Oral HealthNCT05448664
Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
A study testing Family HBM- mobile messaging, Adolescent HBM- mobile messaging and Adolescent e-pamphlets in people with Oral Health, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this study is to investigate the effectiveness of the family and behavioral theory based mobile-health behavioral intervention in enhancing adolescents'good oral health behaviors (mainly oral hygiene practice and free sugar intake control) and preventing common oral diseases (dental caries and periodontal… Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Family HBM- mobile messaging, Adolescent HBM- mobile messaging and Adolescent e-pamphlets
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2023to 30 Dec 2025
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Chinese ethnicity;
- Student living with their own parent(s) or primary caregivers;
- Both student and parent(s) or primary caregiver having their own access to a personal mobile phone with certain Apps to receive the messages in time
Who cannot join
- Student currently on a special diet (e.g. severe inflammatory bowel disease);
- Student has medical conditions know to affect growth or eating (e.g. diabetes, cystic fibrosis);
- Enrollment in other oral health promotion programs or research studies.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, The University of Hong Kong
Hong Kong
PEI LIU, PhD, 28590571, peiliu@hku.hk
About this study
Official title: Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
The aim of this study is to investigate the effectiveness of the family and behavioral theory based mobile-health behavioral intervention in enhancing adolescents'good oral health behaviors (mainly oral hygiene practice and free sugar intake control) and preventing common oral diseases (dental caries and periodontal diseases).
Read the detailed description
The investigators propose a 30-months clustered randomized controlled trial to investigate the effectiveness of Health Belief Model (HBM) and family-based mobile-health intervention in enhancing the adolescents' good oral health behaviors and preventing oral diseases.
This is a three-arm parallel-design cluster-randomized controlled trial. Parents and their children (12 to 15-year-old) will be recruited and randomized into 3 groups based on the school sites.
Messages targeted on six domains guided by HBM will be sent to the adolescents and their parents via mobile phone. Two blocks of HBM-based oral health messages, reminders, feedback and reinforcement messages will be delivered to both students and parents by mobile phone for 24 weeks; while the intervention of the other 2 groups will target on students only or using prevailing oral health education.
The primary outcomes will be caries increment of the adolescents 2-year post-intervention. Change in oral health self-efficacy and behaviors, dental plaque and gingival bleeding index will be the secondary outcomes.
The investigators anticipate the proposed family- and HBM-based behavioral intervention is more effective than HBM-based mobile-health intervention on adolescents alone or prevailing oral health education in improving the adolescents' oral hygiene behaviors, reducing free-sugar intake and preventing oral diseases.
- Conditions
- Oral Health
- Being tested
- Family HBM- mobile messaging, Adolescent HBM- mobile messaging, Adolescent e-pamphlets
- Keywords
- Mobile health, Health Belief Model, Family-based intervention, Oral health, Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family HBM- mobile messagingBehavioural
The intervention will consist of two blocks of text messaging based on HBM model, the messages will be sent to the students and their parents in the following 24 weeks.
Adolescent HBM- mobile messagingBehavioural
The intervention will consist of two blocks of text messaging based on HBM model, the messages will be sent to the students in the following 24 weeks.
Adolescent e-pamphletsBehavioural
The contents of e-version of three pamphlets, published by Department of Health (http://www.toothclub.gov.hk/en/en_index.html) will be distributed in an electronic form and sent via a mobile message.
| Study group | Role | What they receive |
|---|---|---|
| Families HBM- mobile messaging | Experimental | Family- and HBM-based behavioral intervention using mobile messaging Receives: Behavioral: Family HBM- mobile messaging |
| Adolescents HBM- mobile messaging | Active comparator | Student- and HBM-based behavioral intervention using mobile messaging Receives: Behavioral: Adolescent HBM- mobile messaging |
| Adolescents e-pamphlets | Placebo comparator | Prevailing oral health education by e-version of pamphlets through mobile messaging Receives: Behavioral: Adolescent e-pamphlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries increment
Dental caries increment (by tooth level) from baseline to 2 years follow up
Measured: 2 years
Secondary outcomes (4)
Change of oral health self-efficacy
Change from baseline self-efficacy at 2 years
Measured: 2 years
Change of gingival status
Change from baseline gingival bleeding (BOP%) at 2 years, as recommended by the WHO for conducting oral health surveys
Measured: 2 years
Change of toothbrushing behavior
Change from baseline average frequency of toothbrushing per day at 2 years
Measured: 2 years
Change of free-sugar intake
Change from baseline average frequency of intake of sugary snack/drink per day at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Apr 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies 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
- Model description
- Three-arm parallel design cluster randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Dr Liu, Pei Pearl, The University of Hong Kong
- Investigators
- Pei LIU, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448664
- Sponsor's protocol ID
- HMRF 19201281
- Status last verified
- May 2023
- First submitted
- 29 Jun 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu P, Wong MCM, Lee GHM, Yiu CKY, Lo ECM. Family behavior theory-based intervention via mobile messaging to improve oral health of adolescents: study protocol for a cluster randomized controlled trial. Trials. 2022 Nov 16;23(1):941. doi: 10.1186/s13063-022-06861-1.
