Promoting Oral Health Among Smokers Randomized Trial

Promoting Oral Health Among Tobacco Quitline Callers

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Oral Disease
• Intervention / Treatment: Behavioral: Usual Care Control; Behavioral: Enhanced Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 718
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Kaiser Permanente Washington Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care Control; Standard tobacco quitline counseling program and materials + attention-matched text messaging.	Behavioral: 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: Enhanced Intervention; Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
7 Day Point Prevalent Abstinence (PPA)	7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers	2 months post-enrollment
7 Day Point Prevalent Smoking Abstinence (PPA)	Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.	2 months post-enrollment
7 Day Point Prevalent Smoking Abstinence (PPA)	Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.	6 months post-enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up	Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale: Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals. Responses and scoring to the adapted NHIS scale: Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5 Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge. The scores have a range of 7 (minimum) to 35 (maximum). The study outcome is the change in this score between BL and 2 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge.	Baseline to 2 months
Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up	Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale: Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals. Responses and scoring to the adapted NHIS scale: Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5 Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge. The scores have a range of 7 (minimum) to 35 (maximum). The study outcome is the change in this score between BL and 6 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge.	Baseline to 6 months
Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up	SE to see a dentist was assessed using the following question: "As of today, how confident are you that you can…See a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.	Baseline to 2 months
Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up	SE to see a dentist was assessed using the following question: "As of today, how confident are you that you can…See a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.	Baseline to 6 months
Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up	Motivation to stop smoking was assessed using the following question: "As of today, how motivated are you to…Stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.	Baseline to 2 months
Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up	Motivation to stop smoking was assessed using the following question: "As of today, how motivated are you to…Stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.	Baseline to 6 months
Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up	Motivation to see a dentist was assessed using the following question: "As of today, how motivated are you to…see a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.	Baseline to 2 months
Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up	Motivation to see a dentist was assessed using the following question: "As of today, how motivated are you to…see a dentist in the next 6 months?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all motivated", to 5="Very motivated". Higher scores represented higher motivation. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation.	Baseline to 6 months
Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up	SE to quit smoking was assessed using the following question: "As of today, how confident are you that you can…stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.	Baseline to 2 months
Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up	SE to quit smoking was assessed using the following question: "As of today, how confident are you that you can…stop smoking for good or remain quit?" Responses were measured on a 5-point Likert scale ranging from 1="Not at all confident", to 5="Very confident". Higher scores represented higher SE. The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); Consumer Wellness Solutions; University of California
• Investigators: Principal Investigator: Jennifer McClure, PhD, Kaiser Permanente

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Contemp Clin Trials. 2017 Oct;61:133.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 12, 2015
• First Submitted That Met QC Criteria: January 21, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: smoking cessation; tobacco quitlines; oral health care
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases
• Other Study ID Numbers: 14-047-E; U01DE024462-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual level data.