RetentionNCT02436811
Oral Health Literacy and Oral Education
A study testing Written form instruction and Standardized oral instruction in people with Retention, run by Universidade Federal do Paraná at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 12 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Retention
- What is being tested?
- Written form instruction and Standardized oral instruction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women
- To be literate
- Pregnancy maximum in the 32nd week
Who cannot join
- Physical or mental disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Retention
- Being tested
- Written form instruction, Standardized oral instruction, Control
- Keywords
- Health literacy, Pregnant women, Feeding behaviour, Oral health, Child
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written form instructionBehavioural
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 instructionBehavioural
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.
ControlBehavioural
60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
| Study group | Role | What they receive |
|---|---|---|
| Standardized oral instruction | Experimental | 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. Receives: Behavioral: Written form instruction; Behavioral: Control |
| Written form instruction | Experimental | 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). Receives: Behavioral: Standardized oral instruction; Behavioral: Control |
| Control | Experimental | 60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer. Receives: Behavioral: Written form instruction; Behavioral: Standardized oral instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Knowledge Score
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana Reichert Assunção Zanon, Universidade Federal do Paraná
- Investigators
- Luciana R Zanon, DDS, Principal investigator, Adjunct professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436811
- Sponsor's protocol ID
- CAAE 27273314.1.0000.0102
- Status last verified
- Apr 2016
- First submitted
- 29 Apr 2015
- Last updated
- 6 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Literacy and Information Retention in Pregnancy
- ClinicalTrials.gov ID
- NCT02436811
- Acronym / sponsor ID
- CAAE 27273314.1.0000.0102
- Conditions
- Retention
- Keywords
- Health literacy, Pregnant women, Feeding behaviour, Oral health, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Posted 6 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standardized oral instruction | Experimental | Behavioral: Written form instruction, Behavioral: Control60 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. |
| Written form instruction | Experimental | Behavioral: Standardized oral instruction, Behavioral: Control60 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). |
| Control | Experimental | Behavioral: Written form instruction, Behavioral: Standardized oral instruction60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant women
- To be literate
- Pregnancy maximum in the 32nd week
Key exclusion criteria (1 listed)
- Physical or mental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written form instruction60 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). | Behavioural | Control, Standardized oral instruction |
| Standardized oral instruction60 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. | Behavioural | Control, Written form instruction |
| Control60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer. | Behavioural | Standardized oral instruction, Written form instruction |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana R Zanon, DDS principal investigator
Adjunct professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written form instruction and Standardized oral instruction in people with Retention, run by Universidade Federal do Paraná at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.