Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
Phase: NA
Conditions: Smoking Cessation
Sponsor: Jennifer Marler, MD

1 
   
  
  
Outcomes from a Mobile Smoking Cessation Program During a Monitoring Period of 6 
Months 
 
  
Issue Date: September 29, 2017 
  
  
Prepared By:  
                                              
                                                              
 
Sr. Director, Clinical and Medical Affairs, Carrot Inc.                      
                         
             
             
 
Approved By: 
 
  
                                              
                      
                                             
 
President and CEO, Carrot Inc.               
 
  
  
                                              
                                                                                
 
Regulatory Affairs, Carrot Inc. 
  
 
 
 
  
VP, Behavioral Science, Carrot Inc.   
 
 
      
 
 
 
                                              
                                                                                     
 
Director, Clinical Affairs, Carrot Inc. 
  
 
 

CONFIDENTIAL  
Carrot Inc. 
 6-Month Outcomes of a Mobile Smoking Cessation Program Ver B 
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Protocol Summary 
Device Names 
Carbon Monoxide Breath Sensor System (COBSS) and Pivot App 
Protocol Title 
Outcomes from a Mobile Smoking Cessation Program During a Monitoring 
Period of 6 Months 
 
Principal 
Investigators 
 
Protocol Number 
 
Protocol Version 
 
Protocol Shorten 
Name 
 6-Month Outcomes of a Mobile Smoking Cessation Program  
Study Design 
Prospective, open label, single center clinical study enrolling up to 310 subjects  
(up to 50 run-in subjects, and 260 general subjects).. 
No medical decisions will be made related to test results. 
Objective 
We aim to assess a mobile smoking cessation program delivered through the 
Pivot Application (‘App’). We will evaluate user engagement and retention in 
the program, attitude towards smoking and smoking behavior, quit rates, 
relapse rates, and quality of life over the study period, as well as user feedback 
on the program. 
Potential Subjects 
Up to 310 subjects who report daily smoking behavior (smokers). 
Inclusion Criteria 
● 18-65 years of age 
● English speaking 
● Smokes daily 
● Smokes 5 or more cigarettes per day 
● Owns and uses a smartphone (iPhone 5 and above, operating system 
iOS 9.0 and above, or, Android 4.4 and above, operating system 
Android 4.4 and above) 
● Employed at least 20 hours per week 
● Lives in the USA 
● Understands and willing to sign the Informed Consent Form  

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Recruitment 
Potential subjects will be identified via advertisement at outdoor locations (i.e. 
flea markets, outside of movie theaters, shopping malls, train stations, stores 
that sell cigarettes), print media (i.e., local newspapers, billboards), web media 
(i.e., Craigslist, Facebook, Survey Monkey, Instagram, Twitter, Google Ads, 
Reddit, smokefree.gov) and through clinical research recruiters. 
Study Session 
Potential participants will complete an online screening form. Eligible 
participants will be called to confirm eligibility, discuss the study, and have their 
questions about the study answered. Interested eligible participants will then 
be emailed the registration link, which includes the electronic informed 
consent. After providing electronic informed consent, subjects register online 
and receive the COBSS device.  
Baseline questionnaires (demographics, smoking history, and attitude towards 
smoking) are completed, and subjects then self-train to use the COBSS (which 
includes the CO Breath Sensor and Breath Sensor App, or BSA) and the Pivot 
App. The BSA is required for the breath sensor to communicate with the 
subject’s smartphone and allows basic viewing of CO sample values. The Pivot 
App comprises 5 sequential phases (Explore, Build, Mobilize, Quit and 
Secure). The Pivot App provides the user with information about CO sample 
values and CO trends, as well as the ability to log cigarette events (when 
subject smokes), view cigarette consumption trends, view instructional videos, 
complete educational activities and challenges, and engage with a coach.  
During the registration process, subjects are paired with a live coach who will 
provide support using in-app text messaging during the study. 
During the study, subjects log their cigarette events in the Pivot App and 
submit breath samples using the CO Breath Sensor. They also complete short 
(2-8 minutes) activities in the Pivot App, create a quit plan, and periodically 
engage with their coach.  
The primary phase of the study, during which participants are using the Pivot 
program, is 14.5 to 18.5 weeks in duration, depending on participant 
relapse/exit/re-entry rates and navigation of the phases of the Pivot App 
journey (Build is self-guided and lasts 1-28 days). Three months after 
completing the primary phase of the study, participants are asked to complete 
a final exit questionnaire. 
Questionnaires assessing smoking behavior, attitude towards smoking, quality 
of life, engagement with the program and feedback on the program are 
conducted at baseline, at the end of each Pivot App phase and at 3 months 
after completing the primary phase of the study. In addition, more detailed user 
feedback on the experience is sought upon completion of the Secure phase of 
the Pivot App, or upon the end of the participant’s engagement with the app, 
whichever occurs first. Upon return of the study device and completion of the 
questionnaire conducted 3 months after completing the primary phase of the 
study, the study is considered complete. 

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Endpoint and 
analysis 
We will compare the following variables at entry, after completion of each Pivot 
App phase, and/or at exit.  
 
Engagement: 
● Weeks of active engagement 
● Phase completion 
● Number of app opens 
 
Smoking Behavior: 
● Number of cigarettes smoked per day 
● Quit attempts 
● Quit rates: 7-day, 30-day point prevalence 
● Sustained quit (continuous days quit) 
● Smoking reduction (in participants who do not quit) 
 Responses to questionnaires: 
●  Measurements assessing attitude toward smoking 
○ Readiness to quit 
○ Goals related to smoking behavior 
○ Confidence to quit 
○ Difficulty maintaining quit 
● Net Promoter Score (NPS) 
● NPS, Coaching 
● Nicotine Dependence 
● Quality of Life   
  
 
 
 
 
 
 
 
 
 
 

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Carrot Inc. 
 6-Month Outcomes of a Mobile Smoking Cessation Program Ver B 
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Schedule of Study Activities 
  
Screening 
Day 0 
Day 
1 
Pivot App - 
Explore (9 
days) 
Pivot App - 
Build (1 - 
28 days) 
Pivot 
App - 
Mobilize 
(7 days) 
Pivot 
App - 
Quit (7 
days) 
Pivot App 
- Secure 
(11 
weeks) 
Exit - 3 mos after 
Secure or 3 mos 
after the end of 
participant’s 
engagement with 
the app  
Eligibility Confirmed 
X 
 
  
  
  
  
  
  
  
Informed Consent 
 
X 
  
  
  
  
  
  
  
Baseline Questions 
(demographics, 
thoughts about 
smoking) 
 
X 
X 
X 
 
 
 
 
 
Receive COBSS* 
 
  
X 
  
  
  
  
  
  
Cigarette Logging** 
 
  
 
X 
X 
X 
X 
X 
 
Breath Sampling*** 
 
  
 
X 
X 
X 
X 
X 
 
Coach-Initiated 
Interactions 
 
  
 
 X 
X  
X 
X  
X 
  
Questionnaire  
 
 
X 
X 
X 
X 
X 
X 
X 
Questionnaire (thoughts 
about smoking and the 
experience of using the 
device) 
 
  
  
  
  
  
  
 X 
  
Exit questionnaire 
 
 
 
 
 
 
 
 
X 
Return Breath Sensor 
 
 
 
 
 
 
 
 
X 
Study Completion 
 
  
  
  
  
  
  
  
 X 
* COBSS received by participant only after confirmation of eligibility and provision of informed consent  
** Cigarette logging should stop at the beginning of the Quit phase of the Pivot App (assuming participant quits 
smoking), however, participants are asked to log all cigarettes, including those that occur during a lapse or relapse 
*** Suggested breath sampling schedule varies from one phase to the next 
   

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Table of Contents 
1        Introduction 
9 
1.1   
Background 
9 
1.2      Study Rationale 
10 
1.3      Potential Risks and Benefits 
10 
1.3.1        Known Potential Risks 
10 
1.3.2        Known Potential Benefits 
10 
1.3.3        Risk Benefit Assessment 
10 
2        Study Objective 
11 
3        Device Descriptions 
11 
3.1   
Carbon Monoxide Breath Sensor System (COBSS) 
11 
3.1.1        CO Breath Sensor 
11 
3.1.2        Breath Sensor App 
12 
3.2      Pivot App 
12 
4        Study Design and Overview 
13 
4.1   
Study Design 
13 
4.2      Study Endpoint 
14 
4.3      Eligibility Criteria 
15 
4.3.1        Criteria for All Participants 
15 
4.4   
Subject Recruitment and Screening 
16 
4.5   
Subject Stipend 
17 
4.6   
IRB Oversight 
17 
4.7   
Study Environment Description 
17 
4.8   
Study Personnel 
17 
4.9   
Study Site 
17 
5        Study Procedure and Schedule 
19 
5.1      Screening and Day 0 
19 
5.2      Day 1 Entry 
19 
5.3      Pivot Journey 
20 
5.4      Exit 
27 
6        Study Results 
27 
6.1   
Data Collection and Confidentiality 
27 

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6.2     Data Analysis 
27 
6.3      Data Recording and Quality Assurance 
27 
6.4   
Record Retention: 
28 
7        
 
29 
8        References 
30 
9           Document Revision History 
31 
 
 
 
  
  
 
  
 
 
 

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 6-Month Outcomes of a Mobile Smoking Cessation Program Ver B 
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List of Abbreviations 
CO 
Carbon Monoxide 
COBSS 
Carbon Monoxide Breath Sensor System 
CRF 
Case Report Form 
BSA 
Breath Sensor Application 
IRB 
Institutional Review Board 
ICF 
Informed Consent Form 
ppm 
parts per million 
  
  
  
 
 
 
 

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Carrot Inc. 
 6-Month Outcomes of a Mobile Smoking Cessation Program Ver B 
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1        Introduction 
1.1   Background 
The smoking of tobacco products is a leading cause of preventable morbidity and mortality, 
excess health care expenditure, and lost work productivity.  
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
We have developed a personal mobile CO breath sensor (study device, Carrot Sense) that 
communicates with a mobile app (BSA) on a smartphone to display the results to the user. The 
BSA is required for the breath sensor to communicate with the subject’s smartphone and allows 
basic viewing of CO sample values.  In addition, we have developed the Pivot App, which 
provides additional information about CO sample values and CO trends, as well as the ability to 
log cigarette events (when subject smokes), view cigarette consumption trends, complete 
educational modules and challenges, view instructional videos, create a quit plan, and interact 
with one’s coach. Enabling a smoker to monitor and track the level of CO in their breath, while 

