<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/NCT02989766</url>
  </required_header>
  <id_info>
    <org_study_id>25115</org_study_id>
    <nct_id>NCT02989766</nct_id>
  </id_info>
  <brief_title>A Self-Guided Breastfeeding Program</brief_title>
  <official_title>Preparing Mothers for Feeding Their Newborns: A Self-Guided Program for Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This intervention would be a series of self-help-style educational and motivational activity&#xD;
      sheets for patients to complete independently. This will be a randomized clinical control&#xD;
      trial.&#xD;
&#xD;
      Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects&#xD;
      in the intervention arm will complete 3 activity sheets prenatally during their wait time at&#xD;
      the clinic. The first worksheet can be completed the day of recruitment after consent is&#xD;
      signed.&#xD;
&#xD;
      Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration&#xD;
      of breast feeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the benefits of human milk become evident, the investigators are striving to improve the&#xD;
      breastfeeding (BF) rate among new mothers. In April and May of 2014, 73 (71%) of well babies&#xD;
      received human milk at discharge from our postpartum unit, with 40 (35%) and receiving human&#xD;
      milk exclusively. In the neonatal intensive care unit, 83 (89%) received human milk during&#xD;
      those months.&#xD;
&#xD;
      Many of the patients at the teaching institution share risk factors for failure to BF,&#xD;
      including poverty, obesity, unplanned pregnancy and being African American. Efforts have had&#xD;
      limited effect in improving initiation and duration among these patients.&#xD;
&#xD;
      Studies examining the efficacy of various modalities of antenatal education produced modest&#xD;
      results in improving initiation and duration of BF. Several studies examined group BF&#xD;
      education versus routine prenatal care without significant differences in initiation,&#xD;
      exclusivity (the practice of using human milk exclusively and not supplementing with formula)&#xD;
      or duration. Conversely, other study showed a difference in initiation with group education&#xD;
      and showed a difference in exclusivity. Formalized education compared to routine clinical&#xD;
      practice education did not result in a difference in exclusivity in several studies and&#xD;
      neither did a program that included a video showed a difference in initiation with formal&#xD;
      education.&#xD;
&#xD;
      A few studies compared peer counseling to routine prenatal care. One small study of 59 women&#xD;
      found an increase in initiation rate, while a larger study of 2511 women did not find a&#xD;
      difference in initiation or duration.&#xD;
&#xD;
      Other studies found no significant difference in initiation, duration or exclusivity with an&#xD;
      educational program on practical BF skills nor a program on BF attitudes. A small study that&#xD;
      paired BF education with material incentives increased exclusivity. Three studies comparing&#xD;
      interventions by lactation consultants found no difference in initiation or duration,&#xD;
      although one study showed improvement in exclusivity. Postpartum BF self-efficacy correlates&#xD;
      with BF duration and two studies showed improvement in exclusivity with a BF class based on&#xD;
      principles of self-efficacy. These studies based their intervention on Bandura's theory of&#xD;
      self-efficacy, which proposes that an individual's expectation of personal efficacy will&#xD;
      determine her initiation of coping behavior, effort expenditure and duration of persistence.&#xD;
      This theory recognizes four components that contribute to an individual's sense of self-&#xD;
      efficacy, and these include performance accomplishment, vicarious, or social, experience,&#xD;
      verbal persuasion and psychological state. developed a validated scale at measuring prenatal&#xD;
      maternal self-efficacy in breastfeeding.&#xD;
&#xD;
      These two studies used a teaching approach that assumes that pregnant women are adults who&#xD;
      are self-motivated and have past experience that shapes their learning and are a component to&#xD;
      their perception of self-efficacy.&#xD;
&#xD;
      Printed self-help materials are appealing as a low cost intervention that could be widely&#xD;
      implemented. Furthermore, a large study among pregnant women showed that a self-help guide&#xD;
      that is particularly tailored towards pregnant women could be effective in promoting another&#xD;
      healthy behavior modification: smoking cessation. Potentially this method could be effective&#xD;
      when used to prepare mothers for breastfeeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2015</start_date>
  <completion_date type="Actual">July 27, 2017</completion_date>
  <primary_completion_date type="Actual">July 27, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improving duration of BF.</measure>
    <time_frame>16 Months</time_frame>
    <description>It was propose using a 3-part prenatal self-help guide to educate and prepare mothers for breastfeeding.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">335</enrollment>
  <condition>Breastfeeding</condition>
  <arm_group>
    <arm_group_label>A - Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Education on Breast Feeding 3 activity sheets prenatally-study related. Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education on Breast Feeding</intervention_name>
    <description>Subjects in the intervention arm will complete 3 activity sheets prenatally-study related.</description>
    <arm_group_label>A - Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 32 weeks gestation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who have not had an ultrasound confirming viable intrauterine pregnancy.&#xD;
&#xD;
          -  Patients beyond 32 weeks gestation will be excluded as some are unlikely to return for&#xD;
             a sufficient number of prenatal visits to complete the intervention.&#xD;
&#xD;
          -  Patients with medical contraindications to breastfeeding such as HIV or active&#xD;
             substance abuse.&#xD;
&#xD;
          -  Patients planning to take medications in the postpartum period that are incompatible&#xD;
             with breastfeeding such as anti-metabolites.&#xD;
&#xD;
          -  Patients giving birth to a nonviable infant.&#xD;
&#xD;
          -  Patients without adequate reading and writing skills to complete the questionnaires&#xD;
             and activity sheets.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaye Shyken, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>November 17, 2017</last_update_submitted>
  <last_update_submitted_qc>November 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Jaye Shyken, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02989766
org study id: 25115
nct id: NCT02989766
lead sponsor: 
has dmc: No
This intervention would be a series of self-help-style educational and motivational activity
      sheets for patients to complete independently. This will be a randomized clinical control
      trial.

      Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects
      in the intervention arm will complete 3 activity sheets prenatally during their wait time at
      the clinic. The first worksheet can be completed the day of recruitment after consent is
      signed.

      Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration
      of breast feeding.
As the benefits of human milk become evident, the investigators are striving to improve the
      breastfeeding (BF) rate among new mothers. In April and May of 2014, 73 (71%) of well babies
      received human milk at discharge from our postpartum unit, with 40 (35%) and receiving human
      milk exclusively. In the neonatal intensive care unit, 83 (89%) received human milk during
      those months.

      Many of the patients at the teaching institution share risk factors for failure to BF,
      including poverty, obesity, unplanned pregnancy and being African American. Efforts have had
      limited effect in improving initiation and duration among these patients.

      Studies examining the efficacy of various modalities of antenatal education produced modest
      results in improving initiation and duration of BF. Several studies examined group BF
      education versus routine prenatal care without significant differences in initiation,
      exclusivity (the practice of using human milk exclusively and not supplementing with formula)
      or duration. Conversely, other study showed a difference in initiation with group education
      and showed a difference in exclusivity. Formalized education compared to routine clinical
      practice education did not result in a difference in exclusivity in several studies and
      neither did a program that included a video showed a difference in initiation with formal
      education.

      A few studies compared peer counseling to routine prenatal care. One small study of 59 women
      found an increase in initiation rate, while a larger study of 2511 women did not find a
      difference in initiation or duration.

      Other studies found no significant difference in initiation, duration or exclusivity with an
      educational program on practical BF skills nor a program on BF attitudes. A small study that
      paired BF education with material incentives increased exclusivity. Three studies comparing
      interventions by lactation consultants found no difference in initiation or duration,
      although one study showed improvement in exclusivity. Postpartum BF self-efficacy correlates
      with BF duration and two studies showed improvement in exclusivity with a BF class based on
      principles of self-efficacy. These studies based their intervention on Bandura's theory of
      self-efficacy, which proposes that an individual's expectation of personal efficacy will
      determine her initiation of coping behavior, effort expenditure and duration of persistence.
      This theory recognizes four components that contribute to an individual's sense of self-
      efficacy, and these include performance accomplishment, vicarious, or social, experience,
      verbal persuasion and psychological state. developed a validated scale at measuring prenatal
      maternal self-efficacy in breastfeeding.

      These two studies used a teaching approach that assumes that pregnant women are adults who
      are self-motivated and have past experience that shapes their learning and are a component to
      their perception of self-efficacy.

      Printed self-help materials are appealing as a low cost intervention that could be widely
      implemented. Furthermore, a large study among pregnant women showed that a self-help guide
      that is particularly tailored towards pregnant women could be effective in promoting another
      healthy behavior modification: smoking cessation. Potentially this method could be effective
      when used to prepare mothers for breastfeeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: improving duration of BF.
time frame: 16 Months
description: It was propose using a 3-part prenatal self-help guide to educate and prepare mothers for breastfeeding.
arm group label: A - Intervention
arm group type: Active Comparator
description: Education on Breast Feeding 3 activity sheets prenatally-study related. Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire
arm group label: B - Standard of Care
arm group type: No Intervention
description: Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire
intervention type: Behavioral
intervention name: Education on Breast Feeding
description: Subjects in the intervention arm will complete 3 activity sheets prenatally-study related.
arm group label: A - Intervention
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jaye Shyken, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Jaye Shyken, MD
investigator title: MD
sharing ipd: No