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

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).

Study Overview

• Status: Recruiting
• Conditions: Oral Health
• Intervention / Treatment: Behavioral: Family HBM- mobile messaging; Behavioral: Adolescent HBM- mobile messaging; Behavioral: Adolescent e-pamphlets

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 Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei LIU; Phone Number: 852-28590571; Email: peiliu@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Faculty of Dentistry, The University of Hong Kong
    • Contact: PEI LIU, PhD; Phone Number: 28590571; Email: peiliu@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Food and Health Bureau, Hong Kong
• Investigators: Principal Investigator: Pei LIU, The University of Hong Kong

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): July 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Health Belief Model; Oral health; Mobile health; Family-based intervention
• Other Study ID Numbers: HMRF 19201281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No