A WeChat-based Intervention to Support Breastfeeding

August 3, 2020 updated by: Li Tang, Chengdu Jinjiang Maternity and Child Health Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chengdu, China
        • Recruiting
        • Chengdu Qingyang Maternal and Child Health Hospital
        • Contact:
          • Xu Yan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months postpartum
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.
6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant's first feed
Time Frame: 0-7 days postpartum
% of infants fed with breastmilk as their first feed
0-7 days postpartum
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.
0-4 months postpartum
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.
0-6 months postpartum
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.
0-4 months postpartum
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
0-6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Jinjiang Maternity and Child Health Hospital

Collaborators

Curtin University
Chengdu Women's and Children's Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019FYH014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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