Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase Physical Activity
Phase: NA
Conditions: Smoking
Sponsor: Duke University

Study Title: Smoking Treatment and Exercise Program for 
Underserved Populations (STEP UP) 
 
Clinical Trials Identifier: NCT02873754 
 
Protocol and Statistical Analysis Plan, 4/3/2017 

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Page 1 of 21 
Title: Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase 
Physical Activity 
Principal Investigator: Paul Dennis, Ph.D. 
 
Background 
 
Cigarette smoking and physical inactivity are the two greatest behavioral health risks leading to 
chronic disease and premature death in the U.S. (Department of Health and Human Services, 
2004). Smoking alone accounts for 1 in 5 deaths, and physical inactivity, coupled with poor diet, 
accounts for 1 in 6 (Mokdad, Marks, Stroup, & Gerberding, 2004). Both smoking and physical 
inactivity are more prevalent in low-income populations (Hisock, Bauld, Amos, Fidler, & Munato, 
2012; Powell, Slater, Chaloupka, & Harper, 2006). Moreover, both frequently co-occur 
(Kaczynski, Manske, Mannel, & Grewal, 2008), thereby compounding their deleterious effects 
(Strine, Balluz, & Ford, 2007; Ferrucci et al., 1999). In light of this co-occurrence, a number of 
researchers have tested combined smoking and exercise interventions and found that they 
convey better outcomes than stand-alone smoking-cessation efforts (Weinstock, Barry, & Petry, 
2008; Ussher, Taylor, West, & McEwen, 2000).  
 
Contingency management (CM) is an intensive behavioral therapy that provides positive 
reinforcers (e.g., vouchers, money) to individuals contingent upon utilization of an intervention 
or demonstration of an outcome, often abstinence in the case of substance users. CM is a 
particularly powerful tool for generating behavioral change in low-income populations due to 
the greater inherent value of monetary incentives (Lynagh, Sanson-Fisher, & Bonevski, 2013). 
CM has demonstrated strong short-term efficacy in the treatment of substance use, with effect 
sizes eclipsing those of other behavioral treatments (Dutra et al., 2008). Incentive-based 
exercise interventions may be similarly effective for increasing exercise, with one study (Kurti & 
Dallery, 2013) demonstrating that rewarding participants with as little as $1.00 a day for 
meeting daily step goals increased the odds of meeting exercise objectives by a factor of 6.42.  
 
Unfortunately, traditional applications of CM for smoking and other substance misuse have 
been hampered by the need for clinic-based verification of abstinence, which represents a major 
barrier to treatment for low-income populations (Gornick et al., 1996). As a result, these 
approaches have largely been relegated to inpatient and day-treatment programs. Our 
laboratory, however, has developed a smartphone application (app) which allows participants to 
video themselves multiple times daily while using a small carbon monoxide (CO) monitor and to 
transmit the data to a secure server. This innovation has made the use of CM for outpatient 
smoking cessation portable and feasible as well as highly efficacious in treating smoking in 
vulnerable populations (Hertzberg et al., 2013; Carpenter et al., 2015).  
 
Financial incentives have similarly been applied to exercise interventions with positive short-
term effects. The majority of such trials have tested the effect of directly incentivizing weight 
loss via varying combinations of diet and exercise (Volpp et al., 2008; Abrahms & Allen, 1974; 
Harris & Bruner, 1971; Jeffery et al., 1993; Jeffery et al., 1984). According to a recent meta-
analysis of financial-incentive trials (Mantzari et al., 2015), the mean 6-month odds ratio (OR) for 
diet/exercise interventions was 1.66 (95% CI=1.28-2.15). Incentives to participate in physical 
activity have also been applied with slightly smaller effects (Charness & Gneezy, 2009; Jeffery, 
Wing, Thorson, & Burton, 1998; Pope & Harvey-Berino, 2013). However, a major drawback of 
these interventions is that they require extensive face-to-face contact between participants and 

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study personnel. Furthermore, despite immediate short-term gains, significant long-term effects 
on weight loss or engagement in physical activity were observed in none of these studies 
(Mantzari, 2015). Still, incentives may be particularly effective at promoting short-term 
increases in physical activity, which are expected to be beneficial during a smoking quit attempt. 
Note that the purpose of the physical-activity target in this project is to enhance smoking-
cessation outcomes (and other secondary outcomes such as increased steps and improved 
mood) rather than weight control expressly. 
 
In light of recent advances in the development of mobile interventions for exercise (Fanning, 
Mullen, & McAuley, 2012) and evidence that treating physical inactivity concurrently with 
smoking may increase short-term abstinence above and beyond typical smoking interventions 
(Spring et al., 2009), we have designed a Smoking Treatment and Exercise Program for 
Underserved Populations (STEP UP) that uses mobile CM (mCM) to simultaneously promote 
smoking cessation and physical activity.  
 
The purpose of this pilot project is to evaluate the feasibility, acceptability, and efficacy of STEP 
UP. Given the heightened prevalence of smoking and physical inactivity among low-income 
populations, in addition to structural barriers to treatment, we propose to target low-income 
smokers with this intervention.  
 
Methods 
 
Participants 
 
Participants will be adult men and women who smoke cigarettes. We plan to enroll 15 
participants in order to reach a goal of 10 study completers.  
 
