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Promoting Oral Health Among Smokers Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02347124
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : May 15, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Alere Wellbeing
University of California
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Kaiser Permanente

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. 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.

Condition or disease Intervention/treatment Phase
Oral Disease Smoking Behavioral: Usual Care Control Behavioral: Enhanced Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 718 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Oral Health Among Tobacco Quitline Callers
Study Start Date : February 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 7 Day Point Prevalent Abstinence (PPA) [ Time Frame: 6 month post-enrollment ]
    7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.

  2. Professional Dental Care Utilization in Past 6 Months [ Time Frame: 6 months post-enrollment ]
    self-reported utilization of professional dental care during study observation period


Secondary Outcome Measures :
  1. 7 Day Point Prevalent Abstinence (PPA) [ Time Frame: 2 months post-enrollment ]
    7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers

  2. 7 Day Point Prevalent Smoking Abstinence (PPA) [ Time Frame: 2 months post-enrollment ]
    Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.

  3. 7 Day Point Prevalent Smoking Abstinence (PPA) [ Time Frame: 6 months post-enrollment ]
    Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.


Other Outcome Measures:
  1. Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up [ Time Frame: Baseline to 2 months ]

    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.


  2. Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up [ Time Frame: Baseline to 6 months ]

    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.


  3. Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up [ Time Frame: Baseline to 2 months ]

    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.


  4. Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up [ Time Frame: Baseline to 6 months ]

    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.


  5. Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up [ Time Frame: Baseline to 2 months ]

    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.


  6. Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up [ Time Frame: Baseline to 6 months ]

    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.


  7. Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up [ Time Frame: Baseline to 2 months ]

    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.


  8. Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up [ Time Frame: Baseline to 6 months ]

    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.


  9. Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up [ Time Frame: Baseline to 2 months ]

    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.


  10. Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up [ Time Frame: Baseline to 6 months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347124


Locations
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United States, Washington
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
Alere Wellbeing
University of California
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Jennifer McClure, PhD Kaiser Permanente
  Study Documents (Full-Text)

Documents provided by Kaiser Permanente:
Informed Consent Form  [PDF] February 3, 2016


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02347124     History of Changes
Other Study ID Numbers: 14-047-E
U01DE024462-01 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2015    Key Record Dates
Results First Posted: May 15, 2018
Last Update Posted: June 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual level data.

Keywords provided by Kaiser Permanente:
smoking cessation
oral health care
tobacco quitlines

Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases