Enhancing Source Credibility in Tobacco Regulatory Communications
Phase: NA
Conditions: Cigarette Smoking Behavior
Sponsor: UNC Lineberger Comprehensive Cancer Center

Enhancing Source Credibility in Tobacco 
Regulatory Communications 
Center for Regulatory Research on Tobacco Communication, Project Credibility (PI: Adam O. Goldstein) 
Version 6: Protocol for Publication 8/21/2020 
NCT03339206 
 
 

2 
 
Contents 
Administrative Information .......................................................................................................................... 4 
Trial Registration ................................................................................................................................................................. 4 
Funding ................................................................................................................................................................................ 4 
Roles and Responsibilities ................................................................................................................................................... 4 
Study Methods .............................................................................................................................................. 5 
Population for this study ..................................................................................................................................................... 5 
Experimental Conditions ..................................................................................................................................................... 5 
Allocation and Blinding ....................................................................................................................................................... 5 
Messages ............................................................................................................................................................................. 6 
Study Flow ........................................................................................................................................................................... 7 
Days 1-15: Morning Surveys ............................................................................................................................................... 8 
Message Order for Morning Surveys .............................................................................................................................. 8 
Days 16 and 32: Post-test Surveys ...................................................................................................................................... 9 
Compensation Plan ............................................................................................................................................................. 9 
Ethics and Trial Monitoring ......................................................................................................................... 10 
Data Safety ........................................................................................................................................................................ 10 
Monitoring ........................................................................................................................................................................ 10 
Declaration of Interests..................................................................................................................................................... 10 
Dissemination Plan ............................................................................................................................................................ 10 
Statistical Analysis Plan ............................................................................................................................... 11 
Administration Information .............................................................................................................................................. 11 
ClinicalTrials.gov ID ........................................................................................................................................................... 11 
SAP Revision History ......................................................................................................................................................... 11 
Introduction ...................................................................................................................................................................... 11 
Background and Rationale ............................................................................................................................................ 11 
Objectives ..................................................................................................................................................................... 11 
Study Methods .................................................................................................................................................................. 11 
Trial Design.................................................................................................................................................................... 11 
Randomization .............................................................................................................................................................. 12 
Sample Size ....................................................................................................................................................................... 12 
Sample Size Background: .............................................................................................................................................. 12 
Assumptions for the power calculation: ....................................................................................................................... 12 
Based on these assumptions: ....................................................................................................................................... 13 
How does this compare to KyungSu’s simulations? ..................................................................................................... 13 
Recommendation: ........................................................................................................................................................ 13 
Framework ........................................................................................................................................................................ 14 
Statistical Interim Analyses and Stopping Guidance ......................................................................................................... 14 
Timing of Final Analysis ..................................................................................................................................................... 14 
Timing of Outcome Assessments ...................................................................................................................................... 14 
Statistical Principles .......................................................................................................................................................... 15 
Confidence Intervals and P Values ................................................................................................................................ 15 
Level of statistical significance ...................................................................................................................................... 15 
Description and rationale for any adjustment for multiplicity and, if so detailing how the type 1 error is to be 
controlled ...................................................................................................................................................................... 15 
Confidence Intervals to be reported ............................................................................................................................. 15 
Adherence and Protocol Deviations ............................................................................................................................. 15 
Analysis Populations ......................................................................................................................................................... 15 
Definition of analysis populations ................................................................................................................................ 15 
Trial Population ................................................................................................................................................................. 16 
Screening Data .............................................................................................................................................................. 16 

3 
 
Eligibility ........................................................................................................................................................................ 16 
Recruitment .................................................................................................................................................................. 17 
Withdrawal/follow-up .................................................................................................................................................. 18 
Baseline participant characteristics .............................................................................................................................. 18 
Analysis.............................................................................................................................................................................. 19 
Outcome definitions ..................................................................................................................................................... 19 
Analysis Methods .............................................................................................................................................................. 20 
Post test measures ........................................................................................................................................................ 20 
Daily Questionnaire Measures ...................................................................................................................................... 21 
Harms ................................................................................................................................................................................ 21 
Statistical Software ........................................................................................................................................................... 21 
References......................................................................................................................................................................... 21 
Appendix A: Study Measures ...................................................................................................................... 23 
Appendix B: Trial Consent Form ................................................................................................................. 51 
 
 
 

4 
 
Administrative Information 
 
Trial Registration 
Enhancing Source Credibility in Tobacco Regulatory Communications, NCT03339206, 
https://clinicaltrials.gov/ct2/show/study/NCT03339206 
Registration Date: November 13, 2017 
 
Funding 
Research reported in this publication was supported by grant number P50 CA180907 from the National Cancer Institute 
and the FDA Center for Tobacco Products (CTP). The content is solely the responsibility of the authors and does not 
necessarily represent the official views of the NIH or the Food and Drug Administration. 
 
Roles and Responsibilities 
Name 
Role 
Affiliation 
Adam O. Goldstein 
Principal Investigator 
Department of Family Medicine, University of North Carolina at 
Chapel Hill 
Lineberger Comprehensive Cancer Center, University of North 
Carolina at Chapel Hill 
Kristen L. Jarman 
Project Manager 
Lineberger Comprehensive Cancer Center, University of North 
Carolina at Chapel Hill 
Sarah D. Kowitt 
Doctoral Trainee 
Department of Health Behavior, Gillings School of Global Public 
Health, University of North Carolina at Chapel Hill 
Bonnie E. Shook-Sa 
Doctoral Trainee 
Department of Biostatistics, Gillings School of Global Public 
Health, University of North Carolina at Chapel Hill 
Tara L. Queen 
Statistician 
Lineberger Comprehensive Cancer Center, University of North 
Carolina at Chapel Hill 
Kyung Su Kim 
Statistician 
Lineberger Comprehensive Cancer Center, University of North 
Carolina at Chapel Hill 
Leah M. Ranney 
Co-Investigator 
Department of Family Medicine, University of North Carolina at 
Chapel Hill 
Paschal Sheeran 
Co-Investigator 
Department of Psychology and Neuroscience, University of 
North Carolina at Chapel Hill 
Seth M. Noar 
Co-Investigator 
Hussman School of Media and Journalism, University of North 
Carolina at Chapel Hill 
 
 
 
 

5 
 
Study Methods 
Following a pilot to test intervention feasibility, conduct a randomized controlled trial (RCT) of 800 young adult and adult 
smokers to test the hypothesis that optimally framed (high source credibility) FDA cigarette constituent messages will 
increase intentions to quit more than sub-optimally framed (no source attached) cigarette constituent messages or 
control messages (littering). Messages will be presented in a web-enabled format, derived from cigarette constituent 
(hereafter referred to as constituent) messages identified in Project 1 of our CRRTC, and framed based on the outcomes 
from Aim 2 of this project. 
Population for this study 
 
1. Age between 18 and 65 
2. Current Smoker 
3. Not currently enrolled in a smoking cessation program 
4. Not currently using pharmacotherapy for smoking cessation 
5. Work or home access to the Internet 
6. Email account that they regularly use 
7. Have not participated in a smoking study, other than phone survey, in last 3 months 
8. Able to complete a survey on a computer 
9. Able to complete a survey in English 
10. Able to complete surveys delivered via email 
11. Able to complete 3, 20-minute, surveys 
12. Able to complete a 5-min survey each morning for 15 days 
13. Lives in the US 
 
Experimental Conditions 
• 
Optimal Group: receive the risk and constituent messages with optimized source depiction and engagement 
formats.  
• 
Suboptimal Group: receive the risk and constituent messages without source or engagement text. 
• 
Control Group: receive littering messages 
 
Allocation and Blinding 
 
Participants will not be informed specifically about the possible interventions that they may be assigned to. Researchers 
will not be blinded to the condition that participants had been assigned to, however all outcome measures will be 
assessed via online survey. 
 
At the end of the baseline survey, survey software will randomly assign participants to one of the three study arms. 
Participants will have an equal chance of being randomized to each study arm. 
 
 
 

6 
 
 
Messages 
Constituent Message 
Words 
(Characters) 
Littering Message 
Words 
(Characters) 
 
11 (76) 
11 (74) 
 
8 (59) 
8 (55) 
8 (65) 
8 (68) 

7 
 
 
10 (70) 
10 (74) 
 
8 (65) 
8 (61) 
 
Study Flow 
Pilot: Assess whether we can proceed and launch the full study when they have completed post-test 1, allow pilot 
participants to complete the full study (through post-test 2). 
 
Full Study: Baseline survey, then a survey every morning for 15 days assessing previous day behavior and delivering a 
message. Follow up with post surveys at day 16 and 32.  
 
Process:  
 
 
Day 0 - Pre-
Test
Day 1
•Morning: 
View 
message and 
5 min survey
•Evening: 5 
min survey
Day 2-5 
(Repeat Day 1 
with new 
messages)
•Morning: 
View 
message and 
5 min survey
•Evening: 5 
min survey
Day 6-16 
(Repeat days 
1-5 2x)
•Morning: 
View 
message and 
5 min survey
•Evening: 5 
min survey
Day 16 - Post-
Test 1
Day 32 - Post-
Test 2

8 
 
Days 1-15: Morning Surveys 
• 
There are 3 morning surveys, which align with each participant’s condition. Participants will stay in their 
condition throughout the study. Depending on the day, participants will see a different message. 
• 
The morning surveys will be sent out at 7am and will close at 10am. There will be a reminder email 
automatically sent at 8am if the participant has not yet completed the survey. The surveys will be sent according 
to each participant’s time zone. 
• 
At the end of the morning surveys, participants will see a message saying “You’ve completed [x] morning 
survey(s) so far. Keep up the good work!” 
• 
When each survey is emailed out, participants will receive a note that says “If you have any problems, contact 
tobaccosurvey@unc.edu.” 
 
Message Order for Morning Surveys  
• 
In week 1, participants see the following message order: 1-2-5-3-4 (sequence 1) 
• 
In week 2, participants see the following message order: 2-3-1-4-5 (sequence 2) 
• 
In week 3, participants see the following message order: 4-3-5-2-1 (sequence 6) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conditions 1 and 2: 
• 
Message 1 = Ammonia 
• 
Message 2 = Arsenic 
• 
Message 3 = Formaldehyde 
• 
Message 4 = Lead 
• 
Message 5 = Uranium 
Condition 3: 
• 
Message 1 = Bearded man with red trash bin 
• 
Message 2 = Black man with yellow shirt 
• 
Message 3 = White man with blue shirt 
• 
Message 4 = Tan woman with orange hat and lots of cigarette butts in blue bin 
• 
Message 5 = Asian woman with cigarette butts in her hand 
 
Day 
Message 
 
Day 
Message 
Day 1 
1 
 
Day 1 
1 
Day 8 
1 
 
Day 2 
2 
Day 15 
1 
 
Day 3 
5 
Day 2 
2 
 
Day 4 
3 
Day 6 
2 
 
Day 5 
4 
Day 14 
2 
 
Day 6 
2 
Day 4 
3 
 
Day 7 
3 
Day 7 
3 
 
Day 8 
1 
Day 12 
3 
 
Day 9 
4 
Day 5 
4 
 
Day 10 
5 
Day 9 
4 
 
Day 11 
4 
Day 11 
4 
 
Day 12 
3 
Day 3 
5 
 
Day 13 
5 
Day 10 
5 
 
Day 14 
2 
Day 13 
5 
 
Day 15 
1 

9 
 
Days 16 and 32: Post-test Surveys 
• 
All participants will see the same post-test surveys. 
• 
The post-test surveys will be sent out at 7pm and will close 24 hours later. There will be a reminder email 
automatically sent at 8pm if the participant has not yet completed the survey. The surveys will be sent according 
to each participant’s time zone. 
 
