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Status unknownNCT06489054Updated Jul 5, 2024

Effects of Peer-based Education on Adolescent Oral Health Literacy

An interventional study of Peer education and Conventional education in Health Literacy, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 15 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2024, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Non-randomized
Ages
15 Years to 19 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Health Literacy

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Keywords

  • Health Education, Dental
  • Adolescent
03

In context

Health Education

201 studies on the registry are indexed under Health Education; 72 are open to participants now.

This study's enrollment of 360 is above the median of 126 across 193 interventional studies indexed under Health Education.

Browse Health Education studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
360 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherPeer 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.

  • OtherConventional 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.

06

What researchers measure

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.

    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.

Secondary outcomes

  1. Attitudes related to oral health

    A questionnaire will be used to measure attitudes related to oral health before and after the oral health education intervention.

    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.

07

Study locations

1 site
  • Universidade de São Paulo
    São Paulo, 01246904, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Sep 2024, 6 months after the start.

Of 147 non-industry interventional studies with no phase under Health Education, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 6 months is below that.

Counting every sponsor, half of 147 studies reached it within 11 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2024
First posted
Jul 5, 2024
StartActual
Mar 4, 2024
Primary completionEst.
Sep 2024
CompletionEst.
Sep 2024
Last update
Jul 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06489054
Responsible party
Paulo Frazao (Professor (Full), University of Sao Paulo) — Principal investigator
First posted
Jul 5, 2024
Start date
Mar 4, 2024
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jul 5, 2024

Study contacts

Paulo Frazão
study director · University of Sao Paulo
Helene Moura
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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