Health BehaviorNCT04665219
HBM for Empowering Parental Toothbrushing and Sugar Intake Control
A study testing HBM-based text messages and Standard text message in people with Health Behavior and Mobile Phone Use, run by The University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 months
- Conditions the study is for
- Health Behavior, Mobile Phone Use, Early Childhood Caries
- What is being tested?
- HBM-based text messages and Standard text message
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- families that have been participating in another oral health promotion program
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
May Chun Mei WONG, PhD, +(852) 28590422, mcmwong@hku.hk
About this study
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
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
- Being tested
- HBM-based text messages, Standard text message
- Keywords
- Health Belief Model, Mobile Health, Early Childhood Caries, Oral Health Promotion
- Medical subject headings
- Health Behavior, Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBM-based text messagesBehavioural
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 messageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Only receive a standard message. Receives: Behavioral: Standard text message |
| Test group | Experimental | Receive HBM-based messages. Receives: Behavioral: HBM-based text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Change in parental oral health behavior over the study period, 2 times as preferred
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Sep 2020
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor May C.M. Wong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665219
- Sponsor's protocol ID
- HMRF (Ref: 17181971)
- Status last verified
- Mar 2021
- First submitted
- 4 Dec 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40604716Wang 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.
PubMed 35413872
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04665219
- Acronym / sponsor ID
- HMRF (Ref: 17181971)
- Conditions
- Health Behavior, Mobile Phone Use, Early Childhood Caries
- Keywords
- Health Belief Model, Mobile Health, Early Childhood Caries, Oral Health Promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Standard text messageOnly receive a standard message. |
| Test group | Experimental | Behavioral: HBM-based text messagesReceive HBM-based messages. |
Who may qualify
- Ages
- 18 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- families that have been participating in another oral health promotion program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBM-based text messagesThe 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. | Behavioural | Test group |
| Standard text messageParents 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. | Behavioural | Control group |
Primary outcome
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).
3 secondary outcomes
average frequency of parental toothbrushing per day
Time frame: 24 months
average frequency of intake of sugary snack/drink per day
Time frame: 24 months
oral hygiene status using the Visible Plaque Index
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 40604716Wang 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.
- Derived from this study: PubMed 35413872Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBM-based text messages and Standard text message in people with Health Behavior and Mobile Phone Use, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact May Chun Mei Wong, PhD (+(852) 28590422, mcmwong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665219, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.