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Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial

Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448664
Enrollment
900
Registered
2022-07-07
Start date
2023-04-01
Completion date
2025-12-30
Last updated
2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Keywords

Mobile health, Health Belief Model, Family-based intervention, Oral health, Adolescents

Brief 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 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.

Interventions

BEHAVIORALFamily HBM- mobile messaging

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.

BEHAVIORALAdolescent HBM- mobile messaging

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.

BEHAVIORALAdolescent e-pamphlets

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.

Sponsors

Food and Health Bureau, Hong Kong
CollaboratorOTHER_GOV
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Three-arm parallel design cluster randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Caries increment2 yearsDental caries increment (by tooth level) from baseline to 2 years follow up

Secondary

MeasureTime frameDescription
Change of oral health self-efficacy2 yearsChange from baseline self-efficacy at 2 years
Change of gingival status2 yearsChange from baseline gingival bleeding (BOP%) at 2 years, as recommended by the WHO for conducting oral health surveys
Change of toothbrushing behavior2 yearsChange from baseline average frequency of toothbrushing per day at 2 years
Change of free-sugar intake2 yearsChange from baseline average frequency of intake of sugary snack/drink per day at 2 years

Countries

Hong Kong

Contacts

Primary ContactPei LIU
peiliu@hku.hk852-28590571

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026