PubMed 36384815
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05448664
- Acronym / sponsor ID
- HMRF 19201281
- Conditions
- Oral Health
- Keywords
- Mobile health, Health Belief Model, Family-based intervention, Oral health, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Jul 2022 (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.
The aim of this study is to investigate the effectiveness of the family and behavioral theory based mobile-health behavioral intervention in enhancing adolescents'good oral health behaviors (mainly oral hygiene practice and free sugar intake control) and preventing common oral diseases (dental caries and periodontal diseases).
Detailed description
The investigators propose a 30-months clustered randomized controlled trial to investigate the effectiveness of Health Belief Model (HBM) and family-based mobile-health intervention in enhancing the adolescents' good oral health behaviors and preventing oral diseases.
This is a three-arm parallel-design cluster-randomized controlled trial. Parents and their children (12 to 15-year-old) will be recruited and randomized into 3 groups based on the school sites.
Messages targeted on six domains guided by HBM will be sent to the adolescents and their parents via mobile phone. Two blocks of HBM-based oral health messages, reminders, feedback and reinforcement messages will be delivered to both students and parents by mobile phone for 24 weeks; while the intervention of the other 2 groups will target on students only or using prevailing oral health education.
The primary outcomes will be caries increment of the adolescents 2-year post-intervention. Change in oral health self-efficacy and behaviors, dental plaque and gingival bleeding index will be the secondary outcomes.
The investigators anticipate the proposed family- and HBM-based behavioral intervention is more effective than HBM-based mobile-health intervention on adolescents alone or prevailing oral health education in improving the adolescents' oral hygiene behaviors, reducing free-sugar intake and preventing oral diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel design cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Families HBM- mobile messaging | Experimental | Behavioral: Family HBM- mobile messagingFamily- and HBM-based behavioral intervention using mobile messaging |
| Adolescents HBM- mobile messaging | Active comparator | Behavioral: Adolescent HBM- mobile messagingStudent- and HBM-based behavioral intervention using mobile messaging |
| Adolescents e-pamphlets | Placebo comparator | Behavioral: Adolescent e-pamphletsPrevailing oral health education by e-version of pamphlets through mobile messaging |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Chinese ethnicity;
- Student living with their own parent(s) or primary caregivers;
- Both student and parent(s) or primary caregiver having their own access to a personal mobile phone with certain Apps to receive the messages in time
Key exclusion criteria (3 listed)
- Student currently on a special diet (e.g. severe inflammatory bowel disease);
- Student has medical conditions know to affect growth or eating (e.g. diabetes, cystic fibrosis);
- Enrollment in other oral health promotion programs or research studies.
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 |
|---|---|---|
| Family HBM- mobile messagingThe intervention will consist of two blocks of text messaging based on HBM model, the messages will be sent to the students and their parents in the following 24 weeks. | Behavioural | Families HBM- mobile messaging |
| Adolescent HBM- mobile messagingThe intervention will consist of two blocks of text messaging based on HBM model, the messages will be sent to the students in the following 24 weeks. | Behavioural | Adolescents HBM- mobile messaging |
| Adolescent e-pamphletsThe contents of e-version of three pamphlets, published by Department of Health (http://www.toothclub.gov.hk/en/en_index.html) will be distributed in an electronic form and sent via a mobile message. | Behavioural | Adolescents e-pamphlets |
Primary outcome
Caries increment
Time frame: 2 years
Dental caries increment (by tooth level) from baseline to 2 years follow up
4 secondary outcomes
Change of oral health self-efficacy
Time frame: 2 years
Change of gingival status
Time frame: 2 years
Change of toothbrushing behavior
Time frame: 2 years
Change of free-sugar intake
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 36384815Liu P, Wong MCM, Lee GHM, Yiu CKY, Lo ECM. Family behavior theory-based intervention via mobile messaging to improve oral health of adolescents: study protocol for a cluster randomized controlled trial. Trials. 2022 Nov 16;23(1):941. doi: 10.1186/s13063-022-06861-1.
- Individual participant dataSharing planned: No
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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.
Pei LIU principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family HBM- mobile messaging, Adolescent HBM- mobile messaging and Adolescent e-pamphlets in people with Oral Health, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 3 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 18 May 2023. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 Pei LIU (852-28590571, peiliu@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries increment (time frame: 2 years). 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 NCT05448664, which also lists 1 linked publication.
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 18 May 2023.