Development of A Navigation Pilot Intervention to Address the Double Burden of Food Insecurity and Tobacco Use in the Clinical Setting
Phase: NA
Conditions: Smoking Cessation, Food Insecurity
Sponsor: Case Western Reserve University

Study Protocol  
 
Title: An Intervention to Promote Smoking Cessation among Adults with Food Insecurity 
 
ClinicalTrials.gov Identifier NCT05259852 
 
Document Date/Last Updated: January 9, 2023 
 
 
 
 

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Table of Contents 
 
1.0   Objectives .............................................................................................................................................. 3 
2.0   Background............................................................................................................................................ 4 
2.1 Relevant Prior Experience and Gaps in Current Knowledge ................................................................. 4 
2.2 Relevant Preliminary Data ................................................................................................................... 4 
2.3 Scientific Rationale and Significance ................................................................................................... 4 
3.0   Study Endpoints ..................................................................................................................................... 5 
4.0   Study Intervention .................................................................................................................................. 5 
5.0   Procedures Involved ............................................................................................................................... 5 
5.1 Study Design (Overview) ..................................................................................................................... 5 
5.2 Detailed Description of Procedures ...................................................................................................... 6 
5.3 Risk Minimization Procedures and Data Collection Materials .............................................................. 7 
5.4 Type of Data Collected and How Data is Obtained ............................................................................... 8 
6.0 Inclusion and Exclusion Criteria .............................................................................................................. 8 
6.1 Screening Process ................................................................................................................................ 8 
6.2 Inclusion and Exclusion Criteria........................................................................................................... 8 
7.0   Recruitment Methods ............................................................................................................................. 9 
7.1 When, Where, and How Potential Participants are Recruited ................................................................ 9 
7.3 Methods Used to Identify Potential Participants ................................................................................... 9 
7.4 Materials Used to Recruit Participants .................................................................................................. 9 
7.5 Amount and Timing of Participant Payments ....................................................................................... 9 
8.0   Withdrawal of Participants ................................................................................................................... 10 
9.0   Risks to Participants ............................................................................................................................. 10 
10.0 Potential Benefits to Participants .......................................................................................................... 10 
11.0   Data Analysis Plan ............................................................................................................................. 10 
11.1 Data Handling and Security .............................................................................................................. 10 
12.0 Consent Process ................................................................................................................................... 11 
12.1   Process to Document Consent in Writing ....................................................................................... 11 
13.0 References ........................................................................................................................................... 12 
 
 
 

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1.0   Objectives 
Tobacco use continues to be a leading cause of preventable disease and early death. The majority of people 
who smoke are interested in quitting and attempt to quit each year, but successfully quitting can be 
challenging for many reasons. In particular, smoking cessation can be especially hard when smokers are 
dealing with unmet social and health needs and areas of financial stress, which are disproportionately 
experienced by low-income smokers. In this study, we extend previous research showing that food 
insecurity is independently associated with higher odds of smoking and can act as a barrier to quitting 
smoking. Therefore, we design and test a 12-week intervention to assist food-insecure smokers who are 
ready and willing to make a quit attempt. Beyond providing the quit assistance that smokers normally 
receive, the research seeks to address food insecurity in the short-term by providing economic food 
assistance during the quit attempt that will help to meet food needs. We will adapt a patient navigation 
model in which a designated study navigator can help bridge resources and referrals related to tobacco 
cessation and food access, and provide economic food assistance based on individualized needs. We will 
recruit 60 participants for a 12-week study, and all participants will be smokers who are ready to quit and 
have recently experienced food insecurity. All participants will receive quit assistance and information on 
local food assistance resources, and a monthly check-in from the navigator. In addition, half of the 
participants (n=30) will be randomly assigned to the intervention arm, and will receive economic food 
assistance to partially meet their food needs and reduce food insecurity during the cessation attempt. We 
will assess feasibility and acceptability of the intervention, and preliminary outcomes related to smoking 
cessation, such as the number of quit attempts lasting 24 hours or more and the longest length of 
abstinence from tobacco. By conducting this study, we seek to understand whether this type of 
intervention is feasible to conduct, and acceptable to those who participate. The study findings will serve as 
the basis of future research on understanding and addressing tobacco-related and food insecurity-related 
health disparities. Our main research question is whether addressing food insecurity specifically during a 
smoking cessation attempt is helpful for increasing quitting success rates. 
 

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2.0   Background 
2.1 Relevant Prior Experience and Gaps in Current Knowledge 
In the U.S., the existence of socioeconomic disparities in tobacco use is a widely known public health 
problem.1 Of the numerous factors that account for socioeconomic disparities in smoking, one major 
reason is due to disparities in successful quitting. That is, regardless of socioeconomic background, the 
majority of smokers are interested in quitting (68%), and over half (55%) report making at least one 24-
hour quit attempt in the past 12 months.2 However, there are disparities in rates of successful quitting by 
socioeconomic status.3 There is a need to consider novel strategies to address cessation disparities to 
mitigate the disproportionate burden of tobacco-related health problems in socioeconomically 
disadvantaged population groups.   
2.2 Relevant Preliminary Data 
There are many sources of socioeconomic stress that disproportionately affect populations with 
disadvantage. Food insecurity occurs when there is lack of access at all times to enough food for an active, 
healthy life.4 In 2019, 35% of households living below the federal poverty level (FPL) experienced food 
insecurity, compared to 5% of households above 185% of FPL.4 Food insecurity is also significantly higher 
among racial/ethnic minority households, female-headed households, and households with children.4 Food 
insecurity is an important social determinant of health that is independently predictive of a range of chronic 
disease outcomes5, influencing health behaviors related to chronic diseases (such as medication adherence, 
diet quality, eating behaviors, and substance use). As such, food insecurity’s effects on health behaviors are 
most widely considered within specific chronic diseases that are diet-sensitive (such as diabetes, 
hypertension, and hyperlipidemia), or are transmitted through risky behaviors especially among vulnerable 
populations (such as people living with HIV). Beyond behaviors within specific chronic diseases, food 
insecurity has also been linked with tobacco smoking behavior.6 Food insecurity is known to increase the 
odds of current smoking, independent of poverty and other socioeconomic indicators7, as well as mental 
health characteristics that increase likelihood of smoking.6  
A growing body of research has suggested a bidirectional and mutually reinforcing relationship between 
food insecurity and tobacco use.6 Food insecurity is conceptualized to pose a unique barrier to quitting8,9 
due to factors such as psychological stress from food insecurity and appetite regulation from nicotine. In 
turn, however, tobacco-related expenditures can compete with household spending (a phenomenon 
known as smoking-induced deprivation10) to exacerbate food insecurity. While the body of research 
suggests that addressing food insecurity could enhance cessation outcomes, this has not been formally 
tested to our knowledge. That is, such findings on food insecurity and smoking cessation are drawn mainly 
through epidemiological studies following a nationally representative sample of smokers over time8, or 
cross-sectional studies estimating the quit ratio9 (i.e., the proportion of former smokers among ever 
smokers). In order to examine food insecurity’s potential effects on the cessation process and outcomes, 
and whether addressing food insecurity results in more favorable cessation outcomes, there is a need to 
conduct more rigorous clinical and intervention-based studies. 
2.3 Scientific Rationale and Significance 
This proposal is significant for smoking cessation research because there are relatively few evidence-based 
cessation interventions that seek to address the role of socioeconomic stress (such as food insecurity) to improve 
cessation outcomes. This proposal is also significant for food security research. With food insecurity’s wide-ranging 
adverse impacts on chronic disease and health outcomes, food insecurity has been estimated to contribute $77.5 
billion annually in excess healthcare costs11. The latest food security evidence review by Feeding America (the 
largest hunger relief organization in the U.S.) included smoking as a known factor that increases the risk of food 
insecurity12. By addressing food insecurity as a potential strategy to promote successful quit attempts, this research 

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has implications for addressing the double burden of food insecurity and tobacco use. As one of the first 
interventions to examine whether addressing food insecurity affects cessation outcomes, this research provides 
innovative directions in tackling socioeconomic disparities in smoking. 
 
3.0   Study Endpoints 
As a pilot study, primary endpoints are feasibility and acceptability of the intervention. Secondary 
endpoints are the number of quit attempts lasting 24 hours or more over the past 3 months, and the 
longest length of smoking abstinence in days over the past 3 months.   
 
4.0   Study Intervention 
Experimental procedures involve the provision of economic food assistance throughout the 12-week 
duration of the study. Participants in the intervention group will be provided with extra funds intended to 
provide short-term relief from food insecurity during the tobacco cessation attempt. Funds are distributed 
by either VISA gift cards, a check, direct deposit, or a Zelle transaction, based on the participant’s choosing. 
This is done on a monthly basis for 3 months, at a maximum of $250, divided across 3 months. 
 
5.0   Procedures Involved 
5.1 Study Design (Overview) 
For most participants, the full length of participation is about 2.5-3 hours spread across 13 weeks 
(intervention is 12 weeks, and an additional week is included as pre-intervention baseline). For a small 
proportion of participants (n=8-10) who agree to participate in an end-of-study qualitative interview to 
share their experiences of the study, the full length of participation is about 2.5-3.5 hours.  
1. Telephone conversation to discuss study, assess interest and eligibility, answer participant 
questions, and provide instructions on consent process (30 minutes) 
2. Receive consent form via mail. Prior to randomization, complete a baseline assessment via 
telephone/online survey (30-45 minutes) 
3. At week 1 post-randomization, connect with study navigator by telephone to receive information 
and referrals about tobacco cessation and food assistance (30 minutes) 
3a. Participants in the intervention arm will receive instructions about funds (5-10 minutes) 
4. Week 4 post-randomization, check-in call with study navigator (10-15 minutes) 4a. Participants in 
the intervention arm receive additional funds (0-1 minute required for participant) 
5. Week 8 post-randomization, check in call with study navigator (10-15 minutes)  
5a. Participants in the intervention arm receive additional funds (0-1 minute required for 
participant) 
6. Week 12 post-randomization, follow-up assessment (30-45 minutes) 
7. Post-intervention qualitative interviews (30-45 minutes) 

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5.2 Detailed Description of Procedures 
POTENTIAL PARTICIPANT IDENTIFICATION: We will use the electronic health record (EHR) to prescreen 
potential participants for this study. Potential participants will comprise of current patients MetroHealth 
patients from a total of 7 MetroHealth sites within Cuyahoga county. We will use the EHR to prescreen for 
age (21 years or older), smoking status as documented in the EHR (documented as currently smoking), and 
food insecurity status (documented as food insecure based on social determinants of health screening 
conducted during the most recent visit). Using this list, we will send out a recruitment packet in the mail, 
consisting of a 1-page study flyer with key information and a copy of the informed consent document, in 
the form of a non-return cover memo. The flyer will instruct potential participants to contact the study 
team by telephone for further information about the study, and to see if they qualify. 
As needed and based on recruitment rate, the research team will also make telephone calls to follow-up 
with potential participants, after having sent recruitment letters (i.e., there is no “cold” calling without 
sending letters beforehand). Using the prescreened list of individuals, we will randomly follow up with 
individuals on the list until we reach the enrollment target for the wave (n=15-20 enrolled in each wave; 3-4 
enrollment waves; 60 participants in total will be recruited for this study). 
RECRUITMENT, CONSENT, and BASELINE SURVEY: Recruitment will be conducted by telephone, and there 
will be no face-to-face visits as part of this study. The study coordinator will use a script to inform 
participants about the research study being conducted, to assess interest in participating, and to conduct 
an eligibility screening for interested participants. Individuals will be informed prior to the eligibility 
screening that not all people who are interested will qualify for the study based pre-determined eligibility 
criteria. For those who are interested, meet eligibility criteria, and wish to participate, the coordinator will 
go over the consent form, give the opportunity to ask any questions, and after all questions have been 
addressed, will collect verbal consent. Verbal consent will be documented on REDCap, including an 
attestation section from the research coordinator collecting consent. All potential participants will have 
been mailed a hard copy of the consent form (non-return cover memo) at the recruitment phase. 
Participants can be sent another copy as needed. After the research team receives verbal consent, the 
baseline assessment will be conducted by the research coordinator via an online or telephone survey 
(based on participants' preference) that is expected to last up to 45 minutes. 
RANDOMIZATION, ALLOCATION: After the baseline telephone (or online) survey is completed, participants 
will be randomized in the Intervention arm or the Control arm with a 50/50 chance to be randomized in 
either arm. The study analyst who has no contact with participants will use a computer-generated random 
number table to assign participants. In either arm, in Week 1 of the study, all participants will be connected 
to receive usual care for tobacco cessation, based on their preferences. In either arm, the study navigator 
(a community health worker) will review participant responses from the baseline telephone survey and 
reach out to all participants by telephone. This conversation may involve referrals to the tobacco quitline, 
referrals to counseling/classes offered at MetroHealth or in the community (such as Freedom from Smoking 
classes), nicotine replacement therapy and/or pharmacotherapy as prescribed by their primary care 
provider. The study navigator will provide linkages and information to the services available to the 
participant, which will be documented in a semi-structured call log, and used as the basis of following up on 
use of tobacco cessation services in subsequent telephone check-ins in Week 4 and Week 8. 
In either arm, participants also receive information from the study navigator about local food assistance 
resources available to them, such as a list of food pantries and community meal sites and eligibility 
information about federal food assistance programs. Provision of this information will also be documented 
by a semi-structured call log, and will be used as the basis of following up on food assistance resources in 
subsequent check-ins in Week 4 and Week 8. Information about tobacco cessation and food assistance 
resources are provided by telephone and/or in writing, which is within the scope of work for a community 
health worker. 

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In the Intervention arm only, participants will receive economic food assistance to meet their individual 
food and grocery needs during the cessation attempt/study period. This is provided on a monthly basis (3 
times during the 12 weeks of the study) during Week 1, Week 5, and Week 9.  
Participants in the Intervention arm will be provided $83 per month (for a total of $250 for the 12 weeks) to 
partially support the cost of food (i.e., provide short-term food insecurity relief) during the cessation 
attempt. These funds will be in the form of VISA gift cards, a check, a direct deposit transaction, or a Zelle 
transaction, depending on the participant’s choosing. The check, direct deposit, and Zelle options are 
processed through PNC Bank’s E-payment system. We are NOT collecting any bank information from the 
participants. The participant will confirm their bank account information with PNC to deposit the funds or 
mail the check, but the researchers will not see that information. 
Follow-ups: About 4 weeks after randomization, the study navigator will conduct a general check-in call 
with all participants by telephone to follow-up on referrals provided and additional referrals needed. The 
length of the call is anticipated to be 15 minutes. The content/topics and length of discussions will be 
documented through call logs. 
About 8 weeks after randomization, the study navigator will conduct a general check-in call with all 
participants by telephone to follow-up on referrals provided and additional referrals needed. The length of 
the call is anticipated to be 15 minutes. The content/topics and length of discussions will be documented 
through call logs. 
Twelve weeks after randomization (end-of-study), the study coordinator will contact participants to 
complete the follow-up telephone or online REDCap survey, which is expected to last 30-45 minutes. 
END-OF-STUDY QUALITATIVE INTERVIEWS: Participants who were randomized to the intervention group 
and have completed the protocol will be invited to participate in an end-of-study qualitative interview to 
provide more context about food access, and to share their experiences with the intervention. 
Recruitment: Similar to the recruitment procedures for the overall study, we will first mail an invitation 
letter to prior participants, who can contact the research team if they are interested and willing to discuss 
their food access and study intervention experiences through a telephone interview. As needed, we will 
follow up with a telephone call to the target subsample of participants who were sent invitation letters. 
Consent: Verbal consent will be documented on REDCap, including an attestation section from the research 
staff member collecting consent. All potential participants will have been mailed a hard copy of the consent 
form (non-return cover memo) with their invitation letter. Qualitative interviews: Semi-structured, one-on-
one interviews will be conducted by telephone or Zoom, and is expected to last 30-45 minutes. The semi-
structured interview will ask questions related to participants’ food shopping habits and practices, and 
participants’ perceptions about the impact of the economic intervention.  
 
5.3 Risk Minimization Procedures and Data Collection Materials 
To minimize risks related to annoyance or discomfort over study-related assessments (i.e., surveys and 
check-in calls with the study navigator), we will inform all potential participants that assessments may ask 
personal questions, and the estimated duration of the assessments. Participants have the option to skip 
any question that they do not wish to answer in the surveys. To minimize risks related to potential breach 
of confidentiality of research participants, we will use secure research systems, namely REDCap, for store 
any research-related information. To minimize any unforeseeable economic risks (e.g., potential theft of 
the VISA gift cards), we will ask all participants to keep their participation in this study private (such as not 
posting on social media about participation). All data collection materials include an Eligibility Script, a 
Baseline/Follow-up Survey, a Call Log, and a Qualitative Interview Document. All of these sources are 
attached in the IRB submission. 

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5.4 Type of Data Collected and How Data is Obtained 
We are collecting both existing and prospective data. Existing data are collected using electronic health 
records to ascertain potential participants' age, smoking status, and food insecurity screening status. 
Prospective data are obtained through a baseline and 12-week follow-up survey, collected through REDCap 
(survey-administered telephone survey, or self-completed survey), and through semi-structured telephone 
call logs kept by the study navigator.  
For end-of-study qualitative interviews, the interviews will be audio-recorded and transcribed verbatim.  
 
6.0 Inclusion and Exclusion Criteria 
6.1 Screening Process 
Participant eligibility will be determined using a screening questionnaire, by the research coordinator. Prior 
to administering the eligibility questions, all potential participants will be notified that there are specific 
inclusion criteria for the study, and not everyone will qualify for the study. Potential participants will be 
notified after the end of the screening questionnaire whether they are eligible or ineligible based on their 
responses. In some cases, it is possible that eligibility may not be readily apparent. In those cases, potential 
participants will be informed that their responses will be reviewed by the study PI, and they will be 
followed up in the next few days. 
6.2 Inclusion and Exclusion Criteria 
Inclusion:  
• Aged 21 or older 
• Current tobacco smoker, defined as having smoked daily over the past 7 days 
• Willing to make a serious quit attempt in the next 30 days (“Yes” to “In the next 30 days, are you 
willing to try quitting smoking for at least 24 hours?”) 
• Considered food insecure, based on past 30-day screening using the 2-item Hunger Vital Sign, or 
by virtue of having visited a food pantry in the past 30 days 
• A reliable telephone number and a local mailing address where participant can be reached during 
the duration of the study 
 
Exclusion:  
• Aged 20 or younger 
• Non-smoker, or a current tobacco smoker who did not smoke daily over the past 7 days 
• Not interested in quitting at this time, assessed by unwillingness to make a serious quit attempt in 
the next 30 days (“No” to “In the next 30 days, are you willing to try quitting smoking for at least 24 
hours?”) 
• Did not recently experience food insecurity, based on past 30-day screening using the 2-item 
Hunger Vital Sign, or has not visited a food pantry in the past 30 days 
• Does not have a reliable telephone number and a local mailing address where participant can be 
reached during the duration of the study 
 

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7.0   Recruitment Methods 
7.1 When, Where, and How Potential Participants are Recruited 
Recruitment will be conducted by telephone, and there will be no face-to-face visits as part of this study. 
The study coordinator will use a script to inform participants about the research study being conducted, to 
assess interest in participating, and to conduct an eligibility screening for interested participants. 
Individuals will be informed prior to the eligibility screening that not all people who are interested will 
qualify for the study based pre-determined eligibility criteria. For those who are interested, meet eligibility 
criteria, and wish to participate, the coordinator will go over the consent form, give the opportunity to ask 
any questions, and after all questions have been addressed, will collect verbal consent. 
7.3 Methods Used to Identify Potential Participants 
We will use the electronic health record (EHR) to prescreen potential participants for this study. Potential 
participants will comprise of current MetroHealth patients from a total of 7 MetroHealth sites within 
Cuyahoga county. We will use the EHR to prescreen for age (21 years or older), smoking status as 
documented in the EHR (documented as currently smoking), and food insecurity status (documented as 
food insecure based on social determinants of health screening conducted during the most recent visit). 
Using this list, we will send out a recruitment packet in the mail, consisting of a 1-page study flyer with key 
information and a copy of the informed consent document, in the form of a non-return cover memo. The 
flyer will instruct potential participants to contact the study team by telephone for further information 
about the study, and to see if they qualify. 
As needed and based on recruitment rate, the research team will also make telephone calls to follow-up 
with potential participants, after having sent recruitment letters (i.e., there is no “cold” calling without 
sending letters beforehand). Using the prescreened list of individuals, we will randomly follow up with 
individuals on the list until we reach the enrollment target for the wave (n=15-20 enrolled in each wave; 3-4 
enrollment waves; 60 participants in total will be recruited for this study). 
To identify potential participants for the end-of-study qualitative interviews, we will attempt to contact everyone 
who would be eligible based on their intervention assignment and completion of the protocol.   
 
7.4 Materials Used to Recruit Participants 
We will send out a recruitment packet in the mail, consisting of a 1-page study flyer with key information 
and a copy of the informed consent document, in the form of a non-return cover memo. The flyer will 
instruct potential participants to contact the study team by telephone for further information about the 
study, and to see if they qualify. The study coordinator will use an eligibility script to inform participants 
about the research study being conducted, to assess interest in participating, and to conduct an eligibility 
screening for interested participants.  
To recruit potential participants for the end-of-study qualitative interviews, we will send an invitation letter and a 
separate informed consent form as a non-return cover memo. 
 
7.5 Amount and Timing of Participant Payments 
Participants can receive up to $105 for participation in the research study, specifically for their time in 
completing the baseline telephone survey ($20) and the 12-week telephone survey ($35, as increased 
incentive to complete the follow-up survey), and the post-intervention qualitative interview ($50, as 
increased incentive to participate in the interview). These will be paid as a separate VISA gift card each time 
the participant completes the survey, and will be sent by mail. 

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8.0   Withdrawal of Participants  
Participants will be removed from the study for any significant medical events, such as hospitalization, or 
any significant legal events, such as incarceration. Participant non-compliance with research can also be a 
reason for removing a participant from the study. 
 
9.0   Risks to Participants 
Breach of confidentiality is a potential risk associated with this study; however, this risk will be minimized via 
secure storage of the records. Feeling uncomfortable answering questions is a potential risk for this study; 
however, this risk will be minimized by allowing participants to skip any questions they do not wish to answer.  
 
10.0 Potential Benefits to Participants  
For participants in either group, a potential benefit to participants is that they have several opportunities to 
connect with a study navigator who can provide them with useful/relevant information and referrals for 
tobacco cessation and food assistance. 
For participants in the intervention group, a potential benefit of participating in the research is that they 
may experience short-term relief from food insecurity while they are undergoing a smoking cessation 
attempt. 
 
11.0   Data Analysis Plan  
As a pilot study, the primary outcomes pertain to the assessment of feasibility and acceptability, and to 
derive preliminary estimates of tobacco cessation measures and food security status. We will conduct t-
tests and chi-square tests to explore group differences. Feasibility will be assessed by examining the 
number of participants screened, percent eligible to participate, refusal rate, and attrition rate between 
baseline and 12-week follow-up. We will examine participants’ utilization of resources related to tobacco 
cessation and food assistance, to examine feasibility of the navigation model. We will gain feedback from 
the navigator regarding the process of providing referrals and individualized food assistance. We will 
evaluate acceptability through open-ended questions to elicit participant feedback regarding their 
perceptions of helpfulness of food assistance in meeting food needs, helpfulness of food assistance 
specifically during cessation attempt, and additional barriers and facilitators to making a quit attempt or 
staying quit. 
Qualitative interviews will be transcribed and analyzed using inductive and deductive coding process.  
11.1 Data Handling and Security 
The records for this study are all electronic. No information will be stored in paper files. We are using 
MetroHealth’s REDCap to store all of our data. Audio-recordings of qualitative interviews will be kept in the 
REDCap file repository until they are transcribed verbatim, removing any identifying information in the 
transcription process. After that, we will destroy the audio files, and store interview transcript data as a text 
file. Only authorized personnel assigned to the study will have access to the study on REDCap. All personnel 
are affiliated with MetroHealth. 
We will keep records for 6 years after study completion. Records are stored on REDCap only. Identifiable 
data on REDCap will be deleted permanently. Dataset that has removed ALL identifiers will be kept 

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indefinitely. The study coordinator, the P.I., the study navigator, data analyst, and co-investigators will have 
access to REDCap. All team members are assigned to this study. 
12.0 Consent Process 
Potential participants will receive a complete explanation of the study and be asked to consent verbally. 
Participants will receive a non-return cover memo in the mail as a summary of the research. Participants 
will not be asked to sign a consent form. 
Once a potential participant is identified, the study coordinator will go over the study information by 
telephone, and will follow the non-return cover memo that was mailed to potential participants. The 
potential participant will have the opportunity to ask any questions they may have prior to providing their 
verbal consent by telephone. The eligibility screening and study information process will explicitly mention 
that potential participants should discuss the study with their family or friends before consenting, should 
they wish to take their time in deciding. The study coordinator will answer participant questions, and will 
defer any questions that the coordinator cannot answer to the investigators. 
We will use the same consent process for the qualitative interviews.  
12.1   Process to Document Consent in Writing 
Potential participants will be told about the study and its risks and benefits, and if interested, will be 
consented. Participants will be given a copy of a non-return cover memo, which can be found in the local 
sites documents portion of this IRB application. The date and time of consent will be recorded, as well as 
the name of the research personnel who was present at the time of consent. The personnel will provide an 
electronic signature to confirm the consent was received. 
 
 
 
 

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13.0 References 
 
1. U.S. Department of Health and Human Services. The Health Consequences of Smoking- 50 Years of Progress: A 
Report of the Surgeon General. U.S. Department of Health and Human Services, Centers for Disease Control and 
Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office of Smoking and Health; 
2014. Accessed November 3, 2014. http://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-
report.pdf   
 
2. Babb S, Malarcher A, Asman K, Jamal A. Quitting smoking among adults — United States, 2000–2015. MMWR 
Morb Mortal Wkly Rep. 2017;65. doi:10.15585/mmwr.mm6552a1  
 
3. Kotz D, West R. Explaining the social gradient in smoking cessation: It’s not in the trying, but in the succeeding. 
Tob Control. 2009;18(1):43-46. doi:10.1136/tc.2008.025981  
 
4. U.S. Department of Health and Human Services. Smoking Cessation. A Report of the Surgeon General. U.S. 
Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for 
Chronic Disease Prevention and Health Promotion, Office of Smoking and Health; 2020.  
 
5. Coleman-Jensen A, Rabbitt MP, Gregory CA, Singh A. Household Food Security in the United States in 2019. U.S. 
Department of Agriculture, Economic Research Service; 2020. 
https://www.ers.usda.gov/webdocs/publications/99282/err-275.pdf?v=1367.9  
 
6. Gundersen C, Ziliak JP. Food insecurity and health outcomes. Health Aff. 2015;34(11):1830-1839. 
doi:10.1377/hlthaff.2015.0645  
 
7. Kim-Mozeleski JE, Pandey R. The intersection of food insecurity and tobacco use: A scoping review. Health 
Promotion Practice. 2020;21(1_suppl):124S-138S. doi:10.1177/1524839919874054  
 
8. Kim-Mozeleski JE, Pandey R, Tsoh JY. Psychological distress and cigarette smoking among U.S. households by 
income: Considering the role of food insecurity. Preventive Medicine Reports. 2019;16:100983. 
doi:10.1016/j.pmedr.2019.100983  
 
9. Kim-Mozeleski JE, Seligman HK, Yen IH, Shaw SJ, Buchanan DR, Tsoh JY. Changes in food insecurity and smoking 
status over time: Analysis of the 2003 and 2015 Panel Study of Income Dynamics. Am J Health Promot. 
2019;33(5):698-707. doi:10.1177/0890117118814397  
 
10. Kim-Mozeleski JE, Tsoh JY. Food insecurity and psychological distress among former and current smokers with 
low income. Am J Health Promot. 2019;33(2):199-207. doi:10.1177/0890117118784233