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

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05448664
Collaborator
Food and Health Bureau, Hong Kong (Other)
900
3
29.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family HBM- mobile messaging
  • Behavioral: Adolescent HBM- mobile messaging
  • Behavioral: Adolescent e-pamphlets
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three-arm parallel design cluster randomized controlled trialThree-arm parallel design cluster randomized controlled trial
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
May 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Caries increment [2 years]

    Dental caries increment (by tooth level) from baseline to 2 years follow up

Secondary Outcome Measures

  1. Change of oral health self-efficacy [2 years]

    Change from baseline self-efficacy at 2 years

  2. Change of gingival status [2 years]

    Change from baseline gingival bleeding (BOP%) at 2 years, as recommended by the WHO for conducting oral health surveys

  3. Change of toothbrushing behavior [2 years]

    Change from baseline average frequency of toothbrushing per day at 2 years

  4. Change of free-sugar intake [2 years]

    Change from baseline average frequency of intake of sugary snack/drink per day at 2 years

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The University of Hong Kong
  • Food and Health Bureau, Hong Kong

Investigators

  • Principal Investigator: Pei LIU, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Liu, Pei Pearl, Principal Investigator, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05448664
Other Study ID Numbers:
  • HMRF 19201281
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Liu, Pei Pearl, Principal Investigator, The University of Hong Kong

Study Results

No Results Posted as of Jul 7, 2022