HBM for Empowering Parental Toothbrushing and Sugar Intake Control

NCT04665219 | Unknown

• 1 other identifier: HMRF (Ref: 17181971)
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Behavior; Mobile Phone Use; Early Childhood Caries

Keywords

Health Belief Model; Mobile Health; Early Childhood Caries; Oral Health Promotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• average frequency of parental toothbrushing per day

  24 months

• average frequency of intake of sugary snack/drink per day

  24 months

• oral hygiene status using the Visible Plaque Index

  24 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Only receive a standard message.

Behavioral: Standard text message

Test group

EXPERIMENTAL

Receive HBM-based messages.

Behavioral: HBM-based text messages

Interventions

HBM-based text messages BEHAVIORAL

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.

Test group

Standard text message BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

Related Publications (2)

• Wang K, Lee GHM, Liu P, Wong HC, Gao X, Wong SYS, Wong MCM. Development and validation of the health belief model scale for early childhood caries prevention behaviors of parents. BMC Oral Health. 2025 Jul 2;25(1):1051. doi: 10.1186/s12903-025-06416-1.

  PMID: 40604716 DERIVED

• Wang K, Lee GHM, Liu P, Gao X, Wong SYS, Wong MCM. Health belief model for empowering parental toothbrushing and sugar intake control in reducing early childhood caries among young children-study protocol for a cluster randomized controlled trial. Trials. 2022 Apr 12;23(1):298. doi: 10.1186/s13063-022-06208-w.

  PMID: 35413872 DERIVED

MeSH Terms

Conditions

Health Behavior; Cell Phone Use

Condition Hierarchy (Ancestors)

Behavior; Communication; Social Behavior

Central Study Contacts

May Chun Mei Wong, PhD

CONTACT

+(852) 28590422; mcmwong@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: September 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

CN (1)