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logging the times of the cigarette consumption and participating in an educational program with 
coaching may lead to attitude changes, quit attempts, and/or smoking cessation. 
This study aims to assess changes in smoker’s behavior and attitudes toward smoking during 
and after using the Pivot mobile smoking cessation program. 
1.2      Study Rationale 
We will assess engagement, motivation, smoking behavior changes, nicotine dependence, 
smoking cessation rates, quality of life, retention and general feedback in smokers using the 
Pivot mobile smoking cessation program over a period of 3 months, with 3-month follow-up after 
program completion.   
1.3      Potential Risks and Benefits 
1.3.1        Known Potential Risks 
There are no anticipated risks or harms to the subject.  No medical decisions are made based 
on study data. 
1.3.2        Known Potential Benefits 
It is possible that some subjects may experience an increased awareness of their smoking 
behavior, decrease their smoking, or quit smoking altogether. 
1.3.3        Risk Benefit Assessment 
Given the non-invasive nature of the breath sampling and the data collection, there are no 
anticipated risks to subject safety.  This study assesses a mobile smoking cessation program, 
which may help subjects decrease or quit smoking. No medical decisions are made based on 
study data. 
 
 
 

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2        Study Objective 
We aim to assess the Pivot mobile smoking cessation program. We will assess participant 
engagement with and feedback of the program, as well as changes in attitude towards smoking 
and smoking behavior over the study period. 
3        Device Descriptions 
3.1   Carbon Monoxide Breath Sensor System (COBSS) 
The Carbon Monoxide (CO) Breath Sensor System (COBSS) comprises a personal mobile 
breath sensor (CO Breath Sensor) capable of measuring the level of CO in exhaled breath and 
an app for smartphones which displays the exhaled breath CO value to the user.  
3.1.1        CO Breath Sensor 
The CO Breath Sensor (Figure 1) is portable, battery-powered, and small enough to be 
conveniently carried by the user throughout the day (pocket, purse, backpack).  The CO Breath 
Sensor is rechargeable using a micro-USB cable.  The LED pulses orange while charging and 
then solid green when fully charged. 
The CO Breath Sensor pairs to the app (BSA) on the smartphone via low-energy Bluetooth.  
The user submits a breath sample by exhaling (blowing) into the CO Breath Sensor via a 
provided straw (polypropylene, reusable, cleaned with soap and water, replaced as necessary).  
In the study, a pack of 7 straws is provided with the CO Breath Sensor.  
 
 
 
 
 
 
 
 
Figure 1. CO Breath Sensor                                       
Figure 2. BSA CO Log 
  
 
 
 

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3.1.2        Breath Sensor App 
The Breath Sensor App (BSA) for smartphones is required for the breath sensor to 
communicate with the subject’s smartphone and allows basic viewing of CO sample values. The 
CO breath sample values are presented in parts per million (ppm) within color coded bars (see 
Figure 2). A low level in a smoker (CO value of 0-6 ppm, Green) does not mean it is safe to 
smoke. Likewise, a non-smoker may have CO levels higher than 6 ppm (Orange or Red) due to 
environmental exposure. These ranges are derived from many clinical studies using point 
measurements at various times of the day 
. Should the subject submit a breath sample 
using improper technique, s/he will receive an error message in the CO Log. 
The results in the app are stored in a secured database. Study personnel will be able to view 
these results as well as activity in the app. 
The app has features to allow the subject to set reminders, vibration, volume, and other 
preferences. 
3.2      Pivot App 
Participants use the Pivot App as the main focus for study interactions.  In the Pivot App, 
participants may perform the following main actions: 
● View CO sample values, CO load, and CO trends  
● Log cigarettes and see the associated data including cigarette trends  
● Complete educational activities 
● Complete challenges and practice quits related to the educational activities 
● Set a Quit date, then build and revise the Quit Plan 
● Read back all information entered in “My Story” 
● In-app chat with the Pivot coach 
 
More specifically, participants can see their individual CO sample values in the CO Log (as with 
BSA), and can also view CO load (area under the curve for CO exposure over 24 hours) and 
CO load trend day to day. Participants can also log cigarettes, view number of cigarettes 
smoked per day and trends in cigarette consumption. The participant’s location at time of 
cigarette logging will be collected if the participant opts in for this feature.  
In addition, activities are delivered and completed in the Pivot App. These are educational 
activities designed to increase participant’s awareness of smoking risks and raise questions 
about the role of smoking in the participant’s life. Some of these activities are combined with 
“challenges” that the participant can choose to accept or defer, which ask the participant to take 
particular actions related to the educational activity.  These actions can range from thinking 
about a particular way smoking affects their life to attempting to replace smoking a cigarette with 
another activity of their choosing. Coaching provides human support and guidance, and is 
conducted via in-app chat in the Pivot App.  
 
 

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4        Study Design and Overview 
4.1   Study Design 
This is a prospective open-label clinical trial conducted with IRB approval in up to 310  subjects 
who report daily smoking (up to 50 run-in subjects, and 260 general subjects).  Potential 
subjects will be recruited and prescreened as described in section 4.4 
Potential participants will complete the Online Screening Form 
. Each Online 
Screening Form submission will be reviewed by study staff. Eligible participants and those of 
uncertain eligibility (ex. potential participant’s Online Screening Form was incomplete) will be 
contacted by phone by study staff or the clinical recruiter to confirm eligibility, provide more 
details about the study, and answer any questions the potential participant may have. 
 Eligible potential participants who remain interested in participation will be emailed the web 
registration link. This link, along with the phone call that occurred previously, will be used to 
verify the potential participant’s identity. During the identity verification portion of the online 
registration process, the potential participant enters contact information and verifies their identity 
through a link sent to the email address they provide 
.   
Every online submission from a potential participant will be reviewed by study staff and any 
discrepancies will be addressed through a phone call and/or possible videoconference with the 
potential participant (for example, more than one online submission with the same name, 
address, email address or phone number). Should a videoconference be pursued, such 
communication will occur in a private office setting with only necessary study staff present and 
the privacy of the potential participant protected (office door closed; screen not visible to anyone 
other than necessary study staff; headphones used if possible, if not possible, volume at the 
lowest level that allows for coherent dialogue). 
After verification of eligibility and identity, potential participants will be asked to provide informed 
consent. Potential participants will have the opportunity to ask questions of the study 
investigator team during the informed consent process. Those who agree to participate will 
electronically sign the informed consent form 
. 
Study staff must review the eligibility and identity criteria, document the resolution of any 
discrepancies from the identity verification process, answer any questions during the informed 
consent process, and confirm informed consent is signed before approving a participant for 
entry.  
Upon approval for entry, study participants receive the study device. Upon receipt of the study 
device, participants will download the apps on their smartphone and use device labeling (User 
Manual
, Quick Start Guide
 Reference Card
, 
Insert Card
, Box Sleeve Label
) to set up and self-train on the 
device and apps.  
Participants will have access to Customer Service and study staff as well if they need additional 
support. Participants are provided the study instructions during the online registration process: 

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the Pivot mobile smoking cessation program consists of 5 phases (Explore, Build, Mobilize, 
Quit, and Secure); during the study, participants provide breath samples using the CO Breath 
Sensor, log cigarettes in the Pivot app, complete daily activities in the Pivot App, and engage in 
coach-initiated interactions conducted through in-app text. 
 
 
Study participants will be asked to complete questionnaires (in-app and through email) at 
baseline, after each phase, and at exit. In addition, more detailed user feedback on the 
experience is sought upon completion of the Secure phase of the Pivot App, or upon the end of 
the participant’s engagement with the app, whichever occurs first. Upon return of the study 
device and completion of the exit questionnaire (conducted 3 months after completing the 
primary phase of the study), the study is considered complete.  
4.2      Study Endpoint 
Primary endpoint:  
● Phase completion - of those who started a phase, the proportion who completed that 
phase, assessed for each phase of the Pivot program. 
○ Phase completion is defined as completing the last in-app activity from that 
phase 
■ Exception: completion of Secure is defined as being in Secure for 11 
weeks, and having engaged with the program at least once within Secure 
(app open, daily check-in, responds to coach, logs cig), and providing 
smoking status (cigarettes per day and 7-day point prevalence) in the 
end-of-Secure questionnaire   
 
Additional endpoints include: 
 
Engagement: 
● Weeks of active engagement 
● Number of app opens 
● Phase completion -  proportion of intention to treat (ITT) cohort that completes each 
phase 
○ ITT cohort comprises participants who signed informed consent and completed 
onboarding in the Pivot app (i.e. downloaded the BSA and Pivot apps, completed 
device set-up, and completed the three guided breath tests, or GBTs) 
● Program completion - proportion of intention to treat (ITT) cohort who have been in 
Secure for 11 weeks and have engaged with the program at least once (open app, or 
complete a daily check-in, or respond to coach, or log a cigarette), and, provides 
smoking status (cigarettes per day and 7-day point prevalence) in end-of-Secure Survey  
 
Smoking Behavior: 
● Number of cigarettes smoked per day 
● Quit attempts (participant did not smoke for at least 24 hours) 
● Quit rates: 7-day, 30-day point prevalence 

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○ Assessed in the ITT cohort 
○ Assessed in the Per Protocol cohort (individuals who complete the end-of-phase 
survey in the phase during which the question is being asked or, complete the 
exit survey at the end of their engagement with the app, whichever occurs first)  
● Sustained quit (continuous days quit) 
○ Assessed in the ITT cohort 
○ Assessed in the Per Protocol cohort 
● Smoking reduction (in participants who do not quit smoking) - proportion who achieved 
50% cigarettes per day (CPD) reduction or more at study exit 
  
