NCT04499404

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

July 28, 2020

Last Update Submit

August 3, 2020

Conditions

Keywords

exclusive breastfeedingcomplementary feedssmart phone applicationrandomized controlled trialWeChat

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Infant's first feed

    0-7 days postpartum

  • Exclusive breastfeeding duration to 4 months postpartum

    0-4 months postpartum

  • Exclusive breastfeeding duration to 6 months postpartum

    0-6 months postpartum

  • Rate of early introduction of complementary feeding

    0-4 months postpartum

  • Any breastfeeding duration to 6 months postpartum

    0-6 months postpartum

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive breastfeeding-related information from WeChat

Other: Breastfeeding related information delivered by WeChat

Control group

ACTIVE COMPARATOR

Participants receive non-breastfeeding information from WeChat

Other: Non-breastfeeding related information delivered by WeChat

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • own a smart phone;
  • years or above;
  • sufficient language skills (completed secondary school education);
  • carry a singleton fetus;
  • at a gestational age of 28 to 30 weeks;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu Qingyang Maternal and Child Health Hospital

Chengdu, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Li Tang, PhD

    Chengdu Jinjiang Maternity and Child Health Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 5, 2020

Study Start

June 28, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations