Trial Outcomes & Findings for Promoting Oral Health Among Smokers Randomized Trial (NCT NCT02347124)

NCT ID: NCT02347124

Last Updated: 2019-10-08

Results Overview

7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 718 participants
• Primary outcome timeframe: 6 month post-enrollment
• Results posted on: 2019-10-08

Participant Flow

Participants were recruited following registration with the Oregon (OR), Nebraska (NE), or Louisiana (LA) state quitlines. Participants were enrolled between June 2015 and July 2016.

Participant milestones

Measure	Usual Care Control Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Overall Study STARTED	360	358
Overall Study 2 Month Follow-up	298	275
Overall Study COMPLETED	267	259
Overall Study NOT COMPLETED	93	99

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Promoting Oral Health Among Smokers Randomized Trial

Baseline characteristics by cohort

Measure	Usual Care Control n=360 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=358 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)	Total n=718 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 12.2 • n=5 Participants	44.1 years STANDARD_DEVIATION 12.2 • n=7 Participants	44.3 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	223 Participants n=5 Participants	220 Participants n=7 Participants	443 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	138 Participants n=7 Participants	275 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	355 Participants n=5 Participants	342 Participants n=7 Participants	697 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	208 Participants n=5 Participants	209 Participants n=7 Participants	417 Participants n=5 Participants
Race/Ethnicity, Customized Black	113 Participants n=5 Participants	95 Participants n=7 Participants	208 Participants n=5 Participants
Race/Ethnicity, Customized Other or multi-racial	37 Participants n=5 Participants	52 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized Don't Know or Refused	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	360 Participants n=5 Participants	358 Participants n=7 Participants	718 Participants n=5 Participants
Cigarettes per day	18.9 cigarettes STANDARD_DEVIATION 9.5 • n=5 Participants	19.3 cigarettes STANDARD_DEVIATION 9.7 • n=7 Participants	19.1 cigarettes STANDARD_DEVIATION 9.7 • n=5 Participants
Last dental visit > 1 year ago	294 Participants n=5 Participants	282 Participants n=7 Participants	576 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month post-enrollment

Population: All participants with missing data imputed as smokers.

7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.

Outcome measures

Measure	Usual Care Control n=360 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=358 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
7 Day Point Prevalent Abstinence (PPA)	109 Participants	121 Participants

PRIMARY outcome

Timeframe: 6 months post-enrollment

Population: All participants with missing data imputed as not having seen a dentist.

self-reported utilization of professional dental care during study observation period

Outcome measures

Measure	Usual Care Control n=360 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=358 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Professional Dental Care Utilization in Past 6 Months	67 Participants	65 Participants

SECONDARY outcome

Timeframe: 2 months post-enrollment

Population: All participants with missing data imputed as smokers.

7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers

Outcome measures

Measure	Usual Care Control n=360 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=358 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
7 Day Point Prevalent Abstinence (PPA)	116 Participants	127 Participants

SECONDARY outcome

Timeframe: 2 months post-enrollment

Population: Analysis limited to survey respondents (i.e., complete cases only).

Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.

Outcome measures

Measure	Usual Care Control n=297 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=274 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
7 Day Point Prevalent Smoking Abstinence (PPA)	116 Participants	127 Participants

SECONDARY outcome

Timeframe: 6 months post-enrollment

Population: Complete case analysis limited to survey respondents.

Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.

Outcome measures

Measure	Usual Care Control n=267 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=258 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
7 Day Point Prevalent Smoking Abstinence (PPA)	109 Participants	121 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2 months

Population: Participants providing data for this measure at the baseline and 2 month follow-up.

Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:

Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.

Responses and scoring to the adapted NHIS scale:

Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5

Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.

The scores have a range of 7 (minimum) to 35 (maximum).

The study outcome is the change in this score between BL and 2 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge.

Outcome measures

Measure	Usual Care Control n=297 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=274 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up	0.08 scores on a scale Standard Deviation 3.3	0.14 scores on a scale Standard Deviation 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Participants providing data for this measure at baseline and 6 month follow-up.

Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:

Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.

Responses and scoring to the adapted NHIS scale:

Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5

Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.

The scores have a range of 7 (minimum) to 35 (maximum).

The study outcome is the change in this score between BL and 6 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge.

Outcome measures

Measure	Usual Care Control n=265 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=258 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up	-0.17 scores on a scale Standard Deviation 4.0	0.30 scores on a scale Standard Deviation 3.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2 months

Population: Participants who provided responses to this item at baseline and 2 follow-up.

SE to see a dentist was assessed using the following question:

"As of today, how confident are you that you can…See a dentist in the next 6 months?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

Outcome measures

Measure	Usual Care Control n=297 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=271 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up	-0.36 scores on a scale Standard Deviation 1.5	0.01 scores on a scale Standard Deviation 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Participants who provided responses to this item at baseline and 6 month follow-up.

SE to see a dentist was assessed using the following question:

"As of today, how confident are you that you can…See a dentist in the next 6 months?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

Outcome measures

Measure	Usual Care Control n=263 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=255 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up	-0.19 scores on a scale Standard Deviation 1.5	-0.11 scores on a scale Standard Deviation 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2 months

Population: Participants providing responses to this item at baseline and 2 month follow-up

Motivation to stop smoking was assessed using the following question:

"As of today, how motivated are you to…Stop smoking for good or remain quit?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.

The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

Outcome measures

Measure	Usual Care Control n=297 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=273 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up	-0.17 scores on a scale Standard Deviation 0.8	-0.19 scores on a scale Standard Deviation 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Participants providing responses to this item at baseline and 6-month follow-up

Motivation to stop smoking was assessed using the following question:

"As of today, how motivated are you to…Stop smoking for good or remain quit?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.

The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

Outcome measures

Measure	Usual Care Control n=263 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=256 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up	-0.37 scores on a scale Standard Deviation 1.0	-0.40 scores on a scale Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2 months

Population: Participants who provided responses to this item at baseline and 2 month follow-up.

Motivation to see a dentist was assessed using the following question:

"As of today, how motivated are you to…see a dentist in the next 6 months?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.

The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

Outcome measures

Measure	Usual Care Control n=295 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=271 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up	-0.41 scores on a scale Standard Deviation 1.3	-0.19 scores on a scale Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Participants who provided responses to this item at baseline and 6 month follow-up.

Motivation to see a dentist was assessed using the following question:

"As of today, how motivated are you to…see a dentist in the next 6 months?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation.

The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.

The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.

Outcome measures

Measure	Usual Care Control n=262 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=254 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up	-0.35 scores on a scale Standard Deviation 1.2	-0.27 scores on a scale Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 2 months

Population: Participants who provided responses to this item at baseline and 2 month follow-up.

SE to quit smoking was assessed using the following question:

"As of today, how confident are you that you can…stop smoking for good or remain quit?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.

The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

Outcome measures

Measure	Usual Care Control n=296 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=272 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up	-0.13 scores on a scale Standard Deviation 1.1	-0.13 scores on a scale Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Participants who provided responses to this item at baseline and 6 month follow-up.

SE to quit smoking was assessed using the following question:

"As of today, how confident are you that you can…stop smoking for good or remain quit?"

Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE.

The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.

The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.

Outcome measures

Measure	Usual Care Control n=264 Participants Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=256 Participants Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up	-0.41 scores on a scale Standard Deviation 1.4	-0.34 scores on a scale Standard Deviation 1.4

Adverse Events

Usual Care Control

Serious events: 0 serious events

Other events: 11 other events

Deaths: 2 deaths

Enhanced Intervention

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care Control n=360 participants at risk Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=358 participants at risk Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
General disorders change in heartbeat leading to ER visit. Disccontinued use of nicotien patch and resolved.	0.00% 0/360 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.28% 1/358 • Number of events 358 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
General disorders allergic reaction	0.00% 0/360 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.28% 1/358 • Number of events 358 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
Eye disorders Unreversible blindness in right eye	0.00% 0/360 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.28% 1/358 • Number of events 358 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).

Other adverse events

Measure	Usual Care Control n=360 participants at risk Standard tobacco quitline counseling program and materials + attention-matched text messaging. Usual Care Control: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.	Enhanced Intervention n=358 participants at risk Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . Enhanced Intervention: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
General disorders Chest pain or mild tightness	0.28% 1/360 • Number of events 1 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.00% 0/358 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
General disorders Anxiety or stress, mild to moderate	1.1% 4/360 • Number of events 4 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.28% 1/358 • Number of events 1 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
General disorders Insomnia	1.1% 4/360 • Number of events 4 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.28% 1/358 • Number of events 1 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
Nervous system disorders Seizure (pre-existing disorder)	0.28% 1/360 • Number of events 1 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.00% 0/358 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
General disorders Dizziness, mild to moderate	0.28% 1/360 • Number of events 1 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.56% 2/358 • Number of events 2 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
General disorders Behavior or mood change (while taking Zyban)	0.00% 0/360 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.56% 2/358 • Number of events 2 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
General disorders Migraine, low BP, chills and nausea	0.00% 0/360 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).	0.28% 1/358 • Number of events 1 • Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).

Additional Information

Dr. Jennifer McClure

Kaiser Permanente Washington Health Research Institute

Phone: 206-287-2737

Email: mcclure.j@ghc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place