Compensation Plan  
We will pay participants $20 for the initial questionnaire and post-test 1 and post-test 2. We will also pay participants $4 
for each morning questionnaire.  
Bonus system for daily questionnaire completion: 
• 
Bronze: Total of $10 bonus for at least 9 morning surveys. 1 entry into a drawing for additional money. 
• 
Silver: Total of $20 bonus for at least 12 morning surveys. 2 entries into a drawing for additional money. 
• 
Gold: Total of $30 for completing all 15 morning surveys. 3 entries into a drawing for additional money. 
Participants may earn up to $150 for the full study, and will be paid via check.  
 
Drawing for additional money: Three $200 checks will be administered for Bronze, Gold or Silver participants are 
entered into based on how many daily questionnaires they complete. 
 
Participants will receive a message at the end of each morning survey regarding how many morning surveys they have 
completed. Participants will be paid after their participation in the study is completed. 
 
 

10 
 
Ethics and Trial Monitoring 
 
This trial was approved by UNC’s IRB under IRB #17-0610 
All protocol changes will be communicated to the study team, and any change in participant interaction will be approved 
by UNC’s IRB. 
 
Data Safety 
This study proposes research that has been determined to include Security Level 2 data security requirements. I agree to 
accept responsibility for managing these risks appropriately in consultation with departmental and/or campus security 
personnel. The Data Security Requirements addendum can be reviewed here: 
https://guides.lib.unc.edu/datasecurity/irbis 
 
Monitoring 
This trial presents no more than minimal risk to participants, so a data monitoring committee was not necessary. 
Similarly, the trial did not collect data on harms to participants, or assess interim data during the trial. Similarly, there is 
no need for ancillary or post-trail care. 
 
Declaration of Interests 
The study team declare that they have no competing interests. 
 
Dissemination Plan 
The study team plans to disseminate study findings via conference presentation and peer reviewed manuscripts in 
scientific journals. The study team will also share findings via ClinicalTrials.gov registration. 
 
We will follow authorship guidelines depending on the journal to which manuscripts are submitted. 
 
There are currently no plans to make a participant level dataset public. 
 
 
 

11 
 
Statistical Analysis Plan 
 
Administration Information 
ClinicalTrials.gov ID NCT03339206 
SAP Revision History 
Version Number 
Date 
Summary of Changes 
1 
July 24, 2018 
SAP Created, agreed to by Adam O. Goldstein (Project PI), Tara L. Queen 
(Statistical Analyst), KyungSu Kim (Statistical Analyst), and Kristen L. Jarman 
(Study Coordinator, Document Originator) 
 
Introduction 
Background and Rationale 
The Family Smoking Prevention and Tobacco Control Act delegates the U.S. Food and Drug Administration (FDA) to 
communicate the risks of smoking to the public, among other tobacco regulatory responsibilities. Little research 
exists about how FDA, as a regulatory agency, should develop and deliver these messages, and whether they should 
include their source information on the ads. This study will assess the impact of cigarette constituent messages 
with and without FDA source and quit information in a randomized controlled trial. This study will assess the impact of 
cigarette constituent messages with and without FDA source and quit information in a randomized controlled trial.  
 
Objectives 
The investigators hypothesize that cigarette constituent messages will increase intention to quit compared to messages 
about littering cigarettes (the control). The investigators also hypothesize that constituent messages that include FDA 
source and quit information will increase intention to quit compared to messages without that information. 
 
Study Methods 
Trial Design 
Three group parallel trial. 
 
The three conditions are: 
• 
Cigarette constituent message with FDA source and quit information: Messages about the chemical constituents 
of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, an 
image of a person related to the health effect. This arm will also include an FDA logo, and information about the 
benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a 
counterbalanced order. Study investigators used text developed by investigators associated with our Center for 
Regulatory Research on Tobacco Communication. Design of these messages was developed by our team. 
• 
Cigarette constituent message without FDA source or quit information: Messages about the chemical 
constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the 
chemicals, an image of a person related to the health effect. This arm is identical to the arm above, except that 
it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times 
in a counterbalanced order. Study investigators used text developed by investigators associated with our Center 
for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team. 
• 
Cigarette littering message (Control): Messages about littering cigarettes will include text designed to discourage 
people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages 
that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by 

12 
 
investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these 
messages was developed by our team. 
 
Randomization 
At the end of the baseline survey, survey software will randomly assign participants to one of the three study arms. 
Participants will have an equal chance of being randomized to each study arm. 
 
Sample Size 
 
Sample Size Background: 
Our study is examining the difference in quit intention for participants that receive 1) Optimal constituent messages 
with quitline information, and self-efficacy information, or 2) Sub-optimal constituent messages or 3) Messages about 
littering cigarette butts. 
 
No studies from the literature that we could find examined difference in quit intention or quitting behaviors by optimal 
text vs. sub-optimal warning text vs. control in a warning or smoking communication context. 
 
In a meta-analysis by Noar et al. 2014 (Pictorial cigarette pack warnings: a meta-analysis of experimental studies) the 
effect size between pictorial vs. text only warnings on intention to quit smoking was d=0.54. Other outcomes ranged 
between effect size d=-0.03 (recall of warning text), and d=1.82 (intention not to start smoking). 
 
Assumptions for the power calculation:  
• 
The smallest effect size between our groups will be between the optimal and sub-optimal group. If we can see a 
difference between these groups, we will be able to see the larger effects that we expect between the other 
groups. 
• 
We will be using a continuous measure of quit intention (or treating quit intention as a continuous variable, and 
collecting it as a categorical response). 
• 
The effect size on quit intention is likely to be smaller for added self efficacy and quit line text than for added 
pictorial images. 
• 
To be conservative, we will use a one time measure to calculate power, repeated measures would add power to 
this analysis (decrease necessary sample size). 
• 
We will use the d statistic to see what group size would have to be enrolled, and compare two means (optimal 
and sub-optimal) with a t-test 
 

13 
 
Based on these assumptions: 
 
 
The power calculation above is for a smaller effect size than the Noar 2016 paper, d=0.25. If we enroll 253 per group, we 
will have 80% power to detect a small difference between the optimal and sub-optimal group. 
 
For our purposes, that would mean enrolling a total of at least 759 people. 
 
How does this compare to KyungSu’s simulations? 
Based on Kyung Su’s simulations, if we use 3 time points, and enroll around 750 people, we should be able to see an 
effect size of 0.35. This simulation is also very dependent on the assumptions that we started with. 
 
Recommendation: 
To be even more conservative, I would like to enroll at least 800 participants into our study to have enough power to see 
a d=0.25 difference between the optimal and sub-optimal groups. 

14 
 
 
Framework 
Superiority – standard hypothesis testing framework 
 
Statistical Interim Analyses and Stopping Guidance 
NA, this study is no more than minimal risk to participants and does not pose a risk to their health, so we did not carry 
out any interim analyses or set guidelines for stopping the trial early. 
 
Timing of Final Analysis 
Final analysis will take place after all data collection for the RCT is complete. 
 
Timing of Outcome Assessments 
Time 
Pre-Test 
Morning 
Post-Test 1 
Post-Test 2 
Constructs 
• 
Sex, Sexuality 
• 
Hispanic Origin, 
Race 
• 
Address 
• 
Education 
• 
Age 
• 
Health 
• 
Household Size 
• 
Income (above or 
below FPL) 
• 
Trust in FDA and 
CDC 
• 
Nicotine 
Dependence 
(FTND) 
• 
Previous Quit 
Attempts 
• 
Smoking Status 
• 
Quit Intentions 
• 
Littering Intention 
• 
Self Efficacy 
• 
Response Efficacy  
• 
Positive and 
Negative Thoughts 
(Freq, Degree) 
• 
Current OTP Use 
• 
Knowledge of HE 
and Constituents 
• 
Tripartite Risk 
• 
Mental Health (K6) 
• 
Study Information 
• 
All Previous Day 
Behavior Qs 
Previous day behaviors: 
• 
Littering on the 
ground 
• 
Littering from Car 
• 
Forgoing 
• 
Butting out  
• 
Number of 
Cigarettes 
Cognitive Questions: 
• 
Thinking about 
chemicals 
• 
Thinking about risks 
• 
Thinking about 
littering 
• 
Thinking about 
quitting 
• 
Message 
• 
Negative Affect 
• 
Message Credibility 
• 
Perceived 
Effectiveness 
• 
Nicotine 
Dependence 
(FTND) 
• 
Quit Attempts 
• 
Smoking Status 
• 
Quitline Awareness 
• 
Quitline Use 
• 
Quit Intentions 
• 
Quitline Intention 
• 
Littering Intention 
• 
Self Efficacy 
• 
Response Efficacy 
• 
Positive and 
Negative Thoughts 
(Freq, Degree) 
• 
Current OTP Use 
• 
Knowledge of HE 
and Constituents 
• 
Tripartite Risk 
• 
Credibility of FDA 
• 
Mental Health (K6) 
• 
Action 
Expectancies 
• 
Reactance 
• 
Talking about 
messages 
• 
All Previous Day 
Behavior Qs 
• 
Quality Assurance 
Questions 
• 
Nicotine 
Dependence 
(FTND) 
• 
Quit Attempts 
• 
Smoking Status 
• 
Quitline Use 
• 
Quit Intentions 
• 
Quitline Intention 
• 
Littering Intention 
• 
Self Efficacy 
• 
Response Efficacy 
• 
Positive and 
Negative Thoughts 
(Freq, Degree) 
• 
Current OTP Use 
• 
Knowledge of HE 
and Constituents  
• 
Tripartite Risk 
• 
Mental Health (K6) 
• 
Action 
Expectancies 
• 
All Previous Day 
Behavior Qs 

15 
 
 
Statistical Principles 
Confidence Intervals and P Values 
Level of statistical significance 
α=0.05 
 
Description and rationale for any adjustment for multiplicity and, if so detailing how the type 1 error is to 
be controlled 
NA 
 
Confidence Intervals to be reported 
95% CI 
 
Adherence and Protocol Deviations 
Definition of adherence to the intervention and how this is assessed including extent of exposure 
Compliance with the protocol is assessed as follows: 
- 
Completion of daily surveys, during which participants view intervention stimuli. % Compliance = number of 
daily surveys completed / 15 (number of surveys supposed to be completed)*100% 
- 
Completion of post test surveys at post 1 and post 2 
 
Description of how adherence to the intervention will be presented 
- 
Adherence for the daily surveys will be presented with completion % as well as the mean number complete by 
treatment group 
- 
Completion of post test surveys will be presented by % completing each by treatment group 
 
Definition of protocol deviations for the trial 
- 
Minor protocol deviation: change in eligibility (ex: turning 66) between screening and baseline 
- 
Minor protocol deviation: completing the wrong sequence of message days due to survey signal error 
- 
Major protocol deviation: No protocol deviations in this trial will impact the safety or physical or mental integrity 
of the participants in the trial. A slightly older participant, or a participant that receives a slightly different 
number of messages will both be included as covariates during analysis, so they will not impact the scientific 
validity of the trial. Therefore, we do not classify any protocol deviations as ‘major’ 
 
Description of which protocol deviations will be summarized 
- 
Protocol deviations will not be summarized overall, but data related to the deviations will be included in 
manuscripts. For example, we will not say X participants were older than 65, but will include mean age in a 
demographic table by treatment group. Similarly, we will not include how many people completed an extra ‘day’ 
of the protocol, but we will report the mean number of days participants completed by treatment group. 
 
Analysis Populations 
Definition of analysis populations 
Outcomes assessed only at post test (including quit intentions) will be analyzed using multiple imputation such that 
everyone who was randomized will be included in the analysis, and those with missing outcome data will have their 
outcomes imputed. 
 

16 
 
For outcomes that were measured daily, all participants that completed at least one of the daily surveys will be included 
in the planned repeated measure models. 
 
Secondary outcomes may be analyzed using complete case analysis, without imputation. 
Trial Population 
Screening Data 
Screening data will be provided based on the CONSORT guidelines, and CONSORT flow chart will be included with 
publications. 
 
Eligibility 
Minimum Age: 18 Years 
Maximum Age: 65 Years 
Sex: All 
Gender Based: No 
Inclusion Criteria: 
• 
Have smoked at least 100 cigarettes in his or her lifetime 
• 
Currently smoke cigarettes every day or some days 
• 
Work or home access to the internet 
• 
Email account that is regularly used 
• 
Lives in the US 
• 
Comfortable taking a survey in English 
• 
Able to complete a survey on a computer 
• 
Able to complete surveys delivered via email 
• 
Able to complete 3, 20 minute surveys during the study 
• 
Able to complete surveys in the morning for 15 days 
Exclusion Criteria: 
• 
Currently using pharmacotherapy, a quitline, or a quit smoking program or support group for smoking cessation 
• 
Participated in a research study about smoking cigarettes or using other tobacco products in the last 3 months 
 
 

17 
 
Recruitment 
Recruitment data will be provided based on the CONSORT guidelines. The following CONSORT chart will be used as a 
template for reporting recruitment. 
 

18 
 
Withdrawal/follow-up 
Level of withdrawal 
- 
Data collection and the intervention occur using the same surveys, when a participant withdraws from data 
collection, they are withdrawing from follow up and the intervention. 
 
Timing of withdrawal/lost to follow-up data 
- 
Timing of withdrawal will be presented by treatment group, and categorized into each of the following 
timepoints: 
o After baseline but before beginning intervention (before completing first daily survey) 
o During intervention (days 1-15) 
o During post-test follow up period (days 16-32) 
o After post-test follow up period (after day 32) 
 
Reasons and details of how withdrawal/lost to follow-up data will be presented 
- 
Numbers (with reasons) of loss to follow up and withdrawal over the course of the trial will be summarized by 
treatment group 
 
Baseline participant characteristics 
List of baseline characteristics to be summarized 
See Draft Table 1 below. 
Details of how baseline characteristics will be descriptively summarized 
Baseline characteristics will be descriptively summarized as show in Draft Table 1.S 
 
Draft Table 1. Baseline Sample Characteristics 
Sample Characteristics 
Condition 1 
(n=XXX) 
Condition 2 
(n=XXX) 
Condition 3 
(n=XXX) 
Total Sample 
(n=XXX) 
% or 
mean 
95% 
CI 
% or 
mean 
95% 
CI 
% or 
mean 
95% 
CI 
% or 
mean 
95% 
CI 
Gender 
Male 
Female 
Age, years 
Race 
White 
Black or African American 
Other Race 
Ethnicity 
Latino/Hispanic 
Non-Latino/Hispanic 
Education 
<High School (HS) 
G12 or GED, HS Diploma 
Some College 

19 
 
Associate's degree 
Bachelor's degree 
Graduate or professional degree 
Poverty Status 
Below Poverty Line 
Above Poverty Line 
Sexual Orientation 
Straight or heterosexual 
Gay, lesbian, or bisexual 
Current Cigarette Smoking 
Current smoker 
Nonsmoker 
Fagerstrom Nicotine Dependence 
Score (FTND) 
Trust in FDA 
 
 
 
 
 
 
 
 
Number of Times Participants 
Viewed a Message During Follow Up 
To update Table 1 see ‘Table 1 V1.xlsx’ in Analysis Plan folder 
Analysis 
Outcome definitions 
• 
Quit intentions [ Time Frame: day 16 ] PRIMARY OUTCOME 
o 3 item measure with high reliability, average of the 3 items to create a score range 1-4 (Brewer et al., 
2016, 2018; Klein, Zajac, & Monin, 2009) 
o We will compare the differences between pre and post 
• 
Number of cigarettes smoked each day [ Time Frame: Measured daily on days 1-15] 
o Continuous, Modified from FTND (Heatherton, Kozlowski, Frecker, & Fagerström, 1991; Storr, 
Reboussin, & Anthony, 2005) 
• 
Number of cigarettes forgone each day [ Time Frame: Measured daily on days 1-15] 
o Continuous, adapted from Brewer 2016 (Brewer et al., 2016) 
o May be zero inflated, if yes, may choose to dichotomize to 0/1 
• 
Number of cigarettes butted out each day [ Time Frame: Measured daily on days 1-15] 
o Continuous, adapted from Brewer 2016 (Brewer et al., 2016) 
o May be zero inflated, if yes, may choose to dichotomize to 0/1 
• 
Quit attempts during the study [ Time Frame: Measured on days 16 and 32 ] 
o Adaptation from Fagan (Fagan et al., 2007) 
o May be zero inflated, if yes, may choose to dichotomize to 0/1 
• 
Awareness of quitline [ Time Frame: Measured on day 16 ] 
• 
Recall of quitline phone number [ Time Frame: Measured on day 16 ] 
• 
Use of the quitline during the study [ Time Frame: Measured on days 16 and 32 ] 
• 
Intention to use the quitline [ Time Frame: Measured on days 16 and 32 ] 
• 
Quit intentions [Time Frame: Measured on day 32 ] 
o 3 item measure with high reliability, average of the 3 items to create a score range 1-4 (Brewer et al., 
2016, 2018; Klein et al., 2009) 
o We will compare the differences between pre and post 
• 
Self Efficacy [ Time Frame: Measured on days 16 and 32 ] 

20 
 
o 1 item (“IARC HANDBOOKS OF CANCER PREVENTION,” n.d.; Thrasher, Swayampakala, Borland, et al., 
2016; Thrasher, Swayampakala, Cummings, et al., 2016) 
• 
Response Efficacy [ Time Frame: Measured on days 16 and 32 ] 
o 1 item (Thrasher, Swayampakala, Cummings, et al., 2016) 
 
Analysis Methods 
Analysis methods will depend on the time point that the outcome was measured. Post test measures will be analyzed 
differently than measures from the daily surveys, as outlined below. 
Post test measures 
What analysis method will be used and how treatment effects will be presented 
Linear regression for continuous outcomes, logistic for dichotomous. 
Any adjustment for covariates 
Covariates included for the imputation (in addition to treatment group): 
- 
Dose of ads (# of times participants viewed a message) 
- 
Gender (Male, Female, Other) (The GenIUSS Group, 2014) 
- 
Age (continuous) 
- 
Poverty Status (Above or Below Poverty Line)(Brewer et al., 2018; Department of Health and Human Services, 
2017) 
- 
Education (6 categories, same as phone survey) 
- 
FTND Sum Using scoring from Heatherton et al. 1991 (Fagerstrom Test for Nicotine Dependence)(Fagerstrom, 
Heatherton, & Kozlowski, 1990; Heatherton et al., 1991) 
Covariates included in the analysis model (in addition to treatment group): 
- 
Dose of ads (# of times participants viewed a message) 
Methods used for assumptions to be checked for statistical methods 
For continuous outcomes, we assume the distribution of dependent variable given a predictor variable (intervention) is 
1) independent 2) normality 3) constant variance (homogeneity of variance). We can check normality with Q-Q plot of 
the residual or perform Wilk-Shapiro test  and use a scatter plot of residual on predictor variable (intervention) to check 
independence and constant variance. 
Details of alternative methods to be used if distributional assumptions do not hold (eg normality, proportional 
hazards, etc) 
If we have a violation for normality assumption, we can have two options: 1) transform our data so that the shape of our 
response variable become normally distributed or 2) choose the non-parametric method like Kruskal-Wallis which does 
not require the assumption of normality. The ANOVA can be considered a robust test against the normality assumption 
though. If the assumption of homogeneity of variances has been violated, we can use Welch or Brown and Forsythe test. 
Even though we alternatively perform a Kruskal-Wallis test, in most cases, Welch test is best. We don’t expect to have 
dependency issues in our data.  
Any planned sensitivity analyses for each outcome where applicable 
Sensitivity analyses may be carried out using a ‘complete case analysis’ framework 
Any planned subgroup analyses for each outcome including how subgroups are defined 
None a priori 
Missing Data 
Multiple imputation will be used so that everyone who was randomized to an intervention will be included in the 
primary analysis 
Additional Analyses 
None a priori 
 

21 
 
Daily Questionnaire Measures 
What analysis method will be used and how treatment effects will be presented 
Mixed models to account for repeated measures of the same participant. 
Any adjustment for covariates 
Covariates included in the analysis model (in addition to treatment group): 
- 
Dose of ads (# of times participants viewed a message) 
Methods used for assumptions to be checked for statistical methods 
Linear mixed model is an extremely flexible for modeling continuous outcomes. It turns out that linear mixed models are 
robust to violations of some of their assumptions. The followings are the assumptions for linear mixed model: 1) 
Independent (The outcomes of different people are assumed to be statistically independent of each other.) Note: the 
outcomes within a person are correlated. 2) Normality (random effects are assumed to be normally distributed with 
mean zero and the residuals are normally distributed.) 
Details of alternative methods to be used if distributional assumptions do not hold (eg normality, proportional 
hazards, etc) 
Because mixed models are robust to violations of some of their assumptions, we do not anticipate needing to use an 
alternative method. 
Any planned sensitivity analyses for each outcome where applicable 
None a priori 
Any planned subgroup analyses for each outcome including how subgroups are defined 
None a priori 
Missing Data 
Mixed models are appropriate to use and robust to missing data, so we will be able to include everyone who completed 
at least 1 daily questionnaire. 
Additional Analyses 
None a priori 
 
Harms 
Adverse events were not expected in this trial due to the minimal risks to participants, and no threat to participant 
health, so this section is not applicable. 
 
