CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Written form instruction +2 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02436811
NCT02436811N/ACompleted

Literacy and Information Retention in Pregnancy

Universidade Federal do Paraná·interventional·Posted May 7, 2015·Updated May 6, 2016

In Brief

A clinical study evaluating Written form instruction, Standardized oral instruction, and 1 other intervention for Retention. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetention
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 7, 2015
Enrollment StartOct 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.2 years ago

Interventions

Written form instructionbehavioral

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 instructionbehavioral

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.

Controlbehavioral

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