- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06489054
Effects of Peer-based Education on Adolescent Oral Health Literacy
July 3, 2024 updated by: Paulo Frazao, University of Sao Paulo
Effects of a Peer-based Educational Project on Adolescents' Oral Health Literacy
This project aims to identify whether an oral health peer education strategy can influence the level of functional literacy and oral health attitudes of adolescents aged 15 to 19 years.
An experimental study will be carried out, a non-randomized controlled community trial, with two groups of educational strategy in oral health: peer education (experimental group) and conventional education (control group).
For data collection, three questionnaires will be applied: for socioeconomic, demographic and dental data; assessment of oral health literacy (BOHL-AQ); and assessment of oral health attitudes; the last two being applied before and after the intervention.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This project aims to identify whether an oral health peer education strategy can influence the level of functional literacy and oral health attitudes of adolescents aged 15 to 19 years.
An experimental study will be carried out, a non-randomized controlled community trial, carried out in the municipality of Araruna-PB, with two groups of educational strategy in oral health: peer education (experimental group) and conventional education (control group).
For data collection, three questionnaires will be applied: for socioeconomic, demographic and dental data; assessment of oral health literacy (BOHL-AQ); and assessment of oral health attitudes; the last two being applied before and after the intervention.
Descriptive analysis will be performed and a test will be applied to assess the normality of the data.
The psychometric properties of the BOHL-AQ with adolescents will be evaluated using factor analysis.
For literacy and attitude data, a comparison of means before and after the intervention will be performed using the intragroup paired and unpaired Student t test.
All analyzes will be performed using the Statistical Package for the Social Sciences (SPSS) 25.0, considering a significance level of p < 0.05.
Study Type
Interventional
Enrollment (Actual)
360
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
-
-
-
São Paulo, Brazil, 01246904
- Universidade de São Paulo
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adolescents aged 15 to 19 years old, who obtain consent from their parents/guardians (for those under 18 years of age), voluntarily accept to participate in the study and are present on the day the questionnaires are administered.
Exclusion Criteria:
- Adolescents with physical and/or mental disabilities that make it impossible to follow the activities proposed in the intervention and respond to the questionnaires.
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: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer education
An initial assessment will be carried out to determine the socioeconomic, demographic profile and dental data and baseline data on literacy and attitudes related to oral health through questionnaires, after which participants will be invited to participate in a cycle of oral health education activities for three months on the experimental group (peer-based education).
After the experimental stage, the literacy and attitudes questionnaires related to oral health will be reapplied, so that a comparative analysis can be carried out within and between groups.
|
An initial assessment will be carried out to determine the socioeconomic, demographic profile and dental data and baseline data on literacy and attitudes related to oral health through questionnaires, after which participants will be invited to participate in a cycle of oral health education activities for three months on the experimental group (peer-based education).
After the experimental stage, the literacy and attitudes questionnaires related to oral health will be reapplied, so that a comparative analysis can be carried out within and between groups.
|
|
Active Comparator: Conventional education
An initial assessment will be carried out to determine the socioeconomic, demographic profile and dental data and baseline data on literacy and attitudes related to oral health through questionnaires, after which participants will be invited to participate in a cycle of oral health education activities for three months on the control group (dentist lecture).
After the experimental stage, the literacy and attitudes questionnaires related to oral health will be reapplied, so that a comparative analysis can be carried out within and between groups.
|
An initial assessment will be carried out to determine the socioeconomic, demographic profile and dental data and baseline data on literacy and attitudes related to oral health through questionnaires, after which participants will be invited to participate in a cycle of oral health education activities for three months on the control group (dentist lecture).
After the experimental stage, the literacy and attitudes questionnaires related to oral health will be reapplied, so that a comparative analysis can be carried out within and between groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral health literacy
Time Frame: The first data collection (baseline) occurred 2 months after participant recruitment and the second collection will be after the intervention, 3 months after baseline.
|
A specific questionnaire, Brazilian Oral Health Literacy-Adults Questionnaire - BOHL-AQ, will be used to measure oral health literacy before and after the oral health education intervention.
|
The first data collection (baseline) occurred 2 months after participant recruitment and the second collection will be after the intervention, 3 months after baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitudes related to oral health
Time Frame: The first data collection (baseline) occurred 2 months after participant recruitment and the second collection will be after the intervention, 3 months after baseline.
|
A questionnaire will be used to measure attitudes related to oral health before and after the oral health education intervention.
|
The first data collection (baseline) occurred 2 months after participant recruitment and the second collection will be after the intervention, 3 months after baseline.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Paulo Frazão, University of São Paulo
- Principal Investigator: Helene Moura, University of São Paulo
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)
March 4, 2024
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
June 27, 2024
First Submitted That Met QC Criteria
July 3, 2024
First Posted (Actual)
July 5, 2024
Study Record Updates
Last Update Posted (Actual)
July 5, 2024
Last Update Submitted That Met QC Criteria
July 3, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FSP-USP
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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