- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02436811
Oral Health Literacy and Oral Education
Literacy and Information Retention in Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Curitiba, Brazil, 80210170
- Karina Duarte Vilella
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant women
- To be literate
- Pregnancy maximum in the 32nd week
Exclusion Criteria:
- Physical or mental disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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).
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).
|
60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
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.
|
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).
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
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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luciana R Zanon, DDS, Adjunct Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID 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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