<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/NCT02263118</url>
  </required_header>
  <id_info>
    <org_study_id>CE/FM UFM 0062-13</org_study_id>
    <nct_id>NCT02263118</nct_id>
  </id_info>
  <brief_title>A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala</brief_title>
  <official_title>A Mobile-health Pilot Experiment Targeting Mothers With Newborns in Rural Areas of San Juan Sacatepequez, Guatemala, in the Context of Exclusive Breastfeeding Practices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Francisco Marroquín</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ecole Polytechnique, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The SHM Foundation, UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Francisco Marroquín</source>
  <brief_summary>
    <textblock>
      The purpose of this study was to determine whether exposure to m-health platforms promoting&#xD;
      recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding&#xD;
      message to participant mothers, and in improving weight evolution of infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Changes in Knowledge</measure>
    <time_frame>December 2013 - May 2014, 23 weeks</time_frame>
    <description>Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative Nature of Health-related Text-messages</measure>
    <time_frame>December 2013 - May 2014, 23 weeks</time_frame>
    <description>Specifically, we were interested in classifying individual text-messages as social support or health related.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Text-messages Exchanged in Virtual Communities</measure>
    <time_frame>December 2013 - May 2014, 23 weeks</time_frame>
    <description>We were interested in the activity of virtual communities in terms of sent text-messages.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Weight-for-Age Z-score</measure>
    <time_frame>Baseline at December 2013 and 23 weeks later in May 2014</time_frame>
    <description>We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.&#xD;
We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Exclusive Breastfeeding</condition>
  <condition>Co-production of Health in Communities</condition>
  <arm_group>
    <arm_group_label>Uni-directional SMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual communities</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hybrid setup</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals were given a feature phone (simple mobile phone)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Uni-directional SMS</intervention_name>
    <description>Exposure to breastfeeding promoting SMSs</description>
    <arm_group_label>Hybrid setup</arm_group_label>
    <arm_group_label>Uni-directional SMS</arm_group_label>
    <arm_group_label>Virtual communities</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Feature phone</intervention_name>
    <description>Participants were given a feature phone.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Hybrid setup</arm_group_label>
    <arm_group_label>Uni-directional SMS</arm_group_label>
    <arm_group_label>Virtual communities</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual communities</intervention_name>
    <description>Exposure to virtual community communication via SMS</description>
    <arm_group_label>Hybrid setup</arm_group_label>
    <arm_group_label>Virtual communities</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hybrid setup</intervention_name>
    <description>Exposure to virtual community and access to communications with health professional via SMS</description>
    <arm_group_label>Hybrid setup</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Can read&#xD;
&#xD;
          -  Has a baby of less than 4 months of age OR is in her 8th month of pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot read&#xD;
&#xD;
          -  Does not have a newborn&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge Tulio Rodriguez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidad Francisco Marroquin, Guatemala</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose Tomas Prieto</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala</affiliation>
  </overall_official>
  <link>
    <url>http://patojitos.org</url>
    <description>Program's website</description>
  </link>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>May 31, 2015</results_first_submitted>
  <results_first_submitted_qc>June 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 30, 2015</results_first_posted>
  <last_update_submitted>June 29, 2015</last_update_submitted>
  <last_update_submitted_qc>June 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Francisco Marroquín</investigator_affiliation>
    <investigator_full_name>José Tomás PRIETO, PhD</investigator_full_name>
    <investigator_title>Dr. Jose Tomas Prieto</investigator_title>
  </responsible_party>
  <keyword>breastfeeding</keyword>
  <keyword>rural</keyword>
  <keyword>m-health</keyword>
  <keyword>mHealth</keyword>
  <keyword>Patojitos</keyword>
  <keyword>Guatemala</keyword>
  <keyword>exclusive breastfeeding</keyword>
  <keyword>mobile</keyword>
  <keyword>eHealth</keyword>
  <keyword>e-health</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Uni-directional SMS</title>
          <description>Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.</description>
        </group>
        <group group_id="P2">
          <title>Virtual Communities</title>
          <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS</description>
        </group>
        <group group_id="P3">
          <title>Hybrid Setup</title>
          <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS&#xD;
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS</description>
        </group>
        <group group_id="P4">
          <title>Control Group</title>
          <description>Individuals were given a feature phone (simple mobile phone)&#xD;
Feature phone: Participants were given a feature phone.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Indigenous women from San Juan Sacatepequez</population>
      <group_list>
        <group group_id="B1">
          <title>Uni-directional SMS</title>
          <description>Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.</description>
        </group>
        <group group_id="B2">
          <title>Virtual Communities</title>
          <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS</description>
        </group>
        <group group_id="B3">
          <title>Hybrid Setup</title>
          <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS&#xD;
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS</description>
        </group>
        <group group_id="B4">
          <title>Control Group</title>
