A WeChat-based Intervention to Support Breastfeeding

Exclusive Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499404
• Other study ID #: 2019FYH014
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: Chengdu Jinjiang Maternity and Child Health Hospital
• Contact: Li Tang, PhD
• Phone: +86 15002872018
• Email: tangli207[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exclusive Breastfeeding

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chengdu Qingyang Maternal and Child Health Hospital	Chengdu

Sponsors (3)

Lead Sponsor	Collaborator
Chengdu Jinjiang Maternity and Child Health Hospital	Chengdu Women's and Children's Central Hospital, Curtin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive breastfeeding rate at 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.	6 months postpartum
Primary	Full breastfeeding rate at 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.	6 months postpartum
Secondary	Infant's first feed	% of infants fed with breastmilk as their first feed	0-7 days postpartum
Secondary	Exclusive breastfeeding duration to 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.	0-4 months postpartum
Secondary	Exclusive breastfeeding duration to 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.	0-6 months postpartum
Secondary	Rate of early introduction of complementary feeding	Complementary feeding is defined as feeding infants with solid foods and liquids other than breastmilk or infant formula.	0-4 months postpartum
Secondary	Any breastfeeding duration to 6 months postpartum	The child has received breastmilk (direct from the breast or expressed) with or without other drink, formula or other infant food	0-6 months postpartum