Clinical trial NCT05448664: Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
Official title: Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Health
Keywords: Mobile health
Health Belief Model
Family-based intervention
Oral health
Adolescents
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
First posted: 2022-07-07
Enrollment: 900
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm parallel design cluster randomized controlled trial
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Caries increment
timeFrame: 2 years
Secondary outcomes:
measure: Change of oral health self-efficacy
timeFrame: 2 years
measure: Change of gingival status
timeFrame: 2 years
measure: Change of toothbrushing behavior
timeFrame: 2 years
measure: Change of free-sugar intake
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Faculty of Dentistry, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Pei LIU
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.