Responses to questionnaires: 
●  Measurements assessing attitude toward smoking 
○ Readiness to quit 
○ Goals related to smoking behavior 
○ Confidence to quit 
○ Difficulty maintaining quit 
● Net Promoter Score (NPS) 
● NPS, for coaching 
● Nicotine Dependence 
● Quality of Life   
4.3      Eligibility Criteria 
We will seek to enroll up to 310 participants (up to 50 run-in participants, and 260 general 
participants), with the aim of a balance between male and female participants.  Potential 
participants will be classified as outlined below using self-reporting of smoking habits.  
4.3.1        Criteria for All Participants 
All participants must meet all inclusion criteria: 
● 18-65 years of age 
● English speaking 
● Smokes daily 
● Smokes 5 or more cigarettes per day 
● Owns and uses a smartphone (iPhone 5 and above, operating system iOS 9.0 and 
above, or, Android 4.4 and above, operating system Android 4.4 and above) 
● Employed at least 20 hours per week 
● Lives in the USA 
● Understands and willing to sign the Informed Consent Form 
  
While pregnant women are not specifically sought in this study, pregnancy is not an exclusion 
criterion, and pregnant women would be eligible should they meet the inclusion criteria and wish 
to participate. Pregnant women would be considered eligible for the following reasons: the risk 
profile of the device, the fact that recording smoking in the study is by self-report and the 

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modest participant stipend is not linked to smoking in any way, and potential participants reach 
out to the study team if they are interested in participating (i.e. recruitment is passive and wholly 
at the initiation of potential participants, who the study team have no visibility to unless 
contacted by the potential participant). While participants are deemed eligible to enter the study 
based on their self-report of smoking at least 5 cigarettes a day, they are not required or asked 
to smoke any particular amount (or at all) over the course study. Participants are asked to 
provide breath samples in the CO Breath Sensor device throughout the day, as they are able.  
 
The general study (n=260) will employ non-proportional quota sampling as follows to ensure the 
study population mirrors the expected initial intended user population: 
  
Age 
18-29 year olds 
< 20 % of sample 
30-60 year olds 
Remainder 
61-65 year olds 
< 10 % of sample 
Cigarettes Per Day 
(CPD) 
5-10 CPD 
< 25 % of sample 
11-30 CPD 
Remainder 
> 30 CPD 
< 10 % of sample 
Stages of Change* 
Quit 30 days 
≥ 20% of sample 
Quit 6 months 
≥ 20% of sample 
Not interested 
< 20 % of sample 
Sex 
Male 
40-60% 
Female 
40-60% 
 
*Stages of Change question and answer choices: Are you seriously thinking of quitting smoking? A. Yes, within the 
next 30 days  B. Yes, within the next 6 months  C. No, not thinking of quitting 
 
4.4   Subject Recruitment and Screening 
Potential subjects will be identified via advertisement at outdoor locations (i.e. flea markets, 
outside of movie theaters, shopping malls, train stations, stores that sell cigarettes), print media 
(i.e., local newspapers, billboards), web media (i.e., Craigslist, Facebook, Survey Monkey, 
Instagram, Twitter, Google Ads, Reddit, smokefree.gov) and through clinical research recruiters 
. Respondents will be asked to provide contact information (phone 
number, email address), and answer questions on smartphone ownership, employment status 
and hours worked per week, and smoking behavior using the Online Screening Form 
 or through the clinical research recruiter, if applicable.  
Study staff will review each potential participant’s responses to the eligibility questions. Potential 
participants who meet eligibility criteria (or those for whom it is unclear if they meet eligibility 
criteria due to an incomplete Online Screening Form) and meet non-proportional sampling 
needs will be contacted by phone, informed of the study and screened further if necessary (for 
example, collecting complete screening information, or clarifying duplicate entries).  
During this interaction, study personnel will inform the potential subject of the study details and 
will answer any questions. Potential participants will then determine if they would like to proceed 
with the study. Potential participants who would like to proceed will be emailed the online 
registration portal link, which includes the electronic informed consent 
. 

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All subjects will have ample time to read the informed consent and ask questions of the study 
investigator team before signing informed consent. 
4.5   Subject Stipend 
Subjects will be offered a stipend for the study. Payment structure will be described during the 
screening phone call and in the Informed Consent Form. Participant compensation is tied to 
completion of study questionnaires and returning the CO Breath Sensor at the end of the study. 
Participants will be emailed payment after completion of each study questionnaire. Payment will 
be in the form of a Visa e-card. Subjects who are not compliant with the protocol despite efforts 
by study personnel may be terminated from the study. Subjects who are not able to complete 
the study for any reason will be compensated for their completed participation. 
4.6   IRB Oversight 
This study will be conducted with IRB oversight. 
4.7   Study Environment Description 
The entire study, including participant data collection of breath samples, logging cigarettes, 
completing daily activities and interacting with the coach, will be conducted in an ambulatory 
environment, with participants living their daily lives however is typical for them (work, home, 
school, etc.). 
4.8   Study Personnel 
The study team members will be trained by reading the study protocol, informed consent form, 
and reviewing the participant-facing content (BSA app, Pivot app). The study team members will 
have full training on the operation of the study devices and protecting human research 
participants. 
4.9   Study Site 
Study staff and management is headquartered at the Carrot office:
 
. The entire study is conducted remotely; there are no study site 
visits for study participants. 
 
4.10 Sample Size and Justification 
Up to 50 participants will comprise the run-in group. The purpose of the run-in group is to 
provide baseline observations on the functioning of the BSA and Pivot app, and provide the 
opportunity to address unforeseen bugs or issues that arise prior to proceeding with the general 
study.  