Statistical Software 
Statistical analyses will be conducted in SAS 9.4 (Cary, NC) 
 
References 
 
Final Dataset: rct_combined_07232018 [location removed] 
 
Data Cleaning Syntax: 01_Create_Analytic_Files.sas [location removed] 
 
Study Protocol: RCT_Protocol_V5 [location removed] 
 
Analysis plan compiled according to “Guidelines for the Content of Statistical Analysis Plans in Clinical Trials” (Gamble et 
al., 2017) 

22 
 
 
Brewer, N. T., Hall, M. G., Noar, S. M., Parada, H., Stein-Seroussi, A., Bach, L. E., … Ribisl, K. M. (2016). Effect of Pictorial 
Cigarette Pack Warnings on Changes in Smoking Behavior: A Randomized Clinical Trial. JAMA Internal Medicine, 
176(7), 905–912. https://doi.org/10.1001/jamainternmed.2016.2621 
Brewer, N. T., Jeong, M., Mendel, J. R., Hall, M. G., Zhang, D., Parada, H., … Ribisl, K. M. (2018). Cigarette pack messages 
about toxic chemicals: a randomised clinical trial. Tobacco Control, tobaccocontrol-2017-054112. 
https://doi.org/10.1136/tobaccocontrol-2017-054112 
Department of Health and Human Services. (2017). 2017 Annual Update of the HHS Poverty Guidelines. Federal Register 
(Vol. 82). Retrieved from https://www.gpo.gov/fdsys/pkg/FR-2017-01-31/pdf/2017-02076.pdf 
Fagan, P., Augustson, E., Backinger, C. L., O’Connell, M. E., Vollinger, R. E., Kaufman, A., … Gibson, J. T. (2007). Quit 
attempts and intention to quit cigarette smoking among young adults in the United States. American Journal of 
Public Health, 97(8), 1412–1420. https://doi.org/10.2105/AJPH.2006.103697 
Fagerstrom, K. O., Heatherton, T. F., & Kozlowski, L. T. (1990). Nicotine addiction and its assessment. Ear, Nose, & Throat 
Journal, 69(11), 763–765. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/2276350 
Gamble, C., Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Doré, C., … Loder, E. (2017). Guidelines for the Content of 
Statistical Analysis Plans in Clinical Trials. JAMA, 318(23), 2337. https://doi.org/10.1001/jama.2017.18556 
Heatherton, T. F., Kozlowski, L. T., Frecker, R. C., & Fagerström, K. O. (1991). The Fagerström Test for Nicotine 
Dependence: a revision of the Fagerström Tolerance Questionnaire. British Journal of Addiction, 86(9), 1119–1127. 
Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/1932883 
IARC HANDBOOKS OF CANCER PREVENTION. (n.d.). International Agency for Research on Cancer World Health 
Organization, 12. Retrieved from http://www.iarc.fr/en/publications/pdfs-
online/prev/handbook12/Tobacco_vol12_cover.pdf 
Klein, W. M. P., Zajac, L. E., & Monin, M. M. (2009). Worry as a Moderator of the Association Between Risk Perceptions 
and Quitting Intentions in Young Adult and Adult Smokers. Annals of Behavioral Medicine, 38(3), 256–261. 
https://doi.org/10.1007/s12160-009-9143-2 
Storr, C. L., Reboussin, B. A., & Anthony, J. C. (2005). The Fagerström test for nicotine dependence: A comparison of 
standard scoring and latent class analysis approaches. Drug and Alcohol Dependence, 80(2), 241–250. 
https://doi.org/10.1016/j.drugalcdep.2004.04.021 
The GenIUSS Group. (2014). Best Practices for Asking Questions to Idenfity Transgender and Other Gender Minority 
Respondents on Population-Based Surveys. Retrieved from https://williamsinstitute.law.ucla.edu/wp-
content/uploads/geniuss-report-sep-2014.pdf 
Thrasher, J. F., Swayampakala, K., Borland, R., Nagelhout, G., Yong, H.-H., Hammond, D., … Hardin, J. (2016). Influences 
of Self-Efficacy, Response Efficacy, and Reactance on Responses to Cigarette Health Warnings: A Longitudinal Study 
of Adult Smokers in Australia and Canada. Health Communication, 31(12), 1517–1526. 
https://doi.org/10.1080/10410236.2015.1089456 
Thrasher, J. F., Swayampakala, K., Cummings, K. M., Hammond, D., Anshari, D., Krugman, D. M., & Hardin, J. W. (2016). 
Cigarette package inserts can promote efficacy beliefs and sustained smoking cessation attempts: A longitudinal 
assessment of an innovative policy in Canada. Preventive Medicine, 88, 59–65. 
https://doi.org/10.1016/j.ypmed.2016.03.006 
 
 
 

Appendix A: Study Measures 
 
Constructs by Timeframe 
Time 
Pre-Test 
Morning 
Post-Test 1 
Post-Test 2 
Constructs 
• 
Sex, Sexuality 
• 
Hispanic Origin, Race 
• 
Address 
• 
Education 
• 
Age 
• 
Health 
• 
Household Size 
• 
Income (above or 
below FPL) 
• 
Trust in FDA and CDC 
• 
Nicotine Dependence 
(FTND) 
• 
Previous Quit 
Attempts 
• 
Smoking Status 
• 
Quit Intentions 
• 
Littering Intention 
• 
Self Efficacy 
• 
Response Efficacy  
• 
Positive and Negative 
Thoughts (Freq, 
Degree) 
• 
Current OTP Use 
• 
Knowledge of HE and 
Constituents 
• 
Tripartite RiskMental 
Health (K6) 
• 
Study Information 
• 
All Previous Day 
Behavior Qs 
Previous day behaviors: 
• 
Littering on the 
ground 
• 
Littering from Car 
• 
Forgoing 
• 
Butting out  
• 
Number of Cigarettes 
Cognitive Questions: 
• 
Thinking about 
chemicals 
• 
Thinking about risks 
• 
Thinking about 
littering 
• 
Thinking about 
quitting 
• 
Message 
• 
Negative Affect 
• 
Message Credibility 
• 
Perceived 
Effectiveness 
• 
Nicotine Dependence 
(FTND) 
• 
Quit Attempts 
• 
Smoking Status 
• 
Quitline Awareness 
• 
Quitline Use 
• 
Quit Intentions 
• 
Quitline Intention 
• 
Littering Intention 
• 
Self Efficacy 
• 
Response Efficacy 
• 
Positive and Negative 
Thoughts (Freq, 
Degree) 
• 
Current OTP Use 
• 
Knowledge of HE and 
Constituents 
• 
Tripartite Risk 
• 
Credibility of FDA 
• 
Mental Health (K6) 
• 
Action Expectancies 
• 
Reactance 
• 
Talking about 
messages 
• 
All Previous Day 
Behavior Qs 
• 
Quality Assurance 
Questions 
• 
Nicotine Dependence 
(FTND) 
• 
Quit Attempts 
• 
Smoking Status 
• 
Quitline Use 
• 
Quit Intentions 
• 
Quitline Intention 
• 
Littering Intention 
• 
Self Efficacy 
• 
Response Efficacy 
• 
Positive and Negative 
Thoughts (Freq, 
Degree) 
• 
Current OTP Use 
• 
Knowledge of HE and 
Constituents  
• 
Tripartite Risk 
• 
Mental Health (K6) 
• 
Action Expectancies 
• 
All Previous Day 
Behavior Qs 
 

24 
 
 
Pre, Post 1, Post 2 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Instruction 
Please read the consent form on the next 
page to learn more about our research 
study and what we are asking participants 
to do. 
 
Instruction 
 
 
Post 1 
Instruction 
You have now finished the part of the study 
with daily surveys. 
 
This slightly longer survey should take you 
less than 20 minutes to complete. If you 
complete the survey, you will be paid an 
additional $20 in your incentive check. 
 
 
Post1_Inst 
 
Post 2 
Instruction 
This will be the last survey for this study. 
Thank you for your participation! 
 
This survey should take you less than 20 
minutes to complete. If you complete the 
survey, you will be paid an additional $20 in 
your incentive check. 
 
 
 
Post2_Inst 
PAGE BREAK 
 
 
 
 
 
Day 0 - Pre-Test
Day 1
•Morning: View 
message and 5 
min survey
•Evening: 5 min 
survey
Day 2-5 (Repeat 
Day 1 with new 
messages)
•Morning: View 
message and 5 
min survey
•Evening: 5 min 
survey
Day 6-16 (Repeat 
days 1-5 2x)
•Morning: View 
message and 5 
min survey
•Evening: 5 min 
survey
Day 16 - Post-Test 
1
Day 32 - Post-Test 
2

25 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Consent 
Form 
[Include current consent form with 
agreement to participate] 
 
ConsentForm1, 
ConsentForm_Gra
phicConsentForm
2, ConsentForm3 
 
 
PAGE BREAK 
 
 
 
 
 
Sex11 
What sex were you assigned at birth, on 
your original birth certificate?  Was it… 
1 = Male 
2 = Female 
Sex1 
 
 
Sex21 
Do you describe yourself as… 
1= Male 
2= Female 
3= Transgender 
4= Other 
(specify______________) 
Sex2, Sex2_Text 
 
 
Sexual 
Orientation2,3 
Do you consider yourself to be… 
1= Straight or heterosexual 
2= Gay or lesbian 
3= Bisexual 
4= OTHER 
(specify______________) 
Sexuality, 
Sexuality_Text 
 
 
Page Break 
 
 
 
 
 
Hispanic 
Origin3 
Are you of Hispanic, Latino, or Spanish 
origin? 
0= No 
1 = Yes 
Hisp 
 
 
Race3 
Which one of these groups would you say 
best represents your race? 
1=White 
2=Black or African American 
3=American Indian or Alaska 
Native 
4=Asian 
5=Pacific Islander 
6=Other 
Race 
 
 
Page Break 
 
 
 
 
 

26 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Instruction to 
provide 
name and 
address 
Please provide your mailing address below. 
This is where we will send your incentive 
check at the end of the study.  
 
Instr3 
 
 
First Name 
First Name 
Free Response 
FirstName 
 
 
Last Name 
Last Name 
Free Response 
LastName 
 
 
Address Line 
1 
Street Number, Street Name 
Free Response (Validity Check) 
Addr1 
 
 
Address Line 
2 
Apartment Number, Optional Address Line 
2 
Free Response (Validity Check, 
Optional Response) 
Addr2 
 
 
City 
City 
Free Response (Validity Check) 
City 
 
 
Zip 
Zip Code 
Free Response 
Zip 
 
 
State 
State 
Dropdown list 
1= ALABAMA 
2= ALASKA 
3= ARIZONA 
4= ARKANSAS 
5= CALIFORNIA 
6= COLORADO 
7= CONNECTICUT 
8= DELAWARE 
9= DISTRICT OF COLUMBIA 
10= FLORIDA 
11= GEORGIA 
12= HAWAII 
13= IDAHO 
14= ILLINOIS 
15= INDIANA 
16= IOWA  
17= KANSAS  
18= KENTUCKY 
19= LOUISIANA  
20= MAINE  
21= MARYLAND 
22= MASSACHUSETTS  
23= MICHIGAN 
24= MINNESOTA  
25= MISSISSIPPI 
State_0 
 
 

27 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
26= MISSOURI  
27= MONTANA 
28= NEBRASKA 
29= NEVADA 
30= NEW HAMPSHIRE 
31= NEW JERSEY 
32= NEW MEXICO 
33= NEW YORK 
34= NORTH CAROLINA 
35= NORTH DAKOTA 
36= OHIO 
37= OKLAHOMA 
38= OREGON 
39= PENNSYLVANIA 
(40=Puerto Rico* Option not displayed, 
included to align with screener for phone 
survey participants) 
41= RHODE ISLAND 
42= SOUTH CAROLINA 
43= SOUTH DAKOTA 
44= TENNESSEE 
45= TEXAS 
46= UTAH 
47= VERMONT 
48= VIRGINIA 
49= WASHINGTON 
50= WEST VIRGINIA 
51= WISCONSIN 
52= WYOMING 
PAGE BREAK 
 
 
 
 
 
Time Zone 
What time zone are you in? 
-5=Eastern Standard Time (Ex: New York) 
-6=Central Standard Time (Ex: Chicago) 
-7=Mountain Standard Time (Ex: Salt Lake 
City) 
-8=Pacific Standard Time (Ex: Los Angeles) 
-9=Alaska Standard Time (Ex: Anchorage) 
-10=Hawaii-Aleutian Standard Time (Ex: 
Honolulu) 
TimeZone 
 
 
PAGE BREAK 
 
 
 
 
 
Cell Phone 
Number 
Do you have a cell phone? 
1=Yes 
0=No 
Cell_YN 
 
 
PAGE BREAK 
 
 
 
 
 

28 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Cell Phone 
Number 
Cell Phone Number 
Free Response (Validity Check) 
Phone_Number 
 
 
Page Break 
 
 
 
 
 
Education3 
What is the highest degree or level of 
school you have completed? 
[0= NO SCHOOLING COMPLETED 
1= NURSERY SCHOOL TO 4TH 
GRADE 
2= 5TH OR 6TH GRADE 
3= 7TH OR 8TH GRADE 
4= 9TH GRADE 
5= 10TH GRADE 
6= 11TH GRADE 
7= 12TH GRADE - NO DIPLOMA 
8= HIGH SCHOOL GRADUATE - 
high school diploma or the 
equivalent (for example: GED) 
9= SOME COLLEGE CREDIT, BUT 
LESS THAN 1 YEAR 
10= 1 OR MORE YEARS OF 
COLLEGE, NO DEGREE 
11= ASSOCIATE’S DEGREE (FOR 
EXAMPLE: AA, AS)  
12= BACHELOR’S DEGREE (FOR 
EXAMPLE: BA, AB, BS) 
13= MASTER’S DEGREE (FOR 
EXAMPLE: MA, MS, MEng, MEd, 
MSW, MBA) 
14= PROFESSIONAL DEGREE (FOR 
EXAMPLE: MD, DDS, DVM, LLB, 
JD) 
15= DOCTORATE DEGREE (FOR 
EXAMPLE: PhD, EdD)] 
Edu 
 
 

29 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Page Break 
 
 
 
 
 
Age 
How old are you? 
Free response (Must be 3 or 
fewer numbers, between 18-120) 
Age 
 
 
General 
Health3 
Would you say that in general your health 
is: 
 
 
5= Excellent 
4= Very Good 
3= Good 
2= Fair 
1= Poor 
Health 
 
 
Household4 
How many people are in your household, 
including you? 
# of people [restricted to 1-10] 
Household 
 
 
Income4,5 
[Ask only if Household = 1, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than $12,060 
2=Between $12,060 and $18,089 
3=Between $18,090 and $24,119 
4=Between $24,120 and $30,149 
5=Between $30,150 and $36,179 
6=$36,180 or more 
Income_1 
 
 
[Ask only if Household = 2, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than $16,240 
2=Between $16,240 and $24,359 
3=Between $24,360 and $32,479 
4=Between $32,480 and $40,599 
5=Between $40,600 and $48,719 
6=$48,720 or more 
Income_2 
 
 
[Ask only if Household = 3, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than $20,420 
2=Between $20,420 and $30,629 
3=Between $30,630 and $40,839 
4=Between $40,840 and $51,049 
5= Between $51,050 and $61,259 
6=$61,260 or more 
Income_3 
 
 
[Ask only if Household = 4, else skip to 
FTND 1] 
 
1=Less than $24,600 
2=Between $24,600 and $36,899 
3=Between $36,900 and $49,199 
Income_4 
 
 

30 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
4=Between $49,200 and $61,499 
5=Between $61,500 and $73,799 
6=$73,800 or more 
[Ask only if Household = 5, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than $28,780 
2=Between $28,780 and $43,169 
3=Between $43,170 and $57,559 
4=Between $57,560 and $71,949 
5=Between $71,950 and $86,339 
6=$86,430 or more 
Income_5 
 
 
[Ask only if Household = 6, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than $32,960 
2=Between $32,960 and $49,439 
3=Between $49,440 and $65,919 
4=Between $65,920 and $82,399 
5=Between $82,400 and $98,879 
6=$98,880 or more 
Income_6 
 
 
[Ask only if Household = 7, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than$37,140 
2=Between $37,140 and $55,709 
3=Between $55,710 and $74,279 
4=Between $74,280 and $92,849 
5= Between $92,850 and 
$111,419 
6=$111,420 or more 
Income_7 
 
 
[Ask only if Household = 8, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than $41,320 
2=Between $41,320 and $61,979 
3=Between $61,980 and $82,639 
4=Between $82,640 and 
$103,299 
5=Between $103,300 and 
$123,959 
6=$123,960 or more 
Income_8 
 
 
[Ask only if Household = 9, else skip to 
FTND 1] 
 
1=Less than $45,500 
2=Between $45,500 and $68,249 
3=Between $68,250 and $90,999 
Income_9 
 
 

31 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
 
 
4=Between $91,000 and 
$113,749 
5=Between $113,750 and 
$136,549 
6=$136,500 or more 
[Ask only if Household = 10, else skip to 
FTND 1] 
 
Which of the following categories best 
describes your total household income in 
the last 12 months? 
1=Less than $49,680 
2=Between $49,680 and $74,519 
3=Between $74,520 and $99,359 
4=Between $99,360 and 
$124,199 
5=Between $124,200 and 
$149,039 
6=$149,040 or more 
Income_10 
 
 
Page Break 
 
 
 
 
 
Trust in 
Gov3,6 
How much trust do you have in the Federal 
government? 
5= A great deal 
4= A fair amount 
2= Not very much 
1= None at all, or 
3= No opinion 
TrustGov_Pre 
 
 
Trust in 
FDA3,6 
In your opinion, does the Food and Drug 
Administration, or FDA, give trustworthy 
information to the public? 
5 = Definitely yes 
4 = Probably yes 
3 = Neither yes or no 
2 = Probably no 
1 = Definitely no 
FDA_Pre 
 
 
Trust in 
CDC3,6 
In your opinion, does the Centers for 
Disease Control and Prevention, or CDC, 
give trustworthy information to the public? 
5 = Definitely yes 
4 = Probably yes 
3 = Neither yes or no 
2 = Probably no 
1 = Definitely no 
CDC_Pre 
 
 
Page Break 
 
 
 
 
 
Nicotine 
Dependence7 
How soon after you wake up do you smoke 
your first cigarette? 
3 = Within 5 minutes 
2 = 6 – 30 minutes 
FTND1_Pre 
FTND1_Post1 
FTND1_Post2 

32 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
1 = 31-60 minutes 
0 = After 60 minutes 
Do you find it difficult to refrain from 
smoking in places where it is forbidden e.g. 
in church, at the library, in cinema, etc.? 
1 = Yes 
0 = No 
FTND2_Pre 
FTND2_Post1 
FTND2_Post2 
Which cigarette would you hate most to 
give up? 
1 = The first one in the morning 
0 = All others 
FTND3_Pre 
FTND3_Post1 
FTND3_Post2 
Page Break 
 
 
 
 
 
Nicotine 
Dependence7 
How many cigarettes per day do you 
smoke? 
0 = 10 or less 
1 = 11-20 
2 = 21-30 
3 = 31 or more 
FTND4_Pre 
FTND4_Post1 
FTND4_Post2 
Do you smoke more frequently during the 
first hours after waking than during the rest 
of the day? 
1 = Yes 
0 = No 
FTND5_Pre 
FTND5_Post1 
FTND5_Post2 
Do you smoke if you are so ill that you are 
in bed most of the day? 
1 = Yes 
0 = No 
 
FTND6_Pre 
FTND6_Post1 
FTND6_Post2 
Page Break 
 
 
 
 
 
Previous Quit 
Attempts8 
How many times during the past 12 months 
have you stopped smoking for 1 day or 
longer because you were trying to quit 
smoking? 
Dropdown (0-365) 
PQA_Pre 
 
 
Quit 
Attempts8 
Since you started this study, how many 
times have you stopped smoking for 1 day 
or longer because you were trying to quit 
smoking? 
 
 
QuitAtt_Post1 
Dropdown 0-16 
QuitAtt_Post2 
Dropdown 0-32 
Smoking 
Status9 
Do you now smoke cigarettes every day, 
some days or not at all? 
 
2=Every day 
1=Some days 
0=Not at all 
Smoke_Stat_Pre 
Smoke_stat_pos
t1 
Smoke_Stat_post
2 
Page Break 
 
 
 
 
 

33 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Quit Line 
Awareness 
Do you know what national phone number 
you can call for help to quit smoking? 
1 = Yes 
0 = No 
 (If no, skip the next question) 
 
QLAware1 
 
Page Break 
 
 
 
 
 
Quit Line 
Awareness 
follow up 
What is the national phone number? 
Text Box 
 
QLAware2 
 
Page Break 
 
 
 
 
 
Quitline Use 
Since you started this study, have you 
called the Quitline (national phone number 
for help to quit smoking)? 
1 = Yes 
0 = No 
 
 
QL_Use_Post1 
QL_Use_Post2 
Page Break 
 
 
 
 
 
Quit 
Intention4,10 
How interested are you in quitting smoking 
in the next month? 
 
4=Very interested 
3=Somewhat interested 
2=A little interested 
1=Not at all interested 
QI1_Pre 
QI1_Post1 
QI1_Post2 
How much do you plan to quit smoking in 
the next month? 
 
4=Very much 
3=Somewhat 
2=A little 
1=Not at all 
QI2_Pre 
QI2_Post1 
QI2_Post2 
How likely are you to quit smoking in the 
next month? 
 
