Promoting Oral Health Among Smokers Randomized Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

718 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-03-31

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:

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.

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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.

Conditions

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Oral Disease Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care Control

Standard tobacco quitline counseling program and materials + attention-matched text messaging.

Group Type ACTIVE_COMPARATOR

Usual Care Control

Intervention Type 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.

Enhanced Intervention

Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .

Group Type EXPERIMENTAL

Enhanced Intervention

Intervention Type 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)

Interventions

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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.

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No