<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/NCT02186613</url>
  </required_header>
  <id_info>
    <org_study_id>4R14/015</org_study_id>
    <nct_id>NCT02186613</nct_id>
  </id_info>
  <brief_title>Telephone Support From Primary Care for Breastfeeding Mothers</brief_title>
  <official_title>Telephone Support From Primary Care to Breastfeeding Mothers: A Randomized and Multicenter Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Preventive Services and Health Promotion Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a telephone-based support to breastfeeding women with healthy&#xD;
      newborns to improve breastfeeding outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The World Health Organization recommends exclusive breastfeeding to infants until 6 months of&#xD;
      age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at&#xD;
      6 months is only 24.7 in Spain. The investigators believe it is important to increase the&#xD;
      proportion of breastfeeding mothers in their population. Therefore, the investigators have&#xD;
      developed a telephonic support protocol for mothers. The intervention will be performed by&#xD;
      pediatric nurses in Primary Care.&#xD;
&#xD;
      The main aim of this study is to evaluate in a randomized controlled trial the effectiveness&#xD;
      of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to&#xD;
      evaluate the effectiveness of the telephonic support in any breastfeeding.&#xD;
&#xD;
      The investigators hypothesis is that this intervention will increase exclusive breastfeeding&#xD;
      and any breastfeeding rates.&#xD;
&#xD;
      The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants&#xD;
      will include breastfeeding women who have full-term healthy infants. Mothers will be&#xD;
      recruited upon their first arrival to Primary Care from hospital. Eligible mothers who&#xD;
      consent to participate will be randomized into either the intervention group or the control&#xD;
      group. The latter will receive standard postpartum care. The former will receive standard&#xD;
      postpartum care, plus a weekly telephone call during the first two months and every 2 weeks&#xD;
      thereafter between the second and the sixth month. The pediatric nurse responsible for&#xD;
      monitoring the standard care of each and every patient will be the one responsible for&#xD;
      contacting them via telephone. Therefore, the study is not blinded.&#xD;
&#xD;
      The evolution of exclusive breastfeeding will be compared to artificial or supplemented&#xD;
      feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented&#xD;
      with formula will also be valued. Classification into breastfeeding categories is based on&#xD;
      24-hour dietary recall.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</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>Rate of exclusive breastfeeding</measure>
    <time_frame>6 months</time_frame>
    <description>Exclusive breastfeeding at 6 months. (time frame: 6 months)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of exclusive breastfeeding</measure>
    <time_frame>4 months</time_frame>
    <description>Exclusive Breastfeeding at 4 months. (time frame: 4 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of exclusive breastfeeding</measure>
    <time_frame>2 months</time_frame>
    <description>Exclusive breastfeeding at 2 months. (time frame: 2 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of exclusive breastfeeding</measure>
    <time_frame>1 month</time_frame>
    <description>Exclusive breastfeeding at 1 month. (time frame: 1 month)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of non exclusive breastfeeding</measure>
    <time_frame>6 months</time_frame>
    <description>Breastfeeding (non exclusive) at 6 months. (time frame: 6 months)</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of non exclusive breastfeeding</measure>
    <time_frame>4 months</time_frame>
    <description>Breastfeeding (non exclusive) at 4 months. (time frame: 4 months)</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of non exclusive breastfeeding</measure>
    <time_frame>2 months</time_frame>
    <description>Breastfeeding (non exclusive) at 2 months. (time frame: 2 months)</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of non exclusive breastfeeding</measure>
    <time_frame>1 month</time_frame>
    <description>Breastfeeding (non exclusive) at 1 month. (time frame: 1 month)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">434</enrollment>
  <condition>Breast Feeding</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care (office visits at 1, 2, 4 and 6 months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone support</intervention_name>
    <description>Telephone support intervention to improve breastfeeding rates. The intervention will consist in weekly calls during the first two months and every two weeks between the second and the sixth month. The intervention will be done by pediatric nurses and we have developed a protocol of important issues to deal depending on the age of the baby.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers with healthy newborns&#xD;
&#xD;
          -  37 weeks gestation or greater&#xD;
&#xD;
          -  Exclusive breastfeeding or any breastfeeding when arrive at Primary Care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infant or mother admitted in ICU&#xD;
&#xD;
          -  Twin pregnancy&#xD;
&#xD;
          -  Major congenital malformation of babies&#xD;
&#xD;
          -  Mothers age &lt;= 18&#xD;
&#xD;
          -  Inability to understand Spanish/Catalan&#xD;
&#xD;
          -  Mothers who don't have a telephone&#xD;
&#xD;
          -  Mothers who don't give her consent&#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>Josep Balaguer, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jordi Gol i Gorina Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Josep Balaguer Martinez, Doctor</last_name>
    <phone>34-93-4712000</phone>
    <phone_ext>509</phone_ext>
    <email>jbalaguer@ambitcp.catsalut.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jordi Gol i Gurina Foundation</name>
      <address>
        <city>Barcelona</city>
        <zip>08007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josep Balaguer Marinez, Doctor</last_name>
      <phone>34-93-4712000</phone>
      <phone_ext>509</phone_ext>
      <email>jbalaguer@ambitcp.catsalut.net</email>
    </contact>
    <investigator>
      <last_name>Josep Balaguer Martinez, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>June 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>December 19, 2014</last_update_submitted>
  <last_update_submitted_qc>December 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Feeding</keyword>
  <keyword>Telephone</keyword>
  <keyword>Education</keyword>
  <keyword>Primary Health Care</keyword>
  <!-- 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/NCT02186613
org study id: 4R14/015
nct id: NCT02186613
lead sponsor: 
collaborator: 
has dmc: No
The investigators will conduct a telephone-based support to breastfeeding women with healthy
      newborns to improve breastfeeding outcomes.
The World Health Organization recommends exclusive breastfeeding to infants until 6 months of
      age in order to achieve optimum growth. The proportion of exclusive breastfeeding mothers at
      6 months is only 24.7 in Spain. The investigators believe it is important to increase the
      proportion of breastfeeding mothers in their population. Therefore, the investigators have
      developed a telephonic support protocol for mothers. The intervention will be performed by
      pediatric nurses in Primary Care.

      The main aim of this study is to evaluate in a randomized controlled trial the effectiveness
      of telephone-based breastfeeding support in exclusive breastfeeding. The secondary aim is to
      evaluate the effectiveness of the telephonic support in any breastfeeding.

      The investigators hypothesis is that this intervention will increase exclusive breastfeeding
      and any breastfeeding rates.

      The study will be carried out in Cornellà, a semi-urban area near Barcelona. Participants
      will include breastfeeding women who have full-term healthy infants. Mothers will be
      recruited upon their first arrival to Primary Care from hospital. Eligible mothers who
      consent to participate will be randomized into either the intervention group or the control
      group. The latter will receive standard postpartum care. The former will receive standard
      postpartum care, plus a weekly telephone call during the first two months and every 2 weeks
      thereafter between the second and the sixth month. The pediatric nurse responsible for
      monitoring the standard care of each and every patient will be the one responsible for
      contacting them via telephone. Therefore, the study is not blinded.

      The evolution of exclusive breastfeeding will be compared to artificial or supplemented
      feeding at 1, 2, 4 and 6 months. The effect of the intervention on breastfeeding supplemented
      with formula will also be valued. Classification into breastfeeding categories is based on
      24-hour dietary recall.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of exclusive breastfeeding
time frame: 6 months
description: Exclusive breastfeeding at 6 months. (time frame: 6 months)
measure: Rate of exclusive breastfeeding
time frame: 4 months
description: Exclusive Breastfeeding at 4 months. (time frame: 4 months)
measure: Rate of exclusive breastfeeding
time frame: 2 months
description: Exclusive breastfeeding at 2 months. (time frame: 2 months)
measure: Rate of exclusive breastfeeding
time frame: 1 month
description: Exclusive breastfeeding at 1 month. (time frame: 1 month)
measure: Rate of non exclusive breastfeeding
time frame: 6 months
description: Breastfeeding (non exclusive) at 6 months. (time frame: 6 months)
measure: Rate of non exclusive breastfeeding
time frame: 4 months
description: Breastfeeding (non exclusive) at 4 months. (time frame: 4 months)
measure: Rate of non exclusive breastfeeding
time frame: 2 months
description: Breastfeeding (non exclusive) at 2 months. (time frame: 2 months)
measure: Rate of non exclusive breastfeeding
time frame: 1 month
description: Breastfeeding (non exclusive) at 1 month. (time frame: 1 month)
arm group label: Experimental
arm group type: Experimental
description: These mothers and their babies will receive Primary Care standard care (office visits at 1, 2, 4 and 6 months) plus the telephone support
arm group label: No intervention
arm group type: No Intervention
description: Standard care (office visits at 1, 2, 4 and 6 months)
intervention type: Behavioral
intervention name: Telephone support
description: Telephone support intervention to improve breastfeeding rates. The intervention will consist in weekly calls during the first two months and every two weeks between the second and the sixth month. The intervention will be done by pediatric nurses and we have developed a protocol of important issues to deal depending on the age of the baby.
arm group label: Experimental
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Josep Balaguer, Doctor
role: Principal Investigator
affiliation: Jordi Gol i Gorina Foundation
last name: Josep Balaguer Martinez, Doctor
phone: 34-93-4712000
phone ext: 509
email: jbalaguer@ambitcp.catsalut.net
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor