Clinical trial NCT04499404: A WeChat-based Intervention to Support Breastfeeding
Official title: A WeChat-based Intervention to Promote and Support Breastfeeding in China: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exclusive Breastfeeding
Keywords: exclusive breastfeeding
complementary feeds
smart phone application
randomized controlled trial
WeChat
Lead sponsor: Chengdu Jinjiang Maternity and Child Health Hospital
Sponsor class: OTHER
Collaborators: name: Chengdu Women's and Children's Central Hospital
name: Curtin University
First posted: 2020-08-05
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Exclusive breastfeeding rate at 6 months postpartum
timeFrame: 6 months postpartum
measure: Full breastfeeding rate at 6 months postpartum
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Infant's first feed
timeFrame: 0-7 days postpartum
measure: Exclusive breastfeeding duration to 4 months postpartum
timeFrame: 0-4 months postpartum
measure: Exclusive breastfeeding duration to 6 months postpartum
timeFrame: 0-6 months postpartum
measure: Rate of early introduction of complementary feeding
timeFrame: 0-4 months postpartum
measure: Any breastfeeding duration to 6 months postpartum
timeFrame: 0-6 months postpartum
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Qingyang Maternal and Child Health Hospital
Study officials:
affiliation: Chengdu Jinjiang Maternity and Child Health Hospital
name: Li Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.