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临床试验/NCT04665219
NCT04665219Unknown不适用

Health Belief Model for Empowering Parental Toothbrushing and Sugar Intake Control in Reducing Early Childhood Caries Among Young Children - a Cluster Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 518 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
518
试验地点
1
主要终点
dmft/dmfs scores of the children at 4 years old

研究概览

简要总结

It has been recognized that oral health education for parents is critical for the prevention of early childhood caries (ECC). Few parents practiced caries prevention procedures for their children in daily life, though. Inspired by Health Belief Model (HBM) and using text messaging as a vehicle, a novel intervention scheme will be developed in this study. The objective of the present randomized clinical trial (RCT) is to investigate the effectiveness of the HBM-based behavioral intervention using text message to reduce early childhood caries of children at age 4 through promoting the parental oral health care behaviors (toothbrushing and sugar intake control) for their young children compared to conventional oral health education. This RCT will recruit child-parent dyads in 26-36 child help centers or kindergartens with nursery classes located in Hong Kong. A total of 518-628 dyads will be recruited and randomly allocated into the test or control group with a 1:1 ratio. For parents in the test group, the intervention will consist of a set of HBM-based text messages sent regularly in the following 48 weeks. A standard text message will be sent to the parents in the control group. The primary outcome will be dental caries measured by dmft/dmfs of the children at 4 years old.

By HBM-based intervention via a low-cost text messaging vehicle, it should be able to help the parents establish proper oral health behaviors for their children and safeguard the oral health of children in Hong Kong.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Months 至 30 Months(Child)
性别
All
接受健康志愿者

入选标准

  • young child aged18-30 months
  • young children not having any severe medical conditions complicating oral health and dental examination
  • parents having a mobile phone with certain Apps to receive the text messages in time (e.g. WhatsApp or WeChat)
  • parents who can read Chinese

排除标准

  • families that have been participating in another oral health promotion program

结局指标

主要结局

dmft/dmfs scores of the children at 4 years old

时间窗: The children will be examined at the 24 months follow up. The tooth status of the erupted primary teeth would be assessed by careful visual inspection.

The dental caries measured by dmft/dmfs (number of teeth/surfaces that are decayed missing or filled) of the children at aged 4 years (42-54 months).

次要结局

  • average frequency of intake of sugary snack/drink per day(24 months)
  • oral hygiene status using the Visible Plaque Index(24 months)
  • average frequency of parental toothbrushing per day(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor May C.M. Wong

Professor

The University of Hong Kong

研究点 (1)

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