<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04415450</url>
  </required_header>
  <id_info>
    <org_study_id>OCMHS</org_study_id>
    <nct_id>NCT04415450</nct_id>
  </id_info>
  <brief_title>Effect of Nutrition Education on Knowledge and Healthy Dietary Practice Among Pregnant Women</brief_title>
  <official_title>Effect of Nutrition Education by Health Professionals on Pregnancy Specific Nutrition Knowledge and Healthy Dietary Practice Among Pregnant Women in Asmara, Eritrea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orotta College of Medicine and Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Orotta College of Medicine and Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy pregnancy and birth outcomes is greatly influenced by the intake of adequate and&#xD;
      balanced nutrition. Pregnant women's nutritional knowledge and practice have been identified&#xD;
      as an important prerequisites for their proper nutritional intake. The antenatal period with&#xD;
      the opportunities for regular contact with health professionals appears to be the ideal time&#xD;
      and setting to institute the intervention which could maximize pregnant women's outcome and&#xD;
      that of their baby by motivating them to make nutritional changes. The overall objective of&#xD;
      the research was to assess the effect of nutrition education on the appropriate nutritional&#xD;
      knowledge and practice of pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adequate and balanced nutrition during gestation has been recognized as a prerequisite for a&#xD;
      healthy pregnancy and birth outcomes and this is significantly determined by their&#xD;
      nutritional knowledge and practice. This facility based single group pre-post quasi&#xD;
      experimental study design was conducted with the objective of assessing the effect of&#xD;
      nutrition education on the appropriate nutritional knowledge and practice of pregnant women.&#xD;
      The study was conducted in five health facilities providing ANC (Antenatal Care) service in&#xD;
      Asmara on 226 pregnant women. A predesigned and pretested questionnaire was used to collect&#xD;
      data regarding nutritional knowledge via interview by trained data collectors during the&#xD;
      pretest, immediate posttest and six weeks later. This study showed that the current&#xD;
      intervention generally was effective in accomplishing improved knowledge and practice level&#xD;
      of pregnant women. The simple nutrition education messages given to pregnant women using&#xD;
      holistic approach of targeting all the major determinants in a sustained manner played a huge&#xD;
      role in increasing their knowledge regarding nutrition during pregnancy. Knowledge regarding&#xD;
      duration of iron supplementation was very low in this study. At the same time minor knowledge&#xD;
      gap was seen in the sources of main food groups among pregnant women. The provided nutrition&#xD;
      education also helped the pregnant women to improve dietary intake during pregnancy, although&#xD;
      their adherence to iron supplements was decreased. Skipping meals and avoiding certain food&#xD;
      items was also evident in this study. A reassuring concept is that food taboos and cultural&#xD;
      factors were never the reasons that prevented women from consuming the food items. The&#xD;
      educational intervention has shown more positive impact on increasing the scores regarding&#xD;
      knowledge of appropriate nutrition during pregnancy for primigravida mothers than for&#xD;
      multigravida mothers while the improvement in the dietary practice had no interaction with&#xD;
      their socio-demographic characteristics. To sum up, attenuation of maternal and infant&#xD;
      malnutrition may not be remote if pregnant women are well educated and counseled about&#xD;
      nutrition during pregnancy. The study was conducted under limitations of not being able to&#xD;
      control the possible effect of other sources like Television, books, magazines and radio&#xD;
      broadcasting on the change in the knowledge and practice of pregnant women towards nutrition&#xD;
      could not be controlled. Face to face interview may lead to social desirability bias which&#xD;
      may in turn bring higher proportion of correct practice among pregnant women on the follow-up&#xD;
      questioning (as the practice is self-reported).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2018</start_date>
  <completion_date type="Actual">September 24, 2018</completion_date>
  <primary_completion_date type="Actual">September 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pregnant women who were on their first and second trimester of pregnancy</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>knowledge level of pregnant women on nutrition and their appropriate nutrition-related practice after intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>The two outcome variables in this study were the knowledge level of pregnant women and their appropriate nutrition-related practice after intervention. At the Data set of pregnant women the categorical data from the knowledge part of the data collection was recorded to dichotomous data of 1 and 0, where 1 is having the correct answer and 0 is for incorrectly answering. Practice components of the questionnaire of pregnant women were dichotomized to 1 and 0 as well, where 1 is having good practice and 0 is having no practice. Composite scores of knowledge and practice of each pregnant woman was computed. Mean scores of the knowledge (at pre, immediate post and 6 weeks later) and practice (at pre and 6 weeks later) of pregnant women were then calculated. The pregnancy specific NEC was the independent variable in this study. Co-variables on ANC clients were the demographics characteristics addition to source of information and frequency of ANC visits.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">226</enrollment>
  <condition>Pregnancy Nutritional Disease</condition>
  <arm_group>
    <arm_group_label>Nutrition Education Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group is the group who received the intervention which is the nutrition education and counseling. Phase I of the data collection from the experimental group which is the pregnant women (baseline assessment) using a questionnaire immediately before receiving nutrition counseling from their ANC providers first took place. Health professionals then started providing nutrition education to pregnant women preselected and assessed before the intervention. Immediate post education evaluation of the pregnant women was done by the same questionnaire used to assess in the pretest. Phase II or post intervention data collection of pregnant women was done after the client was appointed for 6 weeks after the counseling session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition Education counseling</intervention_name>
    <description>In the context of health education program, an educational intervention was developed by the research team based on a training module. The nutrition education contained introductory messages and focused on meanings of healthy diet, eating a variety of food, eating well with the locally available food, hazards of maternal malnutrition, important supplements to be taken during pregnancy, harmful substances to be avoided, and measures of alleviating common discomforts associated with nutrition during pregnancy. The training program was carried out in the form of counseling using printed materials and flip charts for pictorial representation. Self-reading of leaflets containing the core messages for every topic prepared in the native language of the participants was also employed as the women in the study had one each.</description>
    <arm_group_label>Nutrition Education Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who were on their first and second trimester of pregnancy and willing&#xD;
             to participate in the study were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who were sick at the time of the study and those who cannot communicate&#xD;
             verbally.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lidia G Teweldemedhin, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OCMHS</name>
      <address>
        <city>Asmara</city>
        <state>Maekel</state>
        <zip>10549</zip>
        <country>Eritrea</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Eritrea</country>
  </location_countries>
  <reference>
    <citation>Daba G, Beyene F, Fekadu H, Garoma W: Assessment of knowledge of pregnant mothers on maternal nutrition and associated factors in Guto Gida Woreda, East Wollega Zone, Ethiopia. Journal of Nutrition &amp; Food Sciences 2013, 3(6):1.</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Orotta College of Medicine and Health Sciences</investigator_affiliation>
    <investigator_full_name>Lidia Ghirmai</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Nutrition education</keyword>
  <keyword>Knowledge</keyword>
  <keyword>Practice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>I do not have plans to share my IPD</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415450
org study id: OCMHS
nct id: NCT04415450
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Healthy pregnancy and birth outcomes is greatly influenced by the intake of adequate and
      balanced nutrition. Pregnant women's nutritional knowledge and practice have been identified
      as an important prerequisites for their proper nutritional intake. The antenatal period with
      the opportunities for regular contact with health professionals appears to be the ideal time
      and setting to institute the intervention which could maximize pregnant women's outcome and
      that of their baby by motivating them to make nutritional changes. The overall objective of
      the research was to assess the effect of nutrition education on the appropriate nutritional
      knowledge and practice of pregnant women.
Adequate and balanced nutrition during gestation has been recognized as a prerequisite for a
      healthy pregnancy and birth outcomes and this is significantly determined by their
      nutritional knowledge and practice. This facility based single group pre-post quasi
      experimental study design was conducted with the objective of assessing the effect of
      nutrition education on the appropriate nutritional knowledge and practice of pregnant women.
      The study was conducted in five health facilities providing ANC (Antenatal Care) service in
      Asmara on 226 pregnant women. A predesigned and pretested questionnaire was used to collect
      data regarding nutritional knowledge via interview by trained data collectors during the
      pretest, immediate posttest and six weeks later. This study showed that the current
      intervention generally was effective in accomplishing improved knowledge and practice level
      of pregnant women. The simple nutrition education messages given to pregnant women using
      holistic approach of targeting all the major determinants in a sustained manner played a huge
      role in increasing their knowledge regarding nutrition during pregnancy. Knowledge regarding
      duration of iron supplementation was very low in this study. At the same time minor knowledge
      gap was seen in the sources of main food groups among pregnant women. The provided nutrition
      education also helped the pregnant women to improve dietary intake during pregnancy, although
      their adherence to iron supplements was decreased. Skipping meals and avoiding certain food
      items was also evident in this study. A reassuring concept is that food taboos and cultural
      factors were never the reasons that prevented women from consuming the food items. The
      educational intervention has shown more positive impact on increasing the scores regarding
      knowledge of appropriate nutrition during pregnancy for primigravida mothers than for
      multigravida mothers while the improvement in the dietary practice had no interaction with
      their socio-demographic characteristics. To sum up, attenuation of maternal and infant
      malnutrition may not be remote if pregnant women are well educated and counseled about
      nutrition during pregnancy. The study was conducted under limitations of not being able to
      control the possible effect of other sources like Television, books, magazines and radio
      broadcasting on the change in the knowledge and practice of pregnant women towards nutrition
      could not be controlled. Face to face interview may lead to social desirability bias which
      may in turn bring higher proportion of correct practice among pregnant women on the follow-up
      questioning (as the practice is self-reported).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pregnant women who were on their first and second trimester of pregnancy
primary purpose: Other
masking: None (Open Label)
measure: knowledge level of pregnant women on nutrition and their appropriate nutrition-related practice after intervention
time frame: 6 weeks
description: The two outcome variables in this study were the knowledge level of pregnant women and their appropriate nutrition-related practice after intervention. At the Data set of pregnant women the categorical data from the knowledge part of the data collection was recorded to dichotomous data of 1 and 0, where 1 is having the correct answer and 0 is for incorrectly answering. Practice components of the questionnaire of pregnant women were dichotomized to 1 and 0 as well, where 1 is having good practice and 0 is having no practice. Composite scores of knowledge and practice of each pregnant woman was computed. Mean scores of the knowledge (at pre, immediate post and 6 weeks later) and practice (at pre and 6 weeks later) of pregnant women were then calculated. The pregnancy specific NEC was the independent variable in this study. Co-variables on ANC clients were the demographics characteristics addition to source of information and frequency of ANC visits.
arm group label: Nutrition Education Group
arm group type: Experimental
description: The experimental group is the group who received the intervention which is the nutrition education and counseling. Phase I of the data collection from the experimental group which is the pregnant women (baseline assessment) using a questionnaire immediately before receiving nutrition counseling from their ANC providers first took place. Health professionals then started providing nutrition education to pregnant women preselected and assessed before the intervention. Immediate post education evaluation of the pregnant women was done by the same questionnaire used to assess in the pretest. Phase II or post intervention data collection of pregnant women was done after the client was appointed for 6 weeks after the counseling session.
intervention type: Behavioral
intervention name: Nutrition Education counseling
description: In the context of health education program, an educational intervention was developed by the research team based on a training module. The nutrition education contained introductory messages and focused on meanings of healthy diet, eating a variety of food, eating well with the locally available food, hazards of maternal malnutrition, important supplements to be taken during pregnancy, harmful substances to be avoided, and measures of alleviating common discomforts associated with nutrition during pregnancy. The training program was carried out in the form of counseling using printed materials and flip charts for pictorial representation. Self-reading of leaflets containing the core messages for every topic prepared in the native language of the participants was also employed as the women in the study had one each.
arm group label: Nutrition Education Group
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lidia G Teweldemedhin, MSc
role: Principal Investigator
affiliation: Lecturer
facility: 
country: Eritrea
citation: Daba G, Beyene F, Fekadu H, Garoma W: Assessment of knowledge of pregnant mothers on maternal nutrition and associated factors in Guto Gida Woreda, East Wollega Zone, Ethiopia. Journal of Nutrition & Food Sciences 2013, 3(6):1.
responsible party type: Principal Investigator
investigator affiliation: Orotta College of Medicine and Health Sciences
investigator full name: Lidia Ghirmai
investigator title: Lecturer
mesh term: Nutrition Disorders
sharing ipd: No
ipd description: I do not have plans to share my IPD