BreastfeedingNCT06058871
Ecological Momentary Breastfeeding Intervention
A study testing Regular messages and Nurse-led real-time support messages (chat type) in people with Breastfeeding, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Regular messages and Nurse-led real-time support messages (chat type)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 2 sitesHong Kong
- Study dates
- 22 Apr 2024to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Elizabeth Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
Official title: Ecological Momentary Breastfeeding Intervention to Improve Breastfeeding Outcomes: a Randomized Controlled Trial
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.
Read the detailed description
It is well recognised that breastfeeding is extremely beneficial for child survival, growth, and maternal health and is one of the most effective health interventions for preventing infant and child mortality and promoting lifelong maternal health. In addition, breastfeeding provides significant economic benefits and improves health equity in society. In Hong Kong, data from 2021 shows only 22% of women exclusively breastfeed until six months postpartum, significantly less than both the average global rate of 38% and the World Health Organization (WHO) 2025 target of 50%. Some of the common reasons cited by mothers for early weaning relate to breastfeeding problems that are easily avoided with appropriate early professional support, such as perceived insufficient milk, poor latching and sore breasts. Timely breastfeeding support could therefore promote exclusive breastfeeding. However, such support is often inadequate and has been difficult to obtain during the recent COVID-19 pandemic. In addition, mothers in Hong Kong may find it difficult to leave home during the early postpartum period due to the overwhelming workload and the cultural tradition practice of 'doing the month' in which women remain housebound during the first month postpartum. Therefore, it is be important to provide adequate support to mothers in Hong Kong to ensure that breastfeeding can continue for the optimal duration, thereby providing life-long protection for both mother and infant.
Social cognitive theory (SCT) is widely used to analyse behavioural changes in breastfeeding in response to technology-guided interventions. The investigators will use SCT as a theoretical framework to guide the development of a message library and the delivery of both regular and chat-style support messages. The increased accessibility of an Internet-delivered intervention provides a way to promote each mother's sense of agency by enabling them to access the support they require when they need it. As more people turn to eHealth, the development of an Internet-delivered SCT-based intervention (iSCT-I) to support and educate women may provide a cost-effective way to increase breastfeeding rates. Moreover, the WHO has concluded that will not be possible to reach universal health care coverage without investing in, and broadly adopting, eHealth. EMI is a cost-effective intervention framework that allows personalisation of both the content and delivery method, it can therefore provide a practical and effective strategy for delivering iSCT-I for improving breastfeeding duration and uptake. However, there have been no previous studies of EMI-based breastfeeding interventions. Therefore, the investigators propose an RCT to evaluate the effectiveness of EMI-delivered iSCT-I; a real-time, personalized, and cost-effective approach for improving exclusive breastfeeding rates.
This multi-center randomized control trial adopts two arm design to examine and compare the effects between ecological momentary intervention and usual care to improve breastfeeding outcomes. The study hypotheses are (1) Primiparous mothers who receive an EMI-based breastfeeding intervention will significantly increase their exclusive breastfeeding intention and duration, and (2) The intervention group will have a higher breastfeeding self-efficacy score (BSES) and breastfeeding knowledge and attitude scores at three months postpartum.
A pilot study will be conducted. Aiming to recruit 20 participants. (10:Intervention; 10 Control)
- Conditions
- Breastfeeding
- Being tested
- Regular messages, Nurse-led real-time support messages (chat type)
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular messagesBehavioural
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.
Nurse-led real-time support messages (chat type)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| EMI intervention group | Experimental | Participants 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. Receives: Behavioral: Regular messages; Behavioral: Nurse-led real-time support messages (chat type) |
| Control group | No intervention | Participants 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants in each study groups exclusively breastfeeding
The number of participants who are exclusively breastfeeding at each time point.
Measured: 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.
Measured: At 1, 2, 3 and 6 months postpartum
Secondary outcomes (2)
Breastfeeding self-efficacy scores between the two study groups
Breastfeeding efficacy measured using Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). BSES-SF is a 14-item scale with total score ranging from 14 to 70. A higher score indicates higher breastfeeding self-efficacy.
Measured: baseline and 1 and 3 months postpartum
Infant feeding knowledge and attitude scores between the two study groups
Attitude towards breastfeeding measured using the Iowa Infant Feeding Attitude Scale (IIFAS). IIFAS is a 17-item scale with total score ranging from 17 to 85. A higher score indicates a more favorable attitude towards breastfeeding.
Measured: baseline and 1 and 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start22 Apr 2024
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kris YW Dr Lok, PhD, Principal investigator, School of Nursing, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058871
- Sponsor's protocol ID
- EMB-RCT1
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecological Momentary Breastfeeding Intervention to Improve Breastfeeding Outcomes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06058871
- Acronym / sponsor ID
- EMB-RCT1
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is well recognised that breastfeeding is extremely beneficial for child survival, growth, and maternal health and is one of the most effective health interventions for preventing infant and child mortality and promoting lifelong maternal health. In addition, breastfeeding provides significant economic benefits and improves health equity in society. In Hong Kong, data from 2021 shows only 22% of women exclusively breastfeed until six months postpartum, significantly less than both the average global rate of 38% and the World Health Organization (WHO) 2025 target of 50%. Some of the common reasons cited by mothers for early weaning relate to breastfeeding problems that are easily avoided with appropriate early professional support, such as perceived insufficient milk, poor latching and sore breasts. Timely breastfeeding support could therefore promote exclusive breastfeeding. However, such support is often inadequate and has been difficult to obtain during the recent COVID-19 pandemic. In addition, mothers in Hong Kong may find it difficult to leave home during the early postpartum period due to the overwhelming workload and the cultural tradition practice of 'doing the month' in which women remain housebound during the first month postpartum. Therefore, it is be important to provide adequate support to mothers in Hong Kong to ensure that breastfeeding can continue for the optimal duration, thereby providing life-long protection for both mother and infant.
Social cognitive theory (SCT) is widely used to analyse behavioural changes in breastfeeding in response to technology-guided interventions. The investigators will use SCT as a theoretical framework to guide the development of a message library and the delivery of both regular and chat-style support messages. The increased accessibility of an Internet-delivered intervention provides a way to promote each mother's sense of agency by enabling them to access the support they require when they need it. As more people turn to eHealth, the development of an Internet-delivered SCT-based intervention (iSCT-I) to support and educate women may provide a cost-effective way to increase breastfeeding rates. Moreover, the WHO has concluded that will not be possible to reach universal health care coverage without investing in, and broadly adopting, eHealth. EMI is a cost-effective intervention framework that allows personalisation of both the content and delivery method, it can therefore provide a practical and effective strategy for delivering iSCT-I for improving breastfeeding duration and uptake. However, there have been no previous studies of EMI-based breastfeeding interventions. Therefore, the investigators propose an RCT to evaluate the effectiveness of EMI-delivered iSCT-I; a real-time, personalized, and cost-effective approach for improving exclusive breastfeeding rates.
This multi-center randomized control trial adopts two arm design to examine and compare the effects between ecological momentary intervention and usual care to improve breastfeeding outcomes. The study hypotheses are (1) Primiparous mothers who receive an EMI-based breastfeeding intervention will significantly increase their exclusive breastfeeding intention and duration, and (2) The intervention group will have a higher breastfeeding self-efficacy score (BSES) and breastfeeding knowledge and attitude scores at three months postpartum.
A pilot study will be conducted. Aiming to recruit 20 participants. (10:Intervention; 10 Control)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMI intervention group | Experimental | Behavioral: Regular messages, Behavioral: Nurse-led real-time support messages (chat type)Participants 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 intervention | –Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular messagesThe 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. | Behavioural | EMI intervention group |
| Nurse-led real-time support messages (chat type)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). | Behavioural | EMI intervention group |
Primary outcome
Proportion of participants in each study groups exclusively breastfeeding
Time frame: At 1, 2, 3 and 6 months postpartum
The number of participants who are exclusively breastfeeding at each time point.
Overall duration of any breastfeeding in each study groups
Time frame: At 1, 2, 3 and 6 months postpartum
The number of participants who are any breastfeeding at each time point.
2 secondary outcomes
Breastfeeding self-efficacy scores between the two study groups
Time frame: baseline and 1 and 3 months postpartum
Infant feeding knowledge and attitude scores between the two study groups
Time frame: baseline and 1 and 3 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris YW Dr Lok, PhD principal investigator
School of Nursing, HKU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular messages and Nurse-led real-time support messages (chat type) in people with Breastfeeding, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants in each study groups exclusively breastfeeding (time frame: At 1, 2, 3 and 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.