<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/NCT04499404</url>
  </required_header>
  <id_info>
    <org_study_id>2019FYH014</org_study_id>
    <nct_id>NCT04499404</nct_id>
  </id_info>
  <brief_title>A WeChat-based Intervention to Support Breastfeeding</brief_title>
  <official_title>A WeChat-based Intervention to Promote and Support Breastfeeding in China: A Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu Jinjiang Maternity and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chengdu Women's and Children's Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Curtin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chengdu Jinjiang Maternity and Child Health Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the randomized controlled trial (RCT) is to evaluate the effects of an&#xD;
      intervention program delivered via WeChat platform to support exclusive breastfeeding in&#xD;
      China. WeChat, a free smart phone application, is the most popular social networking platform&#xD;
      in China. It will be used to deliver health educational messages to the study participants.&#xD;
      Our hypothesis is that the intervention program can lead to at least a 10% increase in&#xD;
      exclusive breastfeeding prevalence at 6 months when compared to the control group.&#xD;
&#xD;
      A multicenter RCT of 1,000 participants will be conducted at four maternity hospitals in&#xD;
      Chengdu, China. Eligible pregnant women who consent to participate will be recruited from the&#xD;
      antenatal clinic at around 30 weeks of gestation and will be randomly assigned to either the&#xD;
      intervention or control group on a 1:1 ratio.&#xD;
&#xD;
      After randomization, all participants will be asked to scan a Quick Response code to follow&#xD;
      our WeChat public account, which can send push notifications to alert participants for new&#xD;
      content, topics, links to a searchable library and frequently asked questions and answers.&#xD;
      From baseline until childbirth, control group participants will receive non-breastfeeding&#xD;
      related messages, such as healthy lifestyle and nutrition during pregnancy, from WeChat,&#xD;
      whereas the intervention group participants will receive breastfeeding related messages,&#xD;
      including preparation for breastfeeding after birth and the health benefits of breastfeeding,&#xD;
      from WeChat. After childbirth, intervention group mothers will continue to receive&#xD;
      information about breastfeeding for 6 months. The investigators will use WeChat to remind&#xD;
      mothers about the importance of exclusive breastfeeding, build confidence and motivate them&#xD;
      to continue exclusive breastfeeding. Meanwhile, the control group participants will receive&#xD;
      information on other topics of interest to mothers, such as immunization, safety, infant&#xD;
      growth, and etc.&#xD;
&#xD;
      Each participant will be interviewed in person by trained nurses at baseline, at discharge&#xD;
      and be interviewed by telephone using structured questionnaires at 1, 4, and 6 months&#xD;
      postpartum to collect detailed information on breastfeeding practices. All participants&#xD;
      receive normal prenatal and postpartum maternity services. Cox proportional hazard models and&#xD;
      multilevel mixed regression models will be performed respectively to compare the duration of&#xD;
      exclusive breastfeeding and the rates of exclusive breastfeeding within six months postpartum&#xD;
      between intervention and control groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exclusive breastfeeding rate at 6 months postpartum</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Full breastfeeding rate at 6 months postpartum</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>Infants who are receiving almost all of their nutrients from breast milk but take some other liquids such as water, water-based drinks, oral rehydration solutions, ritual fluids, and drops or syrups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant's first feed</measure>
    <time_frame>0-7 days postpartum</time_frame>
    <description>% of infants fed with breastmilk as their first feed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding duration to 4 months postpartum</measure>
    <time_frame>0-4 months postpartum</time_frame>
    <description>Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding duration to 6 months postpartum</measure>
    <time_frame>0-6 months postpartum</time_frame>
    <description>Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of early introduction of complementary feeding</measure>
    <time_frame>0-4 months postpartum</time_frame>
    <description>Complementary feeding is defined as feeding infants with solid foods and liquids other than breastmilk or infant formula.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any breastfeeding duration to 6 months postpartum</measure>
    <time_frame>0-6 months postpartum</time_frame>
    <description>The child has received breastmilk (direct from the breast or expressed) with or without other drink, formula or other infant food</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Exclusive Breastfeeding</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive breastfeeding-related information from WeChat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive non-breastfeeding information from WeChat</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breastfeeding related information delivered by WeChat</intervention_name>
    <description>Participants in the intervention group will be asked to follow our WeChat public account immoderately after randomization. They will receive breastfeeding related messages three times a week from WeChat, including preparation for breastfeeding after birth and the health benefits of breastfeeding, from baseline until childbirth. After childbirth, intervention group mothers will continue to receive information, which is mainly about breastfeeding, once a week for 6 months. WeChat will send push notifications to remind mothers about the importance of exclusive breastfeeding, build confidence and motivate them to continue exclusive breastfeeding.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-breastfeeding related information delivered by WeChat</intervention_name>
    <description>Participants in the control group will be asked to follow our WeChat public account immoderately after randomization. They will receive messages mainly on topics of healthy lifestyle and nutrition during pregnancy, from baseline until childbirth. After childbirth, they will continue to receive information on other topics of interest to mothers, such as immunization, safety, infant growth, and etc., until 6 months postpartum.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  own a smart phone;&#xD;
&#xD;
          -  18 years or above;&#xD;
&#xD;
          -  sufficient language skills (completed secondary school education);&#xD;
&#xD;
          -  carry a singleton fetus;&#xD;
&#xD;
          -  at a gestational age of 28 to 30 weeks;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have existing medical conditions or pregnancy complications which may inhibit&#xD;
             breastfeeding initiation, according to their medical doctor;&#xD;
&#xD;
          -  intend to give birth in health institutes other than the study hospitals.&#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>Li Tang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chengdu Jinjiang Maternity and Child Health Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Tang, PhD</last_name>
    <phone>+86 15002872018</phone>
    <email>tangli207@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chengdu Qingyang Maternal and Child Health Hospital</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xu Yan</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chengdu Jinjiang Maternity and Child Health Hospital</investigator_affiliation>
    <investigator_full_name>Li Tang</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>exclusive breastfeeding</keyword>
  <keyword>complementary feeds</keyword>
  <keyword>smart phone application</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>WeChat</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/NCT04499404
org study id: 2019FYH014
nct id: NCT04499404
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of the randomized controlled trial (RCT) is to evaluate the effects of an
      intervention program delivered via WeChat platform to support exclusive breastfeeding in
      China. WeChat, a free smart phone application, is the most popular social networking platform
      in China. It will be used to deliver health educational messages to the study participants.
      Our hypothesis is that the intervention program can lead to at least a 10% increase in
      exclusive breastfeeding prevalence at 6 months when compared to the control group.

      A multicenter RCT of 1,000 participants will be conducted at four maternity hospitals in
      Chengdu, China. Eligible pregnant women who consent to participate will be recruited from the
      antenatal clinic at around 30 weeks of gestation and will be randomly assigned to either the
      intervention or control group on a 1:1 ratio.

      After randomization, all participants will be asked to scan a Quick Response code to follow
      our WeChat public account, which can send push notifications to alert participants for new
      content, topics, links to a searchable library and frequently asked questions and answers.
      From baseline until childbirth, control group participants will receive non-breastfeeding
      related messages, such as healthy lifestyle and nutrition during pregnancy, from WeChat,
      whereas the intervention group participants will receive breastfeeding related messages,
      including preparation for breastfeeding after birth and the health benefits of breastfeeding,
      from WeChat. After childbirth, intervention group mothers will continue to receive
      information about breastfeeding for 6 months. The investigators will use WeChat to remind
      mothers about the importance of exclusive breastfeeding, build confidence and motivate them
      to continue exclusive breastfeeding. Meanwhile, the control group participants will receive
      information on other topics of interest to mothers, such as immunization, safety, infant
      growth, and etc.

      Each participant will be interviewed in person by trained nurses at baseline, at discharge
      and be interviewed by telephone using structured questionnaires at 1, 4, and 6 months
      postpartum to collect detailed information on breastfeeding practices. All participants
      receive normal prenatal and postpartum maternity services. Cox proportional hazard models and
      multilevel mixed regression models will be performed respectively to compare the duration of
      exclusive breastfeeding and the rates of exclusive breastfeeding within six months postpartum
      between intervention and control groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Exclusive breastfeeding rate at 6 months postpartum
time frame: 6 months postpartum
description: Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
measure: Full breastfeeding rate at 6 months postpartum
time frame: 6 months postpartum
description: Infants who are receiving almost all of their nutrients from breast milk but take some other liquids such as water, water-based drinks, oral rehydration solutions, ritual fluids, and drops or syrups.
measure: Infant's first feed
time frame: 0-7 days postpartum
description: % of infants fed with breastmilk as their first feed
measure: Exclusive breastfeeding duration to 4 months postpartum
time frame: 0-4 months postpartum
description: Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
measure: Exclusive breastfeeding duration to 6 months postpartum
time frame: 0-6 months postpartum
description: Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
measure: Rate of early introduction of complementary feeding
time frame: 0-4 months postpartum
description: Complementary feeding is defined as feeding infants with solid foods and liquids other than breastmilk or infant formula.
measure: Any breastfeeding duration to 6 months postpartum
time frame: 0-6 months postpartum
description: The child has received breastmilk (direct from the breast or expressed) with or without other drink, formula or other infant food
arm group label: Intervention group
arm group type: Experimental
description: Participants receive breastfeeding-related information from WeChat
arm group label: Control group
arm group type: Active Comparator
description: Participants receive non-breastfeeding information from WeChat
intervention type: Other
intervention name: Breastfeeding related information delivered by WeChat
description: Participants in the intervention group will be asked to follow our WeChat public account immoderately after randomization. They will receive breastfeeding related messages three times a week from WeChat, including preparation for breastfeeding after birth and the health benefits of breastfeeding, from baseline until childbirth. After childbirth, intervention group mothers will continue to receive information, which is mainly about breastfeeding, once a week for 6 months. WeChat will send push notifications to remind mothers about the importance of exclusive breastfeeding, build confidence and motivate them to continue exclusive breastfeeding.
arm group label: Intervention group
intervention type: Other
intervention name: Non-breastfeeding related information delivered by WeChat
description: Participants in the control group will be asked to follow our WeChat public account immoderately after randomization. They will receive messages mainly on topics of healthy lifestyle and nutrition during pregnancy, from baseline until childbirth. After childbirth, they will continue to receive information on other topics of interest to mothers, such as immunization, safety, infant growth, and etc., until 6 months postpartum.
arm group label: Control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Li Tang, PhD
role: Principal Investigator
affiliation: Chengdu Jinjiang Maternity and Child Health Hospital
last name: Li Tang, PhD
phone: +86 15002872018
email: tangli207@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chengdu Jinjiang Maternity and Child Health Hospital
investigator full name: Li Tang
investigator title: Assistant Professor
sharing ipd: No