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Trial record 1 of 1 for:    Mobile-health Intervention to Promote Oral Health in Adolescents
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Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT05448664
Recruitment Status : Not yet recruiting
First Posted : July 7, 2022
Last Update Posted : July 7, 2022
Sponsor:
Collaborator:
Food and Health Bureau, Hong Kong
Information provided by (Responsible Party):
Dr Liu, Pei Pearl, The University of Hong Kong

Study Description
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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
Oral Health Behavioral: Family HBM- mobile messaging Behavioral: Adolescent HBM- mobile messaging Behavioral: Adolescent e-pamphlets Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-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
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Caries increment [ Time Frame: 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 [ Time Frame: 2 years ]
    Change from baseline self-efficacy at 2 years

  2. Change of gingival status [ Time Frame: 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 [ Time Frame: 2 years ]
    Change from baseline average frequency of toothbrushing per day at 2 years

  4. Change of free-sugar intake [ Time Frame: 2 years ]
    Change from baseline average frequency of intake of sugary snack/drink per day at 2 years


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05448664


Contacts
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Contact: Pei LIU 852-28590571 peiliu@hku.hk

Sponsors and Collaborators
The University of Hong Kong
Food and Health Bureau, Hong Kong
Investigators
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Principal Investigator: Pei LIU The University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: July 7, 2022    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, The University of Hong Kong:
Mobile health
Health Belief Model
Family-based intervention
Oral health
Adolescents