The University of Sydney, Westmead Applied Research Centre, Westmead, NSW, Australia.
The University of Sydney, School of Dentistry, Camperdown, NSW, Australia.
PLoS One. 2024 Sep 30;19(9):e0310561. doi: 10.1371/journal.pone.0310561. eCollection 2024.
Despite improvements in health outcomes for children, early childhood dental caries (ECC) remains a chronic lifestyle-mediated disease that affects an estimated 600 million children worldwide. Parental influence on oral health-promoting behaviours is pivotal in preventing ECC. The latest WHO publications Ending Early Childhood Dental Caries and Mobile Technologies for Oral Health highlights the opportunity for mobile Health programs (including text message programs) to improve oral health behaviours and oral health self-efficacy. In response, our team of parents, oral health professionals (academics and health promotion experts), and IT specialists co-designed a 12-week, behavioural theory-informed text message program (called SmilesUp) to address behavioural risk factors specific to ECC. This randomised trial aims to assess whether the SmilesUp program improves parents' oral health promoting behaviours (like tooth brushing twice a day with toothpaste) and oral health self-efficacy for their children compared to usual care.
A randomised controlled trial with a 1:1 parallel design will be conducted among 150 parents with children diagnosed with ECC and accessing public dental care in NSW, Australia. Patients will be stratified by hospital site, and modality of care (Dental General Anaesthetic (DGA) or not) and then randomly assigned to either immediately receive the SMILESup text messaging intervention or receive the program at the end of the study period. The primary outcome at 12 weeks is twice daily brushing with fluoride toothpaste. Secondary outcomes include changes in the intake frequency of sugared drinks and foods, oral health promoting bedtime routines and oral health self-efficacy. The primary analysis will follow an intention-to-treat principle. In addition, a process evaluation will examine barriers, enablers, and opportunities to scale the program.
Ethics approval has been obtained from the Western Sydney Local Health District Human Research Ethics Committee 2022/ETH01920. Study results will be disseminated via peer-reviewed publications and presentations at conferences.
Trial registration number: This clinical trial has been prospectively registered on the ANZCTR from the 27th of March 2023. Registration number: ACTRN12623000325606.
尽管儿童健康状况有所改善，但儿童早期龋齿（ECC）仍然是一种慢性生活方式介导的疾病，估计影响全球 6 亿儿童。父母对口腔健康促进行为的影响对于预防 ECC 至关重要。世界卫生组织最近的出版物《终结儿童早期龋齿》和《移动技术促进口腔健康》强调了移动健康计划（包括短信计划）改善口腔健康行为和口腔健康自我效能的机会。有鉴于此，我们的家长、口腔健康专业人员（学者和健康促进专家）和 IT 专家团队共同设计了一个为期 12 周、基于行为理论的短信程序（称为 SmilesUp），以解决特定于 ECC 的行为风险因素。这项随机试验旨在评估 SmilesUp 程序是否能改善父母对孩子的口腔健康促进行为（如每天用含氟牙膏刷牙两次）和口腔健康自我效能，与常规护理相比。
一项随机对照试验，采用 1:1 平行设计，将在澳大利亚新南威尔士州接受公共牙科护理的 150 名患有 ECC 的儿童的父母进行分层，按医院地点和护理方式（牙科全身麻醉（DGA）或非 DGA）进行分层，然后随机分配到立即接受 SmilesUp 短信干预组或在研究结束时接受该程序组。12 周时的主要结果是每天用含氟牙膏刷牙两次。次要结果包括含糖饮料和食物摄入频率的变化、睡前口腔健康促进习惯和口腔健康自我效能的变化。主要分析将遵循意向治疗原则。此外，还将进行过程评估，以检查扩大该计划的障碍、促进因素和机会。
已获得西悉尼地方卫生区人类研究伦理委员会 2022/ETH01920 的伦理批准。研究结果将通过同行评议的出版物和会议报告进行传播。
试验注册号：这项临床试验已于 2023 年 3 月 27 日在澳大利亚新西兰临床试验注册中心进行了前瞻性注册。注册号：ACTRN12623000325606。
