NCT05448664

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

June 29, 2022

Last Update Submit

May 17, 2023

Conditions

Oral Health

Keywords

Mobile healthHealth Belief ModelFamily-based interventionOral healthAdolescents

Outcome Measures

Primary Outcomes (1)

  • Caries increment

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

    2 years

Secondary Outcomes (4)

  • Change of oral health self-efficacy

    2 years

  • Change of gingival status

    2 years

  • Change of toothbrushing behavior

    2 years

  • Change of free-sugar intake

    2 years

Study Arms (3)

Families HBM- mobile messaging

EXPERIMENTAL

Family- and HBM-based behavioral intervention using mobile messaging

Behavioral: Family HBM- mobile messaging

Adolescents HBM- mobile messaging

ACTIVE COMPARATOR

Student- and HBM-based behavioral intervention using mobile messaging

Behavioral: Adolescent HBM- mobile messaging

Adolescents e-pamphlets

PLACEBO COMPARATOR

Prevailing oral health education by e-version of pamphlets through mobile messaging

Behavioral: Adolescent e-pamphlets

Interventions

Family HBM- mobile messagingBEHAVIORAL

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.

Families HBM- mobile messaging
Adolescent HBM- mobile messagingBEHAVIORAL

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.

Adolescents HBM- mobile messaging
Adolescent e-pamphletsBEHAVIORAL

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.

Adolescents e-pamphlets

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36384815DERIVED

Study Officials

  • Pei LIU

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei LIU

CONTACT

852-28590571peiliu@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Three-arm parallel design cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 7, 2022

Study Start

April 1, 2023

Primary Completion

July 30, 2025

Study Completion

December 30, 2025

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)