HBM for Empowering Parental Toothbrushing and Sugar Intake Control

March 25, 2021 updated by: Professor May C.M. Wong, The University of Hong Kong

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

518

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • The University of Hong Kong
        • Contact:
          • May Chun Mei WONG, PhD
          • Phone Number: +(852) 28590422
          • Email: mcmwong@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Only receive a standard message.
Behavioral: 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.
Experimental: Test group
Receive HBM-based messages.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dmft/dmfs scores of the children at 4 years old
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
average frequency of parental toothbrushing per day
Time Frame: 24 months
Change in parental oral health behavior over the study period, 2 times as preferred
24 months
average frequency of intake of sugary snack/drink per day
Time Frame: 24 months
Change in parental oral health behavior over the study period, 2 times or less frequent as preferred
24 months
oral hygiene status using the Visible Plaque Index
Time Frame: 24 months
The change in presence or absence of plaque on the buccal and lingual surfaces of all primary teeth over the study period.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HMRF (Ref: 17181971)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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