Breastfeeding, ExclusiveNCT04741425
Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes
A study testing REST intervention in people with Breastfeeding, Exclusive and Self Efficacy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Breastmilk is the best food for babies and exclusive breastfeeding is beneficial to mother-baby dyads. It is recommended to exclusively breastfeed babies till 6 months of age and continue with complementary food until aged 2 or above. 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, Exclusive, Self Efficacy
- What is being tested?
- REST intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Feb 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Hong Kong Chinese residents
- at the third trimester (≥32 weeks of gestation)
- aged ≥18 years
- having singleton pregnancy
- able to understand and write in Chinese and speak Cantonese
- delivered in the local public hospitals
- have access to Internet and able to use computer, smartphone or tablet.
Who cannot join
- having serious medical or obstetric complications such as hypertension and/or diabetes
- having psychiatric illness such as depression or schizophrenia
- not staying in Hong Kong for at least 6 months post-delivery
- having complicated delivery (e.g., instrumental or operative delivery, and/or postpartum hemorrhage)
- receiving pharmacological pain relief during their labor
- having baby admitted to the hospital during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes: A Randomised Controlled Trial
Breastmilk is the best food for babies and exclusive breastfeeding is beneficial to mother-baby dyads.
It is recommended to exclusively breastfeed babies till 6 months of age and continue with complementary food until aged 2 or above. This proposed study aims to establish and evaluate an effective intervention in sustaining exclusive breastfeeding among primiparous women up to 6 months postpartum.
Read the detailed description
World Health Organization suggests all infants should be exclusively breastfed for 6 months and continue with complementary food till 2 years old. Yet, the global exclusive breastfeeding rate at 6 months is only around 40%. As for Hong Kong, breastfeeding rate dropped substantially from 87% upon discharge to less than a half at 6 months postpartum and only one-third of women still exclusively breastfed their infants.
According to previous studies, women had early breastfeeding initiation or had breastfed their first child for at least 6 months were more likely to exclusively breastfeed the babies for longer time. However, mothers have early weaning easily due to inadequate breastfeeding knowledge/ skills, lack of lactation support or if they have specific characteristics like being hypertensive/ diabetic, primiparous or having complicated birthing experience. It was also found that maternal breastfeeding education, breastfeeding self-efficacy and their intention all affect the initiation and continuation of breastfeeding.
Among various promotional interventions, educational and supportive interventions were found to be effectively increased breastfeeding duration, while self-efficacy based intervention improved breastfeeding self-efficacy in the first 2 months but not on exclusive breastfeeding rates at 6 months postpartum. In addition, overall, there are inconsistent effects on educational and supportive interventions on breastfeeding outcomes, especially exclusive breastfeeding rate at 6 months postpartum. Also, most of the previous reviews did not focus on the primiparous women. And it is unclear the intervention effects on breastfeeding self-efficacy and exclusive breastfeeding rate of the first time mothers over 6-months.
As a result, a systematic review of 13 randomised controlled trials was done to identify effective approaches to educational and supportive interventions to improve breastfeeding in first time mothers up to at least 6-month postpartum. The result showed educational and supportive interventions were effective in increasing exclusive breastfeeding rate at ≤2 months \& 6 months, partial breastfeeding rate as well as breastfeeding self-efficacy at ≤2 months. The key components in breastfeeding promotion interventions, are those involved multicomponent (that is antenatal group education, postnatal individual breastfeeding coaching together with telephone follow-ups), breastfeeding self-efficacy theory-based that delivered across antenatal and postnatal period with ≥ 3 intervention sessions.
With the current COVID-19 pandemic, all face-to-face interventions in the hospitals are constrained. So the proposed study will be conducted by using Zoom platform and telephone follow-ups. There are one session of online antenatal breastfeeding talk, 5 times daily online postnatal breastfeeding coaching and 7 times weekly postnatal telephone follow-ups. The intervention will be guided by Dennis's breastfeeding self-efficacy framework.
This study aims to determine if a real-time online theory-based education and support plus telephone follow-ups programme (REST) for primiparous women in Hong Kong would increase their exclusive rate, breastfeeding self-efficacy, and other breastfeeding outcomes over 6-month postpartum.
- Conditions
- Breastfeeding, Exclusive, Self Efficacy
- Being tested
- REST intervention
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REST interventionOther
The breastfeeding talk will be conducted by Zoom at the third trimester about breastfeeding benefits and other practical advices. There is also a sharing session by a successful breastfeeding mother and a group discussion with different breastfeeding scenarios.
Once the mothers return home after delivery, individualized breastfeeding coaching will be provided by PI through a daily Zoom videoconference within 24 hours upon hospital discharge till Day 7 after delivery.
During the last breastfeeding videoconference, mothers will be reminded to have weekly telephone follow-ups by PI from week 2 to 2 months postpartum.
Women who are randomised into the intervention group will receive REST in addition to the standard antenatal and postnatal care (described at below) by the Obstetrics Department of their delivery hospitals.
| Study group | Role | What they receive |
|---|---|---|
| REST intervention | Experimental | There will be one session of online antenatal breastfeeding talk, 5 sessions of daily online postnatal individualized breastfeeding coaching, and 7 weekly postnatal telephone follow-ups. Receives: Other: REST intervention |
| Usual care | No intervention | Standard antenatal and postnatal care provided by midwives and lactation consultants in the hospitals through by Zoom or by online self-learning through watching videos and reading pamphlets. Participants can also attend other breastfeeding talks or breastfeeding support groups provided by the non-governmental organizations for maternal care. After delivery, mothers will be taught about baby care at bedside. Breastfeeding skills will also be taught and assessed by the midwives and lactation consultants individually or in group-based breastfeeding talk in the postnatal ward. Upon discharge, a breastfeeding and postnatal hotline will be provided to all women for advices, and a telephone follow-up will be arranged for all the mothers within 3 to 4 days after delivery by midwives or lactation consultants. The mother-baby dyads will be suggested to follow up in MCHCs for baby growth and breastfeeding support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding rate (number of Infants who have only received breastmilk or expressed breastmilk, and no other liquids or solids except vitamins, mineral supplement and medicines) by self-developed postnatal questionnaires
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Measured: At 2 months postpartum (immediately post-intervention)
Exclusive breastfeeding rate (number of Infants who have only received breastmilk or expressed breastmilk, and no other liquids or solids except vitamins, mineral supplement and medicines) by self-developed postnatal questionnaires
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Measured: At 6 months postpartum
Change of breastfeeding self-efficacy (mothers' confidence in their abilities to breastfeed their babies) by the Chinese Hong Kong version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) from baseline to 6 months after delivery
BSES-SF is a 14-item scale with 5-point Likert scale. Total score ranged from 14 to 70 and higher score indicates higher breastfeeding self-efficacy. and the results will be presented as BSES-SF mean scores which are measured by Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) (Dennis, 2003)
Measured: At baseline, 2 months (immediately post-intervention) and 6 months postpartum
Secondary outcomes (5)
Partial breastfeeding rate (number of infants who have been fed with breastmilk together with formula milk or other food/ liquids) by self-developed postnatal questionnaires
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Measured: At 2 months and 6 months postpartum
Breastfeeding initiation rate (number of mothers initiate breastfeeding within 1st hour of delivery) by self-developed postnatal questionnaire
The self-developed postnatal questionnaire are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Measured: At 2 months postpartum
Exclusive breastfeeding duration (total length of time on exclusive breastfeeding) by self-developed postnatal questionnaires
The self-developed postnatal questionnaire are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Measured: At 2 months and 6 months postpartum
Maternal postnatal depression score by the Chinese version of Edinburgh Postnatal Depression Scale (EPDS)
Maternal postnatal depression is one kind of mood disorder, which commonly occurs after the birth of a baby.
In EPDS, there are 10 questions with a total score of 0 to 30. Risk of postnatal depression was defined as EPDS score ≥10, and higher score indicates higher risk of a women suffering from postnatal depression.
Measured: At 2 months and 6 months postpartum
Infant's morbidity (total number of infants getting sick and the types of infectious diseases that requires medical checkup) by self-developed postnatal questionnaires
The medical diseases to be estimated for these morbidities are limited to infectious diseases including respiratory, ear and gastrointestinal infection.
The self-developed postnatal questionnaire are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Measured: At 2 months and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start9 Feb 2021
- Primary completion31 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WONG Mei Sze, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741425
- Sponsor's protocol ID
- 2020.577
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong MS, Chien WT. Effects of an Online Theory-Based Educational Programme for Primiparous Women on Improving Breastfeeding-Related Outcomes: A Randomised Controlled Trial. Scand J Caring Sci. 2025 Mar;39(1):e13320. doi: 10.1111/scs.13320.
PubMed 39865520Wong MS, Chien WT. A Pilot Randomized Controlled Trial of an Online Educational Program for Primiparous Women to Improve Breastfeeding. J Hum Lact. 2023 Feb;39(1):107-118. doi: 10.1177/08903344221125129. Epub 2022 Oct 3.
PubMed 36189735
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04741425
- Acronym / sponsor ID
- 2020.577
- Conditions
- Breastfeeding, Exclusive, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 5 Feb 2021 (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.
Breastmilk is the best food for babies and exclusive breastfeeding is beneficial to mother-baby dyads.
It is recommended to exclusively breastfeed babies till 6 months of age and continue with complementary food until aged 2 or above. This proposed study aims to establish and evaluate an effective intervention in sustaining exclusive breastfeeding among primiparous women up to 6 months postpartum.
Detailed description
World Health Organization suggests all infants should be exclusively breastfed for 6 months and continue with complementary food till 2 years old. Yet, the global exclusive breastfeeding rate at 6 months is only around 40%. As for Hong Kong, breastfeeding rate dropped substantially from 87% upon discharge to less than a half at 6 months postpartum and only one-third of women still exclusively breastfed their infants.
According to previous studies, women had early breastfeeding initiation or had breastfed their first child for at least 6 months were more likely to exclusively breastfeed the babies for longer time. However, mothers have early weaning easily due to inadequate breastfeeding knowledge/ skills, lack of lactation support or if they have specific characteristics like being hypertensive/ diabetic, primiparous or having complicated birthing experience. It was also found that maternal breastfeeding education, breastfeeding self-efficacy and their intention all affect the initiation and continuation of breastfeeding.
Among various promotional interventions, educational and supportive interventions were found to be effectively increased breastfeeding duration, while self-efficacy based intervention improved breastfeeding self-efficacy in the first 2 months but not on exclusive breastfeeding rates at 6 months postpartum. In addition, overall, there are inconsistent effects on educational and supportive interventions on breastfeeding outcomes, especially exclusive breastfeeding rate at 6 months postpartum. Also, most of the previous reviews did not focus on the primiparous women. And it is unclear the intervention effects on breastfeeding self-efficacy and exclusive breastfeeding rate of the first time mothers over 6-months.
As a result, a systematic review of 13 randomised controlled trials was done to identify effective approaches to educational and supportive interventions to improve breastfeeding in first time mothers up to at least 6-month postpartum. The result showed educational and supportive interventions were effective in increasing exclusive breastfeeding rate at ≤2 months \& 6 months, partial breastfeeding rate as well as breastfeeding self-efficacy at ≤2 months. The key components in breastfeeding promotion interventions, are those involved multicomponent (that is antenatal group education, postnatal individual breastfeeding coaching together with telephone follow-ups), breastfeeding self-efficacy theory-based that delivered across antenatal and postnatal period with ≥ 3 intervention sessions.
With the current COVID-19 pandemic, all face-to-face interventions in the hospitals are constrained. So the proposed study will be conducted by using Zoom platform and telephone follow-ups. There are one session of online antenatal breastfeeding talk, 5 times daily online postnatal breastfeeding coaching and 7 times weekly postnatal telephone follow-ups. The intervention will be guided by Dennis's breastfeeding self-efficacy framework.
This study aims to determine if a real-time online theory-based education and support plus telephone follow-ups programme (REST) for primiparous women in Hong Kong would increase their exclusive rate, breastfeeding self-efficacy, and other breastfeeding outcomes over 6-month postpartum.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REST intervention | Experimental | Other: REST interventionThere will be one session of online antenatal breastfeeding talk, 5 sessions of daily online postnatal individualized breastfeeding coaching, and 7 weekly postnatal telephone follow-ups. |
| Usual care | No intervention | –Standard antenatal and postnatal care provided by midwives and lactation consultants in the hospitals through by Zoom or by online self-learning through watching videos and reading pamphlets. Participants can also attend other breastfeeding talks or breastfeeding support groups provided by the non-governmental organizations for maternal care. After delivery, mothers will be taught about baby care at bedside. Breastfeeding skills will also be taught and assessed by the midwives and lactation consultants individually or in group-based breastfeeding talk in the postnatal ward. Upon discharge, a breastfeeding and postnatal hotline will be provided to all women for advices, and a telephone follow-up will be arranged for all the mothers within 3 to 4 days after delivery by midwives or lactation consultants. The mother-baby dyads will be suggested to follow up in MCHCs for baby growth and breastfeeding support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hong Kong Chinese residents
- at the third trimester (≥32 weeks of gestation)
- aged ≥18 years
- having singleton pregnancy
- able to understand and write in Chinese and speak Cantonese
Key exclusion criteria (6 listed)
- having serious medical or obstetric complications such as hypertension and/or diabetes
- having psychiatric illness such as depression or schizophrenia
- not staying in Hong Kong for at least 6 months post-delivery
- having complicated delivery (e.g., instrumental or operative delivery, and/or postpartum hemorrhage)
- receiving pharmacological pain relief during their labor
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 |
|---|---|---|
| REST interventionThe breastfeeding talk will be conducted by Zoom at the third trimester about breastfeeding benefits and other practical advices. There is also a sharing session by a successful breastfeeding mother and a group discussion with different breastfeeding scenarios. Once the mothers return home after delivery, individualized breastfeeding coaching will be provided by PI through a daily Zoom videoconference within 24 hours upon hospital discharge till Day 7 after delivery. During the last breastfeeding videoconference, mothers will be reminded to have weekly telephone follow-ups by PI from week 2 to 2 months postpartum. Women who are randomised into the intervention group will receive REST in addition to the standard antenatal and postnatal care (described at below) by the Obstetrics Department of their delivery hospitals. | Other | REST intervention |
Primary outcome
Exclusive breastfeeding rate (number of Infants who have only received breastmilk or expressed breastmilk, and no other liquids or solids except vitamins, mineral supplement and medicines) by self-developed postnatal questionnaires
Time frame: At 2 months postpartum (immediately post-intervention)
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Exclusive breastfeeding rate (number of Infants who have only received breastmilk or expressed breastmilk, and no other liquids or solids except vitamins, mineral supplement and medicines) by self-developed postnatal questionnaires
Time frame: At 6 months postpartum
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Change of breastfeeding self-efficacy (mothers' confidence in their abilities to breastfeed their babies) by the Chinese Hong Kong version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) from baseline to 6 months after delivery
Time frame: At baseline, 2 months (immediately post-intervention) and 6 months postpartum
BSES-SF is a 14-item scale with 5-point Likert scale. Total score ranged from 14 to 70 and higher score indicates higher breastfeeding self-efficacy. and the results will be presented as BSES-SF mean scores which are measured by Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) (Dennis, 2003)
5 secondary outcomes
Partial breastfeeding rate (number of infants who have been fed with breastmilk together with formula milk or other food/ liquids) by self-developed postnatal questionnaires
Time frame: At 2 months and 6 months postpartum
Breastfeeding initiation rate (number of mothers initiate breastfeeding within 1st hour of delivery) by self-developed postnatal questionnaire
Time frame: At 2 months postpartum
Exclusive breastfeeding duration (total length of time on exclusive breastfeeding) by self-developed postnatal questionnaires
Time frame: At 2 months and 6 months postpartum
Maternal postnatal depression score by the Chinese version of Edinburgh Postnatal Depression Scale (EPDS)
Time frame: At 2 months and 6 months postpartum
Infant's morbidity (total number of infants getting sick and the types of infectious diseases that requires medical checkup) by self-developed postnatal questionnaires
Time frame: At 2 months and 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 39865520Wong MS, Chien WT. Effects of an Online Theory-Based Educational Programme for Primiparous Women on Improving Breastfeeding-Related Outcomes: A Randomised Controlled Trial. Scand J Caring Sci. 2025 Mar;39(1):e13320. doi: 10.1111/scs.13320.
- Derived from this study: PubMed 36189735Wong MS, Chien WT. A Pilot Randomized Controlled Trial of an Online Educational Program for Primiparous Women to Improve Breastfeeding. J Hum Lact. 2023 Feb;39(1):107-118. doi: 10.1177/08903344221125129. Epub 2022 Oct 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REST intervention in people with Breastfeeding, Exclusive and Self Efficacy, run by Chinese University of Hong Kong at 1 site 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 7 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exclusive breastfeeding rate (number of Infants who have only received breastmilk or expressed breastmilk, and no other liquids or solids except vitamins, mineral supplement and medicines) by self-developed postnatal questionnaires (time frame: At 2 months postpartum (immediately post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741425, which also lists 2 linked publications.
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 8 Feb 2023.