Promoting Oral Health Among Tobacco Quitline Callers
Phase: NA
Conditions: Oral Disease, Smoking
Sponsor: Kaiser Permanente

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Oral Health 4 Life: Promoting Oral Health among 
Tobacco Quitline Callers 
NIDCR Protocol Number: 14-047-E   
NIDCR Grant Number:  1-U01-DE024462-01 
Principal Investigator:  Jennifer McClure, PhD 
NIDCR Program Official:  David Clark, DrPH 
Version Number:  9 
7 April  2017 
 

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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Conference on 
Harmonisation guidelines for Good Clinical Practice (ICH E6), the Code of Federal 
Regulations on the Protection of Human Subjects (45 CFR Part 46), and the NIDCR 
Clinical Terms of Award. All personnel involved in the conduct of this study have 
completed human subjects protection training. 
 

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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
Principal Investigator or Clinical Site Investigator: 
Signed: 
Date:  4/17/2017 
Name: Jennifer McClure, PhD 
Title: Director of Research, Faculty & Development; 
Kaiser Permanente Washington Health Research Institute 
(formerly, Group Health Research Institute) 
Signed: 
Date: 4/17/2017 
Name: Terry Bush, PhD 
Title: Investigator; Alere Wellbeing, Inc 
*Note: At the time this research was conducted, The Kaiser Permanente Research
Institute (KPWHRI) was known as the Group Health Research Institute (GHRI).
References to Group Health or GHRI in this protocol are synonymous with KPWHRI.

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TABLE OF CONTENTS 
PAGE 
STATEMENT OF COMPLIANCE .................................................................................................. I 
SIGNATURE PAGE ...................................................................................................................... II 
TABLE OF CONTENTS ............................................................................................................... III 
LIST OF ABBREVIATIONS ......................................................................................................... VI 
PROTOCOL SUMMARY ............................................................................................................ VII 
1 
KEY ROLES AND CONTACT INFORMATION .................................................................... 1 
2 
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ......... 2 
2.1 
Background Information ........................................................................................... 2 
2.2 
Rationale .................................................................................................................. 2 
2.3 
Potential Risks and Benefits ..................................................................................... 5 
2.3.1 
Potential Risks .............................................................................................. 5 
2.3.2 
Potential Benefits .......................................................................................... 5 
3 
OBJECTIVES ....................................................................................................................... 7 
3.1 
Study Objectives ...................................................................................................... 7 
3.2 
Study Outcome Measures ........................................................................................ 7 
3.2.1 
Primary ......................................................................................................... 7 
3.2.2 
Secondary .................................................................................................... 8 
4 
STUDY DESIGN ................................................................................................................ 11 
5 
STUDY ENROLLMENT AND WITHDRAWAL ................................................................... 12 
5.1 
Subject Inclusion Criteria ........................................................................................ 12 
5.2 
Subject Exclusion Criteria ...................................................................................... 12 
5.3 
Strategies for Recruitment and Retention .............................................................. 13 
5.4 
Treatment Assignment Procedures ........................................................................ 14 
5.4.1 
Randomization Procedures (if applicable) .................................................. 14 
5.4.2 
Masking Procedures ................................................................................... 14 
5.5 
Subject Withdrawal ................................................................................................. 14 
5.5.1 
Reasons for Withdrawal ............................................................................. 14 
5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention ................................................................................................. 15 
5.6 
Premature Termination or Suspension of Study .................................................... 15 
6 
STUDY INTERVENTION ................................................................................................... 16 
6.1 
Study Behavioral or Social Intervention(s) Description .......................................... 16 
6.2 
Administration of Intervention ................................................................................. 17 
6.3 
Procedures for Training Interventionists and Monitoring Intervention Fidelity ........ 18 
6.4 
Assessment of Subject Compliance with Study Intervention ................................. 18 
7 
STUDY SCHEDULE .......................................................................................................... 19 
7.1 
Screening (Call 1, Day 0) ....................................................................................... 19 
7.2 
Enrollment/Baseline (Call 1, Day 0) ....................................................................... 19 
7.3 
Intermediate Visits .................................................................................................. 20 
7.3.1 
Control Intervention .................................................................................... 20 

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7.3.2 
Enhanced Intervention: (Usual Care + Oral Health Promotion) .................. 20 
7.4 
Withdrawal Visit ...................................................................................................... 23 
7.5 
Unscheduled Visit ................................................................................................... 23 
8 
STUDY PROCEDURES /EVALUATIONS ......................................................................... 24 
9 
ASSESSMENT OF SAFETY .............................................................................................. 25 
9.1 
Specification of Safety Parameters ........................................................................ 25 
9.1.1 
Unanticipated Problems ............................................................................. 25 
9.1.2 
Adverse Events (AE)/Serious Adverse Events (SAE) ................................ 25 
9.1.3 
Expected Adverse Reactions ..................................................................... 25 
9.2 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 26 
9.3 
Characteristics of an Adverse Event ...................................................................... 26 
9.3.1 
Relationship to Study Intervention .............................................................. 26 
9.3.2 
Expectedness of SAEs ............................................................................... 26 
9.3.3 
Severity of Event ........................................................................................ 26 
9.4 
Reporting Procedures ............................................................................................ 27 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR ................................ 27 
9.4.2 
Serious Adverse Event Reporting to NIDCR .............................................. 27 
9.5 
Halting Rules .......................................................................................................... 28 
10 
STUDY OVERSIGHT ......................................................................................................... 29 
11 
CLINICAL SITE MONITORING .......................................................................................... 30 
12 
STATISTICAL CONSIDERATIONS ................................................................................... 31 
12.1 
Study Hypotheses .................................................................................................. 31 
12.2 
Sample Size Considerations .................................................................................. 31 
12.3 
Planned Interim Analyses (if applicable) ................................................................ 32 
12.4 
Final Analysis Plan ................................................................................................. 32 
13 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .................. 36 
14 
QUALITY CONTROL AND QUALITY ASSURANCE ......................................................... 37 
15 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................. 38 
15.1 
Ethical Standard ..................................................................................................... 38 
15.2 
Institutional Review Board ...................................................................................... 38 
15.3 
Informed Consent Process ..................................................................................... 38 
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) .................... 38 
15.5 
Subject Confidentiality ............................................................................................ 38 
15.6 
Future Use of Identifiable Data ............................................................................... 39 
16 
DATA HANDLING AND RECORD KEEPING .................................................................... 40 
16.1 
Data Management Responsibilities ........................................................................ 40 
16.2 
Data Capture Methods ........................................................................................... 40 
16.3 
Types of Data ......................................................................................................... 40 
16.4 
Schedule and Content of Reports .......................................................................... 40 
16.5 
Study Records Retention ....................................................................................... 41 
16.6 
Protocol Deviations ................................................................................................ 41 
17 
PUBLICATION/DATA SHARING POLICY ......................................................................... 42 
18 
LITERATURE REFERENCES ........................................................................................... 43 

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SUPPLEMENTAL MATERIALS .................................................................................................. 47 
APPENDICES ............................................................................................................................. 48 
APPENDIX A: SCHEDULE OF EVENTS ................................................................................... 49 
 

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LIST OF ABBREVIATIONS 
ADL 
Activities of Daily Living 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GHRI 
Group Health Research Institute 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
NIDCR 
National Institute of Dental and Craniofacial Research, NIH, DHHS 
NIH 
National Institutes of Health 
PPA 
Point Prevalence Abstinence 
RCT 
Randomized Controlled Trial 
SAE 
Serious Adverse Event/Serious Adverse Experience 
UC 
Usual Care 
UP 
Unanticipated Problem 
US 
United States 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
Title: 
Oral Health 4 Life: Promoting Oral Health among Tobacco 
Quitline Callers 
Précis: 
Promoting better oral health is a public health priority.  Tobacco 
users, in particular, are at high risk for oral disease compared to 
non-smokers both as a result of their smoking and the fact that 
many fail to meet recommendations for basic oral health care, 
including daily oral hygiene and regular professional dental 
care.  
The current study will test the effectiveness of a multi-modal 
behavioral intervention (the Oral Health 4 Life program) targeted 
to smokers who are ready to quit smoking and seeking services 
through tobacco quitlines.  Quitline callers have made a 
commitment to improving their health and our research 
suggests most are receptive to learning how to improve their 
oral health, as well.  Moreover, there is reason to believe that 
promoting basic strategies such as brushing, flossing, or rinsing 
with fluoride mouthwash in response to cigarette cravings or 
having a professional dental cleaning to remove tobacco stains 
could promote better oral health and bolster attempts to quit 
smoking.  Thus, an integrated oral health promotion-tobacco 
cessation program could have dual benefits. 
We will partner with Alere Wellbeing, the nation’s largest 
provider of tobacco quitline services.  Leveraging Alere’s 
infrastructure for this intervention increases the likelihood the 
intervention could be disseminated, if effective.  
Smokers (n ~ 742; minimum of 10 and up to ~30 pilot 
participants and ~712 main trial participants) will be recruited 
when they call to enroll in services.  Eligible smokers who have 
not received recent dental care will be randomized to either 
usual care quitline intervention plus control text messaging or an 
enhanced program which integrates standard tobacco cessation 
counseling with a multi-modal, behavioral oral health promotion 
program.  The enhanced program includes behavioral 
counseling, mailed written materials, access to online materials 
and resources, support/ outreach via text messaging, and 
referral information for affordable local dental care.  Follow-up 
assessments will be conducted by phone at 2 and 6 months 

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post-enrollment.  Primary outcomes are: receipt of professional 
dental care following enrollment [yes/no] and self-reported 7 day 
point prevalent smoking abstinence at 6 months [yes/no].  We 
hypothesize that persons who receive the enhanced program 
will be more likely to see a dentist and to quit smoking.  
Secondary outcomes and process measures of interest include: 
whether a participant either receives professional dental care or 
has scheduled a future dental appointment at 6 months, 
smoking abstinence at 2 months, and changes in oral health 
knowledge and relevant attitudes (self-efficacy, motivation, 
perceived oral disease severity, and outcome 
expectations/perceived benefits of oral hygiene) at 2 and 6 
months.  The incremental cost of delivering the Oral Health 4 
Life program will also be examined.   
 
Objectives: 
Primary Objective: To assess the effects of the proposed 
behavioral intervention on tobacco abstinence and utilization of 
professional dental services (primary outcomes).  
Secondary Objectives:  
 Assess the impacts of the enhanced intervention on key 
secondary behavioral outcomes and select intermediate 
outcomes/process measures that could mediate 
treatment effects.  
 Determine the effectiveness of the proposed enhanced 
intervention, whether it warrants dissemination to 
smokers through tobacco quitline programs nationally in 
the current form, or whether further refinement and 
evaluation are warranted.   
 Calculate the incremental cost of adding the Oral Health 
4 Life program to usual quitline care and create a 
decision support tool that quitline sponsors (i.e., potential 
purchasers of the program) can use to inform decisions 
about whether to offer the program. 
 
 
Primary Outcome:  a) Receipt of professional dental care 
following enrollment [yes/no]; and b) self-reported 7 day point 

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prevalent smoking abstinence at 6 months [yes/no; missing 
cases imputed as smokers].  
 
Secondary Outcomes:  a) Whether a person has seen a dental 
care provider since enrollment or scheduled a future dental 
appointment at 6 months; b) 7 day point prevalent abstinence at 
2 months (with missing cases imputed) and smoking abstinence 
at the 2 month and 6 month follow-up among respondents only 
(no missing imputation); c) changes in oral health knowledge; d) 
and relevant attitudes (self-efficacy, motivation, perceived oral 
disease severity, and outcome expectations/perceived benefits 
of oral hygiene) at 2 and 6 months.  The incremental cost of 
delivering the Oral Health 4 Life program will also be examined. 
Population: 
Male and female adult smokers (n ~ 742) aged 18 or older will 
be recruited from participating US tobacco quitlines in Oregon, 
Louisiana, and Nebraska. Those who have not used dental care 
services in the past 6 months and meet other study criteria 
(sections 5.1& 5.2) will be eligible to enroll. 
Phase: 
III 
Number of Sites: 
Study activities will be conducted at two research sites:  Group 
Health Research Institute (GHRI) and Alere Wellbeing, each 
located in downtown Seattle.  However, participants will be 
recruited from multiple state tobacco quitline programs 
managed by Alere.   
Description of  
Intervention: 
Participants will receive a multi-modal, behavioral intervention 
offered in conjunction with standard care tobacco quitline 
intervention.  Oral health promotion intervention will be delivered 
via behavioral phone counseling, mailed materials (educational 
self-help information and oral health aids [e.g., toothbrush, floss, 
etc.]), educational content delivered via a log-in secured study 
website (OralHealth4Life.com), and additional education and 
supportive encouragement offered via a series of text 
messages.  Participants will also receive referral information for 
low cost dental care in their geographic area. 
 
Study Duration: 
We estimate it will take about 30 months to complete the 
proposed RCT. Recruitment will begin at approximately month 7 
of the grant phase, depending on the required timeline for 
finalizing the study materials in collaboration with NIDCR staff.  
~742 participants will be enrolled.  The first ~10 participants will 
constitute a vanguard wave.  Program refinements will be made, 

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as needed, based on our experience with these participants.  
Consequently, we have planned a priori to exclude these 
individuals from the final analytic sample, resulting in a final 
intent to treat sample of ~712. Recruitment, intervention 
delivery, and follow-up assessments will continue through 
approximately month 36.  The remainder of the grant period 
(months 37-48) will be devoted to data management, analyses, 
interpretation, and dissemination of findings.  
 
Subject 
Participation 
Duration: 
Each participant will be enrolled for a period of 6 months. 
Estimated Time to 
Complete 
Enrollment: 
We estimate it will take one month to recruit the vanguard 
participants and up to, but not more than, twenty-three 
additional months to recruit the remaining participants. 
Recruitment pace will depend on the call volume at the 
participating quitlines.  If needed, this will be titrated to ensure 
that the timing and volume of the counseling and follow-up 
surveys do not outpace staff capacity to complete these on 
schedule. 
 

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Schematic of Study Design (NOTE: Reflects final analytic sample, n ~ 712): 
Cohort  
Arm 1 
n~ 356 
Usual Care (UC) 
Arm 2 
N~ 356 
Enhanced Intervention 
Diagram 1:  Study Flow for RCT  
Prior to 
Enrollment 
Screen quitline callers, obtain consent, & collect baseline data 
Randomize 
Usual Care 
N = 356 
Enhanced 
Intervention 
N = 356 
Deliver UC quitline counseling  
call #1 (Day 0) 
Deliver UC quitline counseling + oral 
health counseling call #1 (Day 0) 
Mail UC materials + consent & 
orientation letter (~ Day 2) 
Mail UC + oral health materials + 
consent & orientation letter (~ Day 2) 
Intervention 
(Counseling) 
Contact #1 
Text message outreach #8 - #18 
 (~Weeks 9 – 23) 
Access to secure website  
Deliver UC quitline counseling 
calls #2-#5 (~Week 1 – 10) 
Deliver UC quitline counseling  + oral 
health counseling calls #2-#5 (~ Week 1-10) 
Text message outreach #1-#7 (~ Weeks 1-8) 
Follow-up Phone Assessment #1 (2 months post-enrollment) 
Follow-up Phone Assessment #2 (6 months post-enrollment) 
Intervention 
(Counseling) 
Contact #2-5 
Text message outreach #1-#7 
(~ Weeks 1-8)
Text message outreach #8 - #18 
 (~Weeks 9 – 23) 
Post study period: Access provided to an open-access copy of the OH4L website 
NOTES:  Intervention call timing is tailored for each person, based on their chosen Quit Date.  As a 
result, calls may or may not be complete prior to the 2 month follow-up for all participants. The 
chosen target Quit Date will also affect the timing of the text messaging.  For more detail on the 
timing of the intervention events, see Appendix A Schedule of Events.  

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Table 1.  Overview of Study Activities by Site 
GHRI
Alere Wellbeing
Recruit, screen, & enroll participants 
X 
Collect baseline data 
X 
Provide phone counseling & usual care 
tobacco cessation services 
X
Mail usual care tobacco cessation materials 
X 
Mail consents, study welcome letters & oral 
health promotion materials 
X
Manage text messaging 
X 
Maintain study website(s) 
X 
Conduct follow-up assessments 
X 
Mail participant incentives 
X 
Conduct fidelity monitoring 
X 
X 
Provide regular data feeds to GHRI 
X 
Monitor automated data integrity 
X 
Provide final cost data 
X 
X 
Management of final analytic datasets 
X 
Data analyses 
X 
Interpretation of study findings 
X 
X 
Primary responsibility for publication & 
dissemination of results 
X

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1 KEY ROLES AND CONTACT INFORMATION 
Principal 
Investigator:   
Jennifer McClure, PhD 
Group Health Research Institute 
Medical Monitor: 
NIDCR Medical Monitor  
NIDCR Program 
Official:   
David Clark, DrPH 
Clinical Site 
Investigators: 
Terry Bush, PhD 
Alere Wellbeing, Inc. 
Institutions: 
Group Health Research Institute 
1730 Minor Ave, Suite 1600 
Seattle WA 98101 
 
Alere Wellbeing, Inc 
999 3rd Ave, Suite 2000 
Seattle WA 98104 
 
Betty Irene Moore School of Nursing 
University of California, Davis Health System 
4610 X Street #4202 
Sacramento, CA  95817 
 
Other Key 
Personnel: 
Behavioral Scientist: Sheryl Catz, PhD; University of California, 
Davis & Group Health Research Institute Affiliate Investigator  
 
Economist: Paul Fishman, PhD; Group Health Research Institute 
 
Biostatistician: Jennifer Nelson, PhD; Group Health Research 
Institute 
 

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2 INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
2.1 
Background Information 
Oral disease is a significant public health threat. 
Oral disease affects millions of people in the US. It includes common oral diseases such 
as periodontitis and dental caries, and less common oral and pharyngeal cancers.  
Together these diseases exact a large human toll. Oral disease not only results in 
unnecessary pain, potential physical disfigurement, and emotional suffering, it puts 
individuals at greater risk for subsequent morbidity and mortality1. Treating acute oral 
disease and preventing the onset of future oral disease are important public health 
goals. 
Smokers are a priority population for oral health promotion.  
Tobacco use accounts for an estimated 90% of oral and pharyngeal cancers, and 
smoking is the second leading modifiable risk factor for periodontitis.6  According to the 
National Health and Nutrition Examination Survey (NHANES)7, current smokers have a 
higher prevalence of untreated tooth decay (35.0%) than those who never smoked 
(18.6%) or former smokers (17.7%).  Tooth loss is also strongly associated with 
smoking and more common in current than former or never smokers.8  Two-thirds of 
current US smokers have at least one unmet dental need compared to 55% of non-
smokers.9  Two-thirds do not have an annual dental visit and, in general, fewer smokers 
see the dentist than non-smokers.10, 11  In addition, many smokers fail to seek routine 
health care12, 13, have high rates of alcohol use14-17, poor diets18, and low levels of 
important micronutrients due to oxidative stress from smoking and dietary choices19—all 
contributing factors in oral disease.  Among smokers treated through tobacco quitlines, 
we have observed similarly high levels of self-reported oral disease (based on current 
symptoms) and sub-optimal use of dental care and routine oral hygiene behaviors.20, 21 
In short, smokers represent an important target group for oral health promotion. 
2.2 
Rationale 
Combined oral health promotion and smoking intervention could have synergistic 
effects. 
Promoting better oral health care in conjunction with quitting smoking could enhance 
efforts to stop smoking and vice versa. Best practice smoking cessation counseling is 
grounded in cognitive behavioral therapy (CBT). 22, 23 Standard CBT for nicotine 
dependence in part teaches smokers to use distraction techniques as a means for 
managing cravings and resisting the urge to smoke. This technique can be tailored to 
also promote better oral health by directing smokers to chew sugar-free gum, brush 
their teeth with fluoride toothpaste, gargle with a fluoride mouth rinse, or floss in 
response to cravings to smoke. We’ve found these distraction techniques to be effective 

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for many people because they offer a distraction to thinking about smoking, introduce 
taste sensations which are incompatible with smoking, and engage the smoker in 
behaviors which are physically incompatible with the act of smoking (e.g., one cannot 
smoke and brush their teeth concurrently). These are important behavioral therapeutic 
goals.  Importantly, each behavior also serves a dual benefit of reducing plaque and 
promoting better tooth and gum health.1, 24-26 Practicing these behaviors during the quit 
process could lead to their greater integration in one’s normal daily hygiene routine by 
creating mastery experiences, building individual’s confidence (self-efficacy) in their 
ability to engage in these behaviors, and creating positive outcome expectations (e.g., 
brushing my teeth makes my mouth feel clean and lessens my desire to smoke).  These 
are all important mediators of behavior change. 
Moreover, research shows a positive association between smokers’ concerns about 
tooth discoloration caused by tobacco use and their interest in quitting smoking. 27  
Thus, smokers ready to quit may be particularly receptive to advice to have their teeth 
cleaned around their quit date, to remove tobacco stains and start their new life looking 
like the non-smoker they will soon be.  Smokers who might not otherwise seek 
professional dental care may be willing to do so at this time, particularly if the enhanced 
intervention includes referral to affordable local dental care (as the Oral Health 4 Life 
program does). And having one’s teeth cleaned could provide continued motivation to 
remain quit. In other words, we believe that a dual focus on better oral health and 
tobacco cessation could have potentially powerful synergistic effects to improve 
cessation rates, promote professional dental care utilization, and alter routine oral 
hygiene care. 
Partnering with state-funded tobacco quitlines to promote oral health. 
The Office of the Surgeon General6 and Centers for Disease Control and Prevention1 
have each called for greater partnerships between the public and private sector and 
inclusion of health care organizations, health insurers, and health professionals in 
efforts to promote oral health.  With regard to smokers and tobacco users, the emphasis 
has been placed on empowering dentists and dental hygienists to intervene with their 
patients to promote tobacco abstinence. However, oral health care professionals often 
have limited time and resources to provide behavioral intervention and these efforts fail 
to reach individuals who do not visit a dentist (which may be more than half of smokers 
calling state-funded tobacco quitlines).21 Moreover, many dental professionals are not 
formally trained in behavioral counseling and simply providing oral health education 
alone does not result in lasting behavior change.28-33 
A complementary strategy for intervening with smokers, particularly those not routinely 
seeking dental care, is to integrate oral health promotion efforts into tobacco quitline 
programs.  Tobacco quitlines provide behavioral counseling for tobacco cessation, 
primarily through proactive counseling calls (i.e., calls initiated by the quitline based on 
a pre-determined call schedule) with supplemental outreach via online materials, mail, 

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and/or text messaging.  Quitlines have been shown to be an effective public health 
intervention for smoking cessation.34-37 
All 50 US states offer free tobacco quitline programs funded through state revenues 
and/or the CDC.  All callers are eligible for at least a single counseling call, with 
uninsured callers and other special populations (e.g., pregnant smokers) eligible for 
multi-call programs. According to data from the North American Quitline Consortium, 
nearly 440,000 people received services from state-sponsored quitlines in 2010.38 
Across the various state quitline contracts serviced by Alere Wellbeing, more than 
279,000 people received services in 2012, nearly 352,000 people received services 
through all of their service contracts combined in 2012, and more than 2,235,000 people 
have received services from this company to date.  While the largest in the US, Alere is 
only one of several US tobacco quitline vendors. Thus, tobacco quitlines represent an 
efficient way to reach a large number of smokers who are also in need of oral health 
promotion.  Furthermore, our research demonstrates quitline callers are interested in 
improving their oral health (see section 2.3 below).20, 21 And because quitline callers are 
actively seeking treatment, these individuals may be more amenable to an oral health 
promotion program delivered in conjunction with their tobacco counseling.  That is, 
reaching tobacco users when they enroll in quitline services may represent a ‘teachable 
moment’ for change. 
Significance & Impact Summary 
There is good reason to expect promoting positive oral health care in conjunction with 
smoking cessation will improve abstinence rates and it is known that quitting smoking 
improves oral health outcomes.1  Additionally, increasing utilization of professional 
dental care can reduce risk of disease and allow existing pathology to be treated, 
possibly preventing more serious and costly future disease.  Thus, it is reasonable to 
promote better oral health in tandem with nicotine dependence treatment. Working 
through the tobacco quitlines is an innovative strategy to test this approach. More 
importantly, this partnership enhances the public health significance of the research 
because our intervention has been carefully designed in collaboration with the largest 
US tobacco quitline provider so it can be disseminated on a national level, if effective.  
As such, this work holds the potential to improve oral health care, cessation rates, and 
oral health outcomes among hundreds of thousands of smokers nationwide. Finally, this 
study will provide important information about the added cost of the Oral Health 4 Life 
program to inform quitline purchasers’ (payers) future decisions about offering this 
program. 
Innovation 
Good oral health is good public health. Promoting better oral health among smokers 
should not be shouldered by professional dental care professionals alone. This study 
represents the first time tobacco quitlines, or any nicotine dependence treatment 
program to our knowledge, have been leveraged to promote better oral health care and 