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The target enrollment of 260 for the general study is estimated to yield 100 or more subjects 
completing the study at the last time point (3 months after the end of Secure). Based on power 
calculations, this will detect a 50% reduction in cigarettes, a mean change of 1 or greater in 
ratings assessing attitudes towards smoking, and will provide adequate confidence intervals to 
make historical comparisons.  
 

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5        Study Procedure and Schedule 
5.1      Screening and Day 0 
Study personnel will verify eligibility by reviewing the potential participant’s responses to the 
Online Screening Form 
; eligible participants (applies to both the run-in and 
general study participants) who meet non-proportional quota sampling needs (applies to general 
study participants) will then be called by study staff. During this call, any additional needed 
screening information is obtained, eligibility is confirmed, the study is described and the 
potential participant has the chance to ask questions. If the potential participant would like to 
proceed, the online registration form 
 is emailed to the potential participant. 
Potential participants will be provided an access code at this time to allow access to the 
website.  
Verification of identity and informed consent is performed during the screening phone call and 
during the online registration process. At this time, potential participants create a user login and 
password. An email is then generated and sent to the email address provided by the potential 
participant. To confirm identity, the potential participant must access their email and confirm 
through the provided link. The potential participant then reviews the electronic informed consent 
form on their own timeline and is provided study staff contact information should they have any 
questions. If the potential participant would like to proceed, they electronically sign the informed 
consent form 
. 
5.2      Day 1 Entry 
After providing informed consent, participants complete baseline questions about demographics 
and smoking behavior.  During the Pivot on-line registration process, the participant must 
access his/her email on their smartphone and click on a link to verify identity and further 
proceed in the registration process. The participant will then be emailed the links to download 
the BSA and Pivot apps, which they will do on their smartphone. 
After completing the Pivot on-line registration, the participant will be mailed the COBSS. 
Labeling included with the COBSS includes the User Manual 
, Quick Start 
Guide 
 Reference Card 
, Insert Card 
 and 
Box Sleeve Label 
. 
Participants will then self-train on how to set-up and use the COBSS 
 
and Pivot app 
 using the available study device labeling. While they will be 
instructed to proceed with set-up on their own using the provided labeling, participants will 
ultimately have access to Customer Service and study staff should they need additional 
assistance. 

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During this self-led set-up and onboarding process, participants will be trained on how to 
provide a breath sample and log cigarettes, navigate the BSA and Pivot apps, and what to 
expect regarding coaching.  
Participants who provide informed consent and complete the set-up and onboarding process 
(i.e. complete the 3 Guided Breath Tests) are considered enrolled (applies to run-in and general 
study participants) and comprise the intention-to-treat (ITT) cohort (applies to the general study 
participants). 
5.3      Pivot Journey   
After set-up and onboarding, participants start the Pivot program. The Pivot program consists of 
four primary components: 
● Periodic breath sampling using the CO Breath Sensor 
● Cigarette logging 
● Daily activities and challenges 
● Coaching using in-app chat 
 
During the study, participants submit periodic breath samples (suggested frequency is phase-
dependent) while awake. Participants are instructed to log each cigarette they smoke using the 
Pivot app. 
Participants are also asked to complete the activities presented in the Pivot app. Pivot app 
activities are educational in nature and intended to facilitate exploration and understanding of 
one’s smoking behavior and attitudes. In addition, Build (the second phase of the program) 
includes challenges associated with activities; these challenges enable participants to develop 
skills to assist with quitting 
 
  
In addition, participants will engage with a coach. The coach will initiate interactions with the 
participant by in-app chat throughout each phase of the study. The coach’s primary role is to 
partner with the participant to explore how smoking impacts their time and financial resources, 
what purpose smoking serves in their life, their reasons for why they might want to quit, their 
interest and readiness in quitting, and provide support and encouragement during the quit 
process.  
The Pivot program consists of 5 phases that are intended to be completed sequentially, with 
continuous engagement (i.e. no breaks in between). Acknowledging that challenging life events 
and circumstances occur, participants will be permitted to resume the Pivot program where they 
left off after up to two weeks of non-engagement/absence.   
A summary of each Pivot phase is provided below 
: 
 
 
 
 
 

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 6-Month Outcomes of a Mobile Smoking Cessation Program Ver B 
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Explore 
Duration, pace, key components 
● 
9 days, time based, one activity unlocks each 
24 hours 
Intent 
● 
"Open the Door" 
● 
"Turn on the light bulb" 
● 
Raise awareness and build motivation 
Activity/content 
● 
One activity is unlocked per 24h 
Cigarette logging 
● 
All cigs 
Suggested breath CO sampling 
protocol 
● 
Hourly samples (10) a day for 9 days 
Coaching frequency 
● 
4 coach-initiated touch-points in 9 days 
Study management 
● 
If participant does not use the app at least 
once during the 2 days after onboarding (no 
cig logging, or CO sampling, or start/complete 
activity, or respond to coach outreach), study 
staff will call participant on days 3, 4 and 6  
 
 
 

