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:
- 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Kaiser Permanente Washington Health Research Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Usual Care Control
Standard tobacco quitline counseling program and materials + attention-matched text messaging.
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Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.
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Experimental: Enhanced Intervention
Standard tobacco quitline counseling program and materials + multi-modal oral health promotion program .
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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)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
7 Day Point Prevalent Abstinence (PPA)
Prazo: 6 month post-enrollment
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7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days.
Missing values imputed as smokers.
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6 month post-enrollment
|
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Professional Dental Care Utilization in Past 6 Months
Prazo: 6 months post-enrollment
|
self-reported utilization of professional dental care during study observation period
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6 months post-enrollment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
7 Day Point Prevalent Abstinence (PPA)
Prazo: 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
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2 months post-enrollment
|
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7 Day Point Prevalent Smoking Abstinence (PPA)
Prazo: 2 months post-enrollment
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Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only.
No outcomes imputed.
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2 months post-enrollment
|
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7 Day Point Prevalent Smoking Abstinence (PPA)
Prazo: 6 months post-enrollment
|
Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis.
No outcomes imputed.
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6 months post-enrollment
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up
Prazo: Baseline to 2 months
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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
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Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up
Prazo: 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. |
Baseline to 6 months
|
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Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up
Prazo: 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. |
Baseline to 2 months
|
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Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up
Prazo: 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. |
Baseline to 6 months
|
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Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up
Prazo: 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. |
Baseline to 2 months
|
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Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up
Prazo: 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. |
Baseline to 6 months
|
|
Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up
Prazo: 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. |
Baseline to 2 months
|
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Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up
Prazo: 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. |
Baseline to 6 months
|
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Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up
Prazo: 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. |
Baseline to 2 months
|
|
Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up
Prazo: 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. |
Baseline to 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer McClure, PhD, Kaiser Permanente
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14-047-E
- U01DE024462-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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