CATCH Healthy Smiles: A cluster-RCT of an elementary school oral health intervention

摘要 这项建议响应了NIDCR行为和社会干预临床试验的规划和实施 合作协定(UG3/UH3)。我们的目标是临床评估以学校为基础的行为的效果 降低幼儿园至二年级(K-2)儿童患龋齿风险的干预措施。 儿童健康协调方法(CATH)是一项以证据为基础的协调学校健康计划， 已经经历了几个集群随机对照试验(CRCT)，证明了可持续的长期 改善饮食和体育锻炼行为的有效性，并降低肥胖患病率 低收入、多样化的儿童。作为我们最近为期12个月的R34赠款(R34DE026245)的一部分，我们集成了口头 将健康课程和活动纳入现有的K-2捕获物方案。这项名为《健康捕捉》的新项目 在休斯敦的两个低收入家庭中，对K、一年级和二年级的孩子进行了成功的可行性测试 小学。在113名接受牙科评估的儿童中，54%的儿童在幼儿园，62%的儿童在年级 1%和73%的二年级学生有龋齿经历，定义为任何未经治疗的龋齿或至少一种充填的乳牙或 恒牙。这些结果，以及之前的研究结果，都证明有必要进行循证的学校健康。 口腔健康促进课程。我们的主要目标是：1)在UG3一年规划期(2019-2020年)内， 我们的主要目标是最终确定测量方案，研究数据库，捕捉健康微笑干预 内容和交付框架、学校和教职员工培训，并为26个学校群组招募学校--RCT (CRCT)。2)在2-6年级(UH3,2020-2025)，我们的主要目标是进行一项以学校为基础的CRCT，以确定 Catch健康微笑对降低龋齿发病率和进展的效果 在牙齿(d2，3mft/d2，3mft)和牙面水平(d2，3mf/d2，3mfs)上 幼儿园和二年级以下的26所学校为低收入、种族多元化的学生提供服务 孩子们。我们假设，在3年的随访中(二年级末)，与对照组的儿童相比 学校(n=13所学校；533名儿童)，干预学校的儿童接受染上健康微笑(n=13 学校；533名儿童)将显著降低龋齿的发病率和进展。过程 评估数据将在整个过程中收集，以监测干预剂量、覆盖范围和保真度。我们的次要 目标是：1)量化健康微笑对儿童行为、心理和社会的影响 环境结果，包括儿童口腔健康行为、饮食和学校营养环境，以及2)到 检查这些儿童的行为、心理社会和环境因素(刷牙、饮食、 口腔健康相关生活质量)对儿童龋病风险的干预效果起中介作用。Catch Pre-K套曲 TO高中项目由UTHealth授权给公共慈善机构Catch Global Foundation。这个项目 具有重要意义，因为如果被发现是有效的，一个可伸缩性、可持续性和传播渔获物的平台 已经存在，并开辟了一条研究学校口腔健康的新途径。

ABSTRACT This proposal responds to the NIDCR Behavioral and Social Intervention Clinical Trial Planning & Implementation Cooperative Agreement (UG3/UH3). Our goal is to clinically evaluate the effects of a school-based behavioral intervention to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (K-2) children. Coordinated Approach to Child Health (CATCH) is an evidence-based coordinated school health program, and has undergone several cluster-randomized controlled trials (CRCT) demonstrating sustainable long-term effectiveness in improving eating and physical activity behaviors, and reductions in obesity prevalence among low-income, diverse children. As part of our recent 12-month R34 grant (R34DE026245), we integrated oral health lessons and activities into the existing K-2 CATCH program. The new program, called CATCH Healthy Smiles, was successfully tested for feasibility with K, 1st and 2nd grade children in two low income Houston elementary schools. Of the 113 children with dental assessments, 54% of children in Kindergarten, 62% in grade 1 and 73% in grade 2 had caries experience defined by any untreated caries or at least one filled deciduous or permanent teeth. These results, and those of prior studies, warrant the need for evidence-based school health curricula for oral health promotion. Our primary aims are: 1) In the UG3 one-year planning period (2019-2020), our primary aim is to finalize measurement protocols, study databases, CATCH Healthy Smiles intervention content and delivery framework, school and staff training, and recruit schools for a 26 school cluster-RCT (CRCT). 2) In Years 2-6 (UH3, 2020-2025), our primary aim is to conduct a school-based CRCT to determine the efficacy of CATCH Healthy Smiles in reducing the incidence and progression of dental caries as measured at the tooth (d2,3mft/D2,3MFT) and tooth surface level (d2,3mfs/D2,3MFS) among children starting in kindergarten and following through 2nd grade enrolled across 26 schools serving low-income, ethnically-diverse children. We hypothesize that, at 3-year follow up (end of 2nd grade), as compared to children in the control schools (n=13 schools; 533 children), those in the intervention schools receiving CATCH Health Smiles (n=13 schools; 533 children) will demonstrate significantly reduced incidence and progression of dental caries. Process evaluation data will be collected throughout to monitor intervention dosage, reach and fidelity. Our secondary aims are, 1) to quantify the impact of CATCH Healthy Smiles on child behavioral, psychosocial and environmental outcomes, including child oral health behaviors, diet, and school nutrition environment, and 2) to examine the extent to which these child behavioral, psychosocial and environmental factors (tooth brushing, diet, oral health related quality of life) mediate the intervention effects on child caries risk. The suite of CATCH pre-K to high school programs are licensed by UTHealth to a public charity, the CATCH Global Foundation. This project is significant because if found to be effective, a platform for scalability, sustainability and dissemination of CATCH already exists, and opens a new line of research in school oral health.