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

Study Overview
=================
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.

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

Conditions
-----------------
Oral Health

Intervention / Treatment
-----------------
* Behavioral: Family HBM- mobile messaging
* Behavioral: Adolescent HBM- mobile messaging
* Behavioral: Adolescent e-pamphlets


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-arm parallel design cluster randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Families HBM- mobile messaging<br>Family- and HBM-based behavioral intervention using mobile messaging | Behavioral: Family HBM- mobile messaging<br>* 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.<br>|
| Active Comparator: Adolescents HBM- mobile messaging<br>Student- and HBM-based behavioral intervention using mobile messaging | Behavioral: Adolescent HBM- mobile messaging<br>* 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.<br>|
| Placebo Comparator: Adolescents e-pamphlets<br>Prevailing oral health education by e-version of pamphlets through mobile messaging | Behavioral: Adolescent e-pamphlets<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries increment | Dental caries increment (by tooth level) from baseline to 2 years follow up | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of oral health self-efficacy | Change from baseline self-efficacy at 2 years | 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 | 2 years | 
| Change of toothbrushing behavior | Change from baseline average frequency of toothbrushing per day at 2 years | 2 years | 
| Change of free-sugar intake | Change from baseline average frequency of intake of sugary snack/drink per day at 2 years | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile health, Health Belief Model, Family-based intervention, Oral health, Adolescents