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

Oral Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448664
• Other study ID #: HMRF 19201281
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: Pei LIU
• Phone: 852-28590571
• Email: peiliu[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 diseases).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Health

Intervention

Behavioral:
• Family 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.
• Adolescent 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.
• Adolescent 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.

Locations

Country	Name	City	State
Hong Kong	Faculty of Dentistry, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Food and Health Bureau, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries increment	Dental caries increment (by tooth level) from baseline to 2 years follow up	2 years
Secondary	Change of oral health self-efficacy	Change from baseline self-efficacy at 2 years	2 years
Secondary	Change of gingival status	Change from baseline gingival bleeding (BOP%) at 2 years, as recommended by the WHO for conducting oral health surveys	2 years
Secondary	Change of toothbrushing behavior	Change from baseline average frequency of toothbrushing per day at 2 years	2 years
Secondary	Change of free-sugar intake	Change from baseline average frequency of intake of sugary snack/drink per day at 2 years	2 years