The Effectiveness of an Oral Health Education Programme of Adolescents in Hong Kong

April 27, 2021 updated by: The University of Hong Kong

A Randomized Controlled Trial Evaluating the Efficacy of a Peer-led Theory-based Intervention in Promoting Healthy Behaviors Among Adolescents in Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Baseline survey and dental examination The baseline survey will collect information on participants' background characteristics (e.g., socio-demographics), Social Cognitive Theory (SCT)-related variables (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy), Health Belief Model (HBM)-related variables (reciprocal determinism, behavioral capability, outcome expectations), and oral health behaviors. Validated scales have been identified and will be used in the survey.

To comprehensively assess each participant's oral health status at baseline, their oral hygiene status, caries experience and periodontal condition will be recorded following the recommendations of the World Health Organization (WHO) for oral health surveys. Oral hygiene status will be recorded through plaque index (PI) (Quigley Hein, 1972) on a scale of 0 to 5. Dental caries experience will be recorded by counting the numbers of permanent teeth that are decayed (DT), missing due to caries (MT), and filled (FT) to generate a DMFT score. Periodontal condition will be recorded using the Community Periodontal Index (CPI). Two trained and calibrated examiners (kappa = 0.81 - 0.87 for intra- and inter-examiner reliabilities for the assessment of DMFT and CPI) will perform the clinical examinations using a plane disposable plane intra-oral mirror with a built-in LED light source and a WHO CPI periodontal probe. Ten percent of the participants will be randomly selected and re-examined in each school to continuously monitor intra- and inter-examiner reliabilities of assessing PI DMFT and CPI.

Intervention description A total of five peer-led activities will be conducted in the intervention schools by the well-trained peer leaders within a 6-month intervention period.

  1. In the 1st month of intervention, peer leaders will deliver a poster and a leaflet providing information on healthy oral behaviors based on SCT and HBM. Such materials will be provided at the entrance of the school gate, the canteen, and each class. Peer leaders will encourage students to ask questions when they receive such materials. Participants are free to take an on-site quiz to check assess their knowledge level.
  2. In the 2nd month of intervention, peer leaders will give a specific health talk aiming to raise the awareness of healthy oral behaviors. Schools teachers will encourage all students to participate in this talk. We will video-record this health talk and make it available online to reach more students. This talk will be guided by SCT and HBM, and it will include short testimonials of the good experiences of the peer leaders when performing healthy oral behaviors.
  3. In the 3rd month of intervention, peer leaders will organize a workshop aiming to help the participants practicing skills in performing healthy oral behaviors. Regarding different oral behaviors (tooth brushing, dental flossing, and dental visits), targeted skills will be practiced.
  4. In the 4th month of intervention, peer leaders are encouraged to self-design and conduct one more oral health-related activity that they are interested. Necessary support will be provided by the team. We will record details of this peer leader-initiated activity.
  5. In the 5th or 6th month of intervention, peer leaders will deliver a special talk regarding illness representations for students with existing oral diseases only. The talk will focus on improving illness representation in both cognitive and emotional aspects, and coping strategies will be practiced.

The first follow-up at months 6 The first follow-up at months 6 will include two parts. The first part is to collect participants' self-reported data through questionnaire. An experienced fieldworker will facilitate the survey process, and she will be blind to our group allocation. The month 6 follow-up data suggest an immediate impact of the intervention, as all intervention activities will be conducted within this 6-month intervention period. The proposed time interval (6 months) is reasonable and feasible, as 6 months is the most frequently adopted time frame to assess behavior changes and the dental visit for check-up (one of our primary outcomes) is recommended to adolescents every 6 months. We will compare changes before and after this intervention within interventions group, and we will also investigate the differences between intervention group and control group.

The second follow-up at months 12 The second follow-up at months 12 will include two parts. The first part is to collect participants' self-reported data through survey, the same procedure as the first follow-up at month 6. The month 12 follow up data suggest a prolonged impact of the intervention, as no intervention activities will be conducted between months 6 and months 12.

The second part is to do dental re-examination, using the same methods and criteria as the baseline examination. We will compare the disease status changes before and after intervention within interventions group. The consistency between self-reported healthy oral behaviors and dental examination outcomes will also be calculated. No dental examination will be conducted at month 6 follow up, as oral disease status is not likely to change within a short time period like 6 months.

Data analysis The intra- and inter-examiner reliabilities of assessing PI, DMFT and CPI at the tooth level will be tested through the use of the kappa statistic. Data of DMFT and CPI at the tooth level will be used to generate the oral disease status at the subject level.

