Ecological Momentary Breastfeeding Intervention
1 other identifier
interventional
518
1 country
2
Brief Summary
During Chinese mothers' doing the month, they are often housebound and find it difficult to attend group support or seek help during the first month postpartum which is the critical period in sustaining exclusive breastfeeding and at high risk of weaning. This can adversely affect their general well-being, and are associated with stress, anxiety and postnatal depression. Thus, mothers have expressed the need for real-time, real world, personalized support that allow them to get immediate breastfeeding support, helps in overcoming the challenges and subsequently improve exclusive breastfeeding. The aim of the proposed study is to assess the effectiveness of an ecological momentary intervention (EMI)-based breastfeeding intervention in improving exclusive breastfeeding outcomes and to inform clinical practice and services for breastfeeding mothers in Hong Kong. Such interventions have been considered as a rising shift from traditional model of care towards an e-technology based health model that may improve exclusive breastfeeding duration globally.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
April 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2026
March 5, 2026
December 1, 2025
2.2 years
September 21, 2023
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of participants in each study groups exclusively breastfeeding
The number of participants who are exclusively breastfeeding at each time point.
At 1, 2, 3 and 6 months postpartum
Overall duration of any breastfeeding in each study groups
The number of participants who are any breastfeeding at each time point.
At 1, 2, 3 and 6 months postpartum
Secondary Outcomes (2)
Breastfeeding self-efficacy scores between the two study groups
baseline and 1 and 3 months postpartum
Infant feeding knowledge and attitude scores between the two study groups
baseline and 1 and 3 months postpartum
Study Arms (2)
EMI intervention group
EXPERIMENTALParticipants in the intervention group will receive instant messaging (i.e., an EMI delivery platform). Our multidisciplinary team, including an obstetrician, midwife, lactation consultant, biostatistician, and social psychologist, will develop a message library and protocol for EMI delivery.
Control group
NO INTERVENTIONParticipants in the control group will receive text messages containing general information on breastfeeding from the Hospital Authority, which is open to the public and includes reminder text messages of important follow-up surveys. Messages will not be personalised, and nurse-led real-time support messages will not be available.
Interventions
The EMI-I messages will be delivered in sequence over three months. The content, frequency, and timing of the messages will be determined by participant preferences, as determined during the baseline evaluation, as personalisation is central to such cognitive and behavioural changes. The messages will mainly be text-based, but other forms such as videos will also be used, depending on the needs of the participants.
The nurse will initiate 10-15-minute chats via an online platform (e.g., WhatsApp) after all instant messages for each session have been delivered. The nurse will guide the participants to set goals for breastfeeding. Any anticipated barriers will be discussed. The participants can also initiate the chats. While there is no limit to the number of chat messages, nurse-led real-time support messages will be provided during working hours (i.e., 9 am-6 pm on weekdays).
Eligibility Criteria
You may qualify if:
- be primiparous mothers
- have had a singleton pregnancy and live birth
- have birthed a full-term infant (37-42 weeks gestation)
- speak Cantonese
- be a Hong Kong resident
- have no serious medical or obstetrical complications and have not had their infant admitted to the neonatal intensive care unit (NICU)
You may not qualify if:
- is \< 37 weeks gestation
- has an Apgar score \< 8 at five minutes
- has a birthweight \< 2500 grams
- is born with any severe medical conditions or congenital malformations
- is placed in the special care nursery for more than 48 hours after delivery
- is placed in the intensive care nursery after delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kris YW Dr Lok, PhD
School of Nursing, HKU
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
April 22, 2024
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
June 20, 2026
Last Updated
March 5, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share