4=Very likely 
3=Somewhat likely 
2=A little likely 
1=Not at all likely 
QI3_Pre 
QI3_Post1 
QI3_Post2 
PAGE BREAK 
 
 
 
 
Quitline 
Intention 
If you were to quit smoking in the next 
month, how likely are you to call the 
national quitline for help? 
QLI_Pre 
QLI_Post1 
QLI_Post2 
Littering 
Intention4 
How likely are you to dispose of your 
cigarette butts by dropping them on the 
ground in the next month? 
LI_Pre 
LI_Post1 
LI_Post2 
Page Break 
 
 
 
 
 

34 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Self 
Efficacy11–13 
If you decided to give up smoking 
completely in the next month, how sure are 
you that you would succeed? 
5=Extremely 
4=Very much 
3=Moderately 
2=A little 
1=Not at all 
SE_Pre 
SE_Post1 
SE_Post2 
Response 
Efficacy11 
How much do you think you would benefit 
from health and other gains if you were to 
quit smoking permanently in the next 
month? 
RE_Pre 
RE_Post1 
RE_Post2 
PAGE BREAK 
 
 
 
 
 
Positive 
Thoughts14,15 
During the past 24 hours, how often did 
positive thoughts about smoking come to 
mind (thoughts that just popped into your 
head, or you caught yourself thinking)? 
5=All of the time 
4=Often 
3=Sometimes 
2=Rarely 
1=Never 
Freq_Pos_Pre 
Freq_Pos_Post1 
Freq_Pos_Post2 
PAGE BREAK 
 
 
 
 
 
Positive 
Thoughts14,15 
[displayed if freq_pos ne never] 
 
Considering only your positive thoughts 
about smoking during the past 24 hours, 
how positive were these thoughts?   
1=Not at all Positive 
2=Slightly Positive 
3=Moderately Positive 
4=Very Positive 
5=Extremely Positive 
Degree_Pos_Pre 
Degree_Pos_Po
st1 
Degree_Pos_Post
2 
PAGE BREAK 
 
 
 
 
 
Negative 
Thoughts14,15 
During the past 24 hours, how often did 
negative thoughts about smoking come to 
mind (thoughts that just popped into your 
head, or you caught yourself thinking)? 
5=All of the time 
4=Often 
3=Sometimes 
2=Rarely 
1=Never 
Freq_Neg_Pre 
Freq_Neg_Post1 
Freq_Neg_Post2 
PAGE BREAK 
 
 
 
 
 
Negative 
Thoughts14,15 
[displayed if freq_neg ne never] 
 
Considering only your negative thoughts 
about smoking during the past 24 hours, 
how negative were these thoughts? 
1=Not at all Negative 
2=Slightly Negative 
3=Moderately Negative 
4=Very Negative 
5=Extremely Negative 
Degree_Neg_Pre 
Degree_Neg_Po
st1 
Degree_Neg_Pos
t2 
Page Break 
 
 
 
 
 

35 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Current OTP 
Use16 
In the past 30 days, which of the following 
products have you used at least once? (Pick 
all that apply) 
1. Cigars, cigarillos, or little 
cigars 
2. Smokeless tobacco, for 
example chewing tobacco, 
snuff, dip, or snus 
 
3. Electronic cigarettes, e-
cigarettes, or other vaping 
devices 
4. Water pipes or Hookah 
5. Clove cigarettes 
6. Roll your own cigarettes 
7. None of the above [exclusive] 
OTPUse_Pre1, 
OTPUse_Pre2, 
OTPUse_Pre3, 
OTPUse_Pre4, 
OTPUse_Pre5, 
OTPUse_Pre6, 
OTPUse_Pre7 
 
 
OTP Use 216 
Since you started this research study, which 
of the following products have you used at 
least once? (Pick all that apply) 
1. Cigars, cigarillos, or little 
cigars 
2. Smokeless tobacco, for 
example chewing tobacco, 
snuff, dip, or snus 
3. Electronic cigarettes, e-
cigarettes, or other vaping 
devices 
4. Water pipes or Hookah 
5. Clove cigarettes 
6. Roll your own cigarettes 
7. None of the above [exclusive] 
 
OTPUse_Post1_
1, 
OTPUse_Post1_
2, 
OTPUse_Post1_
3, 
OTPUse_Post1_
4, 
OTPUse_Post1_
5, 
OTPUse_Post1_
6, 
OTPUse_Post1_
7 
OTPUse_Post2_1
, 
OTPUse_Post2_2
, 
OTPUse_Post2_3
, 
OTPUse_Post2_4
, 
OTPUse_Post2_5
, 
OTPUse_Post2_6
, 
OTPUse_Post2_7 
Page Break 
 
 
 
 
 
Knowledge17,
18 
Does cigarette smoke contain… 
(Matrix Question) 
1 = Yes 
0 = No 
2 = Don’t know 
K_Inst1_Pre 
K_Inst1_Post1 
K_Inst1_Post2 

36 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Arsenic 
 
K_As_Pre 
K_As_Post1 
K_As_Post2 
Ammonia 
 
K_Am_Pre 
K_Am_Post1 
K_Am_Post2 
Formaldehyde 
 
K_Form_Pre 
K_Form_Post1 
K_Form_Post2 
Lead 
 
K_Pb_Pre 
K_Pb_Post1 
K_Pb_Post2 
Uranium 
 
K_U_Pre 
K_U_Post1 
K_U_Post2 
Page Break 
 
 
 
 
 
Knowledge17,
18 
Does cigarette smoke  cause… 
(Matrix Question) 
1 = Yes 
0 = No 
2 = Don’t know 
K_Inst2_Pre 
K_Inst2_Post1 
K_Inst2_Post2 
Brain Disorders 
 
K_BD_Pre 
K_BD_Post1 
K_BD_Post2 
Breathing Problems 
 
K_BP_Pre 
K_BP_Post1 
K_BP_Post2 
Cancer 
 
K_Cancer_Pre 
K_Cancer_Post1 
K_Cancer_Post2 
Heart Damage 
 
K_HD_Pre 
K_HD_Post1 
K_HD_Post2 
Kidney Damage 
 
K_KD_Pre 
K_KD_Post1 
K_KD_Post2 
Lung Tumors 
 
K_LT_Pre 
K_LT_Post1 
K_LT_Post2 
Throat Cancer 
 
K_TC_Pre 
K_TC_Post1 
K_TC_Post2 
Page Break 
 
 
 
 
 
Tripartite 
Risk19 
If you continue smoking, how likely is it 
that you…  
(question in matrix format) 
TR1 
TR1 
TR1 
will get heart damage at some point in the 
future? 
 
4=Very Likely 
3=Likely 
2=Unlikely 
1=Very Unlikely 
 
TR1_a_Pre 
TR1_a_Post1 
TR1_a_Post2 
will get throat cancer at some point in the 
future? 
TR1_b_Pre 
TR1_b_Post1 
TR1_b_Post2 
will get lung tumors at some point in the 
future? 
TR1_c_Pre 
TR1_c_Post1 
TR1_c_Post2 
will get kidney damage at some point in the 
future? 
TR1_d_Pre 
TR1_d_Post1 
TR1_d_Post2 
will get breathing problems at some point 
in the future? 
TR1_e_Pre 
TR1_e_Post1 
TR1_e_Post2 
will get cancer at some point in the future? 
TR1_f_Pre 
TR1_f_Post1 
TR1_f_Post2 

37 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
will get a brain disorder at some point in 
the future? 
TR1_g_Pre 
TR1_g_Post1 
TR1_g_Post2 
Page Break 
 
 
 
 
 
Tripartite 
Risk19 
If you continue smoking, how fearful are 
you… 
(question in matrix format) 
TR2 
TR2 
TR2 
of getting heart damage in the future? 
 
4=Very fearful 
3=Fearful 
2=A little fearful 
1=Not at all fearful 
TR2_a_Pre 
TR2_a_Post1 
TR2_a_Post2 
of getting throat cancer in the future? 
TR2_b_Pre 
TR2_b_Post1 
TR2_b_Post2 
of getting lung tumors in the future? 
TR2_c_Pre 
TR2_c_Post1 
TR2_c_Post2 
of getting kidney damage in the future? 
TR2_d_Pre 
TR2_d_Post1 
TR2_d_Post2 
of breathing problems damage in the 
future? 
TR2_e_Pre 
TR2_e_Post1 
TR2_e_Post2 
of getting cancer in the future? 
TR2_f_Pre 
TR2_f_Post1 
TR2_f_Post2 
of getting a brain disorder in the future? 
TR2_g_Pre 
TR2_g_Post1 
TR2_g_Post2 
Page Break 
 
 
 
 
 
Tripartite 
Risk19 
How much do you agree or disagree with 
the following statement: If I continue to 
smoke, I feel very vulnerable to… 
(question in matrix format) 
TR3 
TR3 
TR3 
heart damage 
4=Strongly Agree 
3=Agree 
2=Disagree 
1=Strongly Disagree 
 
TR3_a_Pre 
TR3_a_Post1 
TR3_a_Post2 
throat cancer 
TR3_b_Pre 
TR3_b_Post1 
TR3_b_Post2 
lung tumors 
TR3_c_Pre 
TR3_c_Post1 
TR3_c_Post2 
kidney damage 
TR3_d_Pre 
TR3_d_Post1 
TR3_d_Post2 
breathing problems 
TR3_e_Pre 
TR3_e_Post1 
TR3_e_Post2 
cancer 
TR3_f_Pre 
TR3_f_Post1 
TR3_f_Post2 
brain disorders 
TR3_g_Pre 
TR3_g_Post1 
TR3_g_Post2 
Page Break 
 
 
 
 
 
FDA 
Information3,
6 
The Food and Drug Administration, or FDA, 
is the agency that ensures that food and 
drugs sold in this country are safe. 
 
 
 
FDA_Info_Post1 
 

38 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
The FDA now regulates cigarettes and some 
other tobacco products.  The next series of 
questions is about your opinions toward 
FDA in this role. 
FDA 
Credibility3,6 
Do you trust the FDA to inform the public 
about the risks of tobacco products? 
5 = Definitely yes 
4 = Probably yes 
3 = Neither yes or no 
2 = Probably no 
1 = Definitely no 
 
Cred1_Post1 
 
Is the FDA honest about the risks of 
tobacco products? 
 
Cred2_Post1 
 
Do you believe what the FDA says about 
the risks of tobacco products? 
 
Cred3_Post1 
 
Is the FDA an expert on regulating tobacco 
products? 
 
Cred4_Post1 
 
Is the FDA capable of doing a good job 
regulating tobacco products? 
 
Cred5_Post1 
 
Can the FDA effectively regulate tobacco 
products? 
 
Cred6_Post1 
 
Is the FDA committed to protecting the 
public from possible risks of tobacco 
products? 
 
Cred7_Post1 
 
Do you believe that if the FDA knew that 
certain tobacco products are less harmful 
than thought, they would tell the public? 
 
Cred8_Post1 
 
Page Break 
 
 
 
 
 
Mental 
Health20 
During the past 30 days, about how often 
did you feel… 
(question in matrix format) 
MH1 
MH1 
MH1 
nervous? 
4=All of the time 
3=Most of the time 
2=Some of the time 
1=A little of the time 
0=None of the time 
MH1_a_Pre 
MH1_a_Post1 
MH1_a_Post2 
hopeless? 
MH1_b_Pre 
MH1_b_Post1 
MH1_b_Post2 
restless or fidgety? 
MH1_c_Pre 
MH1_c_Post1 
MH1_c_Post2 
so depressed that nothing could cheer you 
up? 
MH1_d_Pre 
MH1_d_Post1 
MH1_d_Post2 

39 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
that everything was an effort? 
 
 
MH1_e_Pre 
MH1_e_Post1 
MH1_e_Post2 
worthless? 
MH1_f_Pre 
MH1_f_Post1 
MH1_f_Post2 
Page Break 
 
 
 
 
 
Instruction 
Please select the bubble to answer the 
questions about the messages that you saw 
during the study: 
 
 
AE_Inst_Post1 
AE_Inst_Post2 
Action 
expectancies
21 
After seeing the messages, how likely are 
you to seek information about chemicals in 
cigarettes? 
4=Very Likely 
3=Likely 
2=Unlikely 
1=Very Unlikely 
 
AE1_Post1 
AE1_Post2 
After seeing the messages, how likely are 
you to seek help to quit smoking? 
4=Very Likely 
3=Likely 
2=Unlikely 
1=Very Unlikely 
 
AE2_Post1 
AE2_Post2 
Page Break 
 
 
 
 
 
Instruction 
Please select the bubble to show how much 
you agree or disagree with the statements 
below about the messages that you saw 
during the study: 
 
 
React 
 
Reactance22 
The messages were trying to manipulate 
me 
5=Strongly agree 
4=Somewhat agree 
3=Neither agree nor disagree 
2=Somewhat disagree 
1=Strongly disagree 
 
 
 
 
React_1_Post1 
 
The messages made me feel aggravated  
 
React_2_Post1 
 
The health effects on the messages were 
overblown 
 
React_3_Post1 
 
Page Break 
 
 
 
 
 
Conversation
s23,24 
During the study, did you talk to others 
about the messages you received about 
cigarettes? 
1=yes 
0=no 
 
Convo1_Post1 
 

40 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Page Break 
 
 
 
 
 
Conversation
s24 
[only display if convo1_Post1 = 1] 
When you talked about the messages, 
would you say your conversations were 
mostly… 
1=Negative about smoking 
cigarettes 
2=Neutral about smoking 
cigarettes 
3=Positive about smoking 
cigarettes 
 
Convo2_Post1 
 
Page Break 
 
 
 
 
 
Behavior 
Instructions 
Please think about yesterday 
 
Behav_Inst 
Behav_Inst 
Behav_Inst 
 
What time did you wake up yesterday? 
Time 
Time#1_Wake_Hour 
Time#1_Sleep_Hour 
Time#2_Wake_Min 
Time#2_Sleep_Min 
Time#3_Wake_AMPM 
Time#3_Sleep_AMPM 
 
What time did you go to sleep last night? 
Time 
Behavior4 
How many times yesterday did you dispose 
of your cigarette butts by dropping them 
on the ground? 
Dropdown list 0-100, 
101=refused 
Lit1 
Lit1 
Lit1 
How many times yesterday did you dispose 
of your cigarette butts by throwing them or 
dropping them out of the car window? 
Lit2 
Lit2 
Lit2 
How many times yesterday did you stop 
yourself from having a cigarette because 
you wanted to smoke less? 
Forgo 
Forgo 
Forgo 
How many times yesterday did you butt out 
a cigarette before you finished because you 
wanted to smoke less? 
Butt 
Butt 
Butt 
PAGE BREAK 
 
 
 
 
 
Cigarettes 
Smoked7 
Yesterday, from the time you woke up until 
noon, how many cigarettes did you smoke? 
Dropdown list 0-100, 
101=refused 
Cigs_Morn 
Cigs_Morn 
Cigs_Morn 

41 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Yesterday, from noon until you went to 
sleep, how many cigarettes did you smoke?  
Cigs_Afternoon 
Cigs_Afternoon 
Cigs_Afternoon 
PAGE BREAK 
 
 
 
 
 
Thinking 
Instructions4 
Overall yesterday, how much did you… 
 
Think 
Think 
Think 
Thinking 
About 
Chemicals4 
Think about the chemicals in the smoke 
from your cigarettes? 
5=All of the time 
4=Often 
3=Sometimes 
2=Rarely 
1=Never 
Think_Chem 
Think_Chem 
Think_Chem 
Thinking 
About Risks 
Think about the harm your smoking might 
be doing to you? 
Think_Risk 
Think_Risk 
Think_Risk 
Thinking 
About 
Littering 
Think about discarding cigarette butts 
properly? 
Think_Lit 
Think_Lit 
Think_Lit 
Thinking 
about 
quitting 
Think about quitting smoking? 
Think_Quit 
Think_Quit 
Think_Quit 
PAGE BREAK 
 
 
 
 
 
StudyInfo1 
The next few pages give you some more 
information for what to expect during the 
study. 
 
StudyInfo1 
 
 
PAGE BREAK 
 
 
PAGE BREAK 
 
 
StudyInfo2 
Starting tomorrow, you will receive an 
email at 7am every morning for 15 days 
from ‘admin@SurveySignal.com’, with a 
link to a short survey. You have until 11am 
to open the link and answer the survey, or 
you will have to wait until the next one is 
sent. 
 
StudyInfo2 
 
 
PAGE BREAK 
 
 
PAGE BREAK 
 
 

42 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
StudyInfo4 
After 15 days (16 days from now), you will 
receive another email at 7am with a link to 
a 20-minute survey. You will have 24 hours 
to open the link and answer the survey. 
 
Finally, you will receive another email 32 
days from now with a link to a 20-minute 
survey. You will have 24 hours to open the 
link and answer the survey. 
 
StudyInfo4 
 
 
PAGE BREAK 
 
 
PAGE BREAK 
 
 
StudyInfo5 
You will be paid for the study based on how 
many surveys you complete with a check 
that will arrive in the mail after you 
complete the study. 
 
You will receive $20 for completing this 
survey. 
 
For the daily morning surveys, you will be 
paid $4 for each survey that you complete. 
 
For the 20-minute surveys at the end of the 
study, you will receive $20 each if you 
complete them. 
 
When data collection for the full study is 
complete, we will have a drawing for three 
Amazon gift cards, with a $200 value. 
Entries into the drawing will be based on 
completion of the morning surveys. 
Bonus system for Morning Survey 
Completion: 
• Bronze: Total of $10 bonus for at least 9 
morning surveys. 1 entry into Amazon 
gift card drawing. 
 
StudyInfo5 
 
 

43 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
• Silver: Total of $20 bonus for at least for 
at least 12 morning surveys. 2 entries 
into Amazon gift card drawing. 
• Gold: Total of $30 bonus for completing 
all 15 morning surveys. 3 entries into 
Amazon gift card drawing. 
If you complete all the surveys for this 
study, your check amount will be $150. 
PAGE BREAK 
 
 
 
 
 
Quality 
Assurance 
When you took the surveys, ere you able to 
see each message? 
0=No 
1=Yes 
 
QA1 
 
PAGE BREAK 
 
 
 
 
 
Quality 
Assurance 
[IF QA1 = No] Why weren’t you able to see 
each message, when you took the surveys? 
[text box] 
 
QA1 _comment 
 
PAGE BREAK 
 
 
 
 
 
Quality 
Assurance 
Were you able to read the text on each of 
the messages? 
0=No 
1=Yes 
 
QA2 
 
PAGE BREAK 
 
 
 
 
 
Quality 
Assurance 
[IF QA2 = No] Why weren’t you able to read 
the text on each of the messages? 
[text box] 
 
QA2_comment 
 
PAGE BREAK 
 
 
 
 
 
Quality 
Assurance 
Did you understand all of the questions? 
0=No 
1=Yes 
 
QA3 
 
PAGE BREAK 
 
 
 
 
 
Quality 
Assurance 
[IF QA3 = No] Which questions did you 
have trouble understanding and why? 
[text box] 
 
QA3_comment 
 
PAGE BREAK 
 
 
 
 
 
Quality 
Assurance 
Would you do this study again? 
0=No 
1=Yes 
 
QA4 
 

44 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
Quality 
Assurance 
Would you recommend this study to a 
friend? 
0=No 
1=Yes 
 
QA5 
 
Quality 
Assurance 
Did anything annoy you, if so, what? 
[text box] 
 
QA6 
 
Quality 
Assurance 
Is there anything that you would like to 
share about your experience in the study? 
[text box] 
 
QA7 
 
Quality 
Assurance 
Did you have any difficulty remembering 
how many cigarettes you smoked? If yes, 
please explain. 
[text box] 
 
QA8 
 
Quality 
Assurance 
Would you have preferred to receive the 
surveys for this study via text message? 
0=No 
1=Yes 
 
QA9 
 
PAGE BREAK 
 
 
 
 
 
Instructions 
for Enrolling 
in Survey 
Signal 
On the next page, you will be redirected to 
a new link (SurveySignal). It is very 
important that you fill out the information 
on that page (including name, email 
address, etc.). If you do not fill out that 
information, you will NOT be enrolled in 
the study. If you have any questions, email 
Project3@unc.edu. 
 
Once you fill in your information, 
SurveySignal will send you an email to 
verify your email address. Please make sure 
that you verify your email, so that you will 
be enrolled in the study. 
 
Note: If you are using a Mac, you will need 
to open the link in Chrome or Firefox. 
 
SurveySignal_Inst 
 
 
End of 
Survey for 
anyone that 
is no longer a 
Unfortunately you are no longer eligible for 
our study. We will send you a check for $20 
to compensate you for your time 
completing this survey, but you will not be 
able to complete the rest of the study. 
 
 
 
 

45 
 
Construct 
(Source) 
Question Text 
Response Option 
Pretest Var Name 
Post 1 Var Name Post 2 Var Name 
smoker 
(smoke_stat_
pre =0) 
 
Thank you for taking the time to complete 
this survey! 

46 
 
Morning Questionnaire (to be answered between 7am – 11am every morning) 
Construct (Source) 
Question Text 
Response Option 
Var Name 
Study ID 
[Auto-recorded] 
numerical 
 
Behavior 
Instructions 
Please think about yesterday 
 
Behav_Inst 
 
What time did you wake up yesterday? 
Time 
Time#1_Wake_Hour 
Time#1_Sleep_Hour 
Time#2_Wake_Min 
Time#2_Sleep_Min 
Time#3_Wake_AMPM 
Time#3_Sleep_AMPM  
 
What time did you go to sleep last night? 
Time 
Behavior4 
How many times yesterday did you dispose of your cigarette 
butts by dropping them on the ground? 
Dropdown list 0-100, 101=refused 
Lit1 
How many times yesterday did you dispose of your cigarette 
butts by throwing them or dropping them out of the car 
window? 
Lit2 
How many times yesterday did you stop yourself from having a 
cigarette because you wanted to smoke less? 
Forgo 
How many times yesterday did you butt out a cigarette before 
you finished because you wanted to smoke less? 
Butt 
PAGE BREAK 
 
 
 
Cigarettes Smoked7 
Yesterday, from the time you woke up until noon, how many 
cigarettes did you smoke? 
Dropdown list 0-100, 101=refused 
Cigs_Morn 
Yesterday, from noon until you went to sleep, how many 
cigarettes did you smoke?  
Cigs_Afternoon 
PAGE BREAK 
 
 
 
Thinking 
Instructions4 
Overall yesterday, how much did you… 
 
Think 
Thinking About 
Chemicals4 
Think about the chemicals in the smoke from your cigarettes? 
5=All of the time 
4=Often 
3=Sometimes 
2=Rarely 
1=Never 
Think_Chem 
Thinking About 
Risks 
Think about the harm your smoking might be doing to you? 
Think_Risk 
Thinking About 
Littering 
Think about discarding cigarette butts properly? 
Think_Lit 
Thinking about 
quitting 
Think about quitting smoking? 
Think_Quit 

47 
 
Construct (Source) 
Question Text 
Response Option 
Var Name 
PAGE BREAK 
 
 
 
Instruction 
Please view the message on the next screen. After 10 seconds, 
you will be able to click the ‘>>’ to move forward to the next 
page. 
 
[Messages should appear at the top of the screen for all 
subsequent questions] 
 
Morn_Inst1 
Page Break 
 
 
 
Message 
Condition 1 or 2(Arsenic, Formaldehyde, Uranium, Ammonia, 
Lead) Or Control Messages [This should appear on the screen 
for 10 seconds before participants are able to move on to 
questions on the next page] 
 
Message 
Page Break 
 
 
 
Affect Instruction 
How much did the message make you feel… 
 
Affect_Inst 
Affect25–27 
Anxious? 
5=Extremely  
4=Very 
3=Somewhat 
2=A little 
1=Not at all 
 
Affect_1 
Sad? 
Affect_2 
Scared? 
Affect_3 
Guilty? 
Affect_4 
Disgusted? 
Affect_5 
Page Break 
 
 
 
Credibility28 
Please indicate how much you think the message is… 
 
Cred_Inst 
Accurate 
7 = Very accurate 
1 = Not very accurate 
 
Cred_1 
Authentic 
7 = Very authentic 
1 = Not very authentic 
 
Cred_2 
Believable 
7 = Very believable 
1 = Not very believable 
 
Cred_3 
Page Break 
 
 
 

48 
 
Construct (Source) 
Question Text 
Response Option 
Var Name 
Instruction 
Please select the bubble to show how much you agree or 
disagree with the statements below: 
 
PE_Inst 
Perceived 
Effectiveness29 
The message makes me concerned about the health effects of 
smoking. 
5=Strongly agree 
4=Somewhat agree 
3=Neither agree nor disagree 
2=Somewhat disagree 
1=Strongly disagree 
 
 
 
PE_1 
The message makes smoking seem unpleasant to me. 
PE_2 
The message discourages me from wanting to smoke. 
PE_3 
PAGE BREAK 
 
 
 
 
How many cigarettes do you think you will smoke today? 
Dropdown list 0-100, 101=refused 
Cigs_Predict 
PAGE BREAK 
 
 
 
End of Survey 
You’re on day X of the 15 days of morning surveys. You’ve 
completed X morning survey(s) so far. We appreciate your 
response(s). Thank you! 
 
 
 
 
 

49 
 
References for Measures 
 
1.  
The GenIUSS Group. Best Practices for Asking Questions to Idenfity Transgender and Other Gender Minority Respondents on Population-Based Surveys.; 
2014. https://williamsinstitute.law.ucla.edu/wp-content/uploads/geniuss-report-sep-2014.pdf. Accessed June 22, 2018. 
2.  
Sexual Minority Assessment Research Team (SMART). Best Practices for Asking Questions about Sexual Orientation on Surveys.; 2009. 
https://williamsinstitute.law.ucla.edu/wp-content/uploads/SMART-FINAL-Nov-2009.pdf. Accessed June 22, 2018. 
3.  
Boynton MH, Agans RP, Bowling JM, et al. Understanding how perceptions of tobacco constituents and the FDA relate to effective and credible tobacco 
risk messaging: A national phone survey of U.S. adults, 2014–2015. BMC Public Health. 2016;16(1):516. doi:10.1186/s12889-016-3151-5 
4.  
Brewer NT, Jeong M, Mendel JR, et al. Cigarette pack messages about toxic chemicals: a randomised clinical trial. Tob Control. April 
2018:tobaccocontrol-2017-054112. doi:10.1136/tobaccocontrol-2017-054112 
5.  
Department of Health and Human Services. 2017 Annual Update of the HHS Poverty Guidelines. Vol 82.; 2017. https://www.gpo.gov/fdsys/pkg/FR-2017-
01-31/pdf/2017-02076.pdf. Accessed June 22, 2018. 
6.  
Schmidt AM, Jarman KL, Ranney LM, et al. Public Knowledge and Credibility Perceptions of the FDA as a Tobacco Regulator. Nicotine Tob Res. September 
2017. doi:10.1093/ntr/ntx215 
7.  
Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance 
Questionnaire. Br J Addict. 1991;86(9):1119-1127. http://www.ncbi.nlm.nih.gov/pubmed/1932883. Accessed February 25, 2018. 
8.  
Fagan P, Augustson E, Backinger CL, et al. Quit attempts and intention to quit cigarette smoking among young adults in the United States. Am J Public 
Health. 2007;97(8):1412-1420. doi:10.2105/AJPH.2006.103697 
9.  
Centers for Disease Control and Prevention. 2016 Behavioral Risk Factor Surveillance System Questionnaire.; 2016. 
10.  
Klein WMP, Zajac LE, Monin MM. Worry as a Moderator of the Association Between Risk Perceptions and Quitting Intentions in Young Adult and Adult 
Smokers. Ann Behav Med. 2009;38(3):256-261. doi:10.1007/s12160-009-9143-2 
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Thrasher JF, Swayampakala K, Borland R, et al. Influences of Self-Efficacy, Response Efficacy, and Reactance on Responses to Cigarette Health Warnings: 
A Longitudinal Study of Adult Smokers in Australia and Canada. Health Commun. 2016;31(12):1517-1526. doi:10.1080/10410236.2015.1089456 
12.  
Thrasher JF, Swayampakala K, Cummings KM, et al. Cigarette package inserts can promote efficacy beliefs and sustained smoking cessation attempts: A 
longitudinal assessment of an innovative policy in Canada. Prev Med (Baltim). 2016;88:59-65. doi:10.1016/j.ypmed.2016.03.006 
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IARC HANDBOOKS OF CANCER PREVENTION. Int Agency Res Cancer World Heal Organ. 12. http://www.iarc.fr/en/publications/pdfs-
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Appendix B: Trial Consent Form 
University of North Carolina at Chapel Hill 
Consent to Participate in a Research Study 
Adult Participants 
 
Consent Form Version Date: V6, December 18, 2017 
IRB Study # 17-0610 
Title of Study: Enhancing Source Credibility in Tobacco Regulatory Communications - Aim 3 RCT 
Principal Investigator: Adam Goldstein 
Principal Investigator Department: Family Medicine 
Principal Investigator Phone number: (919) 966-4090 
Principal Investigator Email Address: aog@med.unc.edu  
Co-Investigators: Leah Ranney, Seth Noar, Paschal Sheeran 
Funding Source and/or Sponsor: National Institutes of Health (NIH) 
Study Coordinator Contact: Kristen Jarman 
Study Contact Telephone Number: (919) 966-3016 
Study Contact Email: project3@unc.edu  
 
_________________________________________________________________ 
 
What are some general things you should know about research studies? 
You are being asked to take part in a research study.  To join the study is voluntary. 
You may choose not to participate, or you may withdraw your consent to be in the study, for any reason, 
without penalty. 
 
Research studies are designed to obtain new knowledge. This new information may help people in the 
future.   You may not receive any direct benefit from being in the research study. There also may be risks to 
being in research studies.  
 
Details about this study are discussed below.  It is important that you understand this information so that you 
can make an informed choice about being in this research study.  
 
You will be given a copy of this consent form.  You should ask the researchers named above, or staff members 
who may assist them, any questions you have about this study at any time. 
 
What is the purpose of this study? 
The purpose of this research study is to learn how people respond to messages about cigarette use. We will be 
asking participants to complete several surveys over 33 days, to get unique data about how people respond to 
messages about cigarettes.  
 
Who should take part in the study? 
Only participants that have been asked to enroll in the study are eligible. If you did not receive an email 
invitation to take part in the study, and you enroll anyway, you will be removed from the study. 
Additionally, each person can only enroll in the study once. 
 
How many people will take part in this study? 
There will be approximately 1000 people in this research study. 
 
How long will your part in this study last? 

52 
 
Your part in the study will be to answer surveys delivered to your email over 33 days.  
 
What will happen if you take part in the study? 
You will receive emails during the study period to invite you to complete surveys. The chart below describes 
which days you will receive surveys and how long they will be.
 
What are the possible benefits from being in this study? 
 By taking part in this study, participants may increase their knowledge of the health risks associated with 
tobacco use. All participants may experience personal satisfaction of knowing they have contributed to a 
research project aimed at understanding tobacco risk communications. 
 
What are the possible risks or discomforts involved from being in this study? 
Sometimes things happen to people in research studies that may make them feel bad. These are called “risks.” 
Taking part in this research study may involve telling us about your opinions or behaviors that you consider to 
be private or that cause you embarrassment. We will take steps to keep your information safe and private. 
There may be uncommon or previously unknown risks. You should report any problems to the researcher. 
 
What if we learn about new findings or information during the study?  
You will be given any new information gained during the course of the study that might affect your willingness 
to continue your participation.  
 
How will information about you be protected? 
Participants will not be identified in any report or publication about this study. Although every effort will be 
made to keep research records private, there may be times when federal or state law requires the disclosure of 
such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-
Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your 
information in this research study could be reviewed by representatives of the University, research sponsors, or 
government agencies (for example, the FDA) for purposes such as quality control or safety. 
What if you want to stop before your part in the study is complete? 
You can withdraw from this study at any time, without penalty.  The investigators also have the right to stop 
your participation at any time. This could be because you have had an unexpected reaction, or have failed to 
follow instructions, or because the entire study has been stopped. 
Will you receive anything for being in this study? 
You will be receiving a check for up to $150 for taking part in this study. The amount of the check is based on 
the number of study surveys that you complete. 
At the beginning (day 1), middle (day 17) and end (day 33) of this study there are 3 surveys that will take about 
20 minutes to complete. You will be paid $20 for each of these surveys that you complete, for up to $60. 
For 15 days (from day 2 through day 16) during this study, you will receive a survey in the morning that will 
last about 5 minutes each to complete, you must complete this survey between 7am and 11am. You will be paid 
$4 for each morning survey, but you can only take one morning survey each day. You can also earn bonuses for 
completing these survey. 
Day 1 -
20 minute survey
Day 2 - Day 16
•Morning - 5 min 
survey
Day 17 -
20 minute survey
Day 33 -
20 minute survey

53 
 
When data collection for the full study is complete, we will have a drawing for three additional Amazon gift 
cards, with a $200 value. Entries into the drawing will be based on completion of the morning surveys. 
Bonus system for Survey Completion: 
• 
Bronze: Total of $10 bonus for at least 9 morning surveys. 1 entry into Amazon gift card drawing. 
• 
Silver: Total of $20 bonus for at least 12 morning surveys. 2 entries into Amazon gift card drawing. 
• 
Gold: Total of $30 for completing all 15 morning surveys. 3 entries into Amazon gift card drawing. 
For Example: If Amy completes 2 of the 3 surveys that take 20 minutes, and 13 morning surveys, then she 
would get: 
• 
2 x $20 for 20 minute surveys = $40 
• 
13 x $4 for morning surveys = $52 
• 
Silver level for survey completion = $20 
• 
Amy’s Check Amount = $112 
Within 4-6 weeks of completing the study, you will be mailed the check for surveys that you have 
completed. 
If you win the drawing for the Amazon gift card, we will email you the gift card within 7 days of the 
drawing. 
Will it cost you anything to be in this study? 
If you enroll in this study, you will have costs related to completing the surveys on the internet. If you use your 
phone to complete the surveys, this may cost you a small amount of data from your mobile phone plan which 
will not be covered by the study. 
Who is sponsoring this study? 
This research is funded by the National Cancer Institute. This means that the research team is being paid by the 
sponsor for doing the study.  The researchers do not, however, have a direct financial interest with the sponsor 
or in the final results of the study. 
 
What if you have questions about this study? 
You have the right to ask, and have answered, any questions you may have about this research. If you have 
questions about the study (including payments), complaints, concerns, or if a research-related injury occurs, you 
should contact the researchers listed on the first page of this form. 
 
What if you have questions about your rights as a research participant? 
All research on human volunteers is reviewed by a committee that works to protect your rights and welfare.  If 
you have questions or concerns about your rights as a research subject, or if you would like to obtain 
information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to 
IRB_subjects@unc.edu. 
Participant’s Agreement: 
 
I have read the information provided above.  I have asked all the questions I have at this time.  I voluntarily 
agree to participate in this research study. 
 
 [Check Box]