Oral Health Planning Grant

描述(申请人提供)：降低口腔疾病风险和促进更好的口腔健康是公共卫生的优先事项。吸烟者患口腔疾病的风险特别高，这是促进口腔健康的重要目标。我们之前的研究证实，有必要也有机会与烟草公司合作，在烟草使用者中促进更好的口腔保健。吸烟者患口腔疾病的比率很高，而且缺乏最佳的、可修改的自我护理行为(例如，常规的口腔卫生和牙齿护理)。除此之外，他们还吸烟，饮酒率更高，饮食更差(所有目标都是为了改善口腔健康)。在美国，烟草戒烟热线(即主动的、基于电话的尼古丁依赖咨询计划)每年覆盖数十万人。与戒烟热线合作是接触烟草用户以促进更好的口腔健康的理想方式，根据我们之前的研究，美国领先的烟草戒烟热线服务提供商和他们的许多承包商都认为这个概念值得追求。目前的计划拨款建立在我们之前的研究基础上，将允许我们为一项大型随机试验准备申请和所有支持干预和研究材料，以评估综合口腔健康-烟草戒烟咨询计划的有效性。我们之前为吸烟者起草了一份口腔健康促进书面小册子，可以作为这次干预的一部分，但还需要进一步的工作来完善这本小册子，并设计一个附属咨询计划。与对这一奖励机制的期望一致，我们将利用这笔规划赠款开展这项工作，并开发所有必要的研究和干预材料。这些材料将与未来的U01申请一起提交，以在随机临床试验中测试拟议干预的有效性。我们这项为期一年的计划拨款的具体目标是：1)确定Alere WellBeing提供的OE或更多戒烟服务，作为未来随机有效性试验的合作伙伴(Alere WellBeing是美国领先的戒烟服务提供商，迄今已为近200万吸烟者提供戒烟服务)；2)与QUTLINE工作人员密切合作，最终敲定干预设计，并起草建议的顾问干预内容；3)制定书面临床试验方案，包括所有研究材料和干预培训手册；以及4)向NIDCR准备一份U01申请，以测试建议的行为干预。这项程序性研究解决了一个重要的公共健康需求(促进口腔健康)，我们未来的随机试验将解决一个关键的科学需求(评估针对吸烟者的行为咨询计划是否可以改善口腔健康行为)。这项工作高度响应NIDCR的优先事项。 公共卫生相关性：拟议的规划拨款将允许我们为未来的临床试验创建必要的干预措施和其他材料，以测试综合口腔健康促进-烟草奎宁计划。我们还将编写并向NIDCR提交U01申请，以评估拟议干预措施的有效性。我们将与美国领先的烟草戒烟服务提供商(Alere WellBeing)密切合作，完成这项工作。这种合作加强了最终干预计划在被证明有效的情况下能够成功传播的可能性。这项工作与NIDCR的R34临床试验计划资助机制的目标和NIDCR的优先事项非常一致。

DESCRIPTION (provided by applicant): Reducing oral disease risk and promoting better oral health are public health priorities. Tobacco users are at particularly high risk for oral disease ad are important targets for oral health promotion. Our prior research established that there is a need and opportunity to partner with tobacco quitline providers to promote better oral health care among tobacco users. Tobacco users have high rates of oral disease and less than optimal, modifiable self-care behaviors (e.g., routine oral hygiene and dental care). This is in addition to their tobacco use, higher rates of alcohol use, and poorer diets (all targets for improving oral health). Tobacco quitlines (i.e., proactive, phone-based nicotine dependence counseling programs) reach hundreds of thousands of people each year in the U.S. Working with the quitlines is an ideal way to reach tobacco users to promote better oral health and, based on our prior research, the leading U.S. tobacco quitline service provider and many of their contractors agree that this concept is worth pursuing. The current planning grant builds on our prior research and will allow us to prepare an application and all supporting intervention and study materials for a large randomized trial to evaluate the effectiveness of an integrated oral health-tobacco quitline counseling program. We previously drafted an oral health promotion written pamphlet for smokers which can be used as part of this intervention, but further work is necessary to refine this pamphlet and to design an adjunct counseling program. Consistent with the expectations for this award mechanism, we will use this planning grant to conduct this work and to develop all necessary study and intervention materials. These materials will be submitted with a future U01 application to test the effectiveness of the proposed intervention in a randomized clinical trial. Our specific aims for this one year planning grant are to: 1) Identify oe or more tobacco quitlines serviced by Alere Wellbeing to partner with on a future randomized effectiveness trial (Alere Wellbeing is the leading provider of quitline services in the U.S. and has provided cessation services to nearly two million smokers to date.); 2) Work closely with quitline staff to finalize the intervention design and draft the content for the proposed counselin intervention; 3) Develop a written clinical trial protocol, including all study materials and an intervention training manual for the quitline counselors; and 4) Prepare a U01 application to NIDCR to test the proposed behavioral intervention. This programmatic research addresses an important public health need (promoting oral health) and our future randomized trial will address a critical scientific need (evaluating whether a behavioral counseling program targeted to smokers can improve oral health behavior). This work is highly responsive to the priorities of the NIDCR. PUBLIC HEALTH RELEVANCE: The proposed planning grant will allow us to create the intervention and other materials necessary for a future clinical trial to test an integrated oral health promotion-tobacco quitline program. We will also write and submit a U01 application to NIDCR to evaluate the effectiveness of the proposed intervention. We will work closely with the leading provider of U.S. tobacco quitline services (Alere Wellbeing) to accomplish this work. This collaboration strengthens the likelihood that the final intervention program can be successfully disseminated if proven effective. This work is well-aligned with the goals of NIDCR's R34 Clinical Trial Planning Grant mechanism and the priorities of NIDCR.