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Promoting Oral Health Among Smokers Randomized Trial

Not Applicable
Completed
Conditions
Oral Disease
Smoking
Interventions
Behavioral: Usual Care Control
Behavioral: Enhanced Intervention
Registration Number
NCT02347124
Lead Sponsor
Kaiser Permanente
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
718
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Usual Care ControlUsual Care ControlStandard tobacco quitline counseling program and materials + attention-matched text messaging.
Enhanced InterventionEnhanced InterventionStandard tobacco quitline counseling program and materials + multi-modal oral health promotion program .
Primary Outcome Measures
NameTimeMethod
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 Months6 months post-enrollment

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

Secondary Outcome Measures
NameTimeMethod
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)6 months post-enrollment

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

Trial Locations

Locations (1)

Kaiser Permanente Washington Health Research Institute

🇺🇸

Seattle, Washington, United States

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