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

CATCH 健康微笑：小学口腔健康干预的集群随机对照试验

• 批准号: 10668996
• 负责人: Shreela V Sharma
• 金额: $ 110.23万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10668996
• 关键词: 8 year old; Address; American; Behavior; Behavior Therapy; Behavioral; Caregivers; Caries prevention; Charities; Child; Child Health; Childhood; Clinical; Clinical Trials; Code; Complex; Data; Databases; Dental; Dental caries; Diet; Dietary intake; Disease; Eating; Education; Educational Curriculum; Effectiveness; Effectiveness of Interventions; Enrollment; Environment; Environmental Risk Factor; Epidemic; Food; Foundations; Frequencies; Goals; Grant; Health; Health Promotion; Health behavior; High Prevalence; Home; Hour; Incidence; Intake; Intervention; Licensing; Low income; Measurement; Measures; Mediating; Modeling; Monitor; National Institute of Dental and Craniofacial Research; Nursery Schools; Obesity; Oral health; Outcome; Parents; Physical activity; Pilot Projects; Prevalence; Prevention program; Prevention strategy; Protocols documentation; Psychosocial Factor; Randomized, Controlled Trials; Research; Research Personnel; Risk; Risk Reduction; Schools; Smiling; Surveys; Testing; Texas; Tooth structure; Toothbrushing; Training; U-Series Cooperative Agreements; United States; Youth; clinical care; cohort; deciduous tooth; dosage; efficacy evaluation; efficacy testing; elementary school; ethnic diversity; evidence base; experience; feasibility testing; first grade; follow-up; fruits and vegetables; global health; health related quality of life; high school program; improved; intervention effect; kindergarten; lower income families; nutrition; permanent tooth; pilot test; prevent; process evaluation; programs; psychosocial; recruit; school health; second grade; social interventions; study population; teacher; tooth surface; trial design; trial planning

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.

抽象的 该提案响应 NIDCR 行为和社会干预临床试验规划和实施 合作协议（UG3/UH3）。我们的目标是临床评估基于学校的行为的影响 旨在降低幼儿园至二年级 (K-2) 儿童群体龋齿风险的干预措施。 儿童健康协调方法 (CATCH) 是一项基于证据的协调学校健康计划，并且 已经进行了多项整群随机对照试验（CRCT），证明了可持续的长期 改善饮食和身体活动行为以及降低肥胖患病率的有效性 低收入、多样化的儿童。作为我们最近 12 个月 R34 资助 (R34DE026245) 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。新计划名为 CATCH Healthy Smiles 已成功测试了休斯敦两个低收入家庭的幼儿园、一年级和二年级儿童的可行性 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 级和 2 级中的 73% 有龋齿经历，定义为任何未经治疗的龋齿或至少一颗填充乳牙或 恒牙。这些结果以及之前的研究结果证明需要基于证据的学校健康 口腔健康促进课程。我们的主要目标是： 1）在UG3一年规划期内（2019-2020）， 我们的主要目标是最终确定测量方案、研究数据库、CATCH 健康微笑干预 内容和交付框架、学校和员工培训以及为 26 个学校集群招募学校 - RCT （CRCT）。 2) 在 2-6 年级（UH3，2020-2025），我们的主要目标是进行校本 CRCT 以确定 根据测量，CATCH 健康微笑在减少龋齿发生率和进展方面的功效 儿童的牙齿 (d2,3mft/D2,3MFT) 和牙齿表面水平 (d2,3mfs/D2,3MFS) 26 所学校招收幼儿园和二年级学生，为低收入、多元化群体提供服务 孩子们。我们假设，在 3 年的随访中（二年级结束），与对照组的儿童相比 学校（n=13 所学校；533 名儿童），接受 CATCH 健康微笑干预的学校（n=13） 学校； 533 名儿童）将显着降低龋齿的发病率和进展。过程 将在整个过程中收集评估数据，以监测干预剂量、范围和保真度。我们的中学 目标是，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、社会心理和环境因素（刷牙、饮食、 口腔健康相关的生活质量）介导对儿童龋齿风险的干预效果。 CATCH Pre-K 套件 高中项目由 UTHealth 授权给公共慈善机构 CATCH 全球基金会。这个项目 意义重大，因为如果发现有效，那么将成为一个可扩展性、可持续性和传播 CATCH 的平台 已经存在，并开启了学校口腔健康的新研究领域。