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Clinical Trials/NCT04499404
NCT04499404
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A WeChat-based Intervention to Promote and Support Breastfeeding in China: A Multi-center Randomized Controlled Trial

Chengdu Jinjiang Maternity and Child Health Hospital1 site in 1 country1,000 target enrollmentJune 28, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Exclusive Breastfeeding
Sponsor
Chengdu Jinjiang Maternity and Child Health Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Exclusive breastfeeding rate at 6 months postpartum
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2020
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Chengdu Jinjiang Maternity and Child Health Hospital
Responsible Party
Principal Investigator
Principal Investigator

Li Tang

Assistant Professor

Chengdu Jinjiang Maternity and Child Health Hospital

Eligibility 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Exclusive breastfeeding duration to 4 months postpartum(0-4 months postpartum)
  • Infant's first feed(0-7 days postpartum)
  • Exclusive breastfeeding duration to 6 months postpartum(0-6 months postpartum)
  • Any breastfeeding duration to 6 months postpartum(0-6 months postpartum)
  • Rate of early introduction of complementary feeding(0-4 months postpartum)

Study Sites (1)

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