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smoking cessation.  This study will provide critical information about the effectiveness 
and additional cost of this public health intervention strategy for promoting abstinence 
and use of dental health services.  It also offers an important complement to ongoing 
efforts in many dental care settings to promote smoking cessation and refer patients to 
the tobacco quitlines. 
2.3 
Potential Risks and Benefits 
2.3.1 
Potential Risks 
Potential risks include breach of confidentiality and discomfort associated with 
answering research questions.   
Persons who stop smoking may experience symptoms of nicotine withdrawal (e.g., 
irritability and mood changes, headaches, trouble sleeping, constipation, cravings to 
smoke).  These are typically transient and resolve within a few weeks after 
cessation. Nicotine withdrawal symptoms may be reduced in smokers who use 
nicotine replacement therapy (NRT) as an adjunct to the quitline counseling; 
however, they may experience side-effects associated with NRT patch including 
headaches, nausea, trouble sleeping, and rash/irritation at the local patch site.  
These symptoms are typically temporary and resolve either within a few days or 
upon discontinuation of NRT.  Participants in this study may be eligible to receive 
NRT as per the standard of care provided by each participating quitline.  
Participants who visit a dentist or increase their routine brushing and flossing may 
experience mild and temporary discomfort or gum bleeding (e.g., from tooth 
cleaning or flossing).  This will resolve with continued regular oral hygiene. 
2.3.2 
Potential Benefits 
Participants may quit smoking.  As a result, they may reduce their risk of chronic 
disease onset or exacerbation, save money, and benefit from the good feeling of 
knowing that they are tobacco free.  
Participants who see a dentist or change their routine oral health care can reduce 
their risk for future oral disease, may experience improved cosmetic appearance 
and self-esteem, and may experience reduced halitosis or tooth stains.  
All participants in the experimental arm may benefit from increased awareness of 
proper oral hygiene behaviors and receipt of provided oral hygiene tools (e.g., 
toothbrush, floss, etc.).  Those who also change other relevant behaviors such as 
limiting or reducing sugary beverages and alcohol use or increasing fruit and 
vegetable intake could experience additional positive health effects. The positive 
health effects include better oral health, reduced weight, and/or reduced risk of 
chronic disease onset or exacerbation. 

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All participants, regardless of intervention arm, may benefit from the sense of well-
being associated with contributing to research. 
 

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3 OBJECTIVES 
3.1 
Study Objectives 
The primary objective of this study is to assess the effects of the proposed behavioral 
intervention on tobacco abstinence and utilization of professional dental services.   
The secondary objectives of this study include:  
 Assess the impacts of the enhanced intervention on key secondary behavioral 
outcomes and select intermediate outcomes/process measures that could 
mediate treatment effects.  
 Determine the effectiveness of the proposed enhanced intervention, whether it 
warrants dissemination to smokers through tobacco quitline programs nationally 
in the current form, or whether further refinement and evaluation are warranted.   
 Calculate the incremental cost of adding the Oral Health 4 Life program to usual 
quitline care and create a decision support tool that quitline sponsors (i.e., 
potential purchasers of the program) can use to inform decisions about whether 
to offer the program.   
The results of this project will inform whether the proposed intervention warrants further 
evaluation or dissemination through tobacco quitlines based on its effectiveness and 
help purchasers make informed decisions about providing the program. 
The intervention will be offered to people seeking treatment for smoking cessation 
through one of the participating state-funded tobacco quitlines and will reach a high-
need, lower-income population who are eligible for these free services.   
Additional detail on the proposed enhanced intervention is included in sections 6 and 7. 
3.2 
Study Outcome Measures 
Study outcome measures are discussed below.  Copies of the baseline and follow-up 
assessment measures are included in Appendices B and C. 
3.2.1 
Primary  
Smoking abstinence. Per convention, this will be assessed by a self-report of 
no smoking, even a puff, in the past 7 days assessed at 6 month follow-up (i.e., 7 
day point prevalent abstinence).  Missing data will be imputed using a worst case 
scenario in which individuals with missing outcomes will be assumed to be 
smoking for the main outcome analyses. 

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Professional dental care in the past 6 months.  This will be assessed by a 
self-report of professional dental care in the past 6 months at the 2 or 6 month 
follow-up using the a standardized National Health Interview Survey (NHIS) item. 
Missing data will be imputed using a worst case scenario in which individuals 
with missing outcomes will be assumed to have not seen the dentist for the main 
outcome analyses. 
We will use a ‘bogus pipeline’ strategy to encourage valid self-reported dental 
care utilization. Per this standard social psychology methodology, participants 
are told in advance their answers may be verified (e.g., we may contact their 
provider), thereby promoting more truthful reporting.  We will also inform 
participants we are collecting the names and contact information for their dental 
care providers, again to discourage false reporting of service utilization (see 
scripting in follow-up surveys, Appendix C). 
3.2.2 
Secondary 
Secondary behavioral outcomes and process variables of interest are: 
 Smoking abstinence assessed at 2 month follow-up (7 day point prevalent 
abstinence [PPA] with missing cases imputed).  Additionally, we will assess 
abstinence at 2 and 6 months using a complete case (respondent only) analysis 
where missing data values are not imputed, to determine if imputation has a 
meaningful effect on the study results. 
 We will assess whether groups differ in terms of the proportion of participants 
who either seek professional dental care following enrollment or have a future 
appointment scheduled at 6 months.   
 Change in oral health knowledge from baseline to 2 and 6 month follow-up will 
be assessed using a scale adapted from Brennan et al45 to address oral health 
behaviors (as opposed to tooth decay); include smoking, alcohol use, sugar free 
gum, and fruits and vegetables intake; and modify scripting for better phone 
delivery. 
 Change in self-reported self-efficacy and motivation from baseline to 2 and 6 
month follow-up.  Self-efficacy and motivation will be assessed using a 5 point 
Likert-type scale. 
 
Customer Satisfaction and Qualitative Feedback 
3.2.2.1
Feedback will be collected at the end of the 6 month assessment.  All participants will 
be asked to rate how helpful and how satisfied they were with each component of the 

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UC intervention (e.g., calls with a quit coach, Quit for Life stop smoking website, mailed 
stop smoking materials, nicotine replacement, etc.).  Helpfulness and satisfaction will be 
rated on a 5-point Likert scale from “not at all” to “helpful”.  Participants receiving the 
enhanced intervention will also rate each component of the Oral Health 4 Life program 
(e.g., oral health counseling, mailed materials, log-in secured website, oral health aids, 
referral information for low cost dental care, etc.).  Finally, enhanced intervention 
participants will be asked a series of open-ended questions about which enhanced 
intervention components they used, what they liked best, and what they liked least.  
Responses will be transcribed verbatim for future content analysis. 
 
Cost Analysis Measures and Outcomes 
3.2.2.2
Because the goal of the current study is to assess the degree to which the Oral Health 4 
Life program increases the likelihood of both quitting smoking and visiting a dentist and 
each of these outcomes may be of interest to different purchasers, we will provide a 
detailed assessment of the costs for each outcome.  The analysis will examine the 
incremental cost of adding the Oral Health 4 Life program to the standard quitline 
program from the purchaser/payer perspective. 
 
We will assess the estimated additional cost per counseling call for which the Oral 
Health 4 Life program is included and the cost per successful cessation event, based 
on six month outcomes. These calculate these costs we will estimate all resources 
required to develop and maintain the intervention materials (print and web-based), the 
increased personnel time to provide oral health counseling, and other outreach services 
related to Oral Health 4 Life (e.g., text messaging).  All associated effort, labor costs, 
and material costs associated with delivering of the intervention will be tracked at GHRI 
and Alere.   
 
We will also calculate the cost per dental visit attributable to the Oral Health 4 Life 
program and the cost per both a successful cessation event and dental visit, each 
assessed based on primary 6 month outcomes.  The cost per dental visit will be 
assessed as the amount reimbursed by providers for routine preventive office visits.  
This is appropriate because our analysis takes the payer/provider perspective and while 
the amount reimbursed per visit is not the cost incurred by the practice it does capture 
the payer’s financial responsibility.  We will not include patient incurred costs, whether 
due to lost productive time or out of pocket expenses, because these costs are not the 
payer’s responsibility.  Because we will not have claims data containing details about 
specific reimbursable services provided at each visit attributable to the Oral Health 4 
Life program, we will assign the mean dollar amount dental practices are reimbursed for 

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preventive visits based on relative resource intensity weights using the American Dental 
Association’s Current Dental Terminology (CDT) coding scheme. 
 
These data will then inform the creation of a ‘willing to pay’ decision support tool for 
future quitline sponsors that will allow purchasers (e.g., state departments of health) to 
calculate the cost per quit and cost per dental visit using data from the study. 

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4 STUDY DESIGN 
We will conduct a randomized, two arm trial including a small vanguard wave (n  up to ~ 
30) followed by a larger intent to treat sample wave (n ~ 712).  The design and methods 
used in each sample wave will be the same, except the vanguard will launch 
approximately 2 months prior to the main sample wave in order to pilot all methods and 
procedures and allow time to make adjustments, as necessary.  Participants in the 
vanguard wave will not be included in the final analytic sample.   
Participants will be smokers who call to enroll in services in one of the participating 
quitlines [Louisiana, Oregon, and Nebraska], meet eligibility criteria (see sections 5.1 
and 5.2), and volunteer to participate in this study.  Each person will be followed for 6 
months and will complete phone surveys at baseline, 2 months post-enrollment, and 6 
months post-enrollment. 
While not a formal pragmatic trial, the study has been designed to be delivered under 
the conditions of real-world care provided by the tobacco quitlines. As a result, study 
assessments, consent processes, and other activities which are not part of the standard 
of care have been purposefully designed to be brief in order to minimize the impact on 
the standard flow of care, while still allowing us to assess the most important primary 
and secondary outcomes of interest.    
Additionally, due to the nature of the trial, neither participants nor counselors (quit 
coaches) in the enhanced intervention (experimental arm) will be blinded to participants’ 
treatment assignment.  Quit coaches delivering usual care will be aware that 
participants’ are enrolled in a non-standard contract (e.g., a research study), but they 
will not be trained in or exposed to the enhanced intervention to prevent contamination.  
Group Health research staff who conduct follow-up assessments will be blinded to 
treatment assignment.  

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5 STUDY ENROLLMENT AND WITHDRAWAL 
5.1 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, a participant must meet all of the 
following criteria (see also Eligibility Screen in Appendix D): 
 Male or female, aged 18 or older  
 Eligible for multi-call services through a participating tobacco quitline [in 
Louisiana, Nebraska, or Oregon] managed by Alere Wellbeing 
 Can read and speak in English 
 Able to comfortably read small print (i.e., no significant visual impairments that 
limit ability to read the intervention materials) 
 Current daily smoker and smokes at least 5 cigarettes a day 
 Interested in quitting smoking in next 30 days  
 Have some or all natural teeth 
 Have not visited a dentist for a checkup or teeth cleaning in the past 6 months 
and do not have an appointment scheduled in the next 6 months 
 Has a cell phone capable of receiving text messages and provides cell phone 
number 
 Has internet access for personal use 
 Willing to talk about ways to improve their  oral health 
 Provides verbal consent to participate   
5.2 
Subject Exclusion Criteria 
Individuals will be excluded if they: 
 Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., 
has significant cognitive impairment) 
 Plans to move in the next 6 months 
 Are currently enrolled in an in-patient substance abuse treatment facility or are 
incarcerated 

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 Has a household member already enrolled in the study, based on self-report 
and/or mailing address on file 
5.3 
Strategies for Recruitment and Retention 
Recruitment: Following completion of the normal tobacco quitline registration process, 
persons calling each of the eligible quitlines and who have not been deemed ineligible 
based on screening criteria which are collected as part of the normal intake will be 
informed of the study and invited to complete the eligibility screening process.  If eligible 
and interested, potential participants will then be transferred to staff in the Research 
Implementation Unit (RIU).  RIU staff will collect and document verbal consent.  
Responses will be recorded.  Participants who provide consent will complete a baseline 
assessment and then be randomized to treatment using an automated algorithm, prior 
to the treatment initiation.   
If participants do not complete the study enrollment call due to dropping off/hanging up 
the RIU coach will make five attempts on five separate days to be attempting to get 
them back to complete enrollment.  Call attempts will begin the same day or the 
following day that the call is lost.  One voicemail will be left for participants that 
consented to receiving voicemails during Registration.  Staff will stop trying to enroll the 
participant after five call attempts go unanswered.  
 
Retention:  We will use standard procedures to ensure study retention, including 
offering an incentive for completion of each survey ($30), sending reminder letters one 
week prior to each scheduled assessment and marked for return service requested, and 
using phone and internet records to track participants who move and do not have a 
change of address on file with the Post Office or Alere Wellbeing. Difficult to reach 
subjects will be texted an offer of an extra $15 incentive if they call in to complete the 
survey by phone. 
Phone counseling calls will be proactively scheduled and initiated by Alere quit coaches 
on the standard call schedule (see section 7.3). Consistent with standard practice as 
dictated by each quitline contract, at least 3 attempts will be made to complete each of 
the 5 counseling calls with all participants.  Text messages are offered to all study 
participants. The text messages will be proactively delivered on a pre-determined 
schedule with automated delivery (see section 7.3). 
Participants who request to drop out of the intervention will be asked if they are willing 
to remain in the study and be contacted for follow-up assessment.  If not, they will be 
dropped from further contact. 

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5.4 
Treatment Assignment Procedures 
5.4.1 
Randomization Procedures  
Eligible participants who provide consent will be block randomized using an automated 
algorithm built into the Alere systems software.  Randomization will be stratified based 
on whether participants have dental insurance coverage [yes/no] and which tobacco 
quitline they are enrolled in [Louisiana, Nebraska or Oregon], to ensure balance across 
each treatment arm.  Participants will then be randomly assigned to either the usual 
care quitline program or an enhanced quitline program (usual care tobacco quitline 
program + multi-modal oral health promotion intervention).   
Randomization assignments will be monitored by the study biostatistician to confirm 
balanced assignment between groups.  Unless anomalies are noted in the group 
assignments, such as due to a programming error, no changes will be made to the 
randomization code. 
5.4.2 
Masking Procedures 
Intervention:  Due to the nature of the trial, neither participants nor counselors (quit 
coaches) in the enhanced intervention (experimental arm) will be blinded to participants’ 
treatment assignment.  Quit coaches delivering usual care will be aware that 
participants’ are enrolled in a non-standard contract (e.g., a research study), but they 
will not be trained in or exposed to the enhanced intervention to prevent contamination.   
Assessment:  GHRI staff conducting follow-up assessments will be blinded to treatment 
assignment.   
5.5 
Subject Withdrawal 
Subjects may withdraw voluntarily from the study or the investigator may terminate a 
subject's participation. 
5.5.1 
Reasons for Withdrawal 
Subjects are free to withdraw from participation in the study at any time upon request. 
An investigator may terminate a study subject’s participation in the study if: 
 Any adverse event (AE) or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the 
subject. 
 The subject meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation. For example, 
the participant is found to be ineligible after enrollment (e.g., prior household 
member enrolled). 

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5.5.2 
Handling of Subject Withdrawals or Subject Discontinuation of Study 
Intervention 
Participants who request to drop out will be given the option to withdraw from 
participation in the intervention only, but to still participate in the follow-up evaluations.  
Participants who refuse this offer and request to completely withdraw from the study will 
no longer be contacted. However, previously obtained data will be retained with subject 
consent. 
We will not recruit replacement participants for drop-outs. Persons who withdraw as a 
result of an adverse event will be referred for appropriate care. 
5.6 
Premature Termination or Suspension of Study 
This study may be prematurely terminated if, in the opinion of the investigator, the 
sponsor or the IRB there is sufficient reasonable cause. Written notification, 
documenting the reason for study termination, will be provided to the investigator and/or 
sponsor by the terminating party. Circumstances that may warrant termination include, 
but are not limited to: 
 Determination of unexpected, significant, or unacceptable risk to subjects.  
 Insufficient adherence to protocol requirements.  
 Failure to obtain sufficient follow-up data to evaluate the effectiveness of the 
intervention.   
If the study is prematurely terminated or suspended, the sponsor will promptly inform 
the investigators/institutions, and the regulatory authority(ies) of the termination or 
suspension and the reason(s) for the termination or suspension. The IRB/IEC will also 
be informed promptly and provided the reason(s) for the termination or suspension by 
the sponsor or by the investigator/institution, as specified by the applicable regulatory 
requirement(s). 
 

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6 STUDY INTERVENTION 
6.1 
Study Behavioral or Social Intervention(s) Description 
Participants will be randomized to receive usual care treatment through their tobacco 
quitline or the enhanced intervention combining usual care with a multi-modal 
behavioral oral health promotion program. 
Usual care:  Usual care participants will receive standard quitline counseling as 
described below (section 7.3):  
 Written usual care resources offered by mail and Internet, as consistent with the 
standard quitline intervention program 
 Access to a standard course of nicotine replacement therapy, if medically 
appropriate.   
All materials are focused on tobacco cessation and do not include oral health promotion 
materials.  Average call duration in the participating quitlines ranges from 13.76 minutes 
(Oregon) to 14.36 minutes (Nebraska). To control for the effects of the texting 
intervention, we will augment usual care with an attention-matched texting outreach 
focused on health behaviors other than smoking cessation or oral health promotion. 
Additional detail on the texting program is included appendix G. 
The intervention protocol for the usual care counseling is proprietary and is not 
described in this protocol. Standard program components for each state’s program is 
detailed in the table below. Additional information regarding call timing can be found in 
section 7.3. 
 
Phone 
Counseling 
Web-based 
Intervention 
Text  
Messaging 
Nicotine 
Replacement 
Oregon 
4 proactive calls 
Yes 
Not currently 
2 week supply 
patch/gum to 
uninsured  
Nebraska 
5 proactive calls 
Yes 
Not currently 
None 
Louisiana 
5 proactive calls 
Yes 
Not currently 
2 week supply 
patch or gum 
 

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Enhanced (Experimental) Intervention: Experimental participants will receive the 
following care:  
 usual care tobacco quitline counseling 
 additional counseling content focused on oral health promotion 
 mailed oral health promotion materials 
 access to the OralHealth4Life.com log-in secured website and  
 a series of proactively delivered oral health promotion text messages.   
Materials also include referral information for local, low cost professional dental care 
services, a toothbrush, floss, and other oral health hygiene materials.  Additional detail 
on the intervention and timing of the contacts is summarized below in section 7 and 
outlined in Appendix A (Schedule of Events).   
Intervention content is included in Appendix G (Oral Health 4 Life booklet), Appendix F 
(Counseling Protocol and Training Materials), Appendix G (Text Messages and Delivery 
Schedule), and at www.OralHealth4Life.com (website access is restricted during the 
study period).  
6.2 
Administration of Intervention 
The timing of each intervention component is detailed below in section 7 (Study 
Schedule), Diagram 1 (Study Flow for RCT), and Appendix A (Schedule of Events). 
All phone counseling will be delivered by quit coaches at Alere Wellbeing.  Oral health 
counseling will be integrated into each tobacco cessation counseling call following a 
structured intervention protocol.  Each participant may receive up to 5 integrated oral 
health promotion-tobacco cessation counseling calls. 
Written oral health materials and other study-provided oral health aids (e.g., toothbrush, 
floss) will be mailed to participants by staff at GHRI.  Materials will be mailed within 1-2 
days after participants enroll in the study.   
Participants will have secure access to the OralHealth4Life website 
(OralHealth4Life.com) starting on the day of their enrollment.  Directions for accessing 
the site will be provided during the initial counseling call and included in the written 
study materials provided by mail. Following the study, open-access copies of the 
website will be made available to participants randomized to both study arms. 
GHRI staff will oversee delivery of the intervention text messages, which will be sent on 
a standardized schedule (see section 7.3).  Participants will receive up to 16 total text 
messages during the period ranging from the day before their chosen target smoking 
Quit Date to 22 days following their target Quit Date.  Persons who request to stop 
receiving text messages will be opted out of receiving messages at that time.   

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6.3 
Procedures for Training Interventionists and Monitoring Intervention 
Fidelity 
Usual care counselors will be trained by Alere using their standard protocols and 
procedures.  These counselors will also be informed about the basic study overview in 
order to field general questions from participants, but will not be trained on or have 
access to the oral health counseling protocol.   
Counselors delivering the enhanced intervention will be trained to deliver usual care 
smoking intervention and the oral health  counseling by Alere staff.  Training in the oral 
health content will be led by Alere staff, under the direction of Drs. McClure and Catz.  
The additional oral health counseling will be added to the usual care counseling for 
subjects receiving the enhanced intervention. 
Calls (usual care and enhanced) will also be audio taped per Alere’s standard protocol 
and a random sample involving at least 10% of calls will be monitored and coded for 
fidelity to the study protocol. More calls will be monitored, as needed, based on 
observation of interventionist drift or as needed to monitor the enhanced intervention, in 
particular. 
6.4 
Assessment of Subject Compliance with Study Intervention 
Compliance with the counseling will be monitored through automated tracking of 
participants’ quitline calls (e.g., number of calls taken, duration of calls). 
Participants will also be surveyed about their utilization of the written content, log-in 
secured website, and text messages.  
 

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7 STUDY SCHEDULE 
7.1 
Screening (Call 1, Day 0) 
Persons who are eligible for services through one of the participating quitlines and 
preliminarily eligible for the study based on eligibility criteria assessed as part of the 
standard quitline registration process will be informed of the study and invited 
participate. They will be screened for eligibility at the time of their initial quitline 
registration call.  The screening will be conducted by phone by Alere staff trained in the 
study procedures.  Respondents will answer each screening eligibility question.  If a 
caller refuses to answer any screening questions or fails to meet the inclusion criteria 
above, they will be deemed ineligible.  The screening assessment will continue until a 
person is deemed ineligible or the entire survey is completed.   
Eligible persons will be invited to learn more about the study and will be read a scripted 
informed consent.  Persons who give verbal consent to join the study will then complete 
a baseline assessment by phone and be randomized to treatment.  Following 
enrollment, participants will be mailed a written copy of the consent form for their 
records (Appendix H).   
Alere staff will document the consent process for each person including whether they 
agreed to provide consent to be screened [yes/no] and/or to enroll in the study [yes/no]. 
Each person will receive a screening disposition of:  
 Ineligible (with the reason coded) 
  eligible but refused 
 or eligible and enrolled 
7.2 
Enrollment/Baseline (Call 1, Day 0) 
Following completion of the consent process, participants will complete a baseline 
phone interview and be randomized to treatment using the automated algorithm.  
Persons who are randomized to usual care will then be transferred to a usual care quit 
coach.  The quit coaches will have no training in or exposure to the enhanced 
intervention protocol in order to prevent contamination.  Persons assigned to the 
experimental arm will receive counseling from a quit coach in Alere’s Research 
Implementation Unit who has been trained in the enhanced intervention protocol. 
[NOTE: This contact occurs during the same registration call as the screening, consent, 
and baseline interview.] 

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7.3 
Intermediate Visits 
7.3.1 
Control Intervention 
Participants randomized to the control condition will receive standard quitline 
counseling, plus usual care resources offered by mail, Internet, as consistent with the 
standard quitline intervention program.  All materials are focused on tobacco cessation 
and do not include oral health promotion content.  The intervention protocol for this 
counseling is proprietary and is not detailed here.  All standard intervention materials 
will be delivered by Alere per standard procedures.  Control participants will also receive 
an attention-matched texting program.  Texts will be sent on the same delivery schedule 
detailed below for enhanced intervention participants. 
The call schedule is tailored for each person, based on their availability, planned quit 
date(s), and continued program engagement, but generally follows the timeline below: 
Call 1:  Enrollment call/treatment session 1 (pre-target Quit Date [QD])  
Call 2:  QD or QD +1 day (~week 1-2 after Call 1) 
Call 3:  QD + 1-2 weeks (~week 2-4 after Call 1) 
Call 4:  Call 3 + 3 weeks (~week 4-6 after Call 1) 
Call 5:  Call 4 + 3 weeks (~week 6-10 after Call 1) 
Following completion of the first counseling call, usual care participants will receive a 
welcome letter, $30 thank you, and a written copy of the study consent form for their 
records (Appendix H).  These materials will be mailed by GHRI study staff. 
 
Post-Study Access to Website 
7.3.1.1
Following completion of the study, control arm participants will be sent a link via text and 
mail to an open-access copy of the study intervention website. Anonymous 
administrative usage statistics will be collected (e.g., number of page hits, time spent 
per page, etc.) for the control arm copy of the open-access website. 
 
7.3.2 
Enhanced Intervention: (Usual Care + Oral Health Promotion) 
 
Phone Contact 1 & Mailed Materials 
7.3.2.1
Participants assigned to the enhanced intervention will receive standard quitline 
counseling plus additional counseling focused on oral health promotion.  Following 
completion of this call, participants will be mailed usual care tobacco cessation 
materials by Alere Wellbeing staff.  GHRI staff will mail an oral health promotion packet 
to the subjects randomized to receive enhanced intervention. The packet will include a 
study welcome letter, a written oral health booklet (Oral Health 4 Life: A Quick Guide to 

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Better Oral Health) developed for study participants, access to the OralHealth4Life.com 
log-in secured study website which includes additional oral health promotion resources 
and information, oral health promotion supplies (e,g, toothbrush, toothpaste, floss), a 
copy of the written consent form, and a $30 thank you.   
Additional behavioral intervention will be delivered during future phone counseling 
sessions as outlined in the interventionist training materials and via text, as described 
below.   
 
Phone Contact 2-5 
7.3.2.2
Participants will be contacted by phone per the standard Quit for Life tobacco cessation 
program timeline and outreach protocol.  This is a 4 or 5 call program, depending on the 
state contract.  Call 1 occurs prior to the quit date.  Call 2 occurs within a day of the 
target quit date (TQD).  Calls 3-5 are typically scheduled following the TQD.  During 
each of these counseling calls, participants will receive standard cessation counseling 
plus additional counseling to promote better oral health outcomes.  This includes 
advising all participants to schedule a dental check-up/cleaning in the near future, 
advising them to brush and floss daily, providing information about the health benefits of 
routine oral hygiene and risks of tobacco and alcohol to oral health; and recommending 
participants engage in strategies designed to both help them stop smoking and promote 
oral health (e.g., promoting use of sugar free gum, tooth brushing, and flossing as 
strategies for distracting oneself from smoking and managing cravings). The oral health 
promotion counseling is designed to be ‘front loaded’ in calls 1-3, with booster content 
reviewed in calls 4 and 5. Additional detail is included in the Oral Health 4 Life 
Counseling Protocol and Training Materials (Appendix F). 
 
Text Messaging (Enhanced Intervention Group)   
7.3.2.3
Participants will receive a series of text messages designed to reinforce the pro-oral 
health messaging delivered by the quitline counselors and promote use of the Oral 
Health 4 Life log-in secured website.  The messages and timing were developed 
through an iterative process involving focus group feedback and feedback from 
individual smokers to ensure appropriate content, timing, and frequency of contacts.  
Messages are intentionally brief and do not exceed the maximum 160 SMS character 
limit, to prevent wrapping across multiple text messages or truncation.  Message 
content was designed to be responsive to smokers’ specific requests for information 
and encouragement for behavior change.  Message timing was also based on feedback 
provided by smokers, although the messaging will be less frequent than the daily 
schedule focus group participants requested.   
Text messages will be delivered on a standardized schedule based on each person’s 
initial target tobacco quit date (TQD), as follows:   
 One day prior to the TQD 

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 One message per week from TQD + 1 week to TQD + 8 weeks 
 One message every 2 weeks from TQD + 14 weeks through TQD + 22 weeks.   
The same schedule will be used to send text messages in the control arm (see 
message content in Appendix G). 
To ensure consistent delivery and adherence to the planned schedule, GHRI staff will 
set up automatic delivery of all messages within 3 days of enrollment.  All text 
messages will be managed through an online text messaging vendor program.   
Participants will be informed not to respond to text messages.  If they do, they will 
receive an automated reply which informs them we cannot respond directly to their text 
and directs them to the Oral Health 4 Life log-in secured website or to a quitline 
counselor for more information.    
Participants can request to discontinue receiving text messages and remain enrolled in 
the study. 
 
Website 
7.3.2.4
Participants in the enhanced intervention will receive access to the OralHealth4Life.com 
log-in secured website. This site includes similar, but expanded, content to that in the 
Oral Health 4 Life pamphlet including detailed information on where to find local, low-
cost professional dental care in each participating state. Content was developed 
through an iterative process including feedback from oral health specialists (dentist, 
periodontist, & oral pathologist), behavioral scientists, and smokers participating in 
focus groups and individual usability evaluation assessments.  Access to the site will 
require a log-in ID and password, in order to track individual use of the website. 
7.3.2.4.1 Post-Study Access to Website 
Log-in requirements are known to present a barrier to use. Therefore following 
completion of the study, enhanced intervention participants will be sent a link via text 
and mail to an open-access copy of the study website. Anonymous administrative 
usage statistics will be collected (e.g., number of page hits, time spent per page, etc.) 
for the intervention arm copy of the open-access website..  
 
Follow-up Assessments 
7.3.2.5
Follow-up phone surveys will be conducted by the GHRI Survey Research Program at 2 
and 6 months post-enrollment.  Each participant will receive a reminder letter and text 
message approximately one week prior to their interview due date.  Professional 
interviewers will then contact each person by phone to complete the standardized 
interview.   
Persons who are reached by phone but who decline to participate in the full interview 
will be asked to provide information on each of the main outcomes of interest.  Each 

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person who completes an interview (full or abbreviated) will be mailed a thank you letter 
and $30 check or gift card as a thank you for their time. 
During each follow-up contact, survey staff will confirm that the contact information on 
file is correct for each participant (mail address, cell phone number, home number, and 
email address). 
Persons who cannot be reached within 2 weeks of their scheduled due date will be 
mailed a written survey to complete and return by mail.  Persons who are not reached 
by phone and do not return the written survey within 4 weeks post-due date at 2 month 
follow-up or 6 weeks post-due date at 6 month follow-up will be coded as unable to 
reach. Other response options include: refused, deceased, and unknown. 
7.4 
Withdrawal Visit 
Participants who ask to withdraw from all future study contacts (intervention and 
assessment) will be allowed to do so.  We will not conduct an early termination visit, but 
individuals will be asked their reason for drop out and may be asked to provide 
information on the primary outcome variables if drop out occurs within ~ one month of a 
scheduled follow-up assessment.  These interviews will be conducted by study staff at 
GHRI. 
7.5 
Unscheduled Visit 
Since phone counseling is delivered proactively by tobacco quitline staff in accordance 
with a standardized timeline, there will be no unscheduled intervention visits.  Per the 
quitline protocol, participants can call in at any time to receive ad-hoc tobacco cessation 
counseling.  If they occur, these contacts will be separate from the intervention 
delivered as part of this trial, but their occurrence will be tracked by Alere for study 
purposes.  Oral health counseling will be included in these calls.  If the quit coach 
neglects to deliver the oral health counseling, a call back will be made to attempt to 
deliver this content. 
 

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8 STUDY PROCEDURES /EVALUATIONS 
Standard operating procedures for the study will be detailed in the Manual of 
Procedures (MOP), which will be provided to study staff prior to study start-up. 
Overviews of the procedures are provided here. Data collected will be directly entered 
into our electronic data collection system.  
Additional detail regarding study procedures are included in sections 3.2.1, 5, 6, and 7 
above. Baseline and follow-up surveys can be found in the Appendices.  

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9 ASSESSMENT OF SAFETY 
9.1 
Specification of Safety Parameters 
This is a minimal risk behavioral intervention.  Nevertheless, adverse events (AEs) will 
be recorded and reported over the course of the study as outlined below: 
9.1.1 
Unanticipated Problems 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
(UP) involving risks to subjects or others to include, in general, any incident, experience, 
or outcome that meets all of the following criteria: 
 unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
 related or possibly related to participation in the research (“possibly related” 
means there is a reasonable possibility that the incident, experience, or outcome 
may have been caused by the procedures involved in the research); and 
 suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
9.1.2 
Adverse Events (AE)/Serious Adverse Events (SAE) 
An adverse event is any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s 
participation in the research. 
9.1.3 
Expected Adverse Reactions 
Persons who visit a dental professional or change their daily oral hygiene regimen may 
experience temporary changes in gum bleeding or tooth sensitivity.  
Because the study will use phone, mail, and Internet to communicate with participants, it 
is possible that others may learn of their participation in this study (e.g., breach of 
confidentiality).  Expected AE’s in this study are generally considered to be mild (easily 
tolerated) to moderate (discomfort with some interference in usual activities), but not 
severe (incapacitating). 
Persons who stop smoking may experience symptoms of nicotine withdrawal. 

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See additional discussion of potential adverse reactions in section 2.3.1(Potential 
Risks). 
9.2 Time Period and Frequency for Event Assessment and Follow-Up 
Unanticipated problems will be recorded in the data collection system throughout the 
study.  
The PI will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day 
of study participation.  At each study visit, Alere staff will inquire about and record the 
occurrence of AE/SAEs since the last contact.  Events will be followed for outcome 
information until resolution or stabilization.   
9.3 Characteristics of an Adverse Event 
9.3.1 
Relationship to Study Intervention 
AE’s deemed possibly related to the study intervention by Alere staff and Dr. Bush will 
be shared with the PI (Dr. McClure), who will make a final determination whether each 
AE is due to study involvement.  The following guidelines will be used.  [NOTE: Some 
AE’s associated with quitting smoking, but which are not clearly associated with study 
participation will not be passed on to the PI by Dr. Bush or Alere staff.  For example, 
AE’s which are deemed to be related to the stop smoking medication use.  These will be 
managed per Alere’s standard internal protocols for medical oversight.] 
 Associated – The event is temporally related to the study participation and no 
other etiology explains the event.  
 Not Associated – The event is temporally independent of study participation 
and/or the event appears to be explained by another etiology 
9.3.2 
Expectedness of SAEs 
The NIDCR Medical Monitor and the Study PI will be responsible for determining 
whether an SAE is expected or unexpected.  An adverse event will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the 
risk information previously described for the intervention. 
9.3.3 
Severity of Event 
The following scale will be used to grade adverse events: 
1. Mild: no intervention required; no impact on activities of daily living (ADL) 
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate 
impact on ADL 

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3. Severe: significant symptoms requiring invasive intervention; subject seeks 
medical attention, needs major assistance with ADL. 
9.4 
Reporting Procedures 
9.4.1 
Unanticipated Problem Reporting to IRB and NIDCR 
Incidents or events that meet the OHRP criteria for unanticipated problems will be 
reported to the IRB.  Unanticipated problem reports will include: 
 appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number;  
 a detailed description of the adverse event, incident, experience, or outcome;  
 an explanation of the basis for determining that the adverse event, incident, 
experience, or outcome represents an unanticipated problem;  
 a description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the unanticipated problem 
Reporting of Unanticipated Problems to NIDCR is accomplished by submission of an 
Unanticipated Problem Report via fax or email to Rho Product Safety.  Once submitted, 
Rho Product Safety will send a confirmation email to the investigator within 1 business 
day.   
UP Reporting Contact Information:  
 Product Safety Hot Line:  1-888-746-7231 
 Product Safety Fax Line:  1-888-746-3293 
 Product Safety Email:  rho_productsafety@rhoworld.com  
9.4.2 
Serious Adverse Event Reporting to NIDCR 
Any AE meeting the specified Serious Adverse Event criteria will be submitted on an 
SAE form to NIDCR’s centralized safety system via Rho Product Safety. This report 
may be sent by fax or email. Once submitted, Rho Product Safety will send a 
confirmation email to the investigator within 1 business day. The investigator should 
contact Rho Product Safety if this confirmation is not received. This process applies to 
both initial and follow-up SAE reports. 
SAE Reporting Contact Information:  
 Product Safety Hot Line:  1-888-746-7231 (International: 919-595-6486) 

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 Product Safety Fax Line:  1-888-746-3293 (International: 919-287-3998) 
 Product Safety Email:  rho_productsafety@rhoworld.com  
General questions about SAE reporting can be directed to the Rho Product Safety Help 
Line (available 8:00AM – 5:00PM Eastern Time) at 1-888-746-7231or 919-595-6486.  
The study PI or Project Manager will complete a Serious Adverse Event Form within the 
following timelines:  
 All deaths and immediately life-threatening events, whether related or unrelated, 
will be recorded on the Serious Adverse Event Form and sent by fax or email 
within 24 hours of site awareness.  
 Serious adverse events other than death and immediately life-threatening events, 
regardless of relationship, will be reported by fax or email within 72 hours of site 
awareness.  
Other supporting documentation of the event may be requested by the 
pharmacovigilance contractor and should be provided as soon as possible. 
All SAEs will be followed until satisfactory resolution or until the PI or Sub-investigator 
deems the event to be chronic or the patient to be stable 
9.5 
Halting Rules 
Study halting may occur as required by the IRB, NIDCR, or DSMB.  The study PI may 
temporarily suspend enrollment pending review by these authorities if warranted based 
on the presence, type, or frequency of SAE’s or other changes in the study protocol 
which may place participants at greater than anticipated risk. 

