Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01DE024462-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Consumer Wellness Solutions | INDUSTRY |
| University of California | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The investigators hypothesize that, compared to people in the control arm, participants in the enhanced intervention will:
Smokers (n = 722; 10 pilot participants and 712 main trial participants) will be recruited when they call to enroll in services with their state-supported tobacco quitline program. Eligible smokers who provide consent and complete the baseline assessment will be randomized to either usual care quitline intervention plus attention-matched text messaging or an enhanced program which integrates standard tobacco cessation counseling with a multi-modal, behavioral oral health promotion program.
Follow-up assessments will be conducted by phone at 2 and 6 months post-enrollment. In addition to examining primary and secondary outcomes of interest (focused on tobacco cessation and utilization of professional dental care), change in potentially relevant intermediate process measures and the incremental cost of delivering the Oral Health 4 Life program will be examined.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Control | Active Comparator | Standard tobacco quitline counseling program and materials + attention-matched text messaging. |
|
| Enhanced Intervention | Experimental | Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care Control | Behavioral | Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips. |
| Measure | Description | Time Frame |
|---|---|---|
| 7 Day Point Prevalent Abstinence (PPA) | 7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers. | 6 month post-enrollment |
| Professional Dental Care Utilization in Past 6 Months | self-reported utilization of professional dental care during study observation period | 6 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 7 Day Point Prevalent Abstinence (PPA) | 7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers | 2 months post-enrollment |
| 7 Day Point Prevalent Smoking Abstinence (PPA) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Health Knowledge Scale Score From Baseline to 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. |
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer McClure, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28750939 | Background | McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Corrigendum to "Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers" [Contemp. Clin. Trials 57 (2017) 90-97]. Contemp Clin Trials. 2017 Oct;61:133. doi: 10.1016/j.cct.2017.07.011. Epub 2017 Jul 24. No abstract available. | |
| 28412230 | Background | McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers. Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 12. |
Not provided
Not provided
We do not plan to share individual level data.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7 Day Point Prevalent Abstinence (PPA) | 7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers. | All participants with missing data imputed as smokers. | Posted | Count of Participants | Participants | 6 month post-enrollment |
|
Adverse events were monitored during each participant's active enrollment period (6 months post-randomization).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| change in heartbeat leading to ER visit. Disccontinued use of nicotien patch and resolved. | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain or mild tightness | General disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer McClure | Kaiser Permanente Washington Health Research Institute | 206-287-2737 | mcclure.j@ghc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2016 | Oct 20, 2017 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2017 | May 14, 2018 | Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enhanced Intervention | Behavioral | 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) |
|
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.
| 2 months post-enrollment |
| 7 Day Point Prevalent Smoking Abstinence (PPA) | Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed. | 6 months post-enrollment |
| Baseline to 2 months |
| Change in Oral Health Knowledge Scale Score From Baseline to 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. | Baseline to 6 months |
| Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 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 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. | Baseline to 2 months |
| Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 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. | Baseline to 6 months |
| Change in Motivation to Stop Smoking, From Baseline to 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. | Baseline to 2 months |
| Change in Motivation to Stop Smoking, From Baseline to 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. | Baseline to 6 months |
| Change in Motivation for Seeing a Dentist, From Baseline to 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. | Baseline to 2 months |
| Change in Motivation for Seeing a Dentist, From Baseline to 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. | Baseline to 6 months |
| Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 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. | Baseline to 2 months |
| Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 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. | Baseline to 6 months |
| 33605440 | Derived | Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4. |
| 30382910 | Derived | Blasi PR, Krakauer C, Anderson ML, Nelson J, Bush T, Catz SL, McClure JB. Factors associated with future dental care utilization among low-income smokers overdue for dental visits. BMC Oral Health. 2018 Nov 1;18(1):183. doi: 10.1186/s12903-018-0646-8. |
| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 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 | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Cigarettes per day | Mean | Standard Deviation | cigarettes |
|
| Last dental visit > 1 year ago | Count of Participants | 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)
|
|
|
| Primary | Professional Dental Care Utilization in Past 6 Months | self-reported utilization of professional dental care during study observation period | All participants with missing data imputed as not having seen a dentist. | Posted | Count of Participants | Participants | 6 months post-enrollment |
|
|
|
|
| Secondary | 7 Day Point Prevalent Abstinence (PPA) | 7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers | All participants with missing data imputed as smokers. | Posted | Count of Participants | Participants | 2 months post-enrollment |
|
|
|
|
| Secondary | 7 Day Point Prevalent Smoking Abstinence (PPA) | Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed. | Analysis limited to survey respondents (i.e., complete cases only). | Posted | Count of Participants | Participants | 2 months post-enrollment |
|
|
|
|
| Secondary | 7 Day Point Prevalent Smoking Abstinence (PPA) | Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed. | Complete case analysis limited to survey respondents. | Posted | Count of Participants | Participants | 6 months post-enrollment |
|
|
|
|
| Other Pre-specified | Change in Oral Health Knowledge Scale Score From Baseline to 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. | Participants providing data for this measure at the baseline and 2 month follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 2 months |
|
|
|
|
| Other Pre-specified | Change in Oral Health Knowledge Scale Score From Baseline to 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. | Participants providing data for this measure at baseline and 6 month follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 6 months |
|
|
|
|
| Other Pre-specified | Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 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 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. | Participants who provided responses to this item at baseline and 2 follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 2 months |
|
|
|
|
| Other Pre-specified | Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 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. | Participants who provided responses to this item at baseline and 6 month follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 6 months |
|
|
|
|
| Other Pre-specified | Change in Motivation to Stop Smoking, From Baseline to 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. | Participants providing responses to this item at baseline and 2 month follow-up | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 2 months |
|
|
|
|
| Other Pre-specified | Change in Motivation to Stop Smoking, From Baseline to 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. | Participants providing responses to this item at baseline and 6-month follow-up | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 6 months |
|
|
|
|
| Other Pre-specified | Change in Motivation for Seeing a Dentist, From Baseline to 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. | Participants who provided responses to this item at baseline and 2 month follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 2 months |
|
|
|
|
| Other Pre-specified | Change in Motivation for Seeing a Dentist, From Baseline to 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. | Participants who provided responses to this item at baseline and 6 month follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 6 months |
|
|
|
|
| Other Pre-specified | Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 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. | Participants who provided responses to this item at baseline and 2 month follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 2 months |
|
|
|
|
| Other Pre-specified | Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 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. | Participants who provided responses to this item at baseline and 6 month follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to 6 months |
|
|
|
|
| 2 |
| 360 |
| 0 |
| 360 |
| 11 |
| 360 |
| EG001 | 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) | 0 | 358 | 3 | 358 | 7 | 358 |
| allergic reaction | General disorders | Non-systematic Assessment | Swelling of lips and tongue in response to nicotine replacement gum. Discontinued gum and symptoms resolved. |
|
| Unreversible blindness in right eye | Eye disorders | Non-systematic Assessment |
|
| Anxiety or stress, mild to moderate | General disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Seizure (pre-existing disorder) | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness, mild to moderate | General disorders | Non-systematic Assessment |
|
| Behavior or mood change (while taking Zyban) | General disorders | Non-systematic Assessment |
|
| Migraine, low BP, chills and nausea | General disorders | Non-systematic Assessment |
|
Not provided
Not provided