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

摘要 本提案响应NIDCR行为和社会干预临床试验规划和实施 合作协议（UG 3/UH 3）。我们的目标是临床评估以学校为基础的行为干预的效果。 在一组幼儿园至二年级（K-2）儿童中进行干预，以降低龋齿风险。 儿童健康协调方法（CATCH）是一个以证据为基础的协调学校健康计划， 已经进行了几项群集随机对照试验（CRCT），证明了可持续的长期 改善饮食和体育活动行为的有效性，以及减少肥胖患病率， 低收入家庭的孩子作为我们最近12个月的R34补助金（R34 DE 026245）的一部分，我们整合了口头 健康课程和活动纳入现有的K-2 CATCH计划。这个新项目名为CATCH Healthy 微笑，成功地测试了可行性与K，第一和第二年级的儿童在两个低收入休斯顿 小学。在113名接受牙科评估的儿童中，54%的儿童在幼儿园，62%在年级 1和73%的2级有龋齿经历，定义为任何未经治疗的龋齿或至少一个填充的乳牙或 恒牙这些结果，以及先前的研究结果，证明了基于证据的学校健康的必要性 促进口腔健康的课程。我们的主要目标是：1）在UG 3一年规划期（2019-2020年）， 我们的主要目标是最终确定测量协议，研究数据库，CATCH健康微笑干预 内容和教学框架、学校和教职员培训，并为26所学校联网招募学校-RCT （CRCT）。2)在2-6年级（UH 3，2020-2025），我们的主要目标是进行校本CRCT，以确定 CATCH Healthy Smiles在降低龋齿发病率和进展方面的有效性， 年开始的儿童在牙齿（d2，3 mft/D2，3 MFT）和牙齿表面水平（d2，3 mfs/D2，3 MFS） 幼儿园和二年级以下的学生就读于26所为低收入、种族多样性 孩子我们假设，在3年的随访中（二年级结束时），与对照组的儿童相比， 学校（n=13所学校，533名儿童），那些在干预学校接受CATCH健康微笑（n=13 学校; 533名儿童）的龋齿发病率和进展将显著降低。过程 将在整个过程中收集评价数据，以监测干预剂量、覆盖范围和保真度。我们的次要 目的是，1）量化CATCH健康微笑对儿童行为，心理社会和 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） 检查这些儿童行为，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的套件 UTHealth授权给公共慈善机构CATCH Global Foundation。这个项目 如果被认为是有效的，CATCH的可扩展性、可持续性和传播的平台 已经存在，并在学校口腔健康开辟了一条新的研究路线。

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.