Development of a M-Health Smokeless Tobacco Cessation Intervention for Firefighters
Phase: NA
Conditions: Smokeless Tobacco Cessation
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
 
 
Development of a M-Health Smokeless Tobacco Cessation Intervention for Firefighters 
 
Document Date: 2/22/2024 
 
NCT05111041 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
The specific aims are:  
Aim 1: In collaboration with the Professional Firefighters and Paramedics of North Carolina and our 
Advisory board of firefighters, develop a mHealth smokeless tobacco cessation intervention tailored to 
the specific needs of first responders such as firefighters and EMTs / paramedics. Using a co-facilitated 
user centered design approach and guided by the Spiral Technology Action Research Model (STAR) 
Model, we will work with firefighters & EMTS / paramedics to 1) identify and develop intervention 
content, messaging, and m-health modalities for delivery (e.g., text-messaging, text-chat); 2) refine the 
intervention; and 3) conduct usability testing. The outcome of Aim 1 will be a fully developed mHealth 
smokeless tobacco cessation intervention tailored to the unique needs of  first responders (e.g., 
firefighters and EMTs) that is ready for pilot testing. 
Aim 2: To assess the feasibility, acceptability, and preliminary efficacy of the tailored smokeless tobacco 
cessation intervention compared to a usual care control intervention in decreasing smokeless tobacco 
use. This aim will specifically address recruitment and retention to determine feasibility, acceptability as 
measured by the usefulness of the intervention received, and preliminary efficacy of the intervention in 
improving smokeless tobacco cessation at 30-days post intervention completion as measured by self-
reported abstinence from smokeless tobacco use.  This evaluation will be done with 50 firefighters & 
EMTs / paramedics who use smokeless tobacco who will be randomized to the tailored mHealth 
intervention (n=25) or the usual care control (n=25) of a self-help booklet.  Both the intervention and 
control group will be given a 4 week supply of NRT lozenges with instructions of how to use. 
 
 
Background & Significance 
 
Firefighters are at high risk for cancer 
Firefighters and other first responders such as EMTs / paramedics are the front line defense to 
fire, medical, and rescue emergencies and play a critical role in protecting lives and property in our 
communities.  Occupational exposures put firefighters and other emergency medical personnel such as 
EMTs at increased risk for injury and disease.  Firefighters are exposed to both known and suspected 
carcinogens during their work including acetaldehyde, formaldehyde, sulfur dioxide, benzene, toluene, 
and ethylbenzene.  Firefighters are also exposed to flame retardants and plasticizers which have been 
shown to be harmful.  Although exposure is often for short periods of time, exposure levels can be high.   
Occupational exposures put firefighters and paramedics / EMTs at increased risk of developing certain 
types of cancer compared to the general public. A number of studies have examined cancer incidence 
and mortality among firefighters. Results have been inconsistent, but generally indicating elevated risk 
for some cancer types including colon, lung, testicular and head and neck including thyroid.  Lowering 
cancer risk among firefighters is essential to protect those who serve and protect others.  
 
Smokeless tobacco use is a modifiable risk factor for cancer 
It may not be possible for firefighters to avoid occupational exposures with carcinogenic agents; 
however, identifying and minimizing modifiable risk factors, such as tobacco use, has the potential to 
minimize cancer risk. Firefighters use smokeless tobacco at a rate that is higher than the general 
population and the military population. Our preliminary work surveying professional firefighters in 

Central NC found that 14% of firefighters reported smokeless tobacco which far exceeds the general 
population norm in NC (4.5%).  This high prevalence can in part be attributed to non-smoking policies in 
firehouses likely contributing to increased rates of smokeless tobacco use among firefighters.  Even 
though smokeless tobacco does not have the level of toxicity found in combustible tobacco, it is not 
without risk as there are 28 known carcinogens. Smokeless tobacco has been linked to cancer of the 
mouth, esophagus, and pancreas. In addition, smokeless tobacco may increase the risk of mortality from 
heart disease and stroke.  No data is available on the potentially synergistic effect of exposure to 
carcinogens in smokeless tobacco and occupational exposure to cancer-causing compounds.  However, 
reducing rates of smokeless tobacco use among firefighters can reduce cancer risk in this vulnerable 
population.  
 
Firefighters have unique contextual and occupational reasons for smokeless tobacco use 
Smokeless tobacco use is widely accepted among firefighters and is often used on the job, 
perpetuating cultural norms around use in this population. Other unique attributes that may contribute 
to increased use in this population include job stress from dangerous work conditions, sleep deprivation 
and the pressure to stay physically fit. This stress leads to smokeless tobacco use being a form of stress 
reduction or means to mitigate stress among many firefighters.  Cancer fatalism is also common which 
may impede cessation attempts. Many firefighters have adopted an attitude that whatever they do they 
will get cancer and therefore  their motivation is low to change behaviors that are linked to cancer. 
Interventions tailored to these unique needs are needed to increase cessation rates in this population. 
 
Existing smokeless tobacco cessation interventions may not address the specific needs of firefighters 
To date, only one smokeless tobacco cessation intervention (Enough Snuff) has been empirically 
tested and found effective at helping smokeless tobacco users quit. Jitnarin et al recently beta tested 
QUIT SPIT, a culturally tailored version of the 54-page adaption of the Enough Snuff booklet specific for 
firefighters and found the intervention to be feasible and acceptable among those who wanted to quit.  
Firefighters indicated that delivery of the messages via an mHealth platform (app or website) may be 
preferable to the printed version, supporting the significance of our proposed study.  Our current 
intervention is testing an mHealth intervention delivering scheduled gradual reduction (SGR) and 
supportive text messages to smokeless tobacco users interested in quitting. The SGR program has users 
reduce the number of dips per day over 6 weeks by lengthening the interval between dips based on a 
set algorithm. SGR helps mitigate withdrawal symptoms commonly experienced among highly 
dependent chewers by providing even spacing between dips. Further, SGR helps chewers self-regulate 
their behavior and practice restraint strategies in response to tobacco use cues during the reduction 
period prior to quitting.   We have enrolled 12 firefighters in the parent EnufSnuff study to date.  Initial 
reactions to the intervention are positive; however, delivery of SGR to participants who work in shifts 
such as firefighters and EMTs is problematic.   Firefighters work a 10-day cycle with alternating 24-hours 
shifts for 6 days and then 4 days off. Other first responders also work in shifts. Their work also might 
remove the possibility to dip if they are out on an emergency call. This schedule may be a barrier to 
effective engagement with the SGR program.   Through our preliminary work, we have also identified 
cultural norms regarding cancer risk and risk behaviors that could be addressed via supportive text 
messages. More research is needed to develop an mHealth intervention to meet the unique needs of 
first responders, such as firefighters and EMTs who are interested in quitting smokeless tobacco.   

mHealth interventions have the potential to increase the reach and engagement of Firefighters in 
cessation interventions  
mHealth interventions for tobacco cessation have potential to facilitate participant engagement 
and activation by reaching people in the real-world setting. Previous research indicates that features 
which promote engagement (e.g., interactive text messaging) are positively associated with quit rates.  
Following a user-centered design approach and getting input from the target audience is essential for 
developing mHealth interventions that are efficacious and usable. Many mHealth behavior change 
interventions are designed without users in mind thus limiting their potential efficacy. Our proposed 
study will engage firefighters throughout the development process to ensure that the intervention is 
developed to meet their cessation needs. Thus, the potential impact and reach of a user developed, 
mHealth intervention warrants investigation in helping firefighters quit.   
 
Summary  
First responders, such as firefighters and paramedics / EMTs, who use smokeless tobacco 
represent a group vulnerable for tobacco use. Despite their high risk for both tobacco-related and 
occupational-related cancers, this group of smokeless tobacco users has not been widely targeted for 
cessation intervention trials. There are very few interventions available tailored to the unique needs of 
firefighters, and there are currently no mHealth interventions that address smokeless tobacco cessation 
for this population. mHealth interventions have the potential to consistently reach and consistently 
engage many more firefighters who use smokeless tobacco given their varying work schedules, and this 
approach warrants testing in this population. Our proposed study will develop and pilot a mHealth 
intervention to address the unique cessation needs of firefighters who use smokeless tobacco. If 
successful, this pilot will serve as the basis for a larger to trial to test the efficacy of this intervention on a 
larger scale. The proposed study has public health relevance in that the goal is to decrease cancer risk 
among firefighters by increasing access and uptake of tobacco cessation interventions in an 
understudied group of tobacco users. 
 
 
Design & Procedures 
 
In aim 1, the focus was placed on smokeless tobacco cessation intervention with firefighters and EMTs / 
paramedics. We will then test its feasibility, acceptability, and preliminary efficacy. To assure the cultural 
and occupational appropriateness of the intervention, we will recruit n=30 smokeless tobacco users and 
using a participatory, user centered design approach, we will work with firefighters and EMTs to identify 
intervention components and various m-health modalities for delivery (e.g., text messaging, text-chat). 
We will employ a user-centered design guided by the Spiral Technology Action Research Model (STAR) 
Model 23 to develop and refine the intervention, after which we will conduct usability testing by 
observing users interacting with the mHealth intervention. Concurrent think aloud protocols and 
extensive field notes will guide this approach. We will gather feedback through semi-structured 
interviews immediately following use of the intervention program. To evaluate the feasibility and 
acceptability of the intervention we will then recruit 50 smokeless tobacco users and randomize them to 
either the mHealth intervention group (n=25) or the usual care control group (n=25) (Smokeless tobacco 
cessation booklet). We will survey participant’s 30-days after intervention completion. The primary 
outcomes will be feasibility, as measured by the ability to recruit, retain, and engage firefighters in the 

mHealth intervention, and acceptability as measured by self-report usefulness of the intervention. We 
will also assess preliminary efficacy as measured by self-reported abstinence from smokeless tobacco 
use.  
 
 Aim 1: In collaboration with the Professional Firefighters and Paramedics of North Carolina and our 
Community Advisory Board of firefighters, develop a mHealth smokeless tobacco cessation intervention 
tailored to the specific needs of firefighters and other first responders such as EMTs / paramedics. 
Objective: To create a customized smokeless tobacco cessation intervention informed by contextually 
and occupationally relevant data. 
 
Methods and Strategy: We will recruit smokeless tobacco users from a collaborating Central North 
Carolina Fire Department that includes 29 individual fire stations and over 500 Firefighters (See Letter of 
Support). We will also recruit firefighters and EMTs through social media ads that will run nationally in 
the United States.  Inclusion criteria is: 1) 18 years of age and older; 2) Employed as a firefighter or EMT 
/ paramedic; 3) Have used smokeless tobacco for the last year and currently (past 30 days) uses 
smokeless tobacco daily; 4) Have access to a smartphone.  
 
User-centered Design Workshops: To inform intervention development, we will conduct three user-
centered design workshops of up to 10 smokeless tobacco users each at each Fire Department. 
Workshops will focus on: 1) Content development; 2) Content refinement; and 3) Usability testing. We 
will screen those interested in the study for eligibility and obtain contact info to schedule the 
workshops. At the time of the workshop, the study staff will meet with participants who are eligible and 
interested in participating and verbally consent them into the study. The workshop will last 
approximately 60 minutes. The workshop location will be at the firehouse in a private location and/or 
via zoom. When completed in person we will incentivize participants by providing some food before or 
after participation. After each workshop, we will present results to our Advisory Board. 
 
We will use the STAR Model as a framework for developing our intervention during these workshops.  
The STAR model incorporates health promotion theory with systems design approaches using rapid-
cycle change strategies adapted from the organizational improvement research. It involves 5 phases: 
listen, plan, do, study, and act that incorporates stakeholder feedback into technology design.  We will 
start by gathering feedback on unique attributes of smokeless use for firefighters and EMTs / 
paramedics related to occupational factors as well as determine their needs and wants for a mHealth 
cessation intervention. For example, we will ask participants to provide feedback on specifications of 
how shift work contributes to their smokeless use habits and how this type of work may affect 
intervention engagement. We will identify what are salient benefits and barriers to quitting for first 
responders such as firefighters and EMTs. We will also present trigger materials, which include the 
content of messages of our current text-based smokeless tobacco cessation intervention to adapt 
previously successful messaging to the culture and context of smokeless tobacco use among firefighters. 
A moderator will help facilitate the meeting in partnership with one Community Advisory Board member 
from each firehouse. We will audio record each discussion and will transcribe them verbatim. We will 
analyze the transcripts using rapid content analysis to identify themes. We will use the resulting themes 
to inform the intervention development and adaptation using an intervention mapping process.  

After gathering this feedback and incorporating it into the intervention design and content, we will 
present the updated intervention to the firefighters and EMTs in a second workshop to obtain their 
feedback on the design and content. We will use feedback to refine the intervention.  We will then 
conduct usability testing during the third workshop. Usability testing will comprise: 1) observing 
smokeless tobacco users interacting with the intervention, guided by “concurrent think aloud” 
protocols, and taking field notes; and 2) gathering feedback through semi-structured interviews 
immediately following the use of the intervention. Overall usability of the intervention will be measured 
by adapting the System Usability Scale (SUS), a validated tool provided by the US Department of Health 
and Human Services, which consists of 10 items rated from “strongly disagree” to “strongly agree” (e.g., 
“I thought the intervention was easy to use” and “I felt very confident using the  intervention”). 
 
Aim 2: To assess the feasibility, acceptability and preliminary efficacy of the mHealth intervention 
compared to a usual care control intervention in decreasing smokeless tobacco use.  
 
Objective: To determine if the mHealth intervention is feasible and acceptable for smokeless tobacco 
cessation for first responders such as firefighters and EMTs. We will also evaluate preliminary efficacy of 
the intervention in decreasing smokeless tobacco use. 
 
Methods and Strategy: 
Recruitment and Data Collection: We will recruit 50 smokeless tobacco users from collaborating Central 
North Carolina Fire Stations, and from social  media ads that will run nationally in the United States.  
Inclusion criteria: 1) 18 years of age and older; 2) Employed as a professional firefighter or EMT / 
paramedic; 3) Have used smokeless tobacco for the last year and current (past 30 days) smokeless 
tobacco daily use; 4) Have access to a smart cell phone.  
 
Randomization: Eligible participants will be randomized to either the mHealth Intervention (N=25) or 
control (N=25) group. Computerized randomization will be used to deliver a permuted block 
randomization with block sizes of four that will be used to randomly assign participants to one of the 
two intervention groups. The randomization scheme generated by the study statistician will be 
administered using the REDCap system.  
 
Intervention:  
mHealth Intervention: Although the specific content, messaging and delivery strategy will be developed 
with firefighters and EMTs, the proposed mHealth intervention will incorporate evidenced-based 
strategies for cessation and theoretical constructs from the Social Cognitive Theory and the Health Belief 
Model that have been shown to support cessation.   The intervention will contain key steps to quitting 
including: 1) supporting readiness and motivation to quit; 2) setting a quit date and constructing a quit 
plan; 3) dealing with withdrawal symptoms and triggers to use; and 4) maintaining quit status and 
avoiding relapse. 
 
Participants will identify on the baseline survey with would prefer to quit by reduction or by abrupt 
cessation.  All participants will receive support messages and NRT. All participants (including the control 
group) will receive an NRT lozenge guide (to provide to all participants to create a consistent use for all). 
This will be included when  the NRT lozenges  are sent out to each study participant. 

 
Abrupt Cessation: Participants are asked to set a quit date within two-four weeks. This quit date is 
emailed to participants. Participants will receive 8 weeks of messages.   Pre-quit messages will focus on 
health benefits of quitting, building confidence, and making a quit plan.  Post-quit messages will focus 
on dealing with cravings and urges and relapse prevention. 
 
Reduction Cessation: Participants will receive a text at the beginning of each week alerting them to their 
number of dips for each day that week.  They will receive a message reminder in the morning: “Do your 
best to only dip X times today, limit dip in your mouth to 30 minutes.” At the end of each day 
participants will be asked to report how many times they dipped that day. 
 
Text-based Cessation Support Intervention: Participants will receive text-based support messages 2-3 
times per day over ten weeks. The messages are based on constructs of Social Cognitive Theory the 
Health Belief Model and the Theory of Self-regulation. Messages were developed from our pilot work 
with firefighters and address salient features that are associated with smokeless tobacco use in this 
population such as stress. The text-based system with have interactive capabilities, participants can text 
the word CRAVE if they are having a craving and will receive a message to help them deal with the 
craving.   Participants can also text the word SLIP if they have a slip after their quit date and will receive 
a message to get them back on track.  Participants can text MOOD if they need a positive message to 
boost their mood. Finally, participants can text the word CALL, a feature that can be used to address the 
stress that is commonly felt post-call.  Messages will focus around providing mindfulness and deep 
breathing activities to deescalate after participating in a call. 
 
Nicotine Replacement Therapy: We will provide participants via mail nicotine replacement the nicotine 
lozenge at no cost. We will provide a 4 week supply of 4mg Lozenge (mirroring the dose and the length 
to similar studies with smokeless tobacco users) with instructions on how to use. Participants will be 
instructed via text to start their NRT on their quit date. Participants will be instructed to use the 
lozenges every day for 12 weeks. For the first 6 weeks, use 1 lozenge every 1-2 hours. For the next three 
weeks, use 1 lozenge every 2-4 hours. For the last three weeks, use 1 lozenge every 4-8 hours. They 
should not use more than 5 lozenges in 6 hours, or more than 20 lozenges total per day. For any side 
effects potentially related to use of the nicotine replacement, we will instruct participants to stop using 
the lozenge and contact the study phone number to speak to a registered nurse (PI is a registered 
nurse). We will explain side effects that include nausea, light-headedness, headache, poor sleep, mouth 
sores and heart palpitations. We will explain that severe side effects (vomiting, syncope, tachycardia) 
related to use of the nicotine replacement are rare; however, we will make participants aware of these 
and will instruct them to contact the PI (a registered nurse) if they occur.   
 
Usual Care Control: The control arm will receive the Enough Snuff Cessation Booklet. The original 
Enough Snuff Booklet is a self-help cessation intervention endorsed by the NCI in their Research-Tested 
Intervention Programs (RTIPs). 6 The Enough Snuff program has been shown to be efficacious in 
promoting smokeless tobacco cessation in the general population with quit rates ranging from 16-18%. 
 
The Enough Snuff Intervention is a self-help cessation booklet paired with two brief motivational phone 
counseling calls that occur one week after the cessation booklet is sent and the week of the set quit 

date.  The first call focuses on increasing motivation for quitting (e.g. reasons for quitting), setting a quit 
date, and choosing a quit method.  The second call focuses on dealing with tough situations when 
quitting and following through on quit plans. The Enough Snuff program has been shown to be 
efficacious in promoting smokeless tobacco cessation with quit rates ranging from 16-18% and is an 
intervention endorsed by the NCI in their Research-Tested Intervention Programs (RTIPs). For the 
current study we are delivering the program as follows:  
 
Enough Snuff Cessation Booklet: We will provide all control participants with the Enough Snuff Cessation 
Booklet developed by our consultant Dr. Herbert Severson. The manual is organized around four key 
steps to quitting: 1) evaluating readiness and motivation to quit; 2) setting a quit date and selecting a 
quit plan; 3) dealing with withdrawal symptoms; and 4) maintaining quit status.  We will send all 
participants a link to the manual via text-message as well as mailed a hard-copy of the booklet.  
 
Motivational Text-Messages: To deliver the most equivalent intervention to the original Enough Snuff 
Program, we will send participants motivational text messages that map to the content of the phone 
counseling sessions.  One week after the cessation booklet is sent we will text participants twice a week 
for the next 10 weeks. These are separate texts than what the intervention group will receive and 
coincide with the Enuf Snuff booklet.  We will model the messages after the phone content and 
messages will focus on: motivation to quit, setting a quit date, picking a quit plan, motivation to follow-
through with plan and dealing with tough situations when quitting. Messages will refer to the Enough 
Snuff booklet ask for a response from participants. We chose to send text messages to participants 
instead of phone calls as texting is consistent with our mode of contact with participants, less expensive, 
expands our reach, and is highly acceptable according to our pilot work. 
 
Nicotine Replacement Therapy: We will provide participants via mail nicotine replacement the nicotine 
lozenge at no cost. We will provide a 4 week supply of 4mg Lozenge (mirroring the dose and the length 
to similar studies with smokeless tobacco users) with instructions on how to use. Participants will be 
instructed via text to start their NRT on their quit date. Participants will be instructed to use the 
lozenges every day for 12 weeks. For the first 6 weeks, use 1 lozenge every 1-2 hours. For the next three 
weeks, use 1 lozenge every 2-4 hours. For the last three weeks, use 1 lozenge every 4-8 hours. They 
should not use more than 5 lozenges in 6 hours, or more than 20 lozenges total per day. For any side 
effects potentially related to use of the nicotine replacement, we will instruct participants to stop using 
the lozenge and contact the study phone number to speak to a registered nurse (PI is a registered 
nurse). We will explain side effects that include nausea, light-headedness, headache, poor sleep, mouth 
sores and heart palpitations. We will explain that severe side effects (vomiting, syncope, tachycardia) 
related to use of the nicotine replacement are rare; however, we will make participants aware of these 
and will instruct them to contact the PI (a registered nurse) if they occur.   
 
Measures 
 
Feasibility. The feasibility outcomes will be: (a) the number of smokeless tobacco users recruited and 
randomized during the 4-month recruitment period; (b) engagement in the intervention measured by 
the portion of responses to messages that require a response; (c) the retention rates in the mHealth 
intervention compared to the control group at 30-days post intervention completion. We will determine 

the feasibility by: (a) ability to recruit and enroll 50 participants in 4-months; (b) engagement with the 
intervention by having participants respond to at least 75% of messages or engage with 75% of the 
content using both self-report and objective methods. To calculate the proportion of messages read per 
participant, we will use a 5-point Likert scale to ask participants the following questions: “What did you 
typically do when you received a message from the mHealth intervention?” (1= ignored it completely, 
5= read it immediately), “On a typical day, did you read messages you received?” (1= Not at all, 5= read 
the entire message), and On a typical day, did you engage with the intervention you received?”(1= Not 
at all, 5= read the entire message); and (c) ability to retain 80% of the sample at the 30-days follow-up. 
All participants will be given the option to participate in a phone interview with a member of the study 
team to expand on these answers approximately 1 month after their intervention has completed.  
 
Acceptability and Consumer Satisfaction.  To determine acceptability, we will ask the following questions 
using a 5-point Likert scale tailored to each arm of the study: 1) How useful was the intervention in 
helping you to quit smokeless tobacco (1 - Not at all useful, 5 = Extremely useful); 2) whether the 
intervention will change their smokeless tobacco use (1= Will not change at all, 5 = Will change a lot); 3) 
Did the intervention make you think about quitting (1= Not at all; 5 = All the time); and 4) Would you 
recommend the program to a friend (1 = Definitely would not recommend, 5 = Definitely would 
recommend). We will deem the pilot “acceptable” if each question has a mean level of 4 or higher.   
 
Preliminary Impact.   We will measure 7-day point prevalence abstinence at 30-days post intervention. 
We will ask participants: “In the past 7 days, have you used any smokeless tobacco?” and the response 
will be code as no (0) or yes (1).  We will also assess number of quit attempts and if they have been 
tobacco free for 7 days or more at any time during the intervention as secondary outcomes. Any 
participants that claim they have not used tobacco in 7 days will also be given the choice to opt into 
providing a saliva collection sample. Instructions to participants will be sent along with the sample 
collection kits. Samples will be discarded once the nicotine test has been performed.  
 
Sample Characteristics and Other Explanatory Variables. In conjunction with the outcome measures, we 
will collect the following measures to describe the sample characteristics and obtain descriptive 
information regarding these concepts in this population. For this initial study, we want to explore the 
feasibility of obtaining these measures in this population and the current study design and examine the 
heterogeneity of the data. 
 
Demographics.  At baseline, we will assess age, gender, education, marital status, length of time as a 
firefighter or EMT and socioeconomic status (SES). Measures will be adapted from the study team’s 
prior research. 
 
Smokeless Tobacco Use History. At baseline participants will be asked about their smokeless tobacco use 
habit including: number dips/chews per day, age of initiation and number of past quit attempts and past 
use of other tobacco products including electronic cigarettes.  
 
Nicotine Dependence-Smokeless Tobacco. At baseline we will assess nicotine dependence using the 
Severson Smokeless Tobacco Dependence Scale-Short Form (SSTDS). The SSTDS is a validated 

questionnaire that has eight items with a range of scores from 0-19 with higher scores being most 
addicted to nicotine.   
 
Readiness to Quit. At baseline participants will be asked to rate their readiness to quit using oral tobacco 
products. We will use an adaptation of the Contemplation Ladder for smokeless tobacco users that we 
have used extensively in our prior research, which are predictive of quitting tobacco. The participant 
uses a 1-10 scale to rate their readiness to quit, and we have found that a graphic ladder with anchors 
describing levels of readiness at several levels can be easily understood by participants. 
 
Cessation Resources. Participants in both arms will be asked if they accessed government sponsored 
cessation support services, other support for cessation (physician support) or any pharmacotherapy use 
at the 30-day follow-up. 
 
 
Selection of Subjects 
  
Study Sample.  
 
We will target professional firefighters and EMTs who are smokeless tobacco users who live in the 
United States. Inclusion criteria will include: Inclusion criteria is: 1) 18 years of age and older; 2) 
Employed as a professional firefighter (may include volunteer firefighters and EMTs to reach those 
professionals who live in rural areas that do not have paid professionals); 3) Have used smokeless 
tobacco for the last year and currently (past 30 days) uses smokeless tobacco daily; 4) Have access to a 
smartphone. 
 
Projected Enrollment. 
 
We plan to recruit all participants for the current study using established connections between the study 
team and the Professional Firefighters and Paramedics of North Carolina who have expressed interest in 
working with us on the proposed study. We will also include in social media recruitment firefighters and 
EMTs from states within the USA. We will initially target two fire departments in Central North Carolina. 
Should we find that recruitment is still an issue and we need to expand to other local Fire Departments 
we will rely on our Advisory Board to identify other potential local Fire Departments to participate. 
Given this project was developed from an expressed need of firefighters we anticipate we will be able to 
recruit the sample necessary for this study.   
 
Recruitment.  
 
We will recruit 50 firefighters / EMTs who are smokeless tobacco users who live in the USA.  Inclusion 
criteria: 1) 18 years of age and older; 2) Employed as a professional firefighter or EMT (interviews may 
include some volunteers in order to capture very rural areas that do not have paid professionals); 3) 
Have used smokeless tobacco for the last year and current (past 30 days) smokeless tobacco daily use; 
4) Have access to a smart cell phone.  

