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Promoting Oral Health Among Smokers Randomized Trial

Primary Purpose

Oral Disease, Smoking

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Usual Care Control

Enhanced Intervention

About this trial

This is an interventional treatment trial for Oral Disease focused on measuring smoking cessation, oral health care, tobacco quitlines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaiser Permanente Washington Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care Control

Enhanced Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Professional Dental Care Utilization in Past 6 Months

self-reported utilization of professional dental care during study observation period

Secondary Outcome Measures

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

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.

7 Day Point Prevalent Smoking Abstinence (PPA)

Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.

Full Information

NCT ID

NCT02347124

First Posted

January 12, 2015

Last Updated

September 26, 2019

Sponsor

Kaiser Permanente

Collaborators

Consumer Wellness Solutions, University of California, National Institute of Dental and Craniofacial Research (NIDCR)

1. Study Identification

Unique Protocol Identification Number

NCT02347124

Brief Title

Promoting Oral Health Among Smokers Randomized Trial

Official Title

Promoting Oral Health Among Tobacco Quitline Callers

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

Collaborators

Consumer Wellness Solutions, University of California, National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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]. Be more likely to see a dental care professional in the past 6 months at 6 month follow-up [primary outcome]. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Disease, Smoking

Keywords

smoking cessation, oral health care, tobacco quitlines

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

718 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care Control

Arm Type

Active Comparator

Arm Description

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

Arm Title

Enhanced Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Usual Care Control

Intervention Description

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

Intervention Name(s)

Enhanced Intervention

Intervention Description

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 Outcome Measure Information:

Title

7 Day Point Prevalent Abstinence (PPA)

Description

7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.

Time Frame

6 month post-enrollment

Title

Professional Dental Care Utilization in Past 6 Months

Description

self-reported utilization of professional dental care during study observation period

Time Frame

6 months post-enrollment

Secondary Outcome Measure Information:

Title

7 Day Point Prevalent Abstinence (PPA)

Description

7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers

Time Frame

2 months post-enrollment

Title

7 Day Point Prevalent Smoking Abstinence (PPA)

Description

Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.

Time Frame

2 months post-enrollment

Title

7 Day Point Prevalent Smoking Abstinence (PPA)

Description

Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.

Time Frame

6 months post-enrollment

Other Pre-specified Outcome Measures:

Title

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

Description

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.

Time Frame

Baseline to 2 months

Title

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

Description

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.

Time Frame

Baseline to 6 months

Title

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

Description

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.

Time Frame

Baseline to 2 months

Title

Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up

Description

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.

Time Frame

Baseline to 6 months

Title

Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up

Description

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.

Time Frame

Baseline to 2 months

Title

Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up

Description

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.

Time Frame

Baseline to 6 months

Title

Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up

Description

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.

Time Frame

Baseline to 2 months

Title

Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up

Description

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.

Time Frame

Baseline to 6 months

Title

Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up

Description

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.

Time Frame

Baseline to 2 months

Title

Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up

Description

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.

Time Frame

Baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer McClure, PhD

Organizational Affiliation

Kaiser Permanente

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Washington Health Research Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan to share individual level data.

Citations:

PubMed Identifier

28750939

Citation

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.

Results Reference

background

PubMed Identifier

28412230

Citation

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.

Results Reference

background

PubMed Identifier

33605440

Citation

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.

Results Reference

derived

PubMed Identifier

30382910

Citation

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.

Results Reference

derived

Learn more about this trial

Promoting Oral Health Among Smokers Randomized Trial

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