Promoting Oral Health Among Smokers Randomized Trial

NCT02347124 | Completed Results DMC

• 2 other identifiers: 14-047-EU01DE024462-01
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 1

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. 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. 2.Be more likely to see a dental care professional in the past 6 months at 6 month follow-up \[primary outcome\].
3. 3.Exhibit more positive change in relevant oral health knowledge/beliefs and attitudes (e.g., self-efficacy, motivation) that could influence future behavior change.

Conditions

Oral Disease; Smoking

Keywords

smoking cessation; oral health care; tobacco quitlines

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 7 Day Point Prevalent Abstinence (PPA)

  2 months post-enrollment

• 7 Day Point Prevalent Smoking Abstinence (PPA)

  2 months post-enrollment

• 7 Day Point Prevalent Smoking Abstinence (PPA)

  6 months post-enrollment

Other Outcomes (10)

• Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up

  Baseline to 2 months

• Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up

  Baseline to 6 months

• Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up

  Baseline to 2 months

Study Arms (2)

Usual Care Control

ACTIVE COMPARATOR

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

Behavioral: Usual Care Control

Enhanced Intervention

EXPERIMENTAL

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

Behavioral: Enhanced Intervention

Interventions

Usual Care Control 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.

Usual Care Control

Enhanced Intervention 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)

Enhanced Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Consumer Wellness Solutions: collaborator
• University of California: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

• McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Corrigendum to "Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers" [Contemp. Clin. Trials 57 (2017) 90-97]. Contemp Clin Trials. 2017 Oct;61:133. doi: 10.1016/j.cct.2017.07.011. Epub 2017 Jul 24. No abstract available.

  PMID: 28750939 BACKGROUND

• McClure JB, Blasi PR, Cook A, Bush T, Fishman P, Nelson J, Anderson ML, Catz SL. Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers. Contemp Clin Trials. 2017 Jun;57:90-97. doi: 10.1016/j.cct.2017.04.003. Epub 2017 Apr 12.

  PMID: 28412230 BACKGROUND

• Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

  PMID: 33605440 DERIVED

• Blasi PR, Krakauer C, Anderson ML, Nelson J, Bush T, Catz SL, McClure JB. Factors associated with future dental care utilization among low-income smokers overdue for dental visits. BMC Oral Health. 2018 Nov 1;18(1):183. doi: 10.1186/s12903-018-0646-8.

  PMID: 30382910 DERIVED

MeSH Terms

Conditions

Mouth Diseases; Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Behavior; Health Behavior

Limitations and Caveats

The study relied on self-reported smoking and dental care. The focus on socio-economically disadvantaged smokers limits our ability to draw conclusions about the effectiveness of the intervention if offered to higher SES smokers.

Results Point of Contact

• Title: Dr. Jennifer McClure
• Organization: Kaiser Permanente Washington Health Research Institute

mcclure.j@ghc.org

206-287-2737

Study Officials

• Jennifer McClure, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 8, 2019
• Results First Posted: May 15, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)