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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

Tracking Information
First Submitted Date  ICMJE July 28, 2020
First Posted Date  ICMJE August 5, 2020
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE June 28, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Infant's first feed [ Time Frame: 0-7 days postpartum ]
    % of infants fed with breastmilk as their first feed
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A WeChat-based Intervention to Support Breastfeeding
Official Title  ICMJE A WeChat-based Intervention to Promote and Support Breastfeeding in China: A Multi-center Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Exclusive Breastfeeding
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention group
    Participants receive breastfeeding-related information from WeChat
    Intervention: Other: Breastfeeding related information delivered by WeChat
  • Active Comparator: Control group
    Participants receive non-breastfeeding information from WeChat
    Intervention: Other: Non-breastfeeding related information delivered by WeChat
Publications * Tang L, Lee AH, Binns CW, Duan L, Liu Y, Li C. WeChat-based intervention to support breastfeeding for Chinese mothers: protocol of a randomised controlled trial. BMC Med Inform Decis Mak. 2020 Nov 19;20(1):300. doi: 10.1186/s12911-020-01322-8. Erratum in: BMC Med Inform Decis Mak. 2021 Feb 8;21(1):46.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2020)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Li Tang, PhD +86 15002872018 tangli207@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04499404
Other Study ID Numbers  ICMJE 2019FYH014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Li Tang, Chengdu Jinjiang Maternity and Child Health Hospital
Study Sponsor  ICMJE Chengdu Jinjiang Maternity and Child Health Hospital
Collaborators  ICMJE
  • Chengdu Women's and Children's Central Hospital
  • Curtin University
Investigators  ICMJE
Principal Investigator: Li Tang, PhD Chengdu Jinjiang Maternity and Child Health Hospital
PRS Account Chengdu Jinjiang Maternity and Child Health Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP