<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/NCT03807726</url>
  </required_header>
  <id_info>
    <org_study_id>N201701060</org_study_id>
    <nct_id>NCT03807726</nct_id>
  </id_info>
  <brief_title>Empower Breastfeeding Education Program</brief_title>
  <official_title>Empower Breastfeeding: Effects of an Integrated Breastfeeding Education Program on Optimal Breastfeeding Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</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>
      This study results of integrated breastfeeding education program (IBEP) will guide in&#xD;
      designing a theory-based breastfeeding educational module on promotion of optimal&#xD;
      breastfeeding practice in new mother and her partner. The current novel education curriculum&#xD;
      incorporated breastfeeding simulation, mindfulness training, and professional support will&#xD;
      provide important information in supporting use of IBEP in enhancing participants&#xD;
      self-efficacy. This study will show on how simulation teaching and mindfulness training can&#xD;
      be utilized in the field of perinatal teaching to achieve better health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To achieve optimal breastfeeding practice, the development of an integrated breastfeeding&#xD;
      education program (IBEP) which incorporates simulation education, mindfulness training,&#xD;
      professional support targeting the self-efficacy of participants is of vital importance. A&#xD;
      randomized controlled trial of an integrated breastfeeding education program focusing on&#xD;
      participants will be designed with two study objectives: 1) to evaluate the effects of IBEP&#xD;
      on the primary outcome measures of breastfeeding practice as following: a) early initiation&#xD;
      of breastfeeding, b) exclusive breastfeeding rate, c) predominate breastfeeding rate; 2) to&#xD;
      examine the effects of IBEP on the secondary outcome measures, psychosocial correlates of&#xD;
      exclusive breastfeeding including a) breastfeeding self-efficacy, b)anxiety, c) depression,&#xD;
      d) mindful awareness e) infant feeding attitude. These objectives will be examined among&#xD;
      participants in six time periods: a) during pregnancy 24 to 32 weeks education program b) 34&#xD;
      to 40 weeks of pregnancy (after class or third trimester), c)1 week, d) 4weeks, d) 3 months,&#xD;
      e) 6 months postpartum, while the indicators of breastfeeding practice will be examined at&#xD;
      the four periods following delivery.&#xD;
&#xD;
      It is hypothesized that 1) the intervention will result in a better effect on all primary&#xD;
      outcome measures, as compared to those in the control group. Specifically, participants in&#xD;
      IBEP group will show 10 % or greater difference in exclusive breastfeeding rates at six&#xD;
      months than participants in the control group, 2) participants in the IBEP group will&#xD;
      demonstrate larger effects on breastfeeding self-efficacy and mindfulness, and lower anxiety&#xD;
      and depression than those in the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">May 18, 2019</completion_date>
  <primary_completion_date type="Actual">May 18, 2019</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>
    <intervention_model_description>A single-blind randomized controlled trial with a two-arm design will be conducted among new mothers and their partners. The objectives are to determine whether an integrated breastfeeding education program based on breastfeeding self-efficacy theory [28, 31] will increase exclusive breastfeeding duration among women and psychological correlates of exclusive breastfeeding. This is a novel educational intervention incorporated simulation-based courses, mindfulness training, and professional support for targeting mother and her partner's self-efficacy enhancement.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Eligible participants will be randomly assigned to either intervention group or control group. A permuted block randomization method will be used to ensure equal number of subjects in each group. A block size of 4 including 6 different combinations, i.e., AABB, ABAB, ABBA, BBAA, BABA, and BAAB will be adopted. The sequence of block number will be generated randomly by the computer and then apply to the first four subjects and so on. The allocation concealment will be maintained by using opaque sealed envelopes containing the sequence number and will be prepared by the researcher who is not involved in participants' recruitment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Breastfeeding self-efficacy</measure>
    <time_frame>Change from Baseline Breastfeeding self-efficacy at 6 months.</time_frame>
    <description>The Taiwanese version of the Breastfeeding Self-Efficacy Scale -Short form (BSES-SF) will be used to measure new mothers and father's breastfeeding self-efficacy. The mother breastfeeding self-efficacy was referred as a mother's confidence in her ability to breastfeed her infant, while the paternal breastfeeding self-efficacy was measured the father's confidence in his ability to support mothers' breastfeeding. The fathers version has been used previously. The BSES was originally developed by Dennis and Faux (1999) and has been translated into Chinese. It is a 14-item self-reported questionnaire with a 5-point scale that ranges from 1 to 5, with a total score ranging 5~70. A higher score represents a higher level of self-efficacy.The primary outcomes for this trial are commonly used breastfeeding indicators</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding rates</measure>
    <time_frame>Change from Baseline Exclusive breastfeeding rates at 6 months.</time_frame>
    <description>The primary outcomes for this trial are commonly used breastfeeding indicators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>Change from Baseline Anxiety symptoms at 6 months.</time_frame>
    <description>Anxiety symptoms of mother and her partner will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI). The 20 item questionnaire contains a 4-point likert scale of 1 (not at all) to 4 (very much so), with an overall score ranging 20-80. A higher score indicates higher anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Change from Baseline Depressive symptoms at 6 months.</time_frame>
    <description>The Taiwanese version of the Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms among new mother and father. EPDS has been used and tested in father participants with good validity. It is a 10-item self-reported questionnaire with a 4-point scale that ranges from 0 (&quot;no&quot;) to 3 (&quot;most of the time&quot;), with a total score ranging 0~30. A higher score represents a higher level of depression. The suggested cutoff of 12/13 was used to detect probable cases of clinical depression, with a respective sensitivity and specificity of 83% and 89%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful awareness</measure>
    <time_frame>Change from Baseline Mindful awareness at 6 months.</time_frame>
    <description>The Five Facet Mindfulness Questionnaire at baseline, 1, 3 and 6 months The Taiwanese version of the Five Facet Mindfulness Questionnaire (FFMQ) will be adopted to assess new mothers' and partners mindfulness. The FFMQ has been translated into Chinese. It is a 39-item self-reported questionnaire with a 5-point scale that ranges from 1 (almost not) to 5 (almost always). A higher score represents a higher level of mindfulness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Breastfeeding</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both standard usual care and the integrated breastfeeding education program (IBEP) will be provided to the participants in the intervention group. The integrated interventions are consisted of 1) four sessions of simulation breastfeeding education to build up the participants' performance accomplishment and vicarious learning including breastfeeding knowledge, skill, and self-efficacy; 2) two sessions of breastfeeding mindfulness training to equip women and their partners with stress reduction skills for their emotional arousal during breastfeeding; 3) a series of postpartum professional support to offer verbal persuasion in enhancing their breastfeeding skills and levels of self-efficacy. The details of each education components are presented at the following section.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The mother and her partner in the control group will receive the standard usual care provided at the study site. The study site hospital where follows the 10 steps of the Baby Friendly Hospital Initiative will provide breastfeeding care during prenatal check-up and postpartum care. The standard care protocols encompass elements such as prenatal breastfeeding consultation using breastfeeding pamphlets, and postpartum care like skin to skin contact, rooming- in, and breastfeeding consultation using pamphlets. The pregnant women need to register for childbirth class which contains only one breastfeeding class by themselves if needed. After delivery, the mothers are taught on breastfeeding knowledge and skills by the nurses at the postpartum ward or nursey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Simulation breastfeeding education</intervention_name>
    <description>The integrated interventions are consisted of 1) four sessions of simulation breastfeeding education to build up the participants' performance accomplishment and vicarious learning including breastfeeding knowledge, skill, and self-efficacy; 2) two sessions of breastfeeding mindfulness training to equip women and their partners with stress reduction skills for their emotional arousal during breastfeeding; 3) a series of postpartum professional support to offer verbal persuasion in enhancing their breastfeeding skills and levels of self-efficacy.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Breastfeeding mindfulness training</other_name>
    <other_name>Postpartum professional and partner support</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aged 20 years and above. During the first or second trimester of pregnancy. Willing to&#xD;
        breastfeed after delivery Singleton pregnancy. Participants are able to attend the&#xD;
        breastfeeding class.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Chronic medical conditions. Abnormal fetal screening. Preterm delivery before 37 weeks&#xD;
        gestational weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu-Yu Kuo, Doctoral</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University, Taiwan, R.O.C.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Medical University, Taiwan, R.O.C.</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breastfeeding, self-efficacy, education, intervention</keyword>
  <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/NCT03807726
org study id: N201701060
nct id: NCT03807726
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study results of integrated breastfeeding education program (IBEP) will guide in
      designing a theory-based breastfeeding educational module on promotion of optimal
      breastfeeding practice in new mother and her partner. The current novel education curriculum
      incorporated breastfeeding simulation, mindfulness training, and professional support will
      provide important information in supporting use of IBEP in enhancing participants
      self-efficacy. This study will show on how simulation teaching and mindfulness training can
      be utilized in the field of perinatal teaching to achieve better health outcomes.
To achieve optimal breastfeeding practice, the development of an integrated breastfeeding
      education program (IBEP) which incorporates simulation education, mindfulness training,
      professional support targeting the self-efficacy of participants is of vital importance. A
      randomized controlled trial of an integrated breastfeeding education program focusing on
      participants will be designed with two study objectives: 1) to evaluate the effects of IBEP
      on the primary outcome measures of breastfeeding practice as following: a) early initiation
      of breastfeeding, b) exclusive breastfeeding rate, c) predominate breastfeeding rate; 2) to
      examine the effects of IBEP on the secondary outcome measures, psychosocial correlates of
      exclusive breastfeeding including a) breastfeeding self-efficacy, b)anxiety, c) depression,
      d) mindful awareness e) infant feeding attitude. These objectives will be examined among
      participants in six time periods: a) during pregnancy 24 to 32 weeks education program b) 34
      to 40 weeks of pregnancy (after class or third trimester), c)1 week, d) 4weeks, d) 3 months,
      e) 6 months postpartum, while the indicators of breastfeeding practice will be examined at
      the four periods following delivery.

      It is hypothesized that 1) the intervention will result in a better effect on all primary
      outcome measures, as compared to those in the control group. Specifically, participants in
      IBEP group will show 10 % or greater difference in exclusive breastfeeding rates at six
      months than participants in the control group, 2) participants in the IBEP group will
      demonstrate larger effects on breastfeeding self-efficacy and mindfulness, and lower anxiety
      and depression than those in the control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A single-blind randomized controlled trial with a two-arm design will be conducted among new mothers and their partners. The objectives are to determine whether an integrated breastfeeding education program based on breastfeeding self-efficacy theory [28, 31] will increase exclusive breastfeeding duration among women and psychological correlates of exclusive breastfeeding. This is a novel educational intervention incorporated simulation-based courses, mindfulness training, and professional support for targeting mother and her partner's self-efficacy enhancement.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Eligible participants will be randomly assigned to either intervention group or control group. A permuted block randomization method will be used to ensure equal number of subjects in each group. A block size of 4 including 6 different combinations, i.e., AABB, ABAB, ABBA, BBAA, BABA, and BAAB will be adopted. The sequence of block number will be generated randomly by the computer and then apply to the first four subjects and so on. The allocation concealment will be maintained by using opaque sealed envelopes containing the sequence number and will be prepared by the researcher who is not involved in participants' recruitment.
measure: Breastfeeding self-efficacy
time frame: Change from Baseline Breastfeeding self-efficacy at 6 months.
description: The Taiwanese version of the Breastfeeding Self-Efficacy Scale -Short form (BSES-SF) will be used to measure new mothers and father's breastfeeding self-efficacy. The mother breastfeeding self-efficacy was referred as a mother's confidence in her ability to breastfeed her infant, while the paternal breastfeeding self-efficacy was measured the father's confidence in his ability to support mothers' breastfeeding. The fathers version has been used previously. The BSES was originally developed by Dennis and Faux (1999) and has been translated into Chinese. It is a 14-item self-reported questionnaire with a 5-point scale that ranges from 1 to 5, with a total score ranging 5~70. A higher score represents a higher level of self-efficacy.The primary outcomes for this trial are commonly used breastfeeding indicators
measure: Exclusive breastfeeding rates
time frame: Change from Baseline Exclusive breastfeeding rates at 6 months.
description: The primary outcomes for this trial are commonly used breastfeeding indicators
measure: Anxiety symptoms
time frame: Change from Baseline Anxiety symptoms at 6 months.
description: Anxiety symptoms of mother and her partner will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI). The 20 item questionnaire contains a 4-point likert scale of 1 (not at all) to 4 (very much so), with an overall score ranging 20-80. A higher score indicates higher anxiety.
measure: Depressive symptoms
time frame: Change from Baseline Depressive symptoms at 6 months.
description: The Taiwanese version of the Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms among new mother and father. EPDS has been used and tested in father participants with good validity. It is a 10-item self-reported questionnaire with a 4-point scale that ranges from 0 ("no") to 3 ("most of the time"), with a total score ranging 0~30. A higher score represents a higher level of depression. The suggested cutoff of 12/13 was used to detect probable cases of clinical depression, with a respective sensitivity and specificity of 83% and 89%.
measure: Mindful awareness
time frame: Change from Baseline Mindful awareness at 6 months.
description: The Five Facet Mindfulness Questionnaire at baseline, 1, 3 and 6 months The Taiwanese version of the Five Facet Mindfulness Questionnaire (FFMQ) will be adopted to assess new mothers' and partners mindfulness. The FFMQ has been translated into Chinese. It is a 39-item self-reported questionnaire with a 5-point scale that ranges from 1 (almost not) to 5 (almost always). A higher score represents a higher level of mindfulness.
arm group label: Intervention Group
arm group type: Experimental
description: Both standard usual care and the integrated breastfeeding education program (IBEP) will be provided to the participants in the intervention group. The integrated interventions are consisted of 1) four sessions of simulation breastfeeding education to build up the participants' performance accomplishment and vicarious learning including breastfeeding knowledge, skill, and self-efficacy; 2) two sessions of breastfeeding mindfulness training to equip women and their partners with stress reduction skills for their emotional arousal during breastfeeding; 3) a series of postpartum professional support to offer verbal persuasion in enhancing their breastfeeding skills and levels of self-efficacy. The details of each education components are presented at the following section.
arm group label: Control Group
arm group type: No Intervention
description: The mother and her partner in the control group will receive the standard usual care provided at the study site. The study site hospital where follows the 10 steps of the Baby Friendly Hospital Initiative will provide breastfeeding care during prenatal check-up and postpartum care. The standard care protocols encompass elements such as prenatal breastfeeding consultation using breastfeeding pamphlets, and postpartum care like skin to skin contact, rooming- in, and breastfeeding consultation using pamphlets. The pregnant women need to register for childbirth class which contains only one breastfeeding class by themselves if needed. After delivery, the mothers are taught on breastfeeding knowledge and skills by the nurses at the postpartum ward or nursey.
intervention type: Behavioral
intervention name: Simulation breastfeeding education
description: The integrated interventions are consisted of 1) four sessions of simulation breastfeeding education to build up the participants' performance accomplishment and vicarious learning including breastfeeding knowledge, skill, and self-efficacy; 2) two sessions of breastfeeding mindfulness training to equip women and their partners with stress reduction skills for their emotional arousal during breastfeeding; 3) a series of postpartum professional support to offer verbal persuasion in enhancing their breastfeeding skills and levels of self-efficacy.
arm group label: Intervention Group
other name: Breastfeeding mindfulness training
other name: Postpartum professional and partner support
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shu-Yu Kuo, Doctoral
role: Principal Investigator
affiliation: Taipei Medical University, Taiwan, R.O.C.
facility: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: No