Oral Health Literacy and Oral Education
Condition: Retention
Study type: Interventional

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.
    

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.
    

Intervention name(s): Written form instruction; Standardized oral instruction; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Health literacy; Pregnant women; Feeding behaviour; Oral health; Child