Once a month or less 
9.    Don’t know 
Sn_06 
To the best of your knowledge, does ______ smoke cigarettes? 
1. No 
2. Not now, but used to smoke 
3. Yes 
5.        9.   Don’t know 
SN_07 
What does ______ think about your smoking? 
1. Strongly disapproves 
2. Disapproves 
3. Neutral 
4. Approves 
5. Strongly approves 
9.    Don’t know 
 

Ecological Momentary Assessment Questionnaires 
Participant entered data on provided smartphone app -  June 18, 2019 
 
Cigarette log  
participant enters each time they smokes a cigarette 
Construct 
var_id 
Text 
Response 
Response 
type 
Smoking log 
log  
Are you sure you want to log a cigarette? 
Yes, No 
Push Button 
(pick one) 
New Pack 
newpack 
Is this the first cigarette from a new pack? 
Yes, No 
Push Button 
(pick one) 
Pack picture 
pic 
[If New pack= Yes] Please take a picture of the bottom of 
your pack 
[picture] 
Image 
 
 
Event based random assessment – CIGARETTE SURVEY: 
EVERY time the participant indicates first cigarette from a pack AND about 3-4 additional times per day 
Construct 
var_id 
Text 
Response 
Response 
type 
Affect 
feeling 
How are you feeling right now? 
1 (Very BAD!!) -  
7 (Very GOOD!!) 
Graduated 
slider 
rp_satisfy 
How SATISFYING is/was the cigarette? 
1 (not at all) –  
7 (extremely) 
 
attitude 
Right now, you feel like smoking is ....  
1 (Very BAD!!) -  
7 (Very GOOD!!) 
 
rp_vuln3 
How WORRIED are you about getting a serious disease 
from smoking? 
1 (not at all) -  
7 (extremely) 
Graduated 
slider 
Motivation 
motivation
2comply 
How MOTIVATED are you to quit smoking? 
1 (not at all) -  
7 (extremely) 
Graduated 
slider 

Efficacy 
rp_se1 
How EASY would it be to cut down on the number of 
cigarettes you smoke? 
1 (not at all) –  
7 (extremely) 
Graduated 
slider 
self-
efficacy 
How CONFIDENT are you that you could quit smoking 
altogether right now? 
1 (not at all) -  
7 (extremely) 
Graduated 
slider 
Hope 
Hope 
stopping 
How HOPEFUL do you feel about quitting smoking? 
1 (not at all) -  
7 (extremely) 
Graduated 
slider 
 
Evening survey 
Participant to answer at the end of each day 
Construct 
var_id 
Text 
Response 
Response 
type 
Reminder 
reminder 
[An alarm with this message will appear every night at 
9pm] 
Don’t forget to fill out your evening report! 
 
 
Availability 
cig_stock 
How many cigarettes are still in your pack? 
0-20 
Spinner 
Compliance 
with logs 
missed 
Did you miss logging any cigarettes today? 
0-20 
Spinner 
 
Stub 
In the last 24 hours, have you stubbed out a cigarette 
before finishing it? 
Yes, No 
Push Button 
(pick one) 
 
forgo 
In the last 24 hours, did you choose to skip any cigarettes 
that you normally would have smoked? 
Yes, No 
Push Button 
(pick one) 
 
Talk_alter 
In the last 24 hours, have you talked with any of these 
people about good or bad things about smoking or 
quitting? 
No, no one 
[Alter 1] 
[Alter 2] 
[Alter 3] 
[Alter 4] 
[Alter 5] 
Push Button 
(select all 
that apply) 
 
Talk 
In the last 24 hours, have you talked with anyone ELSE 
about good or bad things about smoking or quitting? 
 [check all that apply] 
No, no one 
Spouse or partner 
Check box 
(select all 
that apply) 

Other family member 
Friend 
Coworker 
Someone else 
 
Talk_cont
ent 
[If “yes” to Talk_alter or Talk] 
What did you talk about? 
[check all that apply] 
How much you like smoking 
Dangers of smoking to you 
Benefits of quitting smoking 
Cigarette pack health 
messages are informative 
Cigarette pack health 
messages are NOT 
believable 
Cigarette pack health 
messages are useless 
Other topics [specify] 
_______________ 
Check Box 
(all that 
apply, but 
see note) 
Positive 
cognitive 
elaboration 
Neg_Cog_
elab 
In the last 24 hours, How often have you thought about the 
things you enjoy about smoking? 
1 (not at all) -  
7 (All the time) 
Graduated 
slider 
Harm 
Cognitive 
elaboration 
Harm_Cog
_elab 
In the last 24 hours, How often have you thought about the 
harms from smoking? 
1 (not at all) -  
7 (All the time) 
Graduated 
slider 
Cessation 
Cognitive 
elaboration 
Ces_Cog_
elab 
In the last 24 hours, How often have you thought about the 
potential benefits from quitting smoking? 
1 (not at all) -  
7 (All the time) 
Graduated 
slider 
Response 
efficacy 
response_
efficacy 
How much would quitting smoking now reduce your 
chances of getting a serious disease? 
1 (no chance) -  
7 (certain to happen) 
Graduated 
slider 

Perceived 
susceptibilty 
Perceived
_suscept 
How likely are you to get a serious disease if you continue 
smoking the same amount?  
1 (no chance) -  
7 (certain to happen) 
Graduated 
slider 
Charge 
reminder 
charge 
Please remember to charge your phone tonight. Thank you.