Overview

This trial is active, not recruiting.

Conditions oral disease, smoking
Treatments usual care control, enhanced intervention
Sponsor Group Health Cooperative
Collaborator Alere Wellbeing
Start date February 2015
End date August 2017
Trial size 718 participants
Trial identifier NCT02347124, 14-047-E, U01DE024462-01

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] or at least be more likely to have scheduled a future appointment [secondary 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
(Experimental)
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)

Primary Outcomes

Measure
smoking abstinence as measured by 7 day point prevalent abstinence (PPA)
time frame: 6 month post-enrollment
professional dental care utilization in past 6 months, measured by self-report
time frame: 6 months post-enrollment

Secondary Outcomes

Measure
smoking abstinence as measured by 7 day point prevalent abstinence (PPA)
time frame: 2 months post-enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Promoting Oral Health Among Tobacco Quitline Callers
Principal investigator Jennifer McClure, PhD
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 examing 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Group Health Cooperative.