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HBM for Empowering Parental Toothbrushing and Sugar Intake Control

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ClinicalTrials.gov Identifier: NCT04665219
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Professor May C.M. Wong, The University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Health Behavior Mobile Phone Use Early Childhood Caries Behavioral: HBM-based text messages Behavioral: Standard text message Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665219


Contacts
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Contact: May Chun Mei Wong, PhD +(852) 28590422 mcmwong@hku.hk

Locations
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China
The University of Hong Kong Recruiting
Hong Kong, China
Contact: May Chun Mei WONG, PhD    +(852) 28590422    mcmwong@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Professor May C.M. Wong, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04665219    
Other Study ID Numbers: HMRF (Ref: 17181971)
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor May C.M. Wong, The University of Hong Kong:
Health Belief Model
Mobile Health
Early Childhood Caries
Oral Health Promotion