<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/NCT02214849</url>
  </required_header>
  <id_info>
    <org_study_id>1206010472</org_study_id>
    <nct_id>NCT02214849</nct_id>
  </id_info>
  <brief_title>LATCH: Lactation Advice Thru Texting Can Help</brief_title>
  <official_title>LATCH: Lactation Advice Thru Texting Can Help</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if a two-way texting platform to be used as an&#xD;
      adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among&#xD;
      women enrolled in the WIC program in Connecticut. The hypothesis of the study is that&#xD;
      providing additional information and support through text messaging starting in pregnancy and&#xD;
      continuing after the birth of the child will increase exclusive breastfeeding rates during&#xD;
      the first six months of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Exclusive Breastfeeding Rate</measure>
    <time_frame>2 weeks after birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Exclusive Breastfeeding Rate</measure>
    <time_frame>3 months after birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Exclusive Breastfeeding Rate</measure>
    <time_frame>6 months after birth</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chance in the Percent of WIC Participants Reached by Breastfeedng Counselor</measure>
    <time_frame>48 hours after giving birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors</measure>
    <time_frame>2 weeks after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors</measure>
    <time_frame>3 months after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors</measure>
    <time_frame>6 months after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding self-efficacy</measure>
    <time_frame>2 weeks after birth</time_frame>
    <description>Self-efficacy refers to an individuals' confidence in their capability to initiate, maintain, and (if stopped) re-start breastfeeding. It will be measured with the scale proposed by Schwarzer. Self-efficacy scale includes 5 questions, each with 4 response options ranging from &quot;very false&quot; to &quot;very true&quot;. Average score will be generated by summing responses to questions 1 through 5 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of self-efficacy.&#xD;
Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding self-efficacy</measure>
    <time_frame>3 months after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding self-efficacy</measure>
    <time_frame>6 months after birth</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding action planning</measure>
    <time_frame>2 weeks</time_frame>
    <description>Action planning refers to the &quot;when&quot;, &quot;where&quot;, and &quot;how&quot; of the behavior or the sequence of events making up breastfeeding behaviors. It will be measured with the scale proposed by Schwarzer. Action planning scale includes 7 questions, each with 4 response options ranging from &quot;very false&quot; to &quot;very true&quot;. An average score will be generated by summing responses to questions 1 through 7 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of action planning.&#xD;
Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding action planning</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding action planning</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding coping planning</measure>
    <time_frame>2 weeks</time_frame>
    <description>Coping planning refers to the identification of potential barriers to engaging in and maintaining breastfeeding behavior and the extent to which an individual has developed strategies to cope with those barriers. It will be measured with the scale proposed by Schwarzer. Coping planning scale includes 6 questions, each with 4 response options ranging from &quot;very false&quot; to &quot;very true&quot;. An average score will be generated by summing responses to questions 1 through 6 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of coping planning.&#xD;
Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding coping planning</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in breastfeeding coping planning</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">249</enrollment>
  <condition>Breastfeeding Support</condition>
  <arm_group>
    <arm_group_label>LATCH Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women enrolled in the WIC program and receiving breastfeeding peer counseling services will receive text messages to support them with their breastfeeding intentions. They will start receiving automated text messages starting in pregnancy and continuing throughout the first 6 months after giving birth. Messaging during pregnancy will emphasize what to expect in the hospital, the onset of lactation, skin-to-skin contact with baby, early and often breastfeeding in post-partum period, milk transfer (suck &amp; swallow), positioning (with links), common breastfeeding problems and how to seek help. Throughout the study, participants will be able to respond to automated text messages with specific questions that will be received and answered by their WIC program peer counselors. Texting will also have prompts to respond occasionally (at minimum once every two weeks) to ensure that phone is still in service and that the participant in the intervention arm are receiving intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LATCH Intervention</intervention_name>
    <arm_group_label>LATCH Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women &gt; 18 years&#xD;
&#xD;
          -  Prenatal intention to breastfeed&#xD;
&#xD;
          -  Prenatal enrollment &lt; 28 weeks gestation&#xD;
&#xD;
          -  Have an unlimited text message cell phone plan&#xD;
&#xD;
          -  Knows how to send a text message&#xD;
&#xD;
          -  5th grade literacy level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of fluency in either English or Spanish&#xD;