Intention-to-treat analysis will be conducted. Multiple imputation methods will be used to deal with missing data if it occurs. Between-group (intervention versus control) baseline differences in the frequency distributions of potential confounders will be compared by using chi-square test, t-test, Mann-Whitney test or other statistics. The absolute and relative risks and number needed to treat (and their 95% confidence intervals) for the binary outcomes comparing the two groups at months 6 and 12 will be derived. Adjusted comparisons between the intervention and control groups will be made for all binary outcomes, adjusting for any potential confounders showing p<.10 in the between-group baseline comparisons (if any), using modified Poisson regression with robust sandwich variance estimation. SPSS will be used for data analysis; p<.05 (2-sided) will be taken as statistically significant.

Study Type

Interventional

Enrollment (Actual)

1184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • the Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • undergoing orthondontic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: peer-led theory-based intervention group
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

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.
NO_INTERVENTION: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health behaviors
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition related to oral health knowledge
Time Frame: 12 months
The three components of the HBM constructs and two components of SCT were measured using a self-reported questionnaire. Cronbach's alpha coefficients were 0.74, 0.84, 0.86 for items of HBM and 0.96, 0.74 for items of SCT. Item-total and item-subscale correlation coefficients were also satisfactory (ranging from 0.62 to 0.94, all p<0.05). All the constructs were measured by 59 items. Item responses were measured on a five-point Likert scale; responses ranged from 1 (strongly disagree) to 5 (strongly agree). The average score will be calculated (ranging from 1 to 5). Higher score represents a lower cognition of psychological constructs.
12 months
Child Oral Health Quality of Life Questionnaire (CPQ-16)
Time Frame: 12 months
Child oral health quality of life was evaluated by 16 items. The response options for each item were "never" (scoring 1), "once or twice" (scoring 2), "sometimes" (scoring 3), "often" (scoring 4), or "every day or almost every day (scoring 5). Cronbach's alpha coefficient of this scale was 0.89. The mean inter-item correlations ranged from 0.68 (oral symptoms) to 0.88 (social well-being). The total score of all the items will be calculated (ranging from 16-80). Higher scores represents a lower oral health related quality of life
12 months
Oral health knowledge assessment
Time Frame: 12 months
To assess adolescents' dental knowledge, 21 multiple choice questions on the cause and prevention of dental diseases were asked. One point was given to each correct answer; and no point was given to a wrong answer or a 'don't know' answer. Thus, the dental knowledge score could range from 0 to 21. The adolescents were then categorized into three groups according to their dental knowledge scores - poor (scored 0-7), moderate (scored 8-14) and good (scored 15-21).
12 months
Modified Child Dental Anxiety Scale (MCDAS)
Time Frame: 12 months
Dental anxiety of adolescents was evaluated by 8 items. Each question was answered by using five-Likert scale (not worried=1; very slightly worried=2; fairly worried=3; worried a lot=4; very worried=5). The range of the score was 8-40. Higher scores indicate a more severe dental anxiety.
12 months
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 12 months
GAD-7 was used to evaluate generalized anxiety of adolescents. It was a seven-item self-rating instrument. Each item described one of the typical symptoms of GAD and was evaluated by the frequency in which that symptom emerged over the last two weeks: "Not at all" scored 0, "Several days" scored 1, "More than half the days" scored 2, and "Nearly every day" scored 3. The total score range from 0-21. Higher score indicates a more severe generalized anxiety.
12 months
Self-percept Social Support
Time Frame: 12 months
Material support and emotional support provided from family members, friends and teachers were asked .It was grade using 0-10 point, "0" means "no support", "10" means "a lot of support". The value of each item would be evaluated separately. Lower score means poorer support, higher score means better support.
12 months
Plaque Index (Quigley Hein, 1972)
Time Frame: 12 months

An index that evaluates the plaque revealed on the buccal non-restored surfaces of the teeth on a scale of 0 to 5, defined by G. A. Quigley and J. W. Hein in 1962 and modified by S. Turesky, N. D. Gilmore, and I. Glickman in 1970. All teeth except the third molars are assessed. An index for the entire mouth is determined by dividing the total score by the number of surfaces examined.

Quigley-Hain plaque index 0-No plaque

  1. Isolated flecks of plaque at the gingival margin
  2. A continuous band of plaque up to 1mm at the gingival margin
  3. Plaque greater than 1mm in width and covering up to one third of the tooth surface
  4. Plaque covering from one thirds to two thirds of the tooth surface
  5. Plaque covering more than two thirds of the tooth surface
12 months
DMFT (WHO, 5th edition)
Time Frame: 12 months
DMFT (number of Decayed, Missing due to caries, and Filled Teeth in the permanent dentition)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Hai Ming WONG, PhD, the Faculty of Dentistry, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

July 28, 2020

Study Completion (ACTUAL)

October 31, 2020

Study Registration Dates

First Submitted

September 19, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (ACTUAL)

October 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 18-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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