NCT06489054

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

June 27, 2024

Last Update Submit

July 3, 2024

Conditions

Keywords

Health Education, DentalAdolescent

Outcome Measures

Primary Outcomes (1)

  • Oral health literacy

    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 Outcomes (1)

  • Attitudes related to oral health

    The first data collection (baseline) occurred 2 months after participant recruitment and the second collection will be after the intervention, 3 months after baseline.

Study Arms (2)

Peer education

EXPERIMENTAL

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

Conventional education

ACTIVE COMPARATOR

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

Interventions

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.

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 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.

Conventional education

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Adolescents with physical and/or mental disabilities that make it impossible to follow the activities proposed in the intervention and respond to the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, 01246904, Brazil

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Paulo Frazão

    University of Sao Paulo

    STUDY DIRECTOR
  • Helene Moura

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Experimental group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Full)

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

March 4, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations