Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries

MySmileBuddy 的随机功效试验，一种以家庭为中心的减少儿童早期龋齿的行为干预措施

• 批准号: 10473513
• 负责人: CAROL KUNZEL
• 金额: $ 68.91万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10473513
• 关键词: 5 year old; Academy; Address; Adoption; Affect; Age; American; Behavior; Behavior Therapy; Behavioral; Caregivers; Cariogenic Diet; Child; Childhood; Chronic Disease; Clinic; Community Health Aides; Consensus; Consumption; Counseling; Coupled; Dental; Dental Hygiene; Dental caries; Diet; Disease; Disease Management; Education; Enrollment; Ethnic Origin; Evaluation; Family; Goals; Health Educators; Hispanic; Hispanic Populations; Hygiene; Individual; Instruction; Intervention; Knowledge; Learning; Low income; Maintenance; Measures; Mediating; Mediator of activation protein; Medical; Minority; Motivation; New York City; Nutritionist; Operative Surgical Procedures; Oral health; Parents; Pathway interactions; Pediatric Dentistry; Pediatrics; Population; Preschool Child; Prevention; Preventive; Public Health; Race; Randomized; Randomized Controlled Trials; Research; Risk; Science; Scientist; Social support; Surface; System; Testing; Therapeutic; Tooth Diseases; Tooth structure; Toothpaste; Translating; Treatment Efficacy; United States; Universities; Water fluoridation; Work; base; community setting; community-level factor; design; dietary; disease natural history; early childhood; efficacy evaluation; efficacy trial; health disparity; health information technology; high risk; high risk population; improved; innovation; novel; payment; personalized care; programs; recruit; repaired; scale up; social; social disadvantage

ABSTRACT/ PROJECT SUMMARY Longstanding practice has treated early childhood caries (ECC) primarily through surgical dental repair, reinforced by current payment systems, an approach that does not address the natural history of the disease or the oral hygiene and dietary behaviors that mediate its occurrence. Professional consensus on the value of ECC disease management is emerging but behavioral strategies remain largely unstudied among Hispanic children in the United States. The long-term goal of the proposed study is to reduce oral health disparities and inform a paradigm shift from a focus on treatment to one that also embraces prevention. It is known that using fluoridated toothpaste twice daily and consumption of a low cariogenic diet has both preventive and therapeutic value. What is not known is how to best translate the adoption and maintenance of salutary behaviors to populations at greatest risk. The proposed randomized controlled trial will evaluate the efficacy of a family focused behavioral intervention, MySmileBuddy, to reduce ECC progression in high-risk Hispanic preschoolers. We propose to recruit and enroll 858 two to five year-old children, all with ECC, along with their caregiver from pediatric medical clinics in northern Manhattan, New York City. Specific Aims are: (1) to assess MySmileBuddy's efficacy (versus control) to decrease ECC progression (defined as positive change in number of decayed, missing, or filled teeth (∆dmft>0) or surfaces (∆dfs>0)) measured 12-months post-randomization (and assessed again 24-months post-randomization); (2) to assess MySmileBuddy's efficacy (versus control) to enhance adoption of twice daily fluoridated toothpaste use and consumption of a low cariogenic diet; and (3) to assess causal pathways through which MySmileBuddy influences twice daily fluoridated toothpaste use and consumption of a low cariogenic diet. The proposed research is innovative and represents a departure from the status quo by shifting focus from treatment to prevention, shifting education from verbal instructions and written materials provided by dental professionals to using interactive Health Information Technology delivered by Community Health Workers, and capitalizing on general pediatrics practices as a conduit for promoting children's oral health. At the completion of this study, we will know the extent to which MySmileBuddy promotes parents' acquisition and maintenance of oral hygiene and dietary behaviors that reduce ECC progression in a high-risk population of Hispanic preschool children. Ultimately, such knowledge has the potential to reduce the number of children needlessly affected by this preventable disease.

摘要/项目总结 长期以来的实践主要通过外科牙齿修复来治疗幼儿龋齿（ECC）， 目前的支付系统强化了这一点，这种方法没有解决疾病的自然史 或介导其发生的口腔卫生和饮食行为。专业人士对价值的共识 ECC疾病管理正在出现，但行为策略在西班牙裔中仍基本未被研究 在美国的孩子们。这项拟议研究的长期目标是减少口腔健康差异， 为从注重治疗向同时包括预防的模式转变提供信息。据了解，使用 每天两次使用含氟牙膏和低致龋性饮食， 值目前尚不清楚的是，如何最好地将有益行为的采用和维持转化为 处于最大风险的人群。拟议的随机对照试验将评估一个家庭的疗效 集中的行为干预，MySmileBuddy，以减少高风险西班牙裔的ECC进展 学龄前儿童我们建议招募和登记858名2至5岁的儿童，所有与ECC，连同他们的沿着 来自纽约市曼哈顿北方儿科医疗诊所的护理人员。具体目标是：（1）评估 MySmileBuddy降低ECC进展（定义为数量的积极变化）的疗效（与对照组相比） 随机化后12个月测量的龋齿、缺失或填充牙齿（牙面dmft>0）或表面（牙面dfs>0） (and随机化后24个月再次评估）;（2）评估MySmileBuddy的疗效（与对照组相比） 加强每日使用两次含氟牙膏及进食低致龋食物;及（3） 评估MySmileBuddy影响每日两次含氟牙膏使用的因果途径， 低致龋性饮食。拟议的研究是创新的，代表了对 通过将重点从治疗转向预防，将教育从口头指示和书面指示转变为 由牙科专业人员提供的材料，以使用由 社区卫生工作者，并利用一般儿科实践作为促进 儿童口腔健康。在这项研究完成后，我们将知道MySmileBuddy在多大程度上 促进父母获得和保持口腔卫生和饮食行为，减少ECC 在西班牙裔学龄前儿童的高风险人群中的进展。最终，这些知识 这可能会减少不必要地受到这种可预防疾病影响的儿童人数。