Clinical Trials Directory

Trials / Completed

CompletedNCT02347124

Promoting Oral Health Among Smokers Randomized Trial

Promoting Oral Health Among Tobacco Quitline Callers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
718 (actual)
Sponsor
Kaiser Permanente · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALUsual Care ControlStandard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.
BEHAVIORALEnhanced InterventionStandard 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)

Timeline

Start date
2015-02-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2015-01-27
Last updated
2019-10-08
Results posted
2018-05-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02347124. Inclusion in this directory is not an endorsement.