Oral Health Literacy and Oral Education

April 2, 2016 updated by: Luciana Reichert Assunção Zanon, Universidade Federal do Paraná

Literacy and Information Retention in Pregnancy

This is study aims to evaluate the retention of information on oral health and eating habits in children under two years of age. A total of 180 pregnant women aged between twelve and fifty years of age will be selected for this study. Before the randomization process, the literacy in oral health score will be assessed through previously validated instrument BREALD- 30. Participants will be randomly selected according to the value of BREALD-30, categorized as adequate (≥18) and low (<18) in a specific intervention. Interventions occur in written form through an educational brochure or standardized oral, both with information about the feeding practices and oral health in children under two years. The control group will be the implementation of an educational booklet on oral cancer. To evaluate the association between variables pregnant women will respond to a semi-structured form with questions regarding oral health and nutrition, in three different times: before the intervention, 15 minutes after the intervention and 4 weeks after the intervention. Social and economic and demographic data will be evaluated at baseline. The data will be statistically analyzed by Student's t-tests and ANOVA paired, adopting a 5% significance level. In the event of non-normality of the data, the corresponding non-parametric statistical tests will be applied. This study has the hypothesis that the written intervention presents best results in participants with high literacy and the standardized oral with those with low literacy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 study has the objective to verify the relationship between oral health literacy and information retention in health in pregnant women.

A total of 180 pregnant women with age between 12 and 50 years will be recruited to participate in this study. The inclusion criteria are: gestational age up to 32 weeks and who do not have any health problems that would prohibit participation in the study.

In a first moment, the instrument BREALD-30 (Brazilian Rapid Estimate of Adult Literacy in Dentistry), validated for Brazilian portuguese, will be applied to pregnant women who accept to participate voluntarily in the study . This instrument is composed of 30 words related to oral health. These words should be read aloud to the interviewer, each word read correctly, will receive a score equivalent to 1 (one). Thus, the scores can range from 0 (lowest literacy) to 30 (highest literacy). Pregnant women will be classified according to the score achieved in appropriate literacy (equal and more than 18 points) and low literacy (lower than 18 points) according to the value obtained in the lowest quintile. The reading of the instrument's words lasts about two minutes.

After applying the BREALD-30 instrument, the pregnant women will receive a previously tested form with social and economic and demographic information. This information includes maternal age, marital status (categorized into single, married, separated and widow), number of children, occupation and family income. It will be included a list of household items for assessment of social and economic results according to the criteria of the Brazilian Association of Research Companies.

It will be also assessed the degree of knowledge of mothers about feeding habits and oral health of children under two years of age. This step will include the establishment of a list of statements that express opinions with variations in responses: agree, neither agree nor disagree, disagree and do not know, in a Likert scale. The answers are scored 0-1. Scores can vary from 0 to 9. The application form will last about 10 minutes.

According to the results of BREALD-30, pregnant women will be randomly selected to receive an educational intervention, which is related to oral health and feeding habits in children under two-years of age. After enrollment, the participants will be randomized (1: 1: 1) in three groups: written instruction, oral instruction and control, by raffle using sealed, opaque envelopes. Each group will consist of 60 participants.

Group writing intervention: 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).

Group oral intervention: 60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.

Control group: 60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.

After the educational guidelines pregnant women will respond the same form applied before the interventions, with questions about the relationship between oral health and eating habits in children under two years of age.

Four weeks after the first procedure the same form will be reapplied to assess the retention of health knowledge after an interval of time.

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.
180

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
      • Curitiba, Brazil, 80210170
        • Karina Duarte Vilella

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

12 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women
  • To be literate
  • Pregnancy maximum in the 32nd week

Exclusion Criteria:

  • Physical or mental disability

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: Prevention
  • Allocation: 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: Standardized oral instruction
60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
Behavioral: Written form instruction
60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
Behavioral: Control
60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Experimental: Written form instruction
60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
Behavioral: Control
60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Behavioral: Standardized oral instruction
60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
Experimental: Control
60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Behavioral: Written form instruction
60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
Behavioral: Standardized oral instruction
60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.

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
Changes in the Knowledge Score
Time Frame: The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.
The knowledge score was assessed by nine statements developed and tested in a pilot study including items related to breastfeeding, supplemental feeding, sugar intake, bottle use, oral hygiene, and use of fluoride toothpaste. These statements were rated on a three-level Likert scale, under the following options: "agree," "neither agree nor disagree," and "disagree," in addition to "I don't know." Each correct answer received score 1 whereas incorrect answers such as "neither agree nor disagree" and "I don't know" were assigned score 0. The final scores ranged from 0 to 9. Higher values indicate better outcomes.
The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.

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.
Universidade Federal do Paraná

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.
  • Principal Investigator: Luciana R Zanon, DDS, Adjunct Professor

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

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.
October 1, 2014

Primary Completion (Actual)

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.
December 1, 2015

Study Completion (Actual)

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.
December 1, 2015

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).
April 29, 2015

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.
May 4, 2015

First Posted (Estimate)

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.
May 7, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
May 6, 2016

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.
April 2, 2016

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.
April 1, 2016

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.
  • CAAE 27273314.1.0000.0102

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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