Randomization: Eligible participants will be randomized to either the mHealth Intervention (N=25) or 
control (N=25) group. Computerized randomization will be used to deliver a permuted block 
randomization with block sizes of four that will be used to randomly assign participants to one of the 
two intervention groups. The randomization scheme generated by the study statistician will be 
administered using the REDCap system.  We will also use a graded compensation for surveys with $15 
for baseline and $20 for 30-days post end of program. 
 
 
Risk/Benefit Assessment 
 
This is a minimal risk study. The only risks are the potential for emotional distress in answering questions 
about smokeless tobacco use and the risk associated with smokeless tobacco use, and the potential loss 
of confidentiality. Every precaution will be taken to minimize these risks, including the ability to contact 
the PI for questions or concerns, and using encrypted devices to record PHI. 
 
All participants may decline to be part of the study and may leave the study at any time without loss of 
benefit to which they are entitled. 
 
The focus groups will be conducted in the firefighers' home station or individually via Zoom. Participants 
in focus groups will be familiar with each other and will be free to respond or not respond. Firefighters 
and EMTs will have the PI's email address and can message if they prefer to respond privately. 
 
Intervention participants may choose the time and the place to take their surveys and respond or not 
respond to Mosio secure text messages. This will ensure their comfort with the privacy available to 
them. All study platforms will be secure and approved by Duke OIT, helping to ensure participant 
response confidentiality. 
 
The potential benefits outweigh risks. Those who participate in the intervention have a high probability 
of benefitting if they decrease or cease using smokeless tobacco. 
 
 
Data Analysis & Statistical Considerations 
 
Descriptive statistics will be used to detail the baseline sample characteristic along with the feasibility, 
acceptability, and preliminary efficacy outcomes. The focus of the efficacy analyses will be on looking for 
a signal of intervention effect rather than statistical significance testing or effect size testing due to the 
small size and exploratory nature of this initial statistically underpowered pilot study. Non-directional 
statistical tests will be conducted, and the significance level will be set at 0.05 per test for this 
preliminary study. For the preliminary efficacy analyses, both intention-to-treat (ITT) and completers 
analyses will be conducted. The ITT analysis will include all participants randomized to an intervention 
group regardless of study or treatment completion, while the completer’s analyses will include only 
those who finish the 30-day post-intervention completion assessment. For the ITT analysis, those who 
do not complete the 30-day assessment will be considered non-quitters.  

Sample Characteristics. Intervention group differences in baseline sample characteristics will be tested 
using Wilcoxon Two-Sample Tests for continuous measures and Fisher’s Exact tests for categorical 
measures due to the small sample size per group.  
 
Feasibility. We will describe recruitment, enrollment, and 30-day follow-up attrition rates, as well as 
engagement with the intervention. 
 
Acceptability. Participants' ratings of (a) the usefulness of the intervention received; (b) extent to which 
the intervention received changed their smokeless tobacco use, (c) whether the intervention made 
them think about quitting, and (d) whether or not they would recommend the program to a friend. We 
will compare intervention group differences in the acceptability using Wilcoxon Two-Sample Tests or 
Fisher’s Exact Tests if when the acceptability ratings are dichotomized.  
 
Preliminary Efficacy. The ST cessation (quit) rate per intervention group at 30-days post-intervention will 
be determined for the ITT and completers analyses using Fisher’s Exact Tests. 
 
Power Analysis. Past ST cessation studies (both text and web-based) have yielded ITT quit rates in the 
12%-20% range. We estimate that the mHealth intervention will yield similar quit rates. We expect that 
the quit rate for the control condition will likely be 5%-10%. Given the expected small to medium effect 
sizes (ORs: 1.44 to 2.47), a sample size of 50 (25/arm) will not provide 80% power to detect a statistically 
significant difference in quit rates with significance set at 0.05. Thus, the efficacy analyses will focus on 
looking for a signal of effect and that the intervention is trending in the right direction.