<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/NCT03019484</url>
  </required_header>
  <id_info>
    <org_study_id>NUR-SIALAC</org_study_id>
    <nct_id>NCT03019484</nct_id>
  </id_info>
  <brief_title>Synergy, Self-efficacy, Breastfeeding and Care (SInergia, Autoeficacia, Lactancia y Cuidados)</brief_title>
  <acronym>SIALAC</acronym>
  <official_title>A Complex Intervention to Promote Breastfeeding Self-efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Complejo Hospitalario de Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Pública de Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy&#xD;
      promotion intervention. More specifically our objectives were to: explore changes in&#xD;
      self-efficacy following the intervention; explore changes in the initiation and maintenance&#xD;
      of breastfeeding following the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breastfeeding is the optimal choice for feeding infants in order to ensure a healthy growth&#xD;
      and development. Although breastfeeding has many benefits for the infant and the mother,&#xD;
      breastfeeding rates drop drastically during the first three months after birth. There is a&#xD;
      number of factors that influence the initiation and maintenance of breastfeeding. One of the&#xD;
      key factors is maternal self-efficacy in relation to breastfeeding. The aim of the study was&#xD;
      the development and evaluation of an intervention to enhance maternal perceived self-efficacy&#xD;
      in order to contribute positively to the initiation and maintenance of breastfeeding. This&#xD;
      was done by using a complex intervention approach (MRC framework) to design and assess a&#xD;
      multi-center controlled trial, involving midwives and nurses working at the Complejo&#xD;
      Hospitalario de Navarra (CHN) of the Servicio Navarro de Salud and at the Clínica Universidad&#xD;
      de Navarra (CUN). These health professionals were trained to deliver the intervention. The&#xD;
      intervention was focused on self-efficacy related aspects and took place at three instances&#xD;
      with every mother: in the final stage of pregnancy, during the maternal hospital stay after&#xD;
      giving birth, and in the first days after discharge. The participants in the control group&#xD;
      received the standard care as provided in each health institution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes on Breastfeeding status reported by mothers</measure>
    <time_frame>at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth</time_frame>
    <description>The mothers reported whether they were breastfeeding or not.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes on maternal breastfeeding self-efficacy measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire</measure>
    <time_frame>at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth</time_frame>
    <description>The mothers completed the questionnaire in person in T1 and by phone in T2, T3 and T4</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Breast Feeding</condition>
  <condition>Self Efficacy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention consisted on breastfeeding support at three stages: a) week 28-39 pregnancy: women were provided with written information and watch a breastfeeding self-efficacy enhancing video; b) during hospitalization after birth: based on their responses to the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire and the observation of a whole breastfeed, nurses provided specific advice using active listening. All the relevant information was registered; c) within one week after birth: a nurse or midwife made a phone call to follow-up mothers breastfeeding behaviour, addressing issues that during the hospitalization needed reinforcement, solving any question or matter that they had and providing positive reinforcement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group received standard antenatal and postnatal care by midwives and nurses caring for them during their regular antenatal visits and after delivery.&#xD;
The professionals delivering the intervention were the same than those providing the standard care. That was the reason to first collect the data from the control group and after that organising the training of health professionals to deliver de intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breastfeeding support</intervention_name>
    <description>Self-efficacy</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>SIALAC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intention to breastfeed and no contraindication to do so&#xD;
&#xD;
          -  Speak Spanish&#xD;
&#xD;
          -  Give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwillingness to breastfeed&#xD;
&#xD;
          -  Preterm birth (at &lt;37 weeks gestation)&#xD;
&#xD;
          -  Breastfeeding contraindication (galactosemia)&#xD;
&#xD;
          -  Breastfeeding-related especial situations (multiple birth; newborn weight &lt;2000g;&#xD;
             leporine lip; newborn in intensive care unit)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Antoñanzas, MSc,BSc,RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Complejo Hospitalario de Navarra</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olga Lopez-Dicastilo, PhD,MSc,BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Departamento de Ciencias de la Salud. Universidad Pública de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Facultad de Enfermería. Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Navarra</investigator_affiliation>
    <investigator_full_name>Olga López-Dicastillo</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Self-efficacy</keyword>
  <keyword>Self Efficacy</keyword>
  <keyword>Nurses's Role</keyword>
  <keyword>Professional Role</keyword>
  <keyword>Clinical Trial</keyword>
  <keyword>Breast Feeding</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/NCT03019484
org study id: NUR-SIALAC
nct id: NCT03019484
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy
      promotion intervention. More specifically our objectives were to: explore changes in
      self-efficacy following the intervention; explore changes in the initiation and maintenance
      of breastfeeding following the intervention.
Breastfeeding is the optimal choice for feeding infants in order to ensure a healthy growth
      and development. Although breastfeeding has many benefits for the infant and the mother,
      breastfeeding rates drop drastically during the first three months after birth. There is a
      number of factors that influence the initiation and maintenance of breastfeeding. One of the
      key factors is maternal self-efficacy in relation to breastfeeding. The aim of the study was
      the development and evaluation of an intervention to enhance maternal perceived self-efficacy
      in order to contribute positively to the initiation and maintenance of breastfeeding. This
      was done by using a complex intervention approach (MRC framework) to design and assess a
      multi-center controlled trial, involving midwives and nurses working at the Complejo
      Hospitalario de Navarra (CHN) of the Servicio Navarro de Salud and at the Clínica Universidad
      de Navarra (CUN). These health professionals were trained to deliver the intervention. The
      intervention was focused on self-efficacy related aspects and took place at three instances
      with every mother: in the final stage of pregnancy, during the maternal hospital stay after
      giving birth, and in the first days after discharge. The participants in the control group
      received the standard care as provided in each health institution.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Changes on Breastfeeding status reported by mothers
time frame: at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth
description: The mothers reported whether they were breastfeeding or not.
measure: Changes on maternal breastfeeding self-efficacy measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire
time frame: at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth
description: The mothers completed the questionnaire in person in T1 and by phone in T2, T3 and T4
arm group label: Intervention
arm group type: Experimental
description: The intervention consisted on breastfeeding support at three stages: a) week 28-39 pregnancy: women were provided with written information and watch a breastfeeding self-efficacy enhancing video; b) during hospitalization after birth: based on their responses to the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire and the observation of a whole breastfeed, nurses provided specific advice using active listening. All the relevant information was registered; c) within one week after birth: a nurse or midwife made a phone call to follow-up mothers breastfeeding behaviour, addressing issues that during the hospitalization needed reinforcement, solving any question or matter that they had and providing positive reinforcement.
arm group label: Control: Standard Care
arm group type: No Intervention
description: This group received standard antenatal and postnatal care by midwives and nurses caring for them during their regular antenatal visits and after delivery.
The professionals delivering the intervention were the same than those providing the standard care. That was the reason to first collect the data from the control group and after that organising the training of health professionals to deliver de intervention.
intervention type: Behavioral
intervention name: Breastfeeding support
description: Self-efficacy
arm group label: Intervention
other name: SIALAC
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elena Antoñanzas, MSc,BSc,RN
role: Principal Investigator
affiliation: Complejo Hospitalario de Navarra
last name: Olga Lopez-Dicastilo, PhD,MSc,BSc
role: Principal Investigator
affiliation: University of Navarra
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Navarra
investigator full name: Olga López-Dicastillo
investigator title: PhD
sharing ipd: No