<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/NCT03308058</url>
  </required_header>
  <id_info>
    <org_study_id>430-12</org_study_id>
    <nct_id>NCT03308058</nct_id>
  </id_info>
  <brief_title>Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program</brief_title>
  <official_title>Feasibility of a Touch Screen Computer Based Breast-feeding Educational Support Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breastfeeding has many positive and long lasting impacts on the health of infants and&#xD;
      mothers. The investigators propose to develop a bilingual touch screen computer based&#xD;
      breastfeeding educational support program to promote breastfeeding among Hispanic rural women&#xD;
      living in Scottsbluff area of rural Nebraska. An interactive, tailored, touch screen,&#xD;
      bilingual breastfeeding educational program will be developed to deliver breastfeeding&#xD;
      education to enhance partial or exclusive breastfeeding. An experimental two-group repeated&#xD;
      measures design will be utilized. Ninety four prenatal Hispanic rural women aged 15 years and&#xD;
      above will be enrolled and randomly assigned to either the intervention (computer based&#xD;
      program, N=47) or attention control (printed educational material, N=47) groups at the&#xD;
      Regional West Medical Center in Scottsbluff. Information gathered will include&#xD;
      socio-demographics, familiarity with use of technology and health literacy assessment.&#xD;
      Process variables measured will include breast-feeding knowledge and breast-feeding&#xD;
      self-efficacy. Primary and secondary outcomes include breast-feeding duration in binary&#xD;
      categories (partial or exclusive) and number of sick baby medical visits and months of&#xD;
      illnesses. All assessments will be done at baseline, days 3 and 7, weeks 2 and 6 and months 3&#xD;
      and 6 in both the intervention and attention intervention groups. The current proposed study&#xD;
      may help advance our understanding to use health information technology as a medium to&#xD;
      disseminate bilingual health education programs in rural settings. This exploratory study&#xD;
      will lay a foundation for a larger multicenter randomized controlled clinical trial to&#xD;
      evaluate the impact of computer based educational intervention to promote sustainability of&#xD;
      breastfeeding among women across diverse settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two separate focus groups one in English and Spanish will be performed with six Hispanic&#xD;
      rural women with history of previous pregnancy will be enrolled at the Regional West Medical&#xD;
      Center (RWMC), Scottsbluff, NE. The focus group of 2 hours duration will be performed at the&#xD;
      antenatal clinic at RWMC during months 2 and 3 of the study. The focus group will help&#xD;
      examine factors that affect the decision to continue breast-feeding in pregnant Hispanic&#xD;
      rural women and will guide development of bilingual (English and Spanish) breast-feeding&#xD;
      educational modules during months 4 and 5 of the study. Dr. Aguirre and Ms. Salazar will be&#xD;
      responsible for subject recruitment, focus group assessments and would act as a moderator and&#xD;
      respond to questions and comments during the focus groups. The focus group interviews,&#xD;
      analysis and development of breast-feeding educational modules in English and Spanish will be&#xD;
      finalized during the first 5 months of the study. The focus group sessions will be audio&#xD;
      recorded and stored in a locked cabinet. The sessions recordings will be destroyed at the end&#xD;
      of the research study.&#xD;
&#xD;
      Computer-based Breast-Feeding Educational Support Program: The investigators will modify&#xD;
      existing touch screen, computer based interactive Patient Education and Motivation Tool&#xD;
      (PEMT) to deliver bilingual, breast-feeding educational support program. The existing PEMT&#xD;
      platform allows users to dynamically change the educational content either to English or&#xD;
      Spanish. The modification of the existing PEMT will occur during months 5-7 and will include&#xD;
      several stages:&#xD;
&#xD;
      (i) PEMT modification design (ii) Tailoring (iii) Expert Pretesting using Heuristic&#xD;
      evaluation (iv) Usability and User Testing&#xD;
&#xD;
      Intervention and Evaluation:&#xD;
&#xD;
      The subjects will be randomly enrolled using a 1:1 method with every other subject enrolled&#xD;
      randomized to either the control or intervention group, at RWMC, Scottsbluff. Eligible&#xD;
      individuals, who will meet the inclusion criteria, will be assigned into either intervention&#xD;
      (bilingual Computer based Breast-feeding Educational Support program) or attention control&#xD;
      (bilingual breast-feeding printed educational material) groups using a computer generated&#xD;
      random id during the subject's prenatal visit (i.e. anytime during last six weeks of their&#xD;
      pregnancy). Once randomized, baseline information will be gathered in both the groups.&#xD;
&#xD;
      The difference between the two study groups is that subjects in the intervention (bilingual&#xD;
      Computer based Breast-feeding Educational Support program) will record their baseline&#xD;
      assessment on a computer and receive tailored breast-feeding education compared to the&#xD;
      attention control (bilingual printed breast-feeding educational materials) who will record&#xD;
      their baseline information on paper and receive printed breast-feeding educational material.&#xD;
      Using self-reported responses of the individuals in the intervention group (bilingual&#xD;
      computer based breast-feeding educational support program), the decision logic and algorithm&#xD;
      will process the information and deliver tailored breast-feeding educational messages in&#xD;
      varied multimedia formats using a combination of text, images, and animations to account for&#xD;
      the literacy levels of the subjects.&#xD;
&#xD;
      Appropriate feedback will be given in the form of reinforced educational messages and&#xD;
      encouragement and motivational prompts for those using the computer based program.&#xD;
      Educational session in both the groups will last for 30 minutes. The first educational&#xD;
      session will be performed during the postpartum period, one day before the discharge from the&#xD;
      hospital followed by week 6, months 3 and 6. Specific individualized interventions,&#xD;
      especially during the initial critical 2-6 week period, are needed to prevent deterioration&#xD;
      in intention levels for breast-feeding for 6 months and breast-feeding self-efficacy levels&#xD;
      within the first 2 weeks postpartum which could lead to the decision to discontinue&#xD;
      breast-feeding. Subjects in both the groups will be given telephone reminders for follow up&#xD;
      educational sessions. The touch screen computer based Breast-feeding Educational Support&#xD;
      program will be placed on a mobile cart in the outpatient clinic of the RWMC, Scottsbluff for&#xD;
      the duration of the study and will be collected after the completion of the research.&#xD;
&#xD;
      There will be no repercussions to subjects since the touch screen computers will be placed at&#xD;
      the RWMC and will be used by the subjects enrolled in the study at this site. A web based&#xD;
      version will also be available for an ongoing support to subjects in the intervention group.&#xD;
      A research assistant will be available to guide the subjects in both the intervention (during&#xD;
      the use of the tablet pc program) and the control groups (printed educational material) if&#xD;
      needed. The breast-feeding educational modules and data collection instruments will be both&#xD;
      in English and Spanish.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">January 5, 2018</completion_date>
  <primary_completion_date type="Actual">January 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breastfeeding Assessment</measure>
    <time_frame>0-6 months</time_frame>
    <description>Questionnaire Breastfeeding duration (Specify time) __________</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Breastfeeding Computer education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breastfeeding Computer education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Printed Educational material</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Printed educational material</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breastfeeding computer education</intervention_name>
    <description>Breastfeeding computer education</description>
    <arm_group_label>Breastfeeding Computer education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hispanic females age 15 years and above&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Agreeing to participate in the study&#xD;
&#xD;
          -  Understand spoken English&#xD;
&#xD;
          -  Telephone at home&#xD;
&#xD;
          -  Available for follow-up interview.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental and physical challenge that makes it difficult to use the touch based computer&#xD;
             program&#xD;
&#xD;
          -  unavailability for telephone follow-up and&#xD;
&#xD;
          -  involvement in other clinical trials or protocols related to breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Wilhelm, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional West Medical Center-University of Nebraska Medical Center</name>
      <address>
        <city>Scottsbluff</city>
        <state>Nebraska</state>
        <zip>69361</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Thompson DA, Joshi A, Hernandez RG, Jennings JM, Arora M, Ellen JM. Interactive nutrition education via a touchscreen: is this technology well received by low-income Spanish-speaking parents? Technol Health Care. 2012;20(3):195-203. doi: 10.3233/THC-2012-0669.</citation>
    <PMID>22735734</PMID>
  </reference>
  <reference>
    <citation>Thompson DA, Joshi A, Hernandez RG, Bair-Merritt MH, Arora M, Luna R, Ellen JM. Nutrition education via a touchscreen: a randomized controlled trial in Latino immigrant parents of infants and toddlers. Acad Pediatr. 2012 Sep-Oct;12(5):412-9. doi: 10.1016/j.acap.2012.03.020. Epub 2012 Jun 7.</citation>
    <PMID>22682718</PMID>
  </reference>
  <reference>
    <citation>Joshi A, Weng W, Lichenstein R, Arora M, Sears A. Prospective tracking of a pediatric emergency department e-kiosk to deliver asthma education. Health Informatics J. 2009 Dec;15(4):282-95. doi: 10.1177/1460458209345899.</citation>
    <PMID>20007653</PMID>
  </reference>
  <reference>
    <citation>Joshi A, Arora M, Dai L, Price K, Vizer L, Sears A. Usability of a patient education and motivation tool using heuristic evaluation. J Med Internet Res. 2009 Nov 6;11(4):e47. doi: 10.2196/jmir.1244.</citation>
    <PMID>19897458</PMID>
  </reference>
  <reference>
    <citation>Joshi A, Lichenstein R, Rafei K, Bakar A, Arora M. A pilot study to evaluate self initiated computer patient education in children with acute asthma in pediatric emergency department. Technol Health Care. 2007;15(6):433-44.</citation>
    <PMID>18057566</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <results_first_submitted>January 30, 2018</results_first_submitted>
  <results_first_submitted_qc>March 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2019</results_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Jane Meza, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breastfeeding Rural Hispanic Pregnant</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 5, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03308058/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>There were 46 mothers included in the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Computer Based Breast-feeding Education Group</title>
          <description>This group of mothers received the book of breastfeeding modules and electronically the web based breast feeding educational support program</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>This group received the booklet format of the breast feeding educational support program</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Breastfeeding Computer Education</title>
          <description>Breastfeeding Computer education&#xD;
Breastfeeding computer education: Breastfeeding computer education</description>
        </group>
        <group group_id="B2">
          <title>Printed Educational Material</title>
          <description>Printed educational material</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Breastfeeding Assessment</title>
        <description>Questionnaire Breastfeeding duration (Specify time) __________</description>
        <time_frame>0-6 months</time_frame>
        <population>no other primary or secondary measures to report</population>
        <group_list>
          <group group_id="O1">
            <title>Computer Based Breast-feeding Education Group</title>
            <description>This group of mothers received the book of breastfeeding modules and electronically the web based breast feeding educational support program</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>This group received the booklet format of the breast feeding educational support program</description>
          </group>
        </group_list>
        <measure>
          <title>Breastfeeding Assessment</title>
          <description>Questionnaire Breastfeeding duration (Specify time) __________</description>
          <population>no other primary or secondary measures to report</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.2" spread="65.9"/>
                    <measurement group_id="O2" value="120.3" spread="61.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months per participant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Computer Based Breast-feeding Education Group</title>
          <description>This group of mothers received the book of breastfeeding modules and electronically the web based breast feeding educational support program</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>This group received the booklet format of the breast feeding educational support program</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI, who is no longer with UNMC must approve all publications and make the sponsor AHRQ aware of them.&#xD;
This is restrictive since he is now in New York and the study and data were and are in Nebraska.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jane Meza, Interim Associate Vice Chancellor for Global and Student Support</name_or_title>
      <organization>University of Nebraska Medical Center</organization>
      <phone>402-559-6825</phone>
      <email>jmeza@unmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03308058
org study id: 430-12
nct id: NCT03308058
lead sponsor: 
has dmc: Yes
Breastfeeding has many positive and long lasting impacts on the health of infants and
      mothers. The investigators propose to develop a bilingual touch screen computer based
      breastfeeding educational support program to promote breastfeeding among Hispanic rural women
      living in Scottsbluff area of rural Nebraska. An interactive, tailored, touch screen,
      bilingual breastfeeding educational program will be developed to deliver breastfeeding
      education to enhance partial or exclusive breastfeeding. An experimental two-group repeated
      measures design will be utilized. Ninety four prenatal Hispanic rural women aged 15 years and
      above will be enrolled and randomly assigned to either the intervention (computer based
      program, N=47) or attention control (printed educational material, N=47) groups at the
      Regional West Medical Center in Scottsbluff. Information gathered will include
      socio-demographics, familiarity with use of technology and health literacy assessment.
      Process variables measured will include breast-feeding knowledge and breast-feeding
      self-efficacy. Primary and secondary outcomes include breast-feeding duration in binary
      categories (partial or exclusive) and number of sick baby medical visits and months of
      illnesses. All assessments will be done at baseline, days 3 and 7, weeks 2 and 6 and months 3
      and 6 in both the intervention and attention intervention groups. The current proposed study
      may help advance our understanding to use health information technology as a medium to
      disseminate bilingual health education programs in rural settings. This exploratory study
      will lay a foundation for a larger multicenter randomized controlled clinical trial to
      evaluate the impact of computer based educational intervention to promote sustainability of
      breastfeeding among women across diverse settings.
Two separate focus groups one in English and Spanish will be performed with six Hispanic
      rural women with history of previous pregnancy will be enrolled at the Regional West Medical
      Center (RWMC), Scottsbluff, NE. The focus group of 2 hours duration will be performed at the
      antenatal clinic at RWMC during months 2 and 3 of the study. The focus group will help
      examine factors that affect the decision to continue breast-feeding in pregnant Hispanic
      rural women and will guide development of bilingual (English and Spanish) breast-feeding
      educational modules during months 4 and 5 of the study. Dr. Aguirre and Ms. Salazar will be
      responsible for subject recruitment, focus group assessments and would act as a moderator and
      respond to questions and comments during the focus groups. The focus group interviews,
      analysis and development of breast-feeding educational modules in English and Spanish will be
      finalized during the first 5 months of the study. The focus group sessions will be audio
      recorded and stored in a locked cabinet. The sessions recordings will be destroyed at the end
      of the research study.

      Computer-based Breast-Feeding Educational Support Program: The investigators will modify
      existing touch screen, computer based interactive Patient Education and Motivation Tool
      (PEMT) to deliver bilingual, breast-feeding educational support program. The existing PEMT
      platform allows users to dynamically change the educational content either to English or
      Spanish. The modification of the existing PEMT will occur during months 5-7 and will include
      several stages:

      (i) PEMT modification design (ii) Tailoring (iii) Expert Pretesting using Heuristic
      evaluation (iv) Usability and User Testing

      Intervention and Evaluation:

      The subjects will be randomly enrolled using a 1:1 method with every other subject enrolled
      randomized to either the control or intervention group, at RWMC, Scottsbluff. Eligible
      individuals, who will meet the inclusion criteria, will be assigned into either intervention
      (bilingual Computer based Breast-feeding Educational Support program) or attention control
      (bilingual breast-feeding printed educational material) groups using a computer generated
      random id during the subject's prenatal visit (i.e. anytime during last six weeks of their
      pregnancy). Once randomized, baseline information will be gathered in both the groups.

      The difference between the two study groups is that subjects in the intervention (bilingual
      Computer based Breast-feeding Educational Support program) will record their baseline
      assessment on a computer and receive tailored breast-feeding education compared to the
      attention control (bilingual printed breast-feeding educational materials) who will record
      their baseline information on paper and receive printed breast-feeding educational material.
      Using self-reported responses of the individuals in the intervention group (bilingual
      computer based breast-feeding educational support program), the decision logic and algorithm
      will process the information and deliver tailored breast-feeding educational messages in
      varied multimedia formats using a combination of text, images, and animations to account for
      the literacy levels of the subjects.

      Appropriate feedback will be given in the form of reinforced educational messages and
      encouragement and motivational prompts for those using the computer based program.
      Educational session in both the groups will last for 30 minutes. The first educational
      session will be performed during the postpartum period, one day before the discharge from the
      hospital followed by week 6, months 3 and 6. Specific individualized interventions,
      especially during the initial critical 2-6 week period, are needed to prevent deterioration
      in intention levels for breast-feeding for 6 months and breast-feeding self-efficacy levels
      within the first 2 weeks postpartum which could lead to the decision to discontinue
      breast-feeding. Subjects in both the groups will be given telephone reminders for follow up
      educational sessions. The touch screen computer based Breast-feeding Educational Support
      program will be placed on a mobile cart in the outpatient clinic of the RWMC, Scottsbluff for
      the duration of the study and will be collected after the completion of the research.

      There will be no repercussions to subjects since the touch screen computers will be placed at
      the RWMC and will be used by the subjects enrolled in the study at this site. A web based
      version will also be available for an ongoing support to subjects in the intervention group.
      A research assistant will be available to guide the subjects in both the intervention (during
      the use of the tablet pc program) and the control groups (printed educational material) if
      needed. The breast-feeding educational modules and data collection instruments will be both
      in English and Spanish.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Breastfeeding Assessment
time frame: 0-6 months
description: Questionnaire Breastfeeding duration (Specify time) __________
arm group label: Breastfeeding Computer education
arm group type: Experimental
description: Breastfeeding Computer education
arm group label: Printed Educational material
arm group type: No Intervention
description: Printed educational material
intervention type: Behavioral
intervention name: Breastfeeding computer education
description: Breastfeeding computer education
arm group label: Breastfeeding Computer education
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 35 Years
healthy volunteers: No
last name: Susan Wilhelm, PhD
role: Study Chair
affiliation: University of Nebraska
facility: 
country: United States
citation: Thompson DA, Joshi A, Hernandez RG, Jennings JM, Arora M, Ellen JM. Interactive nutrition education via a touchscreen: is this technology well received by low-income Spanish-speaking parents? Technol Health Care. 2012;20(3):195-203. doi: 10.3233/THC-2012-0669.
PMID: 22735734
citation: Thompson DA, Joshi A, Hernandez RG, Bair-Merritt MH, Arora M, Luna R, Ellen JM. Nutrition education via a touchscreen: a randomized controlled trial in Latino immigrant parents of infants and toddlers. Acad Pediatr. 2012 Sep-Oct;12(5):412-9. doi: 10.1016/j.acap.2012.03.020. Epub 2012 Jun 7.
PMID: 22682718
citation: Joshi A, Weng W, Lichenstein R, Arora M, Sears A. Prospective tracking of a pediatric emergency department e-kiosk to deliver asthma education. Health Informatics J. 2009 Dec;15(4):282-95. doi: 10.1177/1460458209345899.
PMID: 20007653
citation: Joshi A, Arora M, Dai L, Price K, Vizer L, Sears A. Usability of a patient education and motivation tool using heuristic evaluation. J Med Internet Res. 2009 Nov 6;11(4):e47. doi: 10.2196/jmir.1244.
PMID: 19897458
citation: Joshi A, Lichenstein R, Rafei K, Bakar A, Arora M. A pilot study to evaluate self initiated computer patient education in children with acute asthma in pediatric emergency department. Technol Health Care. 2007;15(6):433-44.
PMID: 18057566
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Jane Meza, PhD
investigator title: Principal Investigator
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 