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: 10005037
• 负责人: CAROL KUNZEL
• 金额: $ 78.77万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005037
• 关键词: 5 year old; Academy; Address; Adoption; Affect; Age; American; Behavior; Behavior Therapy; Behavioral; Caregivers; Cariogenic Diet; Child; Childhood; Chronic Disease; Clinic; Communities; 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; Hispanics; 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; design; disease natural history; early childhood; 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/项目摘要 长期实践主要通过外科牙科修复来治疗儿童早期龋齿 (ECC)， 目前的支付系统强化了这种方法，但这种方法并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对其发生价值的专业共识。 ECC 疾病管理正在兴起，但西班牙裔人的行为策略在很大程度上仍未得到研究 该研究的长期目标是减少美国儿童的口腔健康差异。 众所周知，使用药物可以实现从注重治疗到注重预防的范式转变。 每天使用两次含氟牙膏和低致龋饮食具有预防和治疗作用 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价值。 拟议的随机对照试验将评估一个家庭的功效。 重点行为干预 MySmileBuddy 可减少高危西班牙裔 ECC 进展 我们建议招募和招收 858 名 2 至 5 岁的儿童，所有儿童均接受 ECC 教育。 纽约市曼哈顿北部儿科医疗诊所的护理人员 具体目标是： (1) 评估。 MySmileBuddy 减少 ECC 进展（定义为数量的正变化）的功效（与对照相比） 随机化后 12 个月测量的腐烂、缺失或填充的牙齿 (Δdmft>0) 或表面 (Δdfs>0)) （并在随机化后 24 个月再次评估）；(2) 评估 MySmileBuddy 的功效（与对照相比） 加强每日两次含氟牙膏的使用和低致龋饮食；以及 (3) 评估 MySmileBuddy 影响每日两次含氟牙膏使用的因果途径，以及 所提出的研究具有创新性，与以往的研究不同。 将重点从治疗转向预防，将教育从口头指示和书面指示转向 牙科专业人员提供的材料，用于使用交互式健康信息技术 社区卫生工作者，并利用一般儿科实践作为促进 完成这项研究后，我们将了解 MySmileBuddy 的影响程度。 促进父母获得和维持口腔卫生和饮食行为，以减少 ECC 最终，这些知识具有 可能减少受这种可预防疾病不必要影响的儿童数量。