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Build 
Duration, pace, key components 
● 
1 day to 4 weeks based on recommended daily 
pace. Can be longer if content is not consumed 
daily. 
● 
Daily activity+challenge available 
Intent 
● 
For those ready to quit, make a quit plan 
● 
For those not yet ready to quit, raise readiness 
and confidence, then make a quit plan 
Activity/Content 
● 
28 activities and 28 associated challenges in 4 
modules (7 activities and 7 challenges per): 
● 
Prep to Quit (PTQ) 
● 
Smoking & Health 
● 
Motivation Matters 
● 
Potential Pitfalls 
● 
User starts on a specific module based on their 
responses to final Activity (9) of Explore. Users 
whose responses indicate they are ready to quit 
(score of 8 or higher on each of 3 questions 
about readiness, confidence and perceived 
difficulty of quitting), go straight to PTQ. 
Otherwise another module is prioritized. 
● 
User must choose a quit date to unlock PTQ 
● 
User can spend 1 day to 4 weeks in Build, or 
longer if they do the activities slower than daily  
Cigarette logging 
● 
All cigs 
Suggested breath CO sampling 
protocol 
● 
Hourly samples throughout Build 
Coaching frequency 
● 
3 to 4 touch-points per week 
● 
If a user has not completed activities and/or 
hasn’t had a coaching interaction within 3 days, 
the coach will reach out to the user to check in. 
Study management 
● 
If participant does not use the app at least once 
in 7 days (no cig logging, or CO sampling, or 
start/complete activity, or start/complete 
challenge, or complete daily check-in, or 
respond to coach outreach), study staff will 
email on day 9, text on day 10, call on day 11, 
and call on day 13  
 
 
 
 

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Mobilize 
Duration, pace, key components 
● 
7 days based on recommended daily pace 
Intent 
● 
Prepare for Quit Day 
Activity/content 
● 
7 activities, daily pace recommended 
● 
No time lock, but must finish all activities to 
move on 
● 
User can finish faster or slower. Quit date must 
be set within 14 days, but user can push out 
quit date during Mobilize, and thus extend this 
phase of the program 
● 
User prompted to change quit date if not all 
activities are completed 
● 
User prompted to set earlier quit date if they 
finish all activities. 
Cigarette logging 
● 
All cigs 
Suggested breath CO sampling 
protocol 
● 
2 days of "intensive" sampling (hourly) to 
benchmark – beginning and end of Mobilize 
● 
Remaining days in between are 3 breaths a 
day: morning, mid-day, evening 
Coaching frequency 
● 
Intro touch point to Mobilize with two 
interactions on completion of specific activities 
that prepare users for quit day. 
● 
Wrap-up touch point to review quit plan 
● 
If a user has not completed activities, 
milestones and/or has not had a coaching 
interaction within the past 2 days, the coach 
will reach out to the user to check in.  
Study management 
● 
If participant does not use the app at least 
once in 7 days (no cig logging, or CO 
sampling, or start/complete activity, or 
start/complete challenge, or complete daily 
check-in, or respond to coach outreach), study 
staff will email on day 9, text on day 10, call on 
day 11, and call on day 13  
 
 
 
 

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Quit 
Duration, pace, key components 
● 
7 days from quit date, time based, activities 
are unlocked daily 
● 
Daily check-in introduced 
● 
Red ‘guy’ on Pivot app dashboard turns green, 
Crush-a-Craving button added  
 
Intent 
● 
Getting through the toughest week 
● 
Lapse and relapse handling 
 
Activity/content 
● 
Daily check-in, must be completed to access 
rest of app 
● 
One activity is unlocked per 24h 
Cigarette logging 
● 
Daily check-in asks if user smoked previous 
day, if so, then directs them to log cig 
Suggested breath CO sampling 
protocol 
Encourage light use to see progress 
● 
3 breaths a day, morning, mid-day, evening 
● 
Plus every time user has a craving 
Coaching frequency 
● 
Intro touch point to Quit with two strategic 
interactions after completion of smoke-free 
milestones (Quit: 24 hours and 72 hours) 
● 
Wrap-up touch point to review progress, 
celebrate smoke-free milestones and identify 
areas of the quit plan that may need to be 
adjusted going forward – guide to move to 
Secure.   
● 
If a user has not completed activities, 
milestones and/or has not had a coaching 
interaction within the past 2 days, the coach 
will reach out to the user to check in. 
Study management 
● 
If participant does not use the app at least 
once in 7 days (no cig logging, or CO 
sampling, or start/complete activity, or 
start/complete challenge, or complete daily 
check-in, or respond to coach outreach), study 
staff will email on day 9, text on day 10, call on 
day 11, and call on day 13  
 
 
 
 

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Secure 
Duration, pace, key components 
● 
11 weeks from quit date 
● 
Daily check-in 
Intent 
● 
Lapse and relapse handling 
Activity/content 
● 
Daily check-in with journaling 
Cigarette logging 
● 
Daily check-in asks if user smoked previous 
day, if so, then directs them to log cig. 
Suggested breath CO sampling 
protocol 
No explicit sensor use schedule, but sensor is 
incorporated as follows: 
● 
Encourage people who find the 3 times a day 
useful to keep doing that. 
● 
Allow users to set their own milestones, some 
can be sensor related. Pivot app also gives 
trophies for breath samples associated with 
abstinence to augment this. "Take a breath 
samples to celebrate your smoke-free 
success." 
 
Coaching frequency 
● 
3-4 coach-initiated interactions per week for 
the first 3 weeks  
● 
For users who achieve 30day PP at 3 weeks 
or 7 weeks in Secure, coaching frequency 
drops to once weekly, until/unless user 
indicates lapse or relapse. 
Study management 
● 
For the first 3 weeks: If participant does not 
use the app at least once in 7 days (no cig 
logging, or CO sampling, or start/complete 
activity, or start/complete challenge, or 
complete daily check-in, or respond to coach 
outreach), study staff will email on day 9, text 
on day 10, call on day 12, and call on day 14 
● 
For the remaining 7 weeks:  If participant does 
not use the app at least once in 14 days (no 
cig logging, or CO sampling, or start/complete 
activity, or start/complete challenge, or 
complete daily check-in, or respond to coach 
outreach), study staff will email on day 16, text 
on day 17, call on day 19, and call on day 21 
 
 
 

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The following table details the different questions being asked of participants at specific time 
points over the course of the study. 
 
 
 
Baseline 
Explore 
Build 
Mobilize 
Quit  
(1wk) 
Secure - 
1wk (2wk 
post Quit) 
Secure - 
3wk (1mo 
post Quit) 
Secure - 
7wk 
(2mo 
post 
Quit) 
Secure 
- End 
(3mo 
post 
Quit) 
Follow
-up 
(6mo) 
Cigarettes per day 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Tobacco Forms 
Used 
X 
 
X 
 
X 
 
X 
X 
X 
X 
Readiness to Quit 
(1-10) 
X 
X 
X 
X 
 
 
 
 
 
 
Success, if were to 
quit (1-10) 
X 
X 
X 
X 
 
 
 
 
 
 
Difficulty staying 
quit, (1-10) 
X 
X 
X 
X 
 
 
 
 
 
 
Quitting Goal 
X 
X 
X 
X 
 
 
 
 
 
 
Nicotine 
Dependence 
 
X 
 
X 
 
 
 
 
 
 
7day Point 
Prevalence 
 
 
 
 
X 
X 
X 
X 
X 
X 
30day Point 
Prevalence 
 
 
 
 
 
 
X 
X 
X 
X 
Date of Last Cig 
 
 
 
 
X 
X 
X 
X 
X 
X 
Longest Smoke-
free Interval 
 
 
 
 
X 
X 
X 
X 
X 
X 
Quit Attempts 
 
 
 
 
X 
X 
X 
X 
X 
X 
NPS 
 
X 
X 
X 
X 
 
 
 
X 
 
Coach NPS 
 
X 
X 
X 
X 
 
 
 
X 
 
Quality of Life 
X 
 
 
 
 
 
 
 
X 
X 
Cessation 
Medications 
X 
 
 
X 
X 
X 
X 
X 
 
X 

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Participants will receive an email, text or phone call from study staff to inform them they have a 
questionnaire to complete (
 
. 
5.4      Exit 
Three months after completing Secure or 3 months after the last engagement with the Pivot app 
(whichever comes first), the participant is asked to complete the final follow-up questionnaire 
 and return the CO Breath Sensor in the provided pre-paid package. Upon 
completion of the final survey and return of the CO Breath Sensor, the study will be considered 
complete. 
6        Study Results 
6.1   Data Collection and Confidentiality 
Data collection will be electronically administered through participant input in the Pivot online 
registration form, BSA and Pivot apps, and online questionnaires. As it is entered by the 
participant, the study data directly populates a secure database. This database is user ID and 
password protected and will be accessible only by necessary study personnel. For analysis, this 
data is de-identified with participants assigned a study identification number 
. 
The data will be kept for 5 years. 
6.2     Data Analysis 
Data from the run-in participants will be analyzed separately from the data from the general 
study participants. Both cohorts will be analyzed using the ITT and Per Protocol definitions, and 
endpoints described previously.  
Changes in measurements from baseline, to the end of each phase, to exit will be assessed. 
Participants will serve as their own controls and comparisons will be made to no change. One 
sample t-test will be used for numerical data. Fisher’s Exact or Chi square will be used for 
categorical data. 
All deviations from the study protocol will be identified, recorded and analyzed. 
6.3      Data Recording and Quality Assurance 
Data forms will be completed electronically by the study participants. The study team will review 
these data forms in the database prior to completion of the study and seek 
completion/clarification from study participants as needed. Study data is kept in a secure 
database (PostgreSQL and Excel). This electronic file and database are user ID and password 
protected and will be accessible only by necessary study personnel. 

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6.4   Record Retention: 
Record keeping is performed in accordance with the SOP Control of Quality Records, 
. 
 
 

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7        
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
         
 
 
 
 
 
 
 

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8        References 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 

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9           Document Revision History 
Rev.  
A 
Revision Date:  Sept. 20, 
2017 
  
Summary of Changes: 
·         New protocol 
Rev.  
B 
Revision Date:  Sept. 29, 
2017 
  
Summary of Changes: 
• 
Added a run-in group of up to 50 participants (general 
study continues to comprise 260 participants) 
o Informed consent reflects this change 
• 
Provided updated labeling 
• 
Added questions to the questionnaires (Baseline, end 
of Mobilize, end of Quit, Secure 1 week, Secure 3 
weeks, Secure 7 weeks, Secure 11 weeks and Exit) 
about use of smoking cessation medications.