Promoting Oral Health Among Smokers Randomized Trial

Study Overview
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Brief Summary
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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: 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]. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome]. 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
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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.

Official Title
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Promoting Oral Health Among Tobacco Quitline Callers

Conditions
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Oral Disease, Smoking

Intervention / Treatment
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* Behavioral: Usual Care Control
* Behavioral: Enhanced Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Control<br>Standard tobacco quitline counseling program and materials + attention-matched text messaging. | Behavioral: Usual Care Control<br>* Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.<br>|
| Experimental: Enhanced Intervention<br>Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program . | Behavioral: Enhanced Intervention<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, oral health care, tobacco quitlines