HBM for Empowering Parental Toothbrushing and Sugar Intake Control

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665219
• Other study ID #: HMRF (Ref: 17181971)
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2021
• Source: The University of Hong Kong
• Contact: May Chun Mei Wong, PhD
• Phone: +(852) 28590422
• Email: mcmwong[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 518
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 30 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Early Childhood Caries
• Health Behavior
• Mobile Phone Use

Intervention

Behavioral:
• HBM-based text messages
The intervention in the test group will consist of a set of text messages developed based on the HBM to be sent to the parents regularly in the following 48 weeks. During the first 24 weeks, parents will receive a text message (and feedback if deemed appropriate) each week. In the next 24 weeks, the parents will receive a text message every 4 weeks, altogether 30 messages will be sent to the parents. All messages will be sent to the parents individually through free mobile App by a research assistant.
• Standard text message
Parents in the control group will receive an oral health education pamphlet produced by the Oral Health Education Division in the Department of Health, the Government of Hong Kong SAR. In order to maintain a double-blind design in the present study, the pamphlet will be distributed in an electronic form and sent via a text message.

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dmft/dmfs scores of the children at 4 years old	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).	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.
Secondary	average frequency of parental toothbrushing per day	Change in parental oral health behavior over the study period, 2 times as preferred	24 months
Secondary	average frequency of intake of sugary snack/drink per day	Change in parental oral health behavior over the study period, 2 times or less frequent as preferred	24 months
Secondary	oral hygiene status using the Visible Plaque Index	The change in presence or absence of plaque on the buccal and lingual surfaces of all primary teeth over the study period.	24 months