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10 STUDY OVERSIGHT 
A Data and Safety Monitoring Board (DSMB) will be convened to periodically review 
and evaluate the accumulated study data for participant safety, study conduct and 
progress.  Efficacy will not be explicitly monitored as it will not be possible to assess the 
intervention’s efficacy in a meaningful way based on an incomplete sample and the 
study’s low risk level.  The DSMB will also make recommendations to NIDCR 
concerning the continuation, modification, or termination of the study. 
The Board will consist of 6 voting members chosen by NIDCR for their expertise in 
tobacco cessation treatment, quitline counseling, oral health, or biostatistics. The 
NIDCR Medical Monitor will be a blinded, non-voting member of the Board.  The Board 
will meet at least once a year while the study is actively recruiting or providing 
intervention to participants, but may meet more frequently as deemed necessary by the 
Board members.  The DMSB will operate under the rules of an NIDCR-approved charter 
that will be written at the organizational meeting of the DSMB.  At this time, each data 
element that the DSMB needs to assess will be clearly defined. The DSMB will advise 
NIDCR of its findings.  Reports will also be shared annually with the IRB as required. 
Confidentiality will be maintained during all phases of the DSMB review and 
deliberations.  Only voting members will have access to interim analyses of outcome 
data identified by treatment group, except as noted or required by the DSMB.   
All DSMB activities will be in compliance with NIDCR guidelines at note at 
http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm. 
 
 

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11 CLINICAL SITE MONITORING 
Clinical site monitoring will not be done for this study; however, the NIDCR reserves the 
right to conduct independent audits or clinical monitoring as necessary. 
 

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Table 2. Power Calculations 
  
Effect Sizes 
  
  
Control 
Intervention 
Sample 
Size 
   Abstinence 
12% 
20% 
880 
 
12% 
21% 
712 
12% 
22% 
590 
Dental care 
5% 
11% 
856 
 
5% 
12% 
664 
5% 
15% 
376 
All power calculations assume 90% power and use a 
normal approximation approach with pooled variance. 
12 STATISTICAL CONSIDERATIONS 
12.1 
Study Hypotheses 
All hypotheses tested will be evaluations of superiority of the enhanced intervention (UC 
cessation counseling + oral health promotion program) compared to UC (UC cessation 
counseling).  Null hypotheses assume that participants in the enhanced intervention 
group are equal to the participants in the UC group.  We hypothesize that, compared to 
people in the UC arm, participants in the enhanced intervention will: 
a.  Be more likely to quit smoking as evidenced by 7 day PPA rates at 6 month 
follow-up (primary outcome) and at 2 month follow-up (secondary outcome) b.  
Be more likely to see a dental care professional in the past 6 months at 6 month 
follow-up [primary outcome] or at least be more likely to seek dental care or have 
scheduled a future appointment [secondary outcome]. 
c.  Exhibit more positive change in relevant oral health knowledge/beliefs and 
attitudes (e.g., self-efficacy, motivation) that could influence future behavior 
change [secondary outcomes]. 
We hypothesize that positive change in participants’ knowledge, attitudes, and beliefs at 
2 months will mediate positive change in the primary outcome behaviors at 6 months; 
and that the Oral Health 4 Life program will be acceptable to quitline callers 
12.2 
Sample Size Considerations 
This is the first study to examine 
whether an integrated oral health 
promotion-smoking cessation 
program delivered through tobacco 
quitlines will increase abstinence 
rates, so the potential effect size of 
the intervention is unknown.  
Given this, we have powered the 
study to detect a 9% increase in 
abstinence rates between the UC 
(12%) and enhanced intervention 
(21%) at 6 months. A difference of 
this magnitude (nearly a two-fold increase)  would be considered clinically meaningful, 
but is even more significant when viewed in terms of public health impact (defined as 
reach x effectiveness)46 when the potential reach could be hundreds of thousands of 
smokers annually.  Smaller effects could be statistically significant, but an effect of this 
size would be an unambiguous indicator that the intervention warrants dissemination. 
The UC cessation base-rate (12%) is estimated based on the actual end of treatment 
(~6 months) intent to treat 7-day PPA rates observed in the target quitlines (range = 

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11% - 12.5%) and is consistent with the estimated abstinence rate of tobacco quitlines 
based on a meta-analysis of the literature (average cessation rate at 6 months = 12.7% 
(95% CI, 11.3-14.2)).23  With a sample of ~712 people, we will have 90% power to 
detect an 9% difference in rates of smoking abstinence at 6 months assuming a two-
sided alpha-level=0.05 Wald Z test statistic for a difference between proportions using a 
normal approximation with pooled variance47 and UC rate of 12%. This sample is also 
more than sufficient to detect a meaningful difference in the proportion of people who 
receive dental care (see Table 1). Although no participants will have seen a dentist in 
the past 6 months at enrollment as a condition of eligibility, it is possible a few will 
spontaneously seek dental care. Thus, we assume a base rate of 5% for this outcome 
in the UC group at 6 months.  With the proposed sample, we will have >90% power to 
detect a 10% difference in dental care utilization between groups (e.g., 5% vs. 15%) 
and greater power to detect larger increases in treatment utilization.  Increasing 
treatment utilization by 10% or more in this high risk population also has public health 
significance given the potential reach of the program.  Each sample size estimate is 
based on complete case follow-up which will occur by design for all primary outcome 
analyses since we will be imputing missing values for the primary outcomes (missing 
cases will be assumed to be smokers and to not have visited the dentist).  All analyses 
assume an intent to treat analysis with all subjects included as randomized.  With a 
sample of n = 718, we also have 80% power to detect a difference of 7.6% in smoking 
abstinence and 5.6% in dental care utilization. 
12.3 
Planned Interim Analyses (if applicable) 
No interim analyses are planned. 
12.4 
Final Analysis Plan 
 
Analytic Samples.  At the request of our DSMB, main outcomes will be analyzed using two 
analytic samples.  One will include all 737 initially enrolled participants, regardless of study 
eligibility or study retention.  Since no follow-up data is being collected on 19 of these individuals 
because they were ineligible and mistakenly enrolled, primary outcome data for these 
individuals will be treated as missing data.  The second analytic sample (n = 718) will be limited 
to those individuals who were eligible to participate and included in the study.  Analytic findings 
based on this second analytic sample will be considered the primary study results, but we will 
present the results from both analyses if results for the primary outcomes differ between the two 
samples. However, since missing data will be imputed as smokers and non-utilizers of dental 
care, and the 19 individuals not included in the primary analytic sample were equitably 
distributed across groups (9 vs. 10), we do not anticipate their exclusion will alter the primary 
findings.  All analyses will use an ITT methodology such that subjects are analyzed according to 
their assigned treatment group, regardless of noncompliance, protocol deviation or withdrawal 
from treatment utilization.   
 
Primary and secondary analyses. To assess the difference between the experimental and 
control groups for smoking abstinence, the regression model will include data from both follow-
up time points in a single model to improve power and adjust for possible correlation within 

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individuals using generalized estimating equations.1   To assess differences in dental care 
utilization, we will compute whether participants saw a dentist post-enrollment using data from 
each follow-up, then run a single logistic regression model. We will specify an independent 
working correlation structure and estimate robust standard errors to avoid making model 
assumptions about the variance. Models will use a logit link function for the binary primary 
outcomes and odds ratios will be used to quantify differences between groups.  To improve 
precision and power, analyses will be adjusted for the following pre-specified baseline 
characteristics that are expected, based on prior knowledge, to be important predictors of 
outcome or missing data: sex, age, pharmacotherapy use (e.g., NRT), baseline cigarettes per 
day, depression history, self-efficacy, and motivation for quitting. Models will also adjust for 
variables used to stratify randomization (dental insurance coverage and state quitline).   
To estimate the effects of the intervention on secondary outcomes (e.g., completing or 
scheduling a dental appointment, brushing, self-efficacy, motivation, etc.), we will apply similar 
regression models as described for the primary outcomes, using appropriate link functions 
dependent on outcome type, and further adjust for baseline outcome value when appropriate.   
To handle missing follow-up data for the primary outcomes we will assume that missing 
subjects are smokers and are non-users of dental service.  In sensitivity analyses, we will use 
modern imputation methods to impute missing outcome data, based on the observed pattern of 
missingness.2  We also will conduct a respondent only missing data sensitivity analysis that only 
includes subjects with observed outcome data (i.e., a complete case analysis).  
 
   
Mediation Analyses. If the enhanced UC is more effective than UC for either primary 
outcome at 6 months, we will then conduct mediator analyses to assess whether 
relevant secondary outcomes measured at 2 months (self-efficacy, motivation, 
knowledge,) mediate at least part of this effect.  Mediation will be explored separately 
for each significant main outcome.  These analyses will be conducted using the 
framework recommended by Baron and Kenny,49 but using more recent statistical 
methods developed to better quantify and decompose different aspects of the mediation 
effect.50  Having demonstrated the association between the intervention and the 
outcome variable (the “total effect” of the intervention on the outcome), the second step 
will be to demonstrate the association between the intervention and each mediator.  We 
will construct a regression model for each mediator with the 2 month score of the 
mediator as the dependent variable and intervention indicator as independent variables.  
We will conduct this for each potential mediator and only include those mediators that 
have at least a P < 0.10-level significant relationship with the intervention as potential 
mediators in the following step.  The third step is to demonstrate the reduction of the 
intervention effect on the outcome after removing the effect of the mediator(s).  We will 
construct a multi-mediator inverse probability weighted (IPW) regression model.  This 
approach allows us to estimate the direct effect of intervention after rebalancing the 
intervention groups with respect to the mediators. The application of the IPW approach, 
as compared to the traditional approach of adjusting for multiple mediators, allows us to 
more appropriately account for confounding between a mediator and the outcome both 

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by additional mediators and by other measured variables.  Further, we are better able to 
estimate the indirect effects of each mediator in a causal framework through 
decomposition of the total effect of intervention into indirect effects through each 
mediator and the direct effect after accounting for all mediators.  Specifically, we will first 
model the probability of the intervention given the mediators (all mediators that were 
found associated with intervention in step 2) using logistic regression adjusting for 
potential baseline confounders.  From this model we will obtain the estimated 
probabilities that each person received their observed intervention given their observed 
mediator value. We will then use an IPW regression to model the primary outcomes on 
intervention status while adjusting for the baseline level of the outcome and mediator 
and weighting out the effect of the mediator.  Comparing the weighted to the 
unweighted model will allow us to estimate how much of the direct effect of intervention 
on the outcome can be explained by each potential mediator.  We will further be able to 
quantify the amount of effect explained by each mediator independent of the other 
mediators. 
Process Analyses. Summary statistics will be used to characterize quantitative 
acceptability ratings and scores.  T-tests will be used to compare groups’ on continuous 
ratings and chi-squares for proportions.  Open-ended qualitative responses will be 
reviewed by investigators and may be transcribed and coded thematically, as needed to 
provide insight into the participants’ satisfaction with the intervention programs and their 
components. 
Economic Analyses. In addition to addressing the main scientific aims above, we will 
calculate the incremental cost of adding the Oral Health 4 Life program, from the 
perspective of a future payer, and produce a decision support tool that will allow quitline 
sponsors to determine whether, based on their own willingness to pay for quitline 
services, adding the Oral Health 4 Life program makes economic sense.  This 
deliverable reflects quitline purchasers’ concerns about program cost.  The decision 
support tool will be created on a standard Excel spreadsheet and distributed at no cost 
to any individual or group wishing to assess the financial viability of adding the Oral 
Health 4 Life program to their quitline calls.  The decision tool will have three 
components.  The first is a detailed model of the cost associated with the oral health 
program.  To generate this model component we will use activity accounting methods,51 
which uses micro-costing to assign unit costs to every physical and human resource 
required to deliver an intervention or program. To micro-cost the additional cost of oral 
health counseling we will identify each resource required to add this component 
including development and training time, supplies,  the additional time spent per call, 
etc. The second component of the decision tool is the probability of success for each 
positive outcome (cessation, dental visit, both) associated with a quitline program 
incorporating Oral Health 4 Life. This information will be based on trial results and we 
will incorporate uncertainty by using confidence intervals derived from the analyses of 
our trial data as described above. The third component will be a user entered factor 
based on their willingness to pay so that a potential sponsor of Oral Health 4 Life can 
assess, based on alternative assumptions about cost, programmatic success and 

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willingness to pay, whether investing in the Oral Health 4 Life program makes financial 
sense to them. Each user will have the ability to vary each model parameter to 
determine the circumstances under which they would be willing to invest in purchasing 
the Oral Health 4 Life program. Thus, each purchaser can decide for themselves what 
outcomes could be expected based on the amount they are willing to pay. This tool will 
be shared with quitline purchasers to inform individual decisions about whether the 
program provides sufficient perceived value to warrant program costs. 
 

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13 SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Study staff will maintain appropriate treatment and research records for this study, in 
compliance with ICH E6, Section 4.9 and regulatory and institutional requirements for 
the protection of confidentiality of subjects.  Study staff will permit authorized 
representatives of NIDCR and regulatory agencies to examine (and when required by 
applicable law, to copy) research records for the purposes of quality assurance reviews, 
audits, and evaluation of the study safety, progress and data validity.   
 

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14 QUALITY CONTROL AND QUALITY ASSURANCE 
Alere study staff will be trained on the protocol by Drs. McClure, Catz, and Bush and/or 
their proxies, as appropriate to staffs’ role on the project (e.g., screening, assessment, 
intervention delivery).  Counselor training will involve a combination of didactic learning 
and experiential role play until each counselor is adept at delivering the counseling and 
integrating it with usual care.   
Electronic records will be routinely reviewed to ensure quality assurance, including: 
 Randomization assignments (blinded) will be monitored to ensure equitable 
distribution of participants in each arm and to ensure the block stratification 
scheme is maintained. 
 Alere will provide routine reports to GHRI summarizing enrollment metrics 
including: the number of people invited to be screened for eligibility, the number 
who are screened eligible, reasons for ineligibility, the number invited to consent, 
the number who provide consent, the number who complete baseline 
assessments, and metrics on participation in the counseling calls. 
 Alere will send weekly feeds of baseline and screening data to GHRI.  Surveys 
will be periodically checked by the biostatistician or GHRI programmer for 
missing or out of range values, or other evidence of poor data quality.  
Systematic errors will be addressed, as appropriate. 
 The GHRI biostatistician or programmer will conduct regular screening of follow-
up assessment data to identify missing or out of range values, or other evidence 
of poor data quality.  Systematic errors will be addressed, as appropriate. 
Phone contacts with quitline callers are routinely recorded by Alere.  We will randomly 
audit at least 10% of these calls for study participants to monitor fidelity to the 
counseling and may audit other study activities (e.g., screening, consent, and baseline 
interview) as needed.  GHRI fidelity monitors will listen to the randomly sampled calls.  
GHRI staff will be responsible for auditing and coding compliance with study activities, 
except that Alere staff may be responsible for auditing fidelity to the usual care 
counseling.  Standardized rating forms will be used to document compliance with study 
activities, including key elements of the counseling protocol.  As needed to address 
protocol drift, Drs. McClure, Catz, and Bush will ensure that study staff receive 
additional supervision and training. 
Compliance with the follow-up phone surveys will be audited by supervisors in the GHRI 
Survey Research Program following standard protocols for fidelity monitoring 
 

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15 ETHICS/PROTECTION OF HUMAN SUBJECTS 
15.1 
Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the 
principles set forth in The Belmont Report: Ethical Principles and Guidelines for the 
Protection of Human Subjects of Research, as drafted by the US National Commission 
for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 
1979) and codified in 45 CFR Part 46 and/or the ICH E6.  
15.2 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the IRB for review and approval.  Approval of both the protocol and 
the consent form must be obtained before any subject is enrolled.  Any amendment to 
the protocol will require review and approval by the IRB before the changes are 
implemented in the study.   
15.3 
Informed Consent Process 
With IRB approval, participants will provide verbal consent to participate.  Consent will 
be documented by study staff at Alere Wellbeing and all participants will be mailed 
written copies of the consent form for their records.  Informed consent will include 
permission to participate in the randomized trial, to have all data collected as part of 
their quitline counseling program shared with GHRI researchers, and for study staff to 
contact participants by phone, text or email.  Participants will be fully informed of the 
potential risks and benefits of study participation.  Those who decline to consent will still 
be eligible to participate in the usual care tobacco quitline program.  Participants will be 
informed of their right to withdraw their consent to participate at any time.  The consent 
process will conform to all requirements as set forth by the study IRB. 
The consent process will be documented in the study database.   
15.4 
Exclusion of Women, Minorities, and Children (Special Populations) 
Individuals of any gender or racial/ethnic group may participate. Children age 18 to 21 
may participate but persons under the age of consent (18 y.o.) will be excluded. 
15.5 
Subject Confidentiality 
Appropriate steps will be taken to safeguard participant confidentiality.  This includes 
the following: 
 All study data will be maintained on secure, password protected servers at GHRI 
and Alere.  Only study staff who need this information for their work will have 
access. 

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 Electronic data that contains PHI will be transmitted between GHRI and Alere 
using a secure, HIPPA-compliant FTP site. 
 Participants will be identified using subject IDs in all study records. 
 We will establish a Business User Agreement with the text messaging vendor, to 
ensure the confidentiality of study participants is maintained. 
 The study protocol, documentation, data and all other identifying information will 
be held in strict confidence.  No information about the study will be released 
without prior written approval of the sponsor.  The study monitor or other 
authorized representatives of the sponsor may inspect records, as needed. 
15.6 
Future Use of Identifiable Data 
Identifiable information will be destroyed within 5 years of the end of the study, 
consistent with HIPAA and our IRB requirements. 
We have no plans to retain identifiable information beyond this period.  If this plan 
changes, we will obtain appropriate IRB approval and participant consent. 
See also Study Records Retention, section 16.5. 

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16 DATA HANDLING AND RECORD KEEPING 
16.1 
Data Management Responsibilities 
Data collected at Alere Wellbeing and by the GHRI Survey Research Program will be 
captured in electronic records.  Any additional data may be collected on paper and 
added to electronic records (e.g., mailed survey interview if not able to collect by 
phone).  
If needed, all written source documents will be completed in a neat, legible manner to 
ensure accurate interpretation of data. When making changes or corrections, staff will 
cross out the original entry with a single line, and initial and date the change. They will 
NOT ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE 
ORIGINAL SOURCE DOCUMENT. 
Final datasets will be saved electronically, clearly labeled and stored in a secure project 
folder on the GHRI server accessible only to study staff.  Data shared between GHRI 
and Alere Wellbeing will be transferred using a secure FTP site.   
No electronic participant data shall be overwritten by study staff.  As necessary, 
variables may be recoded into new variables for analyses, but will done in a way to 
preserve the original record. All changes will be documented. 
16.2 
Data Capture Methods 
All data will be captured electronically for this study from either phone surveys (e.g., 
manual data entry using phone CATI systems), automated intervention records (e.g., 
Alere system records), or digital audio recordings.   
All electronic records will be kept in a 21 CFR Part-11 compliant data capture system, 
which includes password protection. 
16.3 
Types of Data 
Data for this study will include self-reported survey data (eligibility screening, baseline, 
and follow-up), electronic data on program utilization (e.g., number of calls completed, 
duration of behavioral counseling) and program delivery (number of emails and text 
messages sent), and safety data (e.g., AEs). 
16.4 
Schedule and Content of Reports 
The schedule for data review and reports will be determined by the DSMB during this 
Board’s initial meeting. 

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16.5 
Study Records Retention 
All study data will be maintained for at least 5 years after the conclusion of the study.  At 
that time, consistent with HIPAA guidelines, identifying information and linking files will 
be destroyed unless consent to retain these files is granted by study participants or the 
IRB. 
Following this time, no records will be destroyed without the consent of NIDCR, if 
applicable. It is the responsibility of the sponsor to inform the investigator when these 
documents no longer need to be retained 
16.6 
Protocol Deviations 
All staff will immediately report protocol deviations to the GHRI Project Manager, who 
will inform the PI.  Deviations will be considered any noncompliance with this clinical 
trial protocol, Good Clinical Practice, or the Manual of Procedures.  Deviations will be 
reported in a timely way to the GH IRB.  Deviations will also be reported to the NIDCR 
Program Official via NIDCR_Reports@rhoworld.com once monthly. 
 

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17 PUBLICATION/DATA SHARING POLICY 
This study will comply with the NIH Public Access Policy, which ensures that the public 
has access to the published results of NIH funded research. It requires scientists to 
submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital 
archive PubMed Central upon acceptance for publication. 
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a clinical trials registration policy as a condition for publication.  The ICMJE 
defines a clinical trial as any research project that prospectively assigns human subjects 
to intervention or concurrent comparison or control groups to study the cause-and-effect 
relationship between a medical intervention and a health outcome.  Medical 
interventions include drugs, surgical procedures, devices, behavioral treatments, 
process-of-care changes, and the like.  Health outcomes include any biomedical or 
health-related measures obtained in patients or participants, including pharmacokinetic 
measures and adverse events. The ICMJE policy requires that all clinical trials be 
registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the 
National Library of Medicine.  Other biomedical journals are considering adopting similar 
policies. For interventional clinical trials performed under NIDCR grants and cooperative 
agreements, it is the grantee’s responsibility to register the trial in an acceptable 
registry, so the research results may be considered for publication in ICMJE member 
journals.  The ICMJE does not review specific studies to determine whether registration 
is necessary; instead, the committee recommends that researchers who have questions 
about the need to register err on the side of registration or consult the editorial office of 
the journal in which they wish to publish. 
U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007 or 
FDAAA), Title VIII, Section 801 mandates that a "responsible party" (i.e., the sponsor or 
designated principal investigator) register and report results of certain "applicable 
clinical trials:"  
NIH grantees must take specific steps to ensure compliance with NIH implementation of 
FDAAA. 
 

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18 LITERATURE REFERENCES 
1. 
Centers for Disease Control and Prevention. Oral health: Preventing cavities, gum 
disease, tooth loss, and oral cancer--At a glance 2010. Division of Oral Health NCfCDPaHP, 
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Health Promotion; 2010. 
2. 
Mustapha IZ, Debrey S, Oladubu M, Ugarte R. Markers of systemic bacterial exposure in 
periodontal disease and cardiovascular disease risk: A systematic review and meta-analysis. J 
Periodontol. 2007;78(12):2289-302. 
3. 
Yamazaki K, Honda T, Domon H, Okui T, Kajita K, Amanuma R, et al. Relationship of 
periodontal infection to serum antibody levels to periodontopathic bacteria and inflammatory 
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de Oliveira C, Watt R, Hamer M. Toothbrushing, inflammation, and risk of cardiovascular 
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5. 
Griffin SO, Barker LK, Griffin PM, Cleveland JL, Kohn W. Oral health needs among 
adults in the United States with chronic diseases. J Am Dent Assoc. 2009;140(10):1266-74. 
6. 
US Department of Health and Human Services. Oral Health in America: A Report of the 
Surgeon General. US Department of Health and Human Services NIoDaCR, National Institutes 
of Health, editor. Rockville, MD: US Department of Health and Human Services, National 
Institute of Dental and Craniofacial Research, National Institutes of Health; 2000. 
7. 
Centers for Disease Control and Prevention. Surveillance for dental caries, dental 
sealants, tooth retention, edentulism, and enamel flourosis--United States, 1988-1994 and 
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Human Services; 2005 Contract No.: Document Number|. 
8. 
Ojima M, Hanioka T, Tanaka K, Aoyama H. Cigarette smoking and tooth loss experience 
among young adults: a national record linkage study. BMC Public Health. 2007;7. 
9. 
Griffin SO, Barker LK, Griffin PM, Cleveland JL, Kohn W. Oral health needs among 
adults in the United States with chronic diseases. J Am Dent Assoc. 2009;140(10):1266-74. 
10. 
Drilea SK, Reid BC, Li CH, Hyman JJ, Manski RJ. Dental visits among smoking and 
nonsmoking US adults in 2000. Am J Health Behav. 2005;29(5):462-71. 
11. 
Mucci LA, Brooks DR. Lower use of dental services among long term cigarette smokers. 
J Epidemiol Community Health. 2001;55(6):389-93. 
12. 
Kiefe CI, Williams OD, Greenland KJ, Ulene V, Gardin JM, Raczynski JM. Health care 
access and seven-year change in cigarette smoking - The CARDIA study. Am J Prev Med. 
1998;15(2):146-54. 
13. 
Rutten LJF, Wanke K, Augustson E. Systems and individual factors associated with 
smoking status: Evidence from HINTS. Am J Health Behav. 2005;29(4):302-10. 
14. 
Difranza JR, Guerrera MP. Alcoholism and smoking. J Stud Alcohol. 1990;51(2):130-5. 
15. 
Grant BF, Hasin DS, Chou SP, Stinson FS, Dawson DA. Nicotine dependence and 
psychiatric disorders in the United States - Results from the National Epidemiologic Survey on 
Alcohol and Related Conditions. Arch Gen Psychiatry. 2004;61(11):1107-15. 

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16. 
Falk DE, Yi HY, Hiller-Sturmhofel S. An epidemiologic analysis of co-occurring alcohol 
and tobacco use and disorders - Findings from the National Epidemiologic Survey on Alcohol 
and Related Conditions. Alcohol Res Health. 2006;29(3):162-71. 
17. 
Kahler CW, Strong DR, Papandonatos GD, Colby SM, Clark MA, Boergers J, et al. 
Cigarette smoking and the lifetime alcohol involvement continuum. Drug Alcohol Depend. 
2008;93(1-2):111-20. 
18. 
McClure JB, Divine G, Alexander G, Tolsma D, Rolnick SJ, Stopponi M, et al. A 
comparison of smokers' and nonsmokers' fruit and vegetable intake and relevant psychosocial 
factors. Behav Med. 2009;35(1):14-22. PMCID: PMC2687811. 
19. 
Northrop-Clewes CA, Thurnham DI. Monitoring micronutrients in cigarette smokers. Clin 
Chim Acta. 2007;377(1-2):14-38. 
20. 
McClure JB, Riggs K, St John J, Catz SL. [More] evidence to support oral health 
promotion services targeted to smokers calling tobacco quitlines in the United States. BMC 
Public Health. 2013;13:336. PMCID: PMC3635972. 
21. 
McClure JB, Riggs KR, St. John J, Cerutti B, Zbikowski S. Understanding oral health 
promotion needs and opportunities among tobacco quitline callers. Public Health Reports. 
2012;127(4):401-6. PMCID: PMC3366377. 
22. 
Abrams DB, Niaura R, Brown RA, Emmons KM, Goldstein MG, Monti PM. The tobacco 
dependence treatment handbook. New York, New York: The Guilford Press; 2003. 
23. 
Fiore MC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, et al. Treating 
tobacco use and dependence: 2008 update. Clinical practice guideline. Rockville, MD: U.S. 
Department of Health and Human Services. Public Health Service; 2008. 
24. 
Sambunjak D, Nickerson Jason W, Poklepovic T, Johnson Trevor M, Imai P, Tugwell P, 
et al. Flossing for the management of periodontal diseases and dental caries in adults. 
Cochrane Database Syst Rev [serial on the Internet]. 2011; (12): Available from: 
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD008829.pub2/abstract. 
25. 
Keukenmeester RS, Slot DE, Putt MS, Van der Weijden GA. The effect of sugar-free 
chewing gum on plaque and clinical parameters of gingival inflammation: a systematic review. 
Int J Dent Hyg. 2013;11(1):2-14. 
26. 
Mickenautsch S, Leal SC, Yengopal V, Bezerra AC, Cruvinel V. Sugar-free chewing gum 
and dental caries: a systematic review. J Appl Oral Sci. 2007;15(2):83-8. 
27. 
Rosseel JP, Hilberink SR, Jacobs JE, Maassen IM, Plasschaert AJM, Grol R. Are oral 
health complaints related to smoking cessation intentions? Community Dentist Oral Epidemiol. 
2010;38(5):470-8. 
28. 
Watt RG. Emerging theories into the social determinants of health: Implications for oral 
health promotion. Community Dent Oral Epidemiol. 2002;30(4):241-7. 
29. 
Renz A, Ide M, Newton T, Robinson P, Smith D. Psychological interventions to improve 
adherence to oral hygiene instructions in adults with periodontal diseases. Cochrane Database 
Syst Rev. 2007;18(2):CD005097. 
30. 
Yevlahova D, Satur J. Models for individual oral health promotion and their 
effectiveness: A systematic review. Aust Dent J. 2009;54(3):190-7. 
31. 
Satur JG, Gussy MG, Morgan MV, Calache H, Wright C. Review of the evidence for oral 
health promotion effectiveness. Health Educ J. 2010;69:257-66. 

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32. 
Watt R, Fuller S, Harnett R, Treasure E, Stillman-Lowe C. Oral health promotion 
evaluation - time for development. Community Dent Oral Epidemiol. 2001;29(3):161-6. 
33. 
Newton JT. Psychological models of behavior change and oral hygiene behaviour in 
individuals with periodontitis: A call for more and better trials of interventions. J Clin Periodontol. 
2010;37(10):910-1. 
34. 
Zhu S, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, et al. Evidence of 
real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002;347(14):1087-
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35. 
Orleans CT, Schoenbach VJ, Wagner E, Quade D, Salmon MA, Pearson DC, et al. Self-
help quit smoking interventions:  Effects of self-help materials, social support instructions, and 
telephone counseling. J Consult Clin Psychol. 1991;59(3):439-48. 
36. 
Swan GE, McClure JB, Zbikowski S, McAfee T, Jack L, Catz S, et al. Behavioral 
counseling and varenicline treatment for smoking cessation. Am J Prev Med. 2010;38(5):482-
90. PMCID: PMC2879135. 
37. 
Zbikowski SM, Hapgood J, Barnwell SS, McAfee T. Phone and web-based tobacco 
cessation treatment: real-world utilization patterns and outcomes for 11,000 tobacco users. J 
Med Internet Res. 2008;10(5):e41. PMCID: PMC2630835. 
38. 
North American Quitline Consortium. 2010 Survey final results (full report): U.S. and 
Canada. 2012 [updated 2012; cited 2012 December 7]; Available from: 
http://www.naquitline.org/?page=survey2010. 
39. 
Collins RJ. The mind of the public - from resignation to protection. J Evid Based Dent 
Pract. 2012;12(2):45-6. 
40. 
Kakudate N, Morita M, Sugai M, Kawanami M. Systematic cognitive behavioral approach 
for oral hygiene instruction: A short-term study. Patient Educ Couns. 2009;74(2):191-6. 
41. 
Jonsson B, Ohrn K, Lindberg P, Oscarson N. The effectiveness of an individually tailored 
oral health educational programme on oral hygiene behaviour in patients with periodontal 
disease: a blinded randomized-controlled clinical trial (one-year follow-up). J Clin Periodontol. 
2009;36(12):1025-34. 
42. 
Almomani F, Williams KE, Catley D, Brown C. Effects of an oral health promotion 
program in people with mental illness. J Dent Res. 2009;88(7):648-52. 
43. 
Lopez-Jornet P, Fabio CA, Consuelo RA, Paz AM. Effectiveness of a motivational-
behavioural skills protocol for oral hygiene among patients with hyposalivation. Gerodontology. 
2013. 
44. 
Buglar ME, White KM, Robinson NG. The role of self-efficacy in dental patients' brushing 
and flossing: Testing an extended Health Belief Model. Patient Educ Couns. 2010;78(2):269-72. 
45. 
Brennan D, Spencer J, Roberts-Thomson K. Dental knowledge and oral health among 
middle-aged adults. Australian and New Zealand Journal of Public Health. 2010;34(5):472-5. 
46. 
Abrams DB, Orleans CT, Niaura RS, Goldstein MG, Prochaska JO, Velicer W. 
Integrating Individual and Public Health Perspectives for Treatment of Tobacco Dependence 
Under Managed Health Care:  A Combined Stepped-Care and Matching Model. Ann Behav 
Med. 1996;18(4):290-304. 

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47. 
D'Angostino RB, Chase W, Belanger A. The appropriateness of some common 
procedures for testing the equality of two independent binomial populations. The American 
Statistician. 1988;42(3):198-202. 
48. 
Liang KY, Zeger SL. Longitudinal data-analysis using generalized linear-models. 
Biometrika. 1986;73(1):13-22. 
49. 
Baron R, Kenny DA. The mediator-moderator variable distinction in social psychological 
research: Conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 
1986;51(6):1173-82. 
50. 
VanderWeele TJ. Marginal structural models for the estimation of direct and indirect 
effects. Epidemiology. 2009;20(1):18-26. 
51. 
Frick KD. Microcosting Quantity Data Collection Methods. Medical Care. 
2009;47(7):S76-S81. 
 
 

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SUPPLEMENTAL MATERIALS 
These documents are relevant to the protocol, but they are not considered part of the 
protocol.  They are stored and modified separately. As such, modifications to these 
documents do not require protocol amendments. 
 

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APPENDICES 
Appendix A:  Schedule of Events 
Appendix B:  Baseline Survey 
Appendix C:  Follow-up Surveys 
Appendix D:  Eligibility Screening and Consent Script 
Appendix E: Oral Health 4 Life Intervention Booklet 
Appendix F:  Counseling and Training Protocol 
Appendix G: Text Messages  
Appendix H:  Written Consent Document 
 

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APPENDIX A: SCHEDULE OF EVENTS 
 
 
Call #1 
(Day 0) 
Call 2 
(~Week 
1-2) 
Call 3 
(~Week 
2-4) 
Call 4 
(~Week 
4-6) 
 
 
Call 5 
(~Week 
6-10) 
Text 
messages 
(~Weeks 
1-23) 
Follow-up 
#1 
(~Week 8) 
Follow-up  
#2 
(~ week 24) 
Assessment of Eligibility 
Criteria 
x 
 
 
 
 
 
 
 
Informed Consent  
x 
 
 
 
 
 
 
 
Baseline phone survey 
x 
 
 
 
 
 
 
 
Enhanced 
Intervention 
Counseling 
x 
x 
x 
x 
x 
 
 
 
Text 
Messages
1 
 
 
 
 
 
x 
 
 
Access to 
secure 
website 
x 
x 
x 
x 
x 
x 
 
 
Assessment of 
Unanticipated Problems 
 
x 
x 
x 
x 
 
x 
x 
Mail consent, incentive, 
and written study 
materials 
x (Post-
call 1) 
 
 
 
 
 
 
 
Follow-up phone survey 
 
 
 
 
 
 
x 
x 
Mail thank you and 
incentives 
 
 
 
 
 
 
x 
 (post-2 month 
follow-up) 
x 
 (post-6 
month follow-
up)  
Provide open access to 
copy of study website 
(invite via text and mail) 
 
 
 
 
 
 
 
(post-study 
end) 
Note: Call timing and text messages are subject to individual variability based on timing of the 
initial target quit date (TQD) and participant’s availability to be reached by phone. 

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1 Text messages will be sent to both control subjects and those randomized for the enhanced intervention using the 
time delivery schedule, but content will vary.  
 
 
 
 
1. 
Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous 
outcomes. Biometrics. 1986;42:121-30. 
2. 
Enders CK. Applied Missing Data Analyses. New York: Guilford Press; 2010.