Oral Disease, Smoking
Conditions
Keywords
smoking cessation, oral health care, tobacco quitlines
Brief summary
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: 1. Be more likely to quit smoking as evidenced by 7 day point prevalent abstinence rates at 6 month follow-up \[primary outcome\] and at 2 month follow-up \[secondary outcome\]. 2. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up \[primary outcome\]. 3. Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.
Detailed description
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.
Interventions
BEHAVIORALUsual 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.
BEHAVIORALEnhanced 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)
Sponsors
Consumer Wellness Solutions
University of California
National Institute of Dental and Craniofacial Research (NIDCR)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18 or older * Eligible for multi-call services through a participating tobacco quitline managed by Alere Wellbeing * Can read and speak in English * Current daily smoker and smokes at least 5 cigarettes a day * Interested in quitting smoking in next 30 days * Have some or all natural teeth * Have not visited a dentist for a checkup or teeth cleaning in the past 6 months and do not have an appointment scheduled in the next 6 months * Has a cell phone capable of receiving text messages and provides cell phone number * Has internet access for personal use * Willing to talk about ways to improve their oral health * Provides verbal consent to participate
Exclusion criteria
* Self-report a diagnosis of bipolar disorder, mania, schizophrenia, dementia (e.g., has significant cognitive impairment) * Have lived at the current address less than 6 months or plans to move in the next 6 months * Are currently enrolled in an in-patient substance abuse treatment facility or are incarcerated * Has a household member already enrolled in the study, based on self-report and/or mailing address on file
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7 Day Point Prevalent Abstinence (PPA) | 6 month post-enrollment | 7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers. |
| Professional Dental Care Utilization in Past 6 Months | 6 months post-enrollment | self-reported utilization of professional dental care during study observation period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7 Day Point Prevalent Abstinence (PPA) | 2 months post-enrollment | 7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers |
| 7 Day Point Prevalent Smoking Abstinence (PPA) | 2 months post-enrollment | Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up | Baseline to 2 months | 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. |
| Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up | Baseline to 6 months | 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. |
| Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up | Baseline to 2 months | 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. |
| Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up | Baseline to 2 months | 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. |
| Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up | Baseline to 2 months | 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. |
| Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up | Baseline to 6 months | 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. |
| Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up | Baseline to 6 months | 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. |
| Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up | Baseline to 6 months | 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. |
| Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up | Baseline to 2 months | 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. |
| Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up | Baseline to 6 months | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 360 |
| 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) | 358 |
| Total | 718 |
Baseline characteristics
| Characteristic | Total | Enhanced Intervention | Usual Care Control |
|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 12.2 | 44.1 years STANDARD_DEVIATION 12.2 | 44.5 years STANDARD_DEVIATION 12.2 |
| Cigarettes per day | 19.1 cigarettes STANDARD_DEVIATION 9.7 | 19.3 cigarettes STANDARD_DEVIATION 9.7 | 18.9 cigarettes STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 16 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 697 Participants | 342 Participants | 355 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Last dental visit > 1 year ago | 576 Participants | 282 Participants | 294 Participants |
| Race/Ethnicity, Customized Black | 208 Participants | 95 Participants | 113 Participants |
| Race/Ethnicity, Customized Don't Know or Refused | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other or multi-racial | 89 Participants | 52 Participants | 37 Participants |
| Race/Ethnicity, Customized White | 417 Participants | 209 Participants | 208 Participants |
| Region of Enrollment United States | 718 Participants | 358 Participants | 360 Participants |
| Sex: Female, Male Female | 443 Participants | 220 Participants | 223 Participants |
| Sex: Female, Male Male | 275 Participants | 138 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 360 | 0 / 358 |
| other Total, other adverse events | 11 / 360 | 7 / 358 |
| serious Total, serious adverse events | 0 / 360 | 3 / 358 |
Outcome results
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.
Time frame: 6 month post-enrollment
Population: All participants with missing data imputed as smokers.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control | 7 Day Point Prevalent Abstinence (PPA) | 109 Participants |
| Enhanced Intervention | 7 Day Point Prevalent Abstinence (PPA) | 121 Participants |
p-value: 0.1395% CI: [0.93, 1.78]Regression, Logistic
Primary
Professional Dental Care Utilization in Past 6 Months
self-reported utilization of professional dental care during study observation period
Time frame: 6 months post-enrollment
Population: All participants with missing data imputed as not having seen a dentist.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control | Professional Dental Care Utilization in Past 6 Months | 67 Participants |
| Enhanced Intervention | Professional Dental Care Utilization in Past 6 Months | 65 Participants |
p-value: 0.995% CI: [0.69, 1.53]Regression, Logistic
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
Time frame: 2 months post-enrollment
Population: All participants with missing data imputed as smokers.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control | 7 Day Point Prevalent Abstinence (PPA) | 116 Participants |
| Enhanced Intervention | 7 Day Point Prevalent Abstinence (PPA) | 127 Participants |
p-value: 0.2195% CI: [0.89, 1.69]Regression, Logistic
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.
Time frame: 2 months post-enrollment
Population: Analysis limited to survey respondents (i.e., complete cases only).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control | 7 Day Point Prevalent Smoking Abstinence (PPA) | 116 Participants |
| Enhanced Intervention | 7 Day Point Prevalent Smoking Abstinence (PPA) | 127 Participants |
p-value: 0.0495% CI: [1.01, 2]Regression, Logistic
Secondary
7 Day Point Prevalent Smoking Abstinence (PPA)
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.
Time frame: 6 months post-enrollment
Population: Complete case analysis limited to survey respondents.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control | 7 Day Point Prevalent Smoking Abstinence (PPA) | 109 Participants |
| Enhanced Intervention | 7 Day Point Prevalent Smoking Abstinence (PPA) | 121 Participants |
p-value: 0.0995% CI: [0.95, 1.96]Regression, Logistic
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.
Time frame: Baseline to 2 months
Population: Participants who provided responses to this item at baseline and 2 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up | -0.41 scores on a scale | Standard Deviation 1.3 |
| Enhanced Intervention | Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up | -0.19 scores on a scale | Standard Deviation 1.2 |
p-value: 0.0295% CI: [0.04, 0.41]Regression, Linear
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.
Time frame: Baseline to 6 months
Population: Participants who provided responses to this item at baseline and 6 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up | -0.35 scores on a scale | Standard Deviation 1.2 |
| Enhanced Intervention | Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up | -0.27 scores on a scale | Standard Deviation 1.1 |
p-value: 0.8295% CI: [-0.17, 0.21]Regression, Linear
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.
Time frame: Baseline to 2 months
Population: Participants providing responses to this item at baseline and 2 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up | -0.17 scores on a scale | Standard Deviation 0.8 |
| Enhanced Intervention | Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up | -0.19 scores on a scale | Standard Deviation 0.9 |
p-value: 0.1695% CI: [-0.24, 0.04]Regression, Linear
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.
Time frame: Baseline to 6 months
Population: Participants providing responses to this item at baseline and 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up | -0.37 scores on a scale | Standard Deviation 1 |
| Enhanced Intervention | Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up | -0.40 scores on a scale | Standard Deviation 1 |
p-value: 0.8395% CI: [-0.16, 0.13]Regression, Linear
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.
Time frame: Baseline to 2 months
Population: Participants providing data for this measure at the baseline and 2 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up | 0.08 scores on a scale | Standard Deviation 3.3 |
| Enhanced Intervention | Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up | 0.14 scores on a scale | Standard Deviation 3.7 |
p-value: 0.8595% CI: [-0.57, 0.47]Regression, Linear
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.
Time frame: Baseline to 6 months
Population: Participants providing data for this measure at baseline and 6 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up | -0.17 scores on a scale | Standard Deviation 4 |
| Enhanced Intervention | Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up | 0.30 scores on a scale | Standard Deviation 3.8 |
p-value: 0.1495% CI: [-0.14, 0.96]Regression, Linear
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.
Time frame: Baseline to 2 months
Population: Participants who provided responses to this item at baseline and 2 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | 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 |
| Enhanced Intervention | Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up | -0.13 scores on a scale | Standard Deviation 1.2 |
p-value: 0.895% CI: [-0.2, 0.16]Regression, Linear
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.
Time frame: Baseline to 6 months
Population: Participants who provided responses to this item at baseline and 6 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | 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 |
| Enhanced Intervention | Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up | -0.34 scores on a scale | Standard Deviation 1.4 |
p-value: 0.4595% CI: [-0.11, 0.26]Regression, Linear
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.
Time frame: Baseline to 2 months
Population: Participants who provided responses to this item at baseline and 2 follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | 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 |
| Enhanced Intervention | Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up | 0.01 scores on a scale | Standard Deviation 1.6 |
p-value: 0.00295% CI: [0.13, 0.56]Regression, Linear
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.
Time frame: Baseline to 6 months
Population: Participants who provided responses to this item at baseline and 6 month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control | 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 |
| Enhanced Intervention | Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up | -0.11 scores on a scale | Standard Deviation 1.6 |
p-value: 0.9795% CI: [-0.22, 0.23]Regression, Linear