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A WeChat-based Intervention to Support Breastfeeding

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ClinicalTrials.gov Identifier: NCT04499404
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Chengdu Women's and Children's Central Hospital
Curtin University
Information provided by (Responsible Party):
Li Tang, Chengdu Jinjiang Maternity and Child Health Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Exclusive Breastfeeding Other: Breastfeeding related information delivered by WeChat Other: Non-breastfeeding related information delivered by WeChat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A WeChat-based Intervention to Promote and Support Breastfeeding in China: A Multi-center Randomized Controlled Trial
Actual Study Start Date : June 28, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Intervention group
Participants receive breastfeeding-related information from WeChat
Other: Breastfeeding related information delivered by WeChat
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.

Active Comparator: Control group
Participants receive non-breastfeeding information from WeChat
Other: Non-breastfeeding related information delivered by WeChat
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.




Primary Outcome Measures :
  1. Exclusive breastfeeding rate at 6 months postpartum [ Time Frame: 6 months postpartum ]
    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.

  2. Full breastfeeding rate at 6 months postpartum [ Time Frame: 6 months postpartum ]
    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.


Secondary Outcome Measures :
  1. Infant's first feed [ Time Frame: 0-7 days postpartum ]
    % of infants fed with breastmilk as their first feed

  2. Exclusive breastfeeding duration to 4 months postpartum [ Time Frame: 0-4 months postpartum ]
    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.

  3. Exclusive breastfeeding duration to 6 months postpartum [ Time Frame: 0-6 months postpartum ]
    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.

  4. Rate of early introduction of complementary feeding [ Time Frame: 0-4 months postpartum ]
    Complementary feeding is defined as feeding infants with solid foods and liquids other than breastmilk or infant formula.

  5. Any breastfeeding duration to 6 months postpartum [ Time Frame: 0-6 months postpartum ]
    The child has received breastmilk (direct from the breast or expressed) with or without other drink, formula or other infant food



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • own a smart phone;
  • 18 years or above;
  • sufficient language skills (completed secondary school education);
  • carry a singleton fetus;
  • at a gestational age of 28 to 30 weeks;

Exclusion Criteria:

  • have existing medical conditions or pregnancy complications which may inhibit breastfeeding initiation, according to their medical doctor;
  • intend to give birth in health institutes other than the study hospitals.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499404


Contacts
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Contact: Li Tang, PhD +86 15002872018 tangli207@hotmail.com

Locations
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China
Chengdu Qingyang Maternal and Child Health Hospital Recruiting
Chengdu, China
Contact: Xu Yan         
Sponsors and Collaborators
Chengdu Jinjiang Maternity and Child Health Hospital
Chengdu Women's and Children's Central Hospital
Curtin University
Investigators
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Principal Investigator: Li Tang, PhD Chengdu Jinjiang Maternity and Child Health Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Li Tang, Assistant Professor, Chengdu Jinjiang Maternity and Child Health Hospital
ClinicalTrials.gov Identifier: NCT04499404    
Other Study ID Numbers: 2019FYH014
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Tang, Chengdu Jinjiang Maternity and Child Health Hospital:
exclusive breastfeeding
complementary feeds
smart phone application
randomized controlled trial
WeChat