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临床试验/NCT04562675
NCT04562675已完成不适用

Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries: A Randomized Controlled Trial

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 55 人开始时间: 2012年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
主要终点
dmft index

研究概览

简要总结

The aim of this study was to evaluate the long-term effectiveness of a lay health advisor (LHA) intervention on immigrant children's caries and preventive behaviors.This randomized controlled trial included mother-child pairs in the intervention group (IG) and a brochure-only control group (CG), respectively. The IG received a four-week one-on-one session by an LHA on caries-related knowledge and brushing techniques. Baseline and follow-up surveys were used to collect the data in caries experience and maternal caries preventive behavior.

详细描述

A randomized experimental design was used. Vietnamese women whose children aged 2-6 years were recruited through churches, Chinese schools, immigrant service centers, kindergarten, or recommendations from LHAs in Kaohsiung City in Taiwan. Overall, 30 and 25 Vietnamese mother-child pairs were randomized into the IG and CG. G*Power (version 3.1.9.4) was used for power analysis. A power analysis was established by effect size as the mean difference of filled teeth change between baseline and 8-month follow-up measurement between the IG and CG, with sample size and 0.05 alpha level. The power was greater than 0.802, and research results have adequate power.All children underwent oral examination at baseline and at 1-week, 2- and 8-month follow-ups. Each child was examined by a dentist in accordance with the primary dentition caries experience.Each immigrant mother completed surveys at baseline and at 1-week and 8-month follow-ups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
22 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Vietnamese women whose children aged 2-6 years

排除标准

  • 未提供

结局指标

主要结局

dmft index

时间窗: Change from Baseline dmft at 8 months after intervention

The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.

次要结局

  • Maternal attitude toward oral hygiene(Change from Baseline at 8 months after intervention)
  • Maternal caries-related knowledge(Change from Baseline at 8 months after intervention)
  • Maternal preventive behavior(Change from Baseline at 8 months after intervention)
  • Maternal self-efficacy toward oral hygiene(Change from Baseline at 8 months after intervention)

研究者

申办方类型
Other
责任方
Sponsor

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