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Promoting Oral Health Among Smokers Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02347124
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : May 15, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Alere Wellbeing
University of California
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Kaiser Permanente

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Oral Disease
Smoking
Interventions Behavioral: Usual Care Control
Behavioral: Enhanced Intervention
Enrollment 718
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description

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.

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)

Period Title: Overall Study
Started 360 358
2 Month Follow-up 298 275
Completed 267 259
Not Completed 93 99
Arm/Group Title Usual Care Control Enhanced Intervention Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 360 358 718
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 360 participants 358 participants 718 participants
44.5  (12.2) 44.1  (12.2) 44.3  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 358 participants 718 participants
Female
223
  61.9%
220
  61.5%
443
  61.7%
Male
137
  38.1%
138
  38.5%
275
  38.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 358 participants 718 participants
Hispanic or Latino
5
   1.4%
16
   4.5%
21
   2.9%
Not Hispanic or Latino
355
  98.6%
342
  95.5%
697
  97.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 358 participants 718 participants
White
208
  57.8%
209
  58.4%
417
  58.1%
Black
113
  31.4%
95
  26.5%
208
  29.0%
Other or multi-racial
37
  10.3%
52
  14.5%
89
  12.4%
Don't Know or Refused
2
   0.6%
2
   0.6%
4
   0.6%
[1]
Measure Description:

Subjects were asked: "Which of the following categories best describe your race?" (may indicate all that apply).

Categories offered were: White, Black or African-American, Native Hawaiian or Other Pacific Islander, American Indian, Other, Don't Know, Refused

Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 360 participants 358 participants 718 participants
360
 100.0%
358
 100.0%
718
 100.0%
Cigarettes per day  
Mean (Standard Deviation)
Unit of measure:  Cigarettes
Number Analyzed 360 participants 358 participants 718 participants
18.9  (9.5) 19.3  (9.7) 19.1  (9.7)
Last dental visit > 1 year ago  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 358 participants 718 participants
294
  81.7%
282
  78.8%
576
  80.2%
1.Primary Outcome
Title 7 Day Point Prevalent Abstinence (PPA)
Hide Description 7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.
Time Frame 6 month post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with missing data imputed as smokers.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 360 358
Measure Type: Count of Participants
Unit of Measure: Participants
109
  30.3%
121
  33.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments Adjusted for baseline sex, age, cigarettes per day, depression history, motivation, self-efficacy, current use of a stop-smoking medication, state quitline, and dental insurance.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
0.93 to 1.78
Estimation Comments [Not Specified]
2.Primary Outcome
Title Professional Dental Care Utilization in Past 6 Months
Hide Description self-reported utilization of professional dental care during study observation period
Time Frame 6 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with missing data imputed as not having seen a dentist.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 360 358
Measure Type: Count of Participants
Unit of Measure: Participants
67
  18.6%
65
  18.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments Adjusted for baseline sex, age, depression history, motivation, self-efficacy, state quitline, and dental insurance.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.69 to 1.53
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 7 Day Point Prevalent Abstinence (PPA)
Hide Description 7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers
Time Frame 2 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with missing data imputed as smokers.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 360 358
Measure Type: Count of Participants
Unit of Measure: Participants
116
  32.2%
127
  35.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.89 to 1.69
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 7 Day Point Prevalent Smoking Abstinence (PPA)
Hide Description Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.
Time Frame 2 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis limited to survey respondents (i.e., complete cases only).
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 297 274
Measure Type: Count of Participants
Unit of Measure: Participants
116
  39.1%
127
  46.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.01 to 2.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 7 Day Point Prevalent Smoking Abstinence (PPA)
Hide Description Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.
Time Frame 6 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Complete case analysis limited to survey respondents.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 267 258
Measure Type: Count of Participants
Unit of Measure: Participants
109
  40.8%
121
  46.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.95 to 1.96
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up
Hide Description

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.

Time Frame Baseline to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants providing data for this measure at the baseline and 2 month follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 297 274
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.08  (3.3) 0.14  (3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for sex, age, state quit line, and baseline knowledge score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.57 to 0.47
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up
Hide Description

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.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants providing data for this measure at baseline and 6 month follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 265 258
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.17  (4.0) 0.30  (3.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for sex, age, state quit line, and baseline knowledge score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-0.14 to 0.96
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up
Hide Description

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.

Time Frame Baseline to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to this item at baseline and 2 follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 297 271
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.36  (1.5) 0.01  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for sex, age, state quit line, and baseline self-efficacy score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.13 to 0.56
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up
Hide Description

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.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to this item at baseline and 6 month follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 263 255
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.19  (1.5) -0.11  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments Adjusted for sex, age, state quit line, and baseline self-efficacy score.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.22 to 0.23
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up
Hide Description

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.

Time Frame Baseline to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants providing responses to this item at baseline and 2 month follow-up
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 297 273
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.17  (0.8) -0.19  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for sex, age, state quit line, use of stop-smoking medications, baseline motivation, and baseline cigarettes per day.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.24 to 0.04
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up
Hide Description

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.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants providing responses to this item at baseline and 6-month follow-up
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 263 256
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.37  (1.0) -0.40  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for sex, age, state quit line, use of a smoking cessation medication at baseline, baseline motivation score, and baseline cigarettes per day.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.16 to 0.13
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up
Hide Description

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.

Time Frame Baseline to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to this item at baseline and 2 month follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 295 271
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.41  (1.3) -0.19  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments adjusted for sex, age, state quit line, and baseline motivation score.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
0.04 to 0.41
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up
Hide Description

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.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to this item at baseline and 6 month follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 262 254
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.35  (1.2) -0.27  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.17 to 0.21
Estimation Comments [Not Specified]
14.Other Pre-specified Outcome
Title Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up
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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.

Time Frame Baseline to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to this item at baseline and 2 month follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 296 272
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.13  (1.1) -0.13  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medications.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.20 to 0.16
Estimation Comments [Not Specified]
15.Other Pre-specified Outcome
Title Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up
Hide Description

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.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to this item at baseline and 6 month follow-up.
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 264 256
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.41  (1.4) -0.34  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Control, Enhanced Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.11 to 0.26
Estimation Comments [Not Specified]
Time Frame Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Control Enhanced Intervention
Hide Arm/Group Description

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.

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)

All-Cause Mortality
Usual Care Control Enhanced Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   2/360 (0.56%)      0/358 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Control Enhanced Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/360 (0.00%)      3/358 (0.84%)    
Eye disorders     
Unreversible blindness in right eye *  0/360 (0.00%)  0 1/358 (0.28%)  358
General disorders     
change in heartbeat leading to ER visit. Disccontinued use of nicotien patch and resolved. *  0/360 (0.00%)  0 1/358 (0.28%)  358
allergic reaction * [1]  0/360 (0.00%)  0 1/358 (0.28%)  358
*
Indicates events were collected by non-systematic assessment
[1]
Swelling of lips and tongue in response to nicotine replacement gum. Discontinued gum and symptoms resolved.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Control Enhanced Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/360 (3.06%)      7/358 (1.96%)    
General disorders     
Chest pain or mild tightness *  1/360 (0.28%)  1 0/358 (0.00%)  0
Anxiety or stress, mild to moderate *  4/360 (1.11%)  4 1/358 (0.28%)  1
Insomnia *  4/360 (1.11%)  4 1/358 (0.28%)  1
Dizziness, mild to moderate *  1/360 (0.28%)  1 2/358 (0.56%)  2
Behavior or mood change (while taking Zyban) *  0/360 (0.00%)  0 2/358 (0.56%)  2
Migraine, low BP, chills and nausea *  0/360 (0.00%)  0 1/358 (0.28%)  1
Nervous system disorders     
Seizure (pre-existing disorder) *  1/360 (0.28%)  1 0/358 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
The study relied on self-reported smoking and dental care. The focus on socio-economically disadvantaged smokers limits our ability to draw conclusions about the effectiveness of the intervention if offered to higher SES smokers.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Jennifer McClure
Organization: Kaiser Permanente Washington Health Research Institute
Phone: 206-287-2737
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02347124     History of Changes
Other Study ID Numbers: 14-047-E
U01DE024462-01 ( U.S. NIH Grant/Contract )
First Submitted: January 12, 2015
First Posted: January 27, 2015
Results First Submitted: February 16, 2018
Results First Posted: May 15, 2018
Last Update Posted: June 13, 2018