Participants will be eligible for inclusion in the study if they meet the following criteria:  
• 
current household income less than twice the federal poverty guidelines (Finer & 
Henshaw, 2006; for instance, someone from a family of 4 must have a household 
income less than $48,500 to be eligible) 
• 
currently smoke >10 cigarettes a day 
• 
smoking for at least the past year 
• 
can speak and write fluent conversational English 
• 
are 18-70 years of age 
• 
are willing to make an attempt to quit smoking and increase physical activity 
 
Participants will be excluded from the study for the following:  
• 
inability to walk 
• 
expected to have unstable medication regimen during the study 
• 
currently receiving non-study behavioral treatment for smoking 
• 
myocardial infarction in the past 6 months 
• 
contraindication to nicotine replacement therapy (NRT) or bupropion with no medical 
clearance 
• 
exclusive use of other forms of nicotine such as cigars, pipes, e-cigarettes, or chewing 
tobacco 
• 
current pregnancy 

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• 
current imprisonment or psychiatric hospitalization 
 
Recruitment 
 
Participants will be recruited from outpatient clinics at Duke University Medical Center (DUMC). 
Flyers and brochures will be placed in DUMC clinic areas, and may also be placed in community 
settings such as local restaurants and grocery stores. We will also advertise in local newspapers 
and online classified services such as www.craigslist.com. We will contact administrators and/or 
clinicians at local area community health centers, including Lincoln Community Health Center, to 
get permission to provide recruitment materials at those sites. Upon approval by the Durham 
Veterans Affairs (VA) Medical Center IRB, we will post flyers and brochures at that facility and its 
community-based outpatient clinics. Any flyer posted at the VA-owned facilities will include the 
following statement: “This is not VA research, will not be conducted by VA, has not been 
reviewed by VA’s Institutional Review Board, and is not endorsed by VA. VA is not responsible 
for any costs incurred by a Veteran if the Veteran enters the study as a research subject. The 
announcement is being provided for information only.” 
 
Any participant who contacts by telephone the study coordinator or other study staff regarding 
the study will be provided more information, and will be interviewed using an IRB-approved 
telephone screening. We will retain the deidentified telephone screening information for all 
callers so that we can analyze data regarding telephone screen-outs in order to determine 
recruitment and inclusion/exclusion feasibility.  
 
Study Procedures 
 
Table 1 provides a summary of study procedures, including the timing and location of each 
session and payments associated with them.  
 
Table 1. Study Procedures 
Session # 
Location of Visit 
Procedures 
Payment 
1 
Lab 
Consent; questionnaires; urine drug 
screen and pregnancy test; carbon 
monoxide readings; equipment training; 
counseling session 1 of 5 
$100  
1-3 weeks 
2 
Phone 
Brief phone check-in for participants 
using bupropion; begin bupropion if 
eligible 
n/a 
1 week 
3 
Phone 
Counseling session 2 of 5; begin practice 
mCM monitoring 
n/a 
1 week 
4 
Phone 
QUIT DATE; counseling session 3 of 5; 
begin 4 weeks active mCM monitoring; 
begin nicotine replacement therapy 
(NRT) 
n/a 

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1 week 
5 
Phone 
Counseling session 4 of 5; continue 
active mCM monitoring 
n/a 
1 week 
6 
Phone 
Counseling session 5 of 5; continue 
active mCM monitoring 
n/a 
2 weeks 
7 
Phone or Text 
Message 
Begin 1 week mCM wash-out period 
Up to $798 
mCM 
compensation 
2 weeks post-mCM treatment follow-up 
8 
Phone 
Questionnaires; equipment return; 
treatment adherence measures 
$50 for 
equipment 
return 
3 months after Session 1 
9 
Phone/Lab 
Questionnaires; return to lab and 
provide a saliva sample if abstinence 
reported 
$25 for 
assessment; 
$50 for saliva 
sample 
6 months after Session 1 
10 
Phone/Lab 
Questionnaires; return to lab and 
provide a saliva sample if abstinence 
reported 
$25 for 
assessment; 
$50 for saliva 
sample 
TOTAL COMPENSATION POSSIBLE 
$1098 
 
Once a participant reports to the laboratory to begin the study, the study staff member 
obtaining consent will explain the study in detail, provide the participant with an IRB-approved 
written consent form explaining the procedures and risks, and answer any questions. The initial 
consent process and documentation takes place in a quiet, private office at DUMC (Hock Plaza 
space), and participants are given the chance to thoroughly read the consent prior to 
participation. Participants are given a copy of the signed informed consent form, and are given 
phone numbers to call if they have additional questions about the consent form or the research, 
if they have any problems during the study, or if they have questions about participating in 
research studies in general. No study procedures will begin until informed consent has been 
obtained. 
 
After providing informed consent, potential participants will provide a breath sample to assess 
CO level, and will complete measures (see Measures section herein) regarding mood, exercise 
and smoking history, and sociodemographic data. Urine samples will also be used to screen for 
illicit drug use (to document use). Because the study drugs are each Category C drugs, urine 
pregnancy tests will also be completed for women of childbearing potential. We have developed 
a short interview for female participants; this interview will help us determine which female 
participants must have a urine pregnancy test, and when the test should be done. Female 
participants of childbearing potential who are not pregnant must agree to use appropriate 

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contraception during the course of the study, and to notify study staff if they become pregnant 
during the study.  
 
All enrolled participants will receive a tele-health intervention that combines evidence-based 
telephone cognitive behavioral therapy (CBT) for smoking cessation, access to nicotine 
replacement therapy (NRT) and bupropion, and intensive CM therapy administered via a smart-
phone based application (mCM). The treatment components are separately described below. 
After randomization, participants will be given study equipment, including a smartphone (with 
the condition-appropriate app already installed), CO monitor, Jawbone UP2 fitness tracker, and 
a high-accuracy digital bathroom scale. Participants will receive training in use of all equipment 
at the screening visit. Participants will also complete session 1 of the CBT in person in order to 
enhance therapeutic rapport-building. 
 
Study Devices. Smart phones to be used in this study are the DROID MAXX 2. The phone has an 
octa-core 1.7 Ghz processor, 2 GB RAM, and 5.5” full HD display. The operating system (OS) 
being utilized for the smart phones is Android 5.1.1 Lollipop, see FIPS 140-2 certificate 1998. The 
STEP UP mobile phone app is an adaptation of smoking-cessation mCM mobile phone apps that 
have been used in several IRB-approved studies (PRO0031703, PRO0050835, PRO0048990, 
PRO0061683, PRO0062101) with expert input from Dr. Miriam Morey. Dr. Morey is a Professor 
in the Duke University Department of Medicine and the Associate Director of Research at the 
Durham VA Geriatric Research, Education, and Clinical Centers. Dr. Morey is an exercise 
physiologist and her specialization is in the design and execution of behavioral clinical trials of 
physical activity.  
 
We have modified the app to include physical-activity monitoring components and feedback. 
Step-tracking will be implemented via a Fitbit Flex 2 fitness tracker. The Fitbit Flex 2is a light-
weight wristband capable of tracking physical activity, including steps. Data are transmitted 
from the Fitbit Flex 2to the smart phone via Bluetooth technology and the Fitbit Flex 2 App. Our 
STEP UP mobile app will pull the data from Fitbit’s servers and integrate the data with smoking 
cessation data so that participants and study staff can monitor progress towards step goals. 
Within the STEP UP app, progress toward daily step goals will be conveyed twice daily at semi-
random intervals and will also be available on-demand. The mCM manual includes the 
participant instructions, payment schedules, and app screenshots. 
 
The CO breath monitor to be loaned to participants is the Bedfont/coVita iCO™ Smokerlyzer®. 
The device is a battery operated instrument that measures CO in ppm 
(http://www.bedfont.com/shop/smokerlyzer/ico_smokerlyzer). The Bedfont/coVita iCO™ 
Smokerlyzer® plugs into a smart phone by means of the headphone jack, and communicates 
with the smart phone app developed by our team. Participants are able to see the CO reading 
within the app, and the app collects the CO data directly. Data are stored in the same manner as 
the videorecordings that participants upload (see below and in “Protection From Risks: Data 
Security” herein).   
 
With regards to FDA device issues, Bedfont/coVita will not be seeking 510k Clearance on the 
iCO™ Smokerlyzer® because it does not meet the standard/criteria of a medical device. Device 
manufacturers are required to follow FDA guidance to inform them of when a device 
necessitates 510k application. Per Jason Aversano at Bedfont/coVita, their regulatory team has 
determined that this is not necessary primarily because they do not make a medical claim about 

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the device, as it is not designed to diagnose a disease or illness. Simply measuring CO is not 
diagnosing a disease or illness and Bedfont/coVita makes no medical claim that the iCO™ 
Smokerlyer® can be used to screen for CO poisoning.  
 
Text Messaging Within the App.  Our group has developed a text-messaging support library for 
smoking cessation in collaboration with the Department of Veterans Affairs (VA) Public Health 
Group and NCI (US Department of Veterans Affairs & National Cancer Institute, 2013). This 
library is in use by the VA and was launched nationwide May 2013. As of June 1, 2015, 2,867 
smokers had enrolled in the SmokeFreeVET smoking-cessation program that utilizes this support 
library. We will also use a physical-activity text-message library developed by Drs. Beckham and 
Morey that is currently being used by the GetFitVET program, an 8-week exercise intervention 
for veterans. Pilot data was collected from 10 lower-income individuals ranging from 23 to 65 
years old who were interviewed regarding the content and wording of the individual messages 
and keywords in the library. All reported using a cell phone, with the majority using text-
message communication daily. Qualitative data from these participants were used to modify the 
messages and keyword categories (e.g., framing messages from a positive stance, shorten 
messages). We recently completed a second pilot study with 15 participants, 5 earning under 
$30,000 annually. According to this study, messages providing encouragement were endorsed 
over those detailing the benefits of exercise and those pertaining to goal-setting.  
 
Mobile CM Procedures. Participants will use the smart phone app, CO monitor, and Fitbit Flex 2 
wristband step-tracker to participate in the contingency management portion of the study. The 
STEP UP intervention includes (1) a 1-week training period in which participants are 
compensated simply for uploading videos and wearing the wristband step-tracker, (2) a 4-week 
period of active mCM in which they are compensated based on their own CO readings and 
physical-activity levels (i.e., meeting step goals), and (3) a 1-week fading period in which 
participants are compensated for uploading videos, regardless of their CO readings, and for 
wearing the wristband step-tracker, regardless of steps taken. Reinforcement amounts are 
detailed in the mCM manual provided to participants. Participants will be eligible to earn up to 
$798 across the 6-week intervention and monitoring period. 
 
After the one-week training period, participants will be compensated for CO readings suggesting 
abstinence and wearing the step-tracker, and will be rewarded a bonus for abstinent CO 
readings + reaching step goals established by the counselor. Because reinforcers are most 
effective when delivered immediately after the target behavior is performed (Lattal, 2010), the 
phone app is designed to allow therapists to provide quick feedback on abstinence status, 
financial amount earned, and how the amount was calculated.  
 
In order to verify smoking abstinence, participants will use the smart phone app to provide 
video recordings of him/herself taking CO readings. For each video recording, participants will 
be asked to 1) begin a recording using the smartphone device; 2) breathe in and hold his/her 
breath for the duration of the countdown shown on the screen; 3) when prompted, expel all air 
from lungs into the CO monitor while being video-recorded; 4) hit submit to upload the 
encrypted video recording using encrypted network connections to the secure server. 
 
Through the smart-phone app, participants log-in to a secure website to upload their video 
recordings and see personalized information regarding their reinforcement information. Study 
coordinators can monitor validity and compliance on a daily basis and offer feedback to ongoing 

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participants regarding compensation so they are well-practiced at the procedures by the time 
contingent reinforcement is initiated. During the practice week, participants will be 
compensated $1 (twice per day) for a valid smoking reading. After the practice week, monetary 
reinforcement becomes contingent on abstinence, operationally defined as CO readings that are 
< 6 ppm (after the first week). In the first week of abstinence, smoking cessation compensation 
will be based not on CO < 6ppm, but on a proportion of participant’s baseline CO as defined by 
Lamb (Lamb, Morral, Kirby, Iguchi, & Galbicka, 2004). Because an escalating, versus a fixed 
reinforcement schedule has produced higher abstinence rates (Heil et al., 2008; Stoops et al., 
2009), an escalating schedule will be used in this protocol. 
 
With regards to reinforcement for physical activity, participants are reinforced $1 each day 
he/she wears the step-tracker. In addition, participants will be assigned daily step goals derived 
based on baseline practice-week activity level. Participants recording under 5,000 steps per day 
at baseline will be given an initial goal of increasing their daily steps by 500 steps during the first 
week (Tudor-Locke & Bassett, 2004; Tudor-Locke, Craig, Thyfault, & Spence, 2013). Participants 
recording 5,000 steps or more per day will be given an initial goal of increasing their daily steps 
by 1,000 steps. Daily step goals will increase accordingly each week (i.e., by 500 steps per day if 
under 5,000 or by 1,000 steps per day if 5,000 or over; Tudor-Locke & Bassett, 2004; Tudor-
Locke, Craig, Thyfault, & Spence, 2013). If participants fail to reach daily step goals 4 of 7 days of 
a given week, their daily step goals will not be increased the following week. Participants who 
meet their step goal on a given day will receive a bonus if they have also remained abstinent 
from smoking. Failure to meet the daily step goal will result in the normal abstinence-contingent 
payment without the bonus. No reward will be provided for participants who meet their daily 
step goal but fail to demonstrate abstinence, as the primary goal of the intervention is to 
increase exercise in the service of promoting smoking cessation.  
 
Participants will be asked to return the smart phone and fitness tracker at the end of the 
treatment period. Participants will be allowed to keep the CO monitor since it has a limited 
number of uses. To ensure that participants return the phone and fitness tracker, we are 
providing postage paid return mailers and adding a $50 incentive for equipment return. 
 
Cognitive Behavioral Therapy for Smoking Cessation. Both the STEP UP and comparison 
condition will receive a participant manual and 5 sessions of cognitive-behavioral telephone 
counseling focused on smoking-cessation and increasing physical activity. The smoking-cessation 
content is consistent with the Public Health Service Clinical Practice Guide, and is the same used 
in our published pilot studies and currently funded mCM trials (R01CA037220; 1I01HX001109; 
1I01RX001301). The physical-activity portion of the manual and participant workbook are based 
on telephone-counseling content used in clinical trials exercise interventions run by Dr. Morey at 
Duke University Medical Center and the Durham VA Medical Center.  
 
Pharmacotherapy for Smoking Cessation. Treatment will include standard pharmacotherapy for 
smoking cessation. This consists of bupropion, nicotine patch, and an 8-week course of < 2 
rescue methods (i.e., nicotine gum or lozenge) in participants who are medically eligible to take 
them. Participants will begin bupropion use two weeks prior to the scheduled quit date, and will 
be asked to continue using the medication until the 6-month follow-up. Participants will be 
screened for suitability for NRT and bupropion. If any participant reports a contraindication to 
NRT or bupropion and reports having a primary care physician, the study coordinator and/or 
study physician, Scott Moore, MD, PhD, will attempt to contact the physician for medical 

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clearance. If no contact from the primary healthcare physician can be made, the participants' 
health information will be evaluated by the study physician, Scott Moore, M.D., Ph.D., who will 
provide medical clearance (or not) to participate in the trial and to use smoking-cessation 
pharmacotherapy. Study medications will be provided via mail. 
 
Text-Messaging Support. Text-messaging support has been shown to provide a small effect on 
decreasing smoking and increasing physical activity. Both arms will receive text messages via the 
app (i.e., not via a SMS paid plan). Specifically, participants will receive one smoking-cessation 
and one physical-activity message (randomly selected from a general library that includes 178 
messages) per day during the intervention period. Text messages will be delivered as part of the 
smart phone app. Participants will also receive content-specific messages upon entering key 
phrases (i.e., “no time”, “bad weather”, “pain”, “cravings”, “smoked”, “stress”) associated with 
83 additional messages.   
 
Post-Treatment Session and 3-Month and 6-Month Follow-Up. To eliminate the burden of 
travelling to study appointments for assessments, telephone surveys will be conducted at the 
end of the mCM/mobile assessment phase. At that phone visit, participants will complete 
measures (read aloud by study coordinator) about treatment acceptability, smoking, medication 
adherence, self-efficacy to quit/remain quit, and physical activity.   
 
Participants will be contacted by phone at 3- and 6-months post-screening visit. During the 
phone visit, participants will complete measures (read aloud by study coordinator) about 
smoking, medication adherence, self-efficacy to quit/remain quit, and physical activity. If 
participants report smoking abstinence at the 3 and 6-month follow-ups, they will be asked to 
come to the laboratory to provide a saliva sample and CO reading to bioverify smoking 
abstinence. If any participant is unable to come to the laboratory, he/she will be asked to 
provide a saliva sample by mail. When saliva is collected by mail, participants are sent 
instructions, saliva vials, a brief tobacco use assessment (that includes use of nicotine 
replacement therapies in the prior week), and a postage-paid padded envelope for returning the 
sample to the study coordinator. At each time point, any participant who provides a saliva 
sample will be paid $50. All sample identification will be with an assigned study number rather 
than patient identifiers. Saliva samples will be mailed to Salimetrics, LLC for cotinine assay (see 
“Smoking-Cessation Outcome Measures and Biochemical Verification” herein). 
 
Participant Reimbursement. Participants who drop out will receive partial reimbursement for 
the time and effort they devote to the study. Because monetary reinforcement is an essential 
part of the intervention we are studying, participants will receive payments as reinforcers during 
treatment in addition to payments they receive to compensate for their time and effort on the 
study. Participants are paid: 1) $100 for completion of the screening visit and mCM training; 2) 
up to $798 for mCM; 3) $50 for equipment return at the end of treatment; 4) $25 each for the 
assessments at 3- and 6-month follow-up; and 5) $50 (each) for provision of saliva samples at 3- 
and 6-month follow-up. Participants could be paid up to $1098 for their complete participation.  
 
Study Measures 
 
Table 2 outlines measures to be given at each time point in the study.  
 
 

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Table 2. Study Measures and Schedule of Administration 
 
Baseline 
Weekly 
PT* 
3 Months 
6 Months 
Background Variables 
Demographics 
X 
 
 
 
 
Fagerström Test of Nicotine 
Dependence 
X 
 
X 
X 
X 
Minnesota Nicotine Withdrawal Scale 
 
 
X 
X 
X 
General Smoking History Questionnaire 
X 
 
 
 
 
NRT & Bupropion Contraindications 
X 
 
 
 
 
Stanford 7-Day Physical Activity Recall 
X 
 
X 
X 
X 
Intrapersonal Variable 
Short Form 36 Health Survey 
X 
 
X 
X 
X 
Global Self-Efficacy for Quitting 
Smoking 
X 
 
X 
X 
X 
Readiness-to-Change Questionnaire 
X 
 
X 
X 
X 
NRT & Bupropion Self-Efficacy 
X 
 
X 
X 
X 
Physical Activity Self-Efficacy 
X 
 
X 
X 
X 
Social Support 
X 
 
X 
X 
X 
Positive and Negative Affect 
X 
X 
X 
 
 
Physical Vigor 
X 
X 
X 
 
 
Process Measures 
Treatment-Acceptability Survey 
 
 
X 
 
 
Use of Smoking-Cessation Aids 
 
X 
X 
X 
X 
Morisky Adherence Questionnaire 
 
X 
X 
X 
X 
Outcome Measures 
Prolonged Abstinence: 7-day 
 
X 
X 
X 
X 
Prolonged Abstinence: 30-day 
 
 
 
X 
X 
Quit Attempts 
 
 
X 
X 
X 
Timeline Follow-Back-Quit Attempts 
 
 
X 
X 
X 
Steps (Assessed by Step-Tracker) 
X 
X 
X 
 
 
*Post Treatment 
 
Demographic Measures. Age, race, gender, marital status, education, employment status, travel 
time, cell and smartphone use will be collected from each participant at baseline. 
 
Physical Activity-Related Measures. The Stanford 7-day Physical Activity Recall (PAR) Scale (Sallis 
et al., 1985) will be used to quantify total engagement in physical activity at baseline, post-quit, 
3-month follow-up, and 6-month follow-up. During the mobile monitoring period (baseline, 
treatment, and 1-week post-treatment) mean daily steps will be collected remotely and 
tabulated each week. 
 
Smoking-Related Measures. The Fagerström Test of Nicotine Dependence (FTND; Heatherton, 
Kozlowski, Frecker, & Fagerström, 1991), Minnesota Nicotine Withdrawal Scale (Hughes & 

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Page 10 of 21 
Hatsukami, 1986), and a general smoking history questionnaire (e.g., number of cigarettes 
smoked/day, age of first smoking, number of previous quit attempts, living with a smoker) will 
be used to measure smoking behaviors. Participants will be asked to respond to several 
questions to determine if he/she has contraindications to receive smoking-cessation 
medications. 
 
Quality of Life. Physical- and mental-health quality of life will be measured at baseline, post-
treatment, and at 3- and 6-month follow-ups using the Short Form 36 Health Survey (Ware & 
Sherbourne, 1992).  
  
Self-Efficacy, Readiness to Change, and Social Support. A single item (“How confident are you 
that you will be able to quit smoking?” 1 = “Not at all confident” to 4 = “Very confident”; 
Shiffman et al., 2000) will be used to measure global self-efficacy for quitting smoking at 
baseline, post-treatment, 3-month follow-up, and 6-month follow-up. The use of a global 
measure of SE is supported by previous studies in which multiple-item SE questionnaires formed 
a unifactorial construct (Baer, Holt, & Lichtenstein, 1986). The Readiness-to-Change 
Questionnaire (RCQ; Rollnick, Heather, Gold & Hall, 1992), which is designed to assess attitudes 
toward quitting smoking (Heather, Rollnick, & Bell, 1993), will also be administered at those 
time points. Self-efficacy for taking NRT and bupropion as prescribed will be assessed on a 10-
point Likert scale. Self-efficacy for increasing physical activity will be similarly assessed on a 10-
point Likert scale. Social support will be assessed using a single item used in the NIH PROMISE 
study (Williams et al., 1992): “Do you have someone you feel close to, someone you can trust 
and confide in?”  
 
Affect and Physical Vigor. Positive and negative affect and physical vigor will be quantified at 
baseline, each week during the 6-week intervention and monitoring period, and at post-
treatment. Positive and negative affect will be measured using 2 Likert-scale items: “During the 
past week, to what extent have you felt positive (e.g., happy, proud, excited)/negative (e.g., 
angry, irritable, upset)?” Responses range from 1 (“Very slightly or not at all”) to 5 
(“Extremely”). Physical vigor will be measured using 5 items from the Shirom-Melamed Vigor 
Measure (Shirom, 2003). Participants will be prompted to indicate how often they have felt each 
of the following during the past week: “I feel full of pep,” “I feel I have physical strength,” 
“Feeling vigorous,” “I feel energetic,” and “Feelings of vitality”, with responses ranging from 1 
(“Never or almost never”) to 7 (“Always or almost always”). 
 
Measures of Treatment Acceptability. Participants’ satisfaction with the intervention will be 
assessed via an in-depth interview, including 17 Likert-scale survey items, at the end of 
treatment. These items will assess: 1) reactions to the topics discussed and skills reviewed; 2) 
comfort with the counselor; 3) opinions of the materials used in session and homework (e.g., 
participant workbook); 4) overall satisfaction with the intervention at that point in time; and 5) 
comfort with the mHealth applications (mCM for smoking cessation and physical activity and 
supportive messaging).  
 
Measures of Treatment Feasibility and Adherence. Feasibility of participant retention will be 
assessed by detailed tracking of attendance at each treatment session. Measures will include 
number of counseling sessions completed, the number of missed or cancelled appointments, 
and the proportion of participants who withdraw/drop out or are lost to follow-up. Participants 
who withdraw from treatment will be contacted to elicit feedback on their reasons for dropping 

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out. Feasibility of the use of the mHealth applications will be assessed by tracking: 1) the 
proportion of required videos uploaded using the mCM app; 2) participants use of the text-
messaging keywords; 3) information regarding lost or stolen cell phones; and 4) participants’ use 
of and comfort with the mHealth apps at the beginning and end of the intervention. We will also 
assess the number of participants who have a) mobile smart phones and b) current subscription 
to and size of mobile data plans (which will inform budgeting for a larger trial). 
 
Medication adherence to NRT and bupropion will be assessed. Individuals who are optimally 
adherent have been found to be more than twice as likely (52%) to be abstinent at 6 months 
than were those with lower adherence (25%; Catz et al., 2011). Optimal adherence will be 
defined as using > 80% of their NRT and bupropion. The primary self-report measure of 
adherence will be the number of days NRT (and bupropion if prescribed) are used during the 
study period. Participants will also complete the Morisky Adherence Questionnaire (Morisky, 
Green, & Levine, 1986). This 8-item questionnaire is a general adherence measure that produces 
unintentional and purposeful non-adherence subscales. The questionnaire has been validated 
with smokers as an adherence screening measure (Toll, McKee, Martin, Jatlow, & O’Malley, 
2007) and as a post-treatment measure of adherence (Catz et al., 2011). Days of medication use 
will be recorded at each telephone session and follow-up during treatment, post-treatment and 
3- and 6-month follow-ups (for bupropion). 
 
Smoking-Cessation Outcome Measures and Biochemical Verification. Our choice of primary and 
secondary smoking endpoints follows recommendations by the Society of Research on Nicotine 
and Tobacco (SRNT; Hughes et al., 2003). Self-reported and bio-verified prolonged abstinence at 
the 3- and 6-month follow-ups will be the primary endpoints. Prolonged abstinence will exclude 
tobacco use in the first 2 weeks following the quit date (Hughes et al., 2003). Self-reported 
prolonged abstinence will be verified by cotinine assay. CO and saliva samples will be collected 
from participants who report prolonged abstinence at each follow-up. Saliva samples will be 
sent to the Duke University Nicotine Research Program to be analyzed for the presence of 
cotinine using a standard cut point of 10 ng/ml to determine abstinence. A blind sample of 5% 
will be rerun to assure test accuracy of saliva samples. Secondary smoking outcomes will include 
7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as 
no tobacco use in the prior 7 or 30 days respectively. Additionally, participants will be asked if 
they have made one or more quit attempts in each follow-up period using a time-line follow 
back method (Lewis-Esquerre et al., 2005). We have recent experience using this method to 
assess daily smoking behavior (Carpenter et al., 2015).  
 
Potential Risks 
 
There is a risk of discomfort or distress in answering questions on the study measures. However, 
distress and discomfort related to questionnaire completion is usually temporary and well-
tolerated. Risks also include discomfort related to quitting smoking. Quitting smoking may cause 
difficulty concentrating, poor sleep, increased appetite, anxious or depressed mood, and craving 
for cigarettes. Participants will be offered NRT, and there are risks associated with the use of 
NRT. Minimal risks associated with wearing a nicotine patch include skin irritation, dizziness, 
lightheadedness, increased heart rate or blood pressure, nausea or vomiting. If a participant 
indicates a contraindication to NRT (e.g. uncontrolled hypertension), medical clearance for NRT 
will be sought from the participant’s primary care physician and/or the study physician. If a 
participant with a seizure disorder, history of or current hepatitis and/or cirrhosis, renal 

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impairment, and/or uncontrolled diabetes wishes to enroll in the study, he/she will not receive 
contraindicated medications.  
 
Participants who are medically eligible will also be prescribed bupropion SR. Risks of bupropion 
use include dry mouth, insomnia, nausea, constipation, headache, shakiness or jitteriness, skin 
rash, sweating, allergic reaction, change in appetite, weight loss, dizziness, tremor, thinking 
abnormally, hot flashes, worsening depression or suicidal thoughts and behavior, and ringing in 
the ears. At the highest dosage of bupropion to be used in this study, seizures occurred in 1 out 
of every 1000 (0.1%) who took this drug. Participants are informed that they are not required to 
take bupropion, and will be allowed to participate in the study if they refuse to do so.  
 
The risk of doing moderate exercise is low, and may be associated with risk of injury, falls, 
fainting, dizziness, or muscle soreness. There is even the risk of sudden death or stroke. To 
minimize these risks during exercise, participants will be instructed to exercise at a comfortable 
level and to never push themselves to a point beyond where they feel safe. Participants will also 
be monitored and instructed to report symptoms such as unusual shortness of breath, dizziness, 
tightness or pain in the chest or arms, skipping heart beats, numbness, loss of balance, nausea, 
or blurred vision. 
 
There is a potential risk associated with the loss of confidentiality of study data. Specifically, 
collection and transfer of videotaped carbon-monoxide monitoring have risks with regards to 
privacy and confidentiality. Please see “Protection Against Risk and Data Security Measures” for 
details on reduction of risk with regards to the proposed videotaping. 
 
Protection Against Risk and Data Security Measures 
 
While participants may benefit from quitting smoking and increasing physical activity, there are 
no guaranteed benefits to the individual participant and no immediate benefits of the proposed 
research to others. There are potential benefits to others from the information generated that 
potentially will be helpful in developing new combined treatments for smoking and physical 
activity. In our opinion, the anticipated benefits of this study outweigh the potential risks.  
 
The study is completely voluntary and participants are informed that they are free to refuse to 
answer any items on the questionnaires or questions from the interview that they do not wish 
to answer. They are also informed that they are free to decline participation in any procedure 
and can withdraw from the study at any time. 
 
Potential risks will be minimized by carefully screening potential participants according to the 
inclusion/exclusion criteria, closely monitoring symptom levels, and following established 
laboratory procedures associated with participant safety.  
 
We have included at the end of this full protocol a data flow diagram that describes data 
movement within the study. We will be providing the study phones to participants for the 
course of the monitoring period and will retrieve them at the conclusion of monitoring. Phones 
will be equipped with the STEP UP mobile app developed by our team, and with Fitbit Flex 2 App 
to allow data to be transferred to Fitbit’s servers. Their API states that they use OAuth 2.0 to 
authenticate API requests and that must be done over secured (SSL/TLS) connections. 

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Participant data that is updated to Fitbit’s servers will be deidentified, and no actual participant 
information will be provided to Fitbit in order to set up the accounts.  
 
On the smart phones, we will restrict access to the following applications: internet browsers, 
installation of apps, deletion of apps, and in-app purchases. We will prevent access to music, 
podcasts, movies, TV shows, apps, and other websites. We will prevent ability to change the 
following: accounts, cellular data use, background app updates, location services, contacts, 
calendars, reminders, photos, Bluetooth sharing, microphone, Twitter, Facebook, and 
advertising. We will have the ability to remotely wipe the phones if they are not returned. We 
will encourage participants via consent to only enter information on the phone that they are 
comfortable with sharing with the entities listed below.    
 
Regarding mobile information security, we have taken care in previous projects using similar 
methods and technology to develop procedures to limit the risk of breach of confidentiality and 
privacy. For example, the smart phone is programmed such that a staff member will set up the 
telephone and enter the participant’s code into the phone. When uploading a video, 
participants upload directly from the phone to an approved website that has been vetted by 
Duke’s information security officers, and the phone programming ensures that the video is 
uploaded into the correct participant’s area of the website. This ensures that study participants’ 
data is stored in the correct place, and that study participants cannot view any other 
participants’ data. Participants are asked to review their videos before posting, and they can 
choose not to upload any video that they do not wish to upload for any reason. In previous 
studies that have been run using this methodology, we have had no participant complaints 
regarding issues of privacy and confidentiality related to use of the smart phone videotaping 
procedures. In order to enhance participants’ privacy, we will restrict access to several of the 
telephone’s ancillary applications, and we have the ability to remotely delete data from any 
phones that are not returned to the study team. 
 
For the study’s website, we will use shared server space provided by InMotion Hosting, Inc 
(website www.Calhounlab.com). We will be using AES-256-CBC encryption with SHAI for 
message authentication and RSA as the key exchange mechanism. The video recordings will be 
collected on devices that are FIPS-140-2 compliant. The data at rest at InMotion Hosting is AES-
256 encrypted at rest, and the data being transferred are encrypted at transfer (AES-256). Data 
will be unencrypted only by study staff members who have access to the secured server at 
InMotion Hosting; the encryption key is held only by our staff. This will ensure all video uploads 
and data that the participant sends over the internet via their phones will only be transferred 
over encrypted network connections, essentially nullifying the possibility of someone gaining 
access to the video before it reaches our server. InMotion also runs audits regularly of the 
websites hosted within their shared servers to prevent scriptside vulnerabilities, as well as 
having a 24/7 support team monitoring their servers. The web application written for this study 
has been checked for SQL injection, Code Injection, XSS, and RFI vulnerabilities and has passed. 
The site will only be accessible by the study participants and the study coordinators via 512-bit 
SHA-2 hashed passwords. 
 
In previous studies using this methodology that have been run in the Traumatic Stress and 
Health Research Laboratory, we have had no participant complaints regarding issues of privacy 
and confidentiality related to use of the smart phone videotaping procedures. As security 
controls have not been validated for InMotion Hosting, we will include a statement in the 

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Page 14 of 21 
informed consent that the data/videos voluntarily submitted will be sent to InMotion and are no 
longer covered by Duke privacy protections. 
 
Data that links participants to information collected in the course of a given study will be kept 
separately from identifying information in an electronic, password-protected MS Access 
database stored at duhsnas-pri\dusom_psych\private\Beckham Logs\STEP UP; the key 
connecting identifying information and data will be stored here as well. Hard copy paper records 
will be stored in a locked filing cabinet in the study coordinator’s locked office, within Dr. 
Dennis’ laboratory space at Hock Plaza. Information from the interview and/or questionnaires 
may be entered into a computerized database that will be stored on the DUMC server at 
duhsnas-pri\dusom_psych\private\ Beckham Logs\STEP UP in a password-protected database 
separate from the “logbook” of identifying information. This database is accessible only by Dr. 
Dennis and study staff. Any staff members who leave the study for any reason will have access 
to study resources, including data, removed immediately. 
 
Data and Safety Monitoring Plan 
 
Quitting smoking and increasing physical activity should enhance rather than jeopardize health 
status, and potential serious adverse events (SAEs) for participants in this project are not 
expected. Regardless, we will minimize potential risk by careful screening of potential 
participants (e.g., medical clearance by their primary care provider if there are contraindications 
to smoking cessation pharmacotherapy).  
 
Dr. Dennis will serve as the primary safety monitor for the proposed study, and Scott Moore, 
M.D., Ph.D. will serve as the study physician and Medical Monitor. As Medical Monitor, Dr. 
Moore will provide additional safety monitoring with regards to medication use. Dr. Moore is a 
board-certified psychiatrist with years of experience in the provision of smoking cessation 
services. He has served as the medical director of the Durham VA Medical Center’s smoking 
cessation clinic, and has served as a study physician on several smoking cessation studies run by 
our group. As study physician, Dr. Moore will ensure participants are medically cleared to 
participate in this trial and will review all reports of adverse events sent by the study 
coordinator and evaluate the patient as necessary to determine whether there is any corrective 
action needed. Dr. Moore will review all reports of adverse events sent by the study coordinator 
and determine whether there is any corrective action to be taken. 
 
Further data safety and monitoring will be provided by the PI. There will be several ongoing 
mechanisms for monitoring and reporting of adverse events (AEs), including serious adverse 
events (SAEs): 1) ongoing participant contact via study personnel; 2) a telephone number 
provided to participants to report concerns related to study participation; 3) weekly meetings 
between Dr. Dennis and study personnel. 
 
The PI will meet at least weekly with study personnel to discuss participants’ reactions to the 
intervention, proper delivery of the intervention, and any adverse events or unanticipated 
problems. Regular meetings between investigators and the project manager will allow for 
ongoing progress reports, including the number of participants currently involved in the study 
groups, attrition rates, and scheduled data collection from participants, as well as notification 
and review of any AEs. Safety monitoring for AEs will be conducted in real time by the PI and/or 
project manager. The following information about adverse events will be collected: 1) the onset 

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and resolution of the AE, 2) an assessment of the severity or intensity (use existing grading 
scales whenever possible), 3) an assessment of the relationship of the event to the study 
(definitely, probably, possibly or not related), and 4) action taken (e.g., none, referral to 
physician, start or increase concomitant medication). The PI will determine the severity of the 
event, will assign attribution to the event, and will monitor the event until its resolution. Any 
adverse events will be reported to the IRB in accordance with the IRB guidelines.  
 
In order to monitor possible adverse events, participants will be instructed to report any 
adverse effects of study participation as soon as possible to research staff; they will have 
contact information needed to report these problems to study personnel. Participants will also 
be questioned about any side effects of the study medications (i.e., nicotine replacement 
therapy and bupropion) to further monitor any adverse reactions.  
 
Outcome Measurement and Biochemical Verification 
 
Self-reported and bioverified prolonged abstinence from smoking at the 3 and 6-month follow-
up will be the primary end-point. Prolonged abstinence will exclude tobacco use in the first two 
weeks following the quit date to give participants time to achieve initial abstinence (Hughes et 
al., 2003). Self-reported prolonged abstinence will be verified by cotinine assay, a metabolite of 
nicotine in the saliva. Saliva samples will be collected from participants who report prolonged 
abstinence at each follow-up. They will be mailed to Salimetrics LLC for saliva cotinine assays. 
Saliva samples will be analyzed for the presence of cotinine using a standard cut point of 10 
ng/ml to determine abstinence. A blind sample of 5% will be run again to assure test accuracy of 
saliva samples. Secondary smoking outcomes will include 7- and 30-day point prevalence 
abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 
30 days, respectively. 
 
Data Analyses 
 
Descriptive statistics will be used to summarize all study variables, including smoking history and 
current use, nicotine-dependence level, self-efficacy, readiness to change, and social support. 
For continuous variables, means, standard deviations, ranges, and histograms will be generated. 
For categorical variables, frequencies and proportions will be generated. Individual and mean 
trajectory plots of the longitudinal outcome variables will be constructed to understand their 
general trends over time (i.e., post-treatment, 3- and 6-month follow-ups). We will examine all 
variables to determine if parametric distributional assumptions (e.g., normality for the 
continuous variables) are valid. Variables not meeting distributional assumptions will either be 
transformed or modeled using non-parametric or semi-parametric methods (e.g., quasi-
likelihood methods; McCullagh & Nelder, 1989). In order to describe the compliance/completion 
of the sample in terms of smoking-cessation aids and intervention completion, these variables 
will be summarized. In terms of descriptors for outcome measures, we will record number of 
quit attempts, quality of life, and number of weekly steps, and utilize time-line follow-back data 
to identify when participants may have lapsed. Potential covariates (e.g., age, gender, minority 
status) will be evaluated for inclusion in models. If any of these variables have a significant 
bivariate effect on treatment outcomes, they will be entered first in statistical models. 
  
Missing Data. Because the main predictors of interest, treatment group and demographics, are 
collected at baseline, we do not anticipate much missing data. We do, however, anticipate 

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missing values in the longitudinal outcomes owing to dropout, an inability to reach participants, 
or item non-response. Multilevel modeling (MLM), which employs maximum and pseudo-
maximum likelihood estimation, is proposed to address this issue. MLM uses all available data; 
as such, it can accommodate data missing at random. Because individuals with the least missing 
data have the most influence on model results, analyses will be conducted to determine 
whether missingness is systematic (i.e., associated with individual differences in either baseline 
parameters or time-related changes in observed variables). If data are deemed not to be missing 
at random, additional approaches to deal with missingness in the response will also be explored, 
including imputing missing values by multiple-imputation procedures as described by Schafer 
(Schafer & Graham, 2002).  
 
The feasibility and acceptability of STEP UP will be assessed. Content analysis of the cohort 
interviews will yield descriptive data regarding participants' perceptions of specific components 
of the treatment at each development phase. Participant feedback will be used to evaluate the 
user experience so that the phone app and counseling procedures can be enjoyable to the 
target population. We will describe participant recruitment (proportion of participants 
screened/enrolled), participant treatment retention (number of sessions completed, drop outs). 
Acceptability of STEP UP will be assessed via descriptive analyses of the ordinal-level outcomes 
on the treatment-acceptability survey completed at the conclusion of the RCT. Participants’ 
responses to open-ended questions will be compiled for content analysis. In addition to 
evaluating participant satisfaction, we will describe use of mHealth applications (adherence with 
mCM videos, compliance with wearing the step-tracker, comfort with the app), medication 
adherence, participant smoking-cessation and physical-activity content knowledge before and 
after treatment, and treatment fidelity. All of these data will provide critical information prior to 
planning a larger RCT. 
 
 
 
 

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Data Flow Diagram for PRO00074576 
 
 
 
Data at 
Duke 
Participant 
InMotion 
H
ti
Video-recordings and step 
data are uploaded via smart 
phone app; data are AES-256 
encrypted during transfer 
Data are AES-
256 encrypted 
at rest. 
Data accessed by study team 
at www.Calhounlab.com. 
Only study team members 
have encryption key to 
access data at rest. 
Video-recordings captured 
using Duke managed Droid 
Maxx 2 running Android 
5.1.1 Lollipop with FIPS 140-
2 level encryption, see 
certificate 1998  
Participants receive data re: 
compensation via Duke managed 
device equipped with app developed 
by study team 
Fitbit Server 
Deidentified data are 
collected by Fitbit Flext 2 
fitness tracker and 
transmitted to Flex 2 App via 
Bluetooth technology 
Fitbit Flext 2 UP 
A
Data from Flex 2 App are 
transmitted to Fitbit servers 
Data are downloaded from Fitbit to 
STEP UP app using Oauth 2.0 
authentication over encrypted 
connections 
STEP UP App