NCT03694496

Brief Summary

This project aims to evaluate the relative efficacy of a peer-led intervention based on the Social Cognitive Theory and Health Belief Model versus the control (only pamphlet delivery) on increasing the prevalence of healthy oral behaviors and oral health status among adolescents in Hong Kong. A two-arm non-blinded randomized controlled trial will be conducted among random samples of adolescents enrolling in secondary schools in Hong Kong. In addition to a baseline survey, two follow-up evaluative surveys will be conducted at months 6 and 12. Survey questionnaires will be conducted to participants at three time points (baseline, 6-, 12-month follow-up). Dental check-up examinations will be evaluated at two time points (baseline, 6-month follow-up). Repeated measures will be used to record participants' background, oral behaviors, theory based cognition, and potential confounders. Validated scales will be used. DMFT, plaque index and CPI index will be used to assess the oral health status of participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

April 30, 2021

Status Verified

February 1, 2021

Enrollment Period

1.9 years

First QC Date

September 19, 2018

Last Update Submit

April 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oral health behaviors

    It was evaluated using a self-report measure. Tooth brushing, flossing will be aluated by asking how often you performed this behavior. The answer should be two times a day, once a day, several times per week, once a week, never.

    12 months

Secondary Outcomes (8)

  • Cognition related to oral health knowledge

    12 months

  • Child Oral Health Quality of Life Questionnaire (CPQ-16)

    12 months

  • Oral health knowledge assessment

    12 months

  • Modified Child Dental Anxiety Scale (MCDAS)

    12 months

  • Generalized Anxiety Disorder-7 (GAD-7)

    12 months

  • +3 more secondary outcomes

Study Arms (2)

peer-led theory-based intervention group

EXPERIMENTAL

2-6 students (depending on the headcount of the grade 2 students of the school) will be selected as peer leaders and they will receive oral health training first. After being trained and qualified, they will deliver oral health talks and workshops to their peers. The peer leaders will be requested to conduct six activities during 6 months, including health talks, workshops, information leaflets, etc.

Behavioral: peer-led theory-based intervention group

Control group

NO INTERVENTION

Participants in the control group will continue their present practice, and no additional interventions will be given except oral health pamphlets delivery. We will record their present practice in detail. As the control group is in different schools, so they will have very low opportunity to get access to the peer-led activities conducted in the intervention group. Contamination will be quite minimum.

Interventions

We plan to select 2-8 peer leaders in S2 students within each school in the intervention group. A total of 25-48 peer leaders will be selected and trained in this study. An experienced behavioural scientist will train the peer leaders through lectures, workshops, and individual counselling. A total of 6 hours training (3 hours per day x 2 days) will be conducted during weekends. Peer leaders will practice in groups, and only those who pass the evaluation are allowed to conduct peer-led interventions. We will record the performance and give specific feedback to each peer leader.

peer-led theory-based intervention group

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Grade 2 students of Secondary schools at the baseline recruitment
  • Agree to voluntarily participate
  • Do not intend to leave Hong Kong within the next 12 months

You may not qualify if:

  • undergoing orthondontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Faculty of Dentistry

Hong Kong, 999077, Hong Kong

Location

Related Publications (16)

  • Petersen PE. [Continuous improvement of oral health in the 21st century: the approach of the WHO Global Oral Health Programme]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2004 Nov;39(6):441-4. No abstract available. Chinese.

    PMID: 15854309BACKGROUND
  • Shaw WC, Meek SC, Jones DS. Nicknames, teasing, harassment and the salience of dental features among school children. Br J Orthod. 1980 Apr;7(2):75-80. doi: 10.1179/bjo.7.2.75. No abstract available.

    PMID: 6932969BACKGROUND
  • McGrath C, Broder H, Wilson-Genderson M. Assessing the impact of oral health on the life quality of children: implications for research and practice. Community Dent Oral Epidemiol. 2004 Apr;32(2):81-5. doi: 10.1111/j.1600-0528.2004.00149.x.

    PMID: 15061856BACKGROUND
  • Mak KK, Day JR. Dental health behaviours among early adolescents in Hong Kong. Int J Dent Hyg. 2011 May;9(2):122-6. doi: 10.1111/j.1601-5037.2010.00452.x.

    PMID: 21078081BACKGROUND
  • Wong HM, McGrath CP, King NM, Lo EC. Oral health-related quality of life in Hong Kong preschool children. Caries Res. 2011;45(4):370-6. doi: 10.1159/000330231. Epub 2011 Aug 3.

    PMID: 21822015BACKGROUND
  • de Silva AM, Hegde S, Akudo Nwagbara B, Calache H, Gussy MG, Nasser M, Morrice HR, Riggs E, Leong PM, Meyenn LK, Yousefi-Nooraie R. Community-based population-level interventions for promoting child oral health. Cochrane Database Syst Rev. 2016 Sep 15;9(9):CD009837. doi: 10.1002/14651858.CD009837.pub2.

    PMID: 27629283BACKGROUND
  • Watt RG. Strategies and approaches in oral disease prevention and health promotion. Bull World Health Organ. 2005 Sep;83(9):711-8. Epub 2005 Sep 30.

    PMID: 16211164BACKGROUND
  • Wu L, Gao X, Lo ECM, Ho SMY, McGrath C, Wong MCM. Motivational Interviewing to Promote Oral Health in Adolescents. J Adolesc Health. 2017 Sep;61(3):378-384. doi: 10.1016/j.jadohealth.2017.03.010. Epub 2017 May 19.

    PMID: 28532895BACKGROUND
  • Husseini A, Slot DE, Van der Weijden GA. The efficacy of oral irrigation in addition to a toothbrush on plaque and the clinical parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008 Nov;6(4):304-14. doi: 10.1111/j.1601-5037.2008.00343.x.

    PMID: 19138181BACKGROUND
  • Dumitrescu AL, Dogaru BC, Duta C, Manolescu BN. Testing five social-cognitive models to explain predictors of personal oral health behaviours and intention to improve them. Oral Health Prev Dent. 2014;12(4):345-55. doi: 10.3290/j.ohpd.a31662.

    PMID: 24624388BACKGROUND
  • Pakpour AH, Sniehotta FF. Perceived behavioural control and coping planning predict dental brushing behaviour among Iranian adolescents. J Clin Periodontol. 2012 Feb;39(2):132-7. doi: 10.1111/j.1600-051X.2011.01826.x. Epub 2011 Dec 12.

    PMID: 22150555BACKGROUND
  • Mellanby AR, Rees JB, Tripp JH. Peer-led and adult-led school health education: a critical review of available comparative research. Health Educ Res. 2000 Oct;15(5):533-45. doi: 10.1093/her/15.5.533.

    PMID: 11184213BACKGROUND
  • Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004 Apr;31(2):143-64. doi: 10.1177/1090198104263660.

    PMID: 15090118BACKGROUND
  • Janz NK, Becker MH. The Health Belief Model: a decade later. Health Educ Q. 1984 Spring;11(1):1-47. doi: 10.1177/109019818401100101.

    PMID: 6392204BACKGROUND
  • Xiang B, Wong HM, McGrath CPJ. The efficacy of peer-led oral health programs based on Social Cognitive Theory and Health Belief Model among Hong Kong adolescents: a cluster-randomized controlled trial. Transl Behav Med. 2022 Mar 17;12(3):423-432. doi: 10.1093/tbm/ibab142.

  • Xiang B, McGrath CPJ, Wong HM. The Efficacy of a Multi-Theory-Based Peer-Led Intervention on Oral Health Among Hong Kong Adolescents: A Cluster-Randomized Controlled Trial. J Adolesc Health. 2022 Feb;70(2):267-274. doi: 10.1016/j.jadohealth.2021.08.001. Epub 2021 Sep 11.

Related Links

MeSH Terms

Conditions

Dental CariesPeriodontal Diseases

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesMouth Diseases

Study Officials

  • Hai Ming WONG, PhD

    the Faculty of Dentistry, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
.An experienced fieldworker will facilitate the survey process, and she will be blind to our group allocation. Two experienced dentists will conduct the dental examinations who don't know the group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2018

First Posted

October 3, 2018

Study Start

September 1, 2018

Primary Completion

July 28, 2020

Study Completion

October 31, 2020

Last Updated

April 30, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations