N/A
N=180
Oral Health Literacy and Oral Education
Retention
Bottom Line
View on ClinicalTrials.gov: NCT02436811 ↗Enrolled (actual)
180
Serious AEs
—
Results posted
May 2016
Primary outcome: Primary: Changes in the Knowledge Score — 4.81; 4.86; 4.64; 7.10 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Written form instruction (Behavioral); Standardized oral instruction (Behavioral); Control (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Universidade Federal do Paraná
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Knowledge Score |
4.81; 4.86; 4.64; 7.10; 5.84; 4.74 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Pregnant women
- To be literate
- Pregnancy maximum in the 32nd week
Exclusion Criteria
- Physical or mental disability
Data sourced from ClinicalTrials.gov (NCT02436811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.