Oral Health Literacy and Oral Education

Retention Clinical Trial

Official title:

Literacy and Information Retention in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02436811
• Other study ID #: CAAE 27273314.1.0000.0102
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2015
• Last updated: May 4, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2015
• Source: Universidade Federal do Paraná
• Contact: Luciana R Zanon, DDS
• Phone: 554133604025
• Email: lurassuncao[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women

• To be literate

• Pregnancy maximum in the 32nd week

Exclusion Criteria:

• Physical or mental disability

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Retention

Intervention

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

Locations

Country	Name	City	State
Brazil	Karina Duarte Vilella	Curitiba

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the Knowledge score		changes in the knowledge score will be measured by answers to nine statements before, fifty minutes after and four weeks after the interventions	Yes