&#xD;
          -  Infant born premature (&lt;37 weeks)&#xD;
&#xD;
          -  &gt; 3 days in NICU&#xD;
&#xD;
          -  Any major maternal-newborn medical problem affecting breastfeeding&#xD;
&#xD;
          -  Birth weight &lt;5lbs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafael Perez-Escamilla, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nurit Harari, MD</last_name>
    <role>Study Director</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale School of Public Health</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>April 28, 2017</last_update_submitted>
  <last_update_submitted_qc>April 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breastfeeding</keyword>
  <keyword>Breastfeeding peer counseling</keyword>
  <keyword>Exclusive breastfeeding</keyword>
  <keyword>Formula supplementation</keyword>
  <keyword>Mobile health</keyword>
  <keyword>WIC program</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/NCT02214849
org study id: 1206010472
nct id: NCT02214849
lead sponsor: 
has dmc: No
The purpose of this study is to find out if a two-way texting platform to be used as an
      adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among
      women enrolled in the WIC program in Connecticut. The hypothesis of the study is that
      providing additional information and support through text messaging starting in pregnancy and
      continuing after the birth of the child will increase exclusive breastfeeding rates during
      the first six months of life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Exclusive Breastfeeding Rate
time frame: 2 weeks after birth
measure: Change in Exclusive Breastfeeding Rate
time frame: 3 months after birth
measure: Change in Exclusive Breastfeeding Rate
time frame: 6 months after birth
measure: Chance in the Percent of WIC Participants Reached by Breastfeedng Counselor
time frame: 48 hours after giving birth
measure: Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors
time frame: 2 weeks after birth
measure: Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors
time frame: 3 months after birth
measure: Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors
time frame: 6 months after birth
measure: Change in breastfeeding self-efficacy
time frame: 2 weeks after birth
description: Self-efficacy refers to an individuals' confidence in their capability to initiate, maintain, and (if stopped) re-start breastfeeding. It will be measured with the scale proposed by Schwarzer. Self-efficacy scale includes 5 questions, each with 4 response options ranging from "very false" to "very true". Average score will be generated by summing responses to questions 1 through 5 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of self-efficacy.
Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.
measure: Change in breastfeeding self-efficacy
time frame: 3 months after birth
measure: Change in breastfeeding self-efficacy
time frame: 6 months after birth
measure: Change in breastfeeding action planning
time frame: 2 weeks
description: Action planning refers to the "when", "where", and "how" of the behavior or the sequence of events making up breastfeeding behaviors. It will be measured with the scale proposed by Schwarzer. Action planning scale includes 7 questions, each with 4 response options ranging from "very false" to "very true". An average score will be generated by summing responses to questions 1 through 7 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of action planning.
Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.
measure: Change in breastfeeding action planning
time frame: 3 months
measure: Change in breastfeeding action planning
time frame: 6 months
measure: Change in breastfeeding coping planning
time frame: 2 weeks
description: Coping planning refers to the identification of potential barriers to engaging in and maintaining breastfeeding behavior and the extent to which an individual has developed strategies to cope with those barriers. It will be measured with the scale proposed by Schwarzer. Coping planning scale includes 6 questions, each with 4 response options ranging from "very false" to "very true". An average score will be generated by summing responses to questions 1 through 6 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of coping planning.
Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.
measure: Change in breastfeeding coping planning
time frame: 3 months
measure: Change in breastfeeding coping planning
time frame: 6 months
arm group label: LATCH Intervention
arm group type: Experimental
description: Women enrolled in the WIC program and receiving breastfeeding peer counseling services will receive text messages to support them with their breastfeeding intentions. They will start receiving automated text messages starting in pregnancy and continuing throughout the first 6 months after giving birth. Messaging during pregnancy will emphasize what to expect in the hospital, the onset of lactation, skin-to-skin contact with baby, early and often breastfeeding in post-partum period, milk transfer (suck & swallow), positioning (with links), common breastfeeding problems and how to seek help. Throughout the study, participants will be able to respond to automated text messages with specific questions that will be received and answered by their WIC program peer counselors. Texting will also have prompts to respond occasionally (at minimum once every two weeks) to ensure that phone is still in service and that the participant in the intervention arm are receiving intervention.
intervention type: Behavioral
intervention name: LATCH Intervention
arm group label: LATCH Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rafael Perez-Escamilla, PhD
role: Principal Investigator
affiliation: Yale University
last name: Nurit Harari, MD
role: Study Director
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor