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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paulo Frazão, University of Sao Paulo
  • Principal Investigator: Helene Moura, University of Sao 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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