          <description>Individuals were given a feature phone (simple mobile phone)&#xD;
Feature phone: Participants were given a feature phone.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="22"/>
            <count group_id="B4" value="12"/>
            <count group_id="B5" value="78"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>16-22 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>23-30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;30 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Gender of participant's baby</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal experience</title>
          <description>Does the participant have other children?</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <description>Women's education</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some primary school education</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some high school education</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; High school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Aware of exclusive breastfeeding message</title>
          <description>Was the participant aware of exclusive breastfeeding practice at enrollment?</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Aware</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Aware</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Changes in Knowledge</title>
        <description>Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).</description>
        <time_frame>December 2013 - May 2014, 23 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Uni-directional SMS</title>
            <description>Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
          <group group_id="O2">
            <title>Virtual Communities</title>
            <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS</description>
          </group>
          <group group_id="O3">
            <title>Hybrid Setup</title>
            <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS&#xD;
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS</description>
          </group>
          <group group_id="O4">
            <title>Control Group</title>
            <description>Individuals were given a feature phone (simple mobile phone)&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Changes in Knowledge</title>
          <description>Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Learned it</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Forgot it</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Remembered it</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Continued to be unaware at the end of experiment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Qualitative Nature of Health-related Text-messages</title>
        <description>Specifically, we were interested in classifying individual text-messages as social support or health related.</description>
        <time_frame>December 2013 - May 2014, 23 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Uni-directional SMS</title>
            <description>Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
          <group group_id="O2">
            <title>Virtual Communities</title>
            <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS</description>
          </group>
          <group group_id="O3">
            <title>Hybrid Setup</title>
            <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS&#xD;
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS</description>
          </group>
          <group group_id="O4">
            <title>Control Group</title>
            <description>Individuals were given a feature phone (simple mobile phone)&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Nature of Health-related Text-messages</title>
          <description>Specifically, we were interested in classifying individual text-messages as social support or health related.</description>
          <units>Number of text messages</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Text messages shared in groups</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2793"/>
                <count group_id="O3" value="909"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Health related messages</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="761"/>
                    <measurement group_id="O3" value="501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social support related messages</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1961"/>
                    <measurement group_id="O3" value="356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other messages</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Text-messages Exchanged in Virtual Communities</title>
        <description>We were interested in the activity of virtual communities in terms of sent text-messages.</description>
        <time_frame>December 2013 - May 2014, 23 weeks</time_frame>
        <population>In &quot;virtual communities&quot;, participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the &quot;hybrid setup&quot;, participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional.</population>
        <group_list>
          <group group_id="O1">
            <title>Uni-directional SMS</title>
            <description>There were no virtual communities in this group: participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
          <group group_id="O2">
            <title>Virtual Communities</title>
            <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS</description>
          </group>
          <group group_id="O3">
            <title>Hybrid Setup</title>
            <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS&#xD;
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS</description>
          </group>
          <group group_id="O4">
            <title>Control Group</title>
            <description>There were no virtual communities in this group: individuals were given a feature phone (simple mobile phone)&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Text-messages Exchanged in Virtual Communities</title>
          <description>We were interested in the activity of virtual communities in terms of sent text-messages.</description>
          <population>In &quot;virtual communities&quot;, participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the &quot;hybrid setup&quot;, participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional.</population>
          <units>Number of text messages</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2793"/>
                    <measurement group_id="O3" value="909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Weight-for-Age Z-score</title>
        <description>We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.&#xD;
We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies.</description>
        <time_frame>Baseline at December 2013 and 23 weeks later in May 2014</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Uni-directional SMS</title>
            <description>Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
          <group group_id="O2">
            <title>Virtual Communities</title>
            <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS</description>
          </group>
          <group group_id="O3">
            <title>Hybrid Setup</title>
            <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS&#xD;
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS</description>
          </group>
          <group group_id="O4">
            <title>Control Group</title>
            <description>Individuals were given a feature phone (simple mobile phone)&#xD;
Feature phone: Participants were given a feature phone.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Weight-for-Age Z-score</title>
          <description>We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.&#xD;
We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies.</description>
          <units>z-score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.064" lower_limit="-0.355" upper_limit="0.228"/>
                    <measurement group_id="O2" value="0.030" lower_limit="-0.282" upper_limit="0.343"/>
                    <measurement group_id="O3" value="0.199" lower_limit="-0.331" upper_limit="0.728"/>
                    <measurement group_id="O4" value="-0.197" lower_limit="-0.834" upper_limit="0.441"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>23 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Uni-directional SMS</title>
          <description>Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.</description>
        </group>
        <group group_id="E2">
          <title>Virtual Communities</title>
          <description>Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS</description>
        </group>
        <group group_id="E3">
          <title>Hybrid Setup</title>
          <description>Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.&#xD;
Uni-directional SMS: Exposure to breastfeeding promoting SMSs&#xD;
Feature phone: Participants were given a feature phone.&#xD;
Virtual communities: Exposure to virtual community communication via SMS&#xD;
Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS</description>
        </group>
        <group group_id="E4">
          <title>Control Group</title>
          <description>Individuals were given a feature phone (simple mobile phone)&#xD;
Feature phone: Participants were given a feature phone.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Future work could consider a wider time span and inspect complementary instruments to ensure consistency between answers to interviews and behaviour. SMSs in virtual communities could be further analyzed to locate longitudinal changes in knowledge.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Jose Tomas Prieto</name_or_title>
      <organization>Ecole Polytechnique</organization>
      <phone>+50252800643</phone>
      <email>jose-tomas.prieto@polytechnique.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02263118
org study id: CE/FM UFM 0062-13
nct id: NCT02263118
lead sponsor: 
collaborator: 
collaborator: 
The purpose of this study was to determine whether exposure to m-health platforms promoting
      recommended breastfeeding practices was effective in transmitting the exclusive breastfeeding
      message to participant mothers, and in improving weight evolution of infants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
measure: Number of Participants With Changes in Knowledge
time frame: December 2013 - May 2014, 23 weeks
description: Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).
measure: Qualitative Nature of Health-related Text-messages
time frame: December 2013 - May 2014, 23 weeks
description: Specifically, we were interested in classifying individual text-messages as social support or health related.
measure: Number of Text-messages Exchanged in Virtual Communities
time frame: December 2013 - May 2014, 23 weeks
description: We were interested in the activity of virtual communities in terms of sent text-messages.
measure: Mean Change in Weight-for-Age Z-score
time frame: Baseline at December 2013 and 23 weeks later in May 2014
description: We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.
We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies.
arm group label: Uni-directional SMS
arm group type: Experimental
description: Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.
arm group label: Virtual communities
arm group type: Experimental
description: Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.
arm group label: Hybrid setup
arm group type: Experimental
description: Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.
arm group label: Control group
arm group type: Experimental
description: Individuals were given a feature phone (simple mobile phone)
intervention type: Other
intervention name: Uni-directional SMS
description: Exposure to breastfeeding promoting SMSs
arm group label: Hybrid setup
arm group label: Uni-directional SMS
arm group label: Virtual communities
intervention type: Device
intervention name: Feature phone
description: Participants were given a feature phone.
arm group label: Control group
arm group label: Hybrid setup
arm group label: Uni-directional SMS
arm group label: Virtual communities
intervention type: Other
intervention name: Virtual communities
description: Exposure to virtual community communication via SMS
arm group label: Hybrid setup
arm group label: Virtual communities
intervention type: Other
intervention name: Hybrid setup
description: Exposure to virtual community and access to communications with health professional via SMS
arm group label: Hybrid setup
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jorge Tulio Rodriguez, MD
role: Study Chair
affiliation: Universidad Francisco Marroquin, Guatemala
last name: Jose Tomas Prieto
role: Principal Investigator
affiliation: Ecole Polytechnique, France; Universidad Francisco Marroquin, Guatemala
url: http://patojitos.org
description: Program's website
responsible party type: Principal Investigator
investigator affiliation: Universidad Francisco Marroquín
investigator full name: José Tomás PRIETO, PhD
investigator title: Dr. Jose Tomas Prieto
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Future work could consider a wider time span and inspect complementary instruments to ensure consistency between answers to interviews and behaviour. SMSs in virtual communities could be further analyzed to locate longitudinal changes in knowledge.
point of contact: 