Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT05448664|
Recruitment Status : Not yet recruiting
First Posted : July 7, 2022
Last Update Posted : July 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Oral Health||Behavioral: Family HBM- mobile messaging Behavioral: Adolescent HBM- mobile messaging Behavioral: Adolescent e-pamphlets||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Three-arm parallel design cluster randomized controlled trial|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial|
|Estimated Study Start Date :||December 1, 2022|
|Estimated Primary Completion Date :||December 1, 2024|
|Estimated Study Completion Date :||May 30, 2025|
Experimental: Families HBM- mobile messaging
Family- and HBM-based behavioral intervention using mobile messaging
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.
Active Comparator: Adolescents HBM- mobile messaging
Student- and HBM-based behavioral intervention using mobile messaging
Behavioral: 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.
Placebo Comparator: Adolescents e-pamphlets
Prevailing oral health education by e-version of pamphlets through mobile messaging
Behavioral: 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.
- Caries increment [ Time Frame: 2 years ]Dental caries increment (by tooth level) from baseline to 2 years follow up
- Change of oral health self-efficacy [ Time Frame: 2 years ]Change from baseline self-efficacy at 2 years
- Change of gingival status [ Time Frame: 2 years ]Change from baseline gingival bleeding (BOP%) at 2 years, as recommended by the WHO for conducting oral health surveys
- Change of toothbrushing behavior [ Time Frame: 2 years ]Change from baseline average frequency of toothbrushing per day at 2 years
- Change of free-sugar intake [ Time Frame: 2 years ]Change from baseline average frequency of intake of sugary snack/drink per day at 2 years
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): NCT05448664
|Contact: Pei LIUemail@example.com|
|Principal Investigator:||Pei LIU||The University of Hong Kong|