Oral Health Literacy and Oral Education

NCT02436811 | Completed Results DMC

• 1 other identifier: CAAE 27273314.1.0000.0102
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retention

Keywords

Health literacy; Pregnant women; Feeding behaviour; Oral health; Child

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (3)

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.

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).

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.

Behavioral: Written form instruction; Behavioral: Standardized oral instruction

Interventions

Written form instruction BEHAVIORAL

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).

Control; Standardized oral instruction

Standardized oral instruction BEHAVIORAL

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; Written form instruction

Control BEHAVIORAL

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

Standardized oral instruction; Written form instruction

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women
• To be literate
• Pregnancy maximum in the 32nd week

You may not qualify if:

• Physical or mental disability

Sponsors & Collaborators

• Universidade Federal do Paraná: lead

Study Sites (1)

Karina Duarte Vilella

Curitiba, Brazil, 80210170, Brazil

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Results Point of Contact

• Title: Dr Luciana Reichert Assunção Zanon
• Organization: Universidade Federal do Paraná

lurassuncao@yahoo.com.br

554133604025

Study Officials

• Luciana R Zanon, DDS

  Adjunct professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 7, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 6, 2016
• Results First Posted: May 6, 2016

Record last verified: 2016-04

Locations

BR (1)