BreastfeedingNCT05851651
Gestational Diabetes and Antenatal Human Milk Expression
A study testing Antenatal milk expression and breastfeeding self-efficacy enhancement in people with Breastfeeding, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
Exclusive breastfeeding is global recognized as the optimal infant feeding. Hong Kong is committed to promoting, protecting and supporting the global movement for successful breastfeeding. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Antenatal milk expression and breastfeeding self-efficacy enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 2 sitesHong Kong
- Study dates
- 10 May 2023to 10 May 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed gestational diabetes without on insulin
- can read and speak Chinese
- Hong Kong resident and stay in Hong Kong after delivery
- no serious medical or obstetrical complications
- no mental health illness or history
- have regular antenatal check-up
Show all 10Show fewer
- singleton pregnancy
- primiparous or multiparous women
- intention to breastfeed
- pre-pregnancy BMI<25
Who cannot join
- do not have Hong Kong Identify Card
- breastfeeding elder child at pregnancy
- cannot understand the study
- give birth <37 weeks of gestation
- a known fetal anomaly or any suspicion of fetal compromise
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Kwong Wah Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
About this study
Official title: The Effects and Experience of a Gestational Diabetes and Antenatal Human Milk Expression (GAME) Programme in Hong Kong Chinese Women
Exclusive breastfeeding is global recognized as the optimal infant feeding. Hong Kong is committed to promoting, protecting and supporting the global movement for successful breastfeeding. Exclusive breastfeeding is especially strongly recommended and supported to the maternal history of Gestational Diabetes Mellitus (GDM). This study aims to examine the acceptability and feasibility of Antenatal human milk expression (AME) as breastfeeding intervention to improve breastfeeding for GDM women. The efficacy of AME practice on the breastfeeding exclusivity will also be investigated. It is hypothesized that AME will increase breastfeeding exclusivity compare with women receiving standard care, and will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth.
Read the detailed description
The incidence of GDM has been increasing worldwide and varied globally. Women with previous GDM have a 7-fold higher risk of developing diabetes mellitus over their lifetime. It has emerged global public health concern. Studies found that women with GDM breastfeed her baby significantly reduce the risk of Type 2 Diabetes and cardiometabolic disease, and improve postpartum glucose metabolism. However, evidence shows that GDM women have breastfeeding challenges and barriers. Women with diabetes experience delay in lactogenesis and infant have increased risk hypoglycaemia, they require blood monitoring and are often admit to the neonatal unit. As a result, the infants are more likely to have early receiving of formula supplementation. Besides, evidence indicated that low maternal confidence, increase depressive symptoms and breastfeeding self-efficacy among GDM women. Therefore, early lactation support was necessary. Greater support for GDM women reduces the risks of hypoglycaemia, formula supplementation and early weaning. It has been proposed that hand expression of breast milk in pregnancy may promote breastfeeding. Mothers with diabetes can express colostrum antenatally for use rather than infant formula if necessary.
Though Antenatal Milk Expression (AME) advises women at risk of early lactation problems, very limited evidence regarding the safety and efficacy of the practice. Also, very limited evidence investigated the AME for diabetes women for improving infant outcomes. Few studies found that AME increased confidence and contributed to better preparation on breastfeeding, but AME on depressive symptoms is under examined.
In Hong Kong, AME is not widely practice with inconsistent advice. It may raise concern on culture diversity regarding conservative culture in Chinese. There is lack of local article on the feasibility and acceptability of AME practice for GDM women in Hong Kong. Local clinical protocol on the implementation of AME and instructions on the practice is also absent. Given cultural differences in breastfeeding motivation and self-regulation as compared with those of oversea countries, the motivation of Hong Kong pregnant women engages in antenatal education and receiving social and breastfeeding support may be differ from women in the West. Thus, it is important to evaluate the efficacy and experience of AME on Hong Kong Chinese to assess cultural acceptability and effectiveness in supporting baby-friendly hospital practice and breastfeeding continuation.
Limited qualitative study compares breastfeeding self-efficacy on GDM women and positive impacts of the self-efficacy on breastfeeding prevalence and duration. Besides, qualitative study on the experiences and perceptions of GDM women on breastfeeding, and the experience on the collection and storage of expressed colostrum are very rare.
This blocked randomized, parallel-armed controlled trial with mixed method study design which integrating with quantitative and qualitative study will be conducted to examine (1) the acceptability and feasibility of AME as breastfeeding intervention to improve breastfeeding for GDM women, how and why AME works or does not work using qualitative research; (2) to understand the experience and perceptions of antenatal milk expression among the GDM women and (3) to investigate the efficacy of AME practice on the breastfeeding exclusivity. The secondary aims are determining whether AME as mediating variables in the effect on the breastfeeding self-efficacy among Hong Kong GDM women in Hong Kong.
The study hypotheses are (1) Antenatal human milk expression (AME) will increase breastfeeding exclusivity on hospital discharge, at 4 weeks and 8 weeks postpartum compare women receiving standard care (2) AME will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth.
- Conditions
- Breastfeeding
- Being tested
- Antenatal milk expression and breastfeeding self-efficacy enhancement
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal milk expression and breastfeeding self-efficacy enhancementBehavioural
A face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation will be arranged. The session will approximately last for 45minutes. GDM leaflet and GAME fact sheet are used to facilitate the teaching. The benefits of breastfeeding for women with GDM will be addressed. Maternal metabolic control, calories consumed, and weight loss are addressed for the extra benefits of breastfeeding for GDM women. The possible challenges of GDM on breastfeeding will be supported. The antenatal human milk expression will be taught by International Board-Certified Lactation Consultant. Participants will be encouraged to express colostrum twice daily for up to 10 minutes until admitted to hospital to give birth. They will receive a weekly phone follows up from 38 weeks before delivery and they can contact the researcher by phone in the information sheet if any questions.
| Study group | Role | What they receive |
|---|---|---|
| Standard care plus an antenatal milk expression education | Experimental | Participants will have one face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation and telephone follow-up weekly till delivery. Receives: Behavioral: Antenatal milk expression and breastfeeding self-efficacy enhancement |
| Standard hospital antenatal care | No intervention | Participants will receive standard care include prenatal breastfeeding education at gestation of 24-36 weeks same as intervention group. They will not discuss about antenatal milk expression, breastfeeding self-efficacy and the effects of breastfeeding on GDM women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Feeding pattern
Exclusive breastfeeding prevalence
Measured: At 4 weeks postpartum
Infant Feeding pattern
Exclusive breastfeeding prevalence
Measured: At 8 weeks postpartum
Secondary outcomes (4)
Women's self-determination toward breastfeeding
Chinese Breastfeeding Self -Regulation Questionnaire is a psychometric tested valid and reliable tool to measure maternal self-determination towards breastfeeding. The Cronbach's alpha of the BSRQ was 0.86. For every one-point increase in the BSRQ score, participants had 15% higher odds of any breastfeeding (OR=1.15, 95%CI 1.07-1.23) and 9% higher odds of exclusive breastfeeding (OR=1.09, 95%CI 1.02-1.17) at 6 weeks postpartum.
Measured: At baseline, 4 weeks and 8 weeks postpartum
Women's self-efficacy in breastfeeding
Breastfeeding Self-Efficacy Scale-Short Form is used to measure maternal breastfeed confidence during postpartum. This instrument consists of 14 items, ranging from 1 = 'Not at all confident' to 5= 'Very confident.' The summary score from 14 to 70 is created by adding 14 items. The scale is psychometrically tested, demonstrates a consistent high reliability and validity. Low breastfeeding self- efficacy is significant predictor of early attrition of breastfeeding.
Measured: At baseline, 4 weeks and 8 weeks postpartum
Women's perinatal/postnatal depression
Edinburgh Perinatal/Postnatal Depression Scale is used during antepartum and postpartum. It consist of 10 items include anxiety and depressive and symptoms; cut-off point is 9/10. It has a sensitivity of 0.86 and specificity of 0.78 with a positive predictive value of 73%. It psychometrically tested, high reliability and validity for perinatal and at 6 weeks postpartum. Successful breastfeeding is predictive of lower maternal depressive symptomology.
Measured: At baseline, 4 weeks and 8 weeks postpartum
Women's prevalence of Impaired Glucose Tolerance
Prevalence of IGT among participants according to breastfeeding status (any breastfeeding or exclusive formula feeding) will be collected from medical record for the fasting blood sugar testing at 6 weeks postpartum.
Measured: At 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start10 May 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Ngai Ms Leung, MPH, Principal investigator, Department of Obstetrics and Gynaecology, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851651
- Sponsor's protocol ID
- GAME
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung YN, Chau PH, Dai Y, Lam CCO, Leung WC, Lok KYW. The Gestational Diabetes Antenatal Milk Expression (GAME) trial: effects on breastfeeding outcomes and maternal mental health-A randomised controlled trial. EClinicalMedicine. 2026 Aug 5;98:104130. doi: 10.1016/j.eclinm.2026.104130. eCollection 2026 Aug.
PubMed 42592109
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Experience of a Gestational Diabetes and Antenatal Human Milk Expression (GAME) Programme in Hong Kong Chinese Women
- ClinicalTrials.gov ID
- NCT05851651
- Acronym / sponsor ID
- GAME
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 10 May 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.
Exclusive breastfeeding is global recognized as the optimal infant feeding. Hong Kong is committed to promoting, protecting and supporting the global movement for successful breastfeeding. Exclusive breastfeeding is especially strongly recommended and supported to the maternal history of Gestational Diabetes Mellitus (GDM). This study aims to examine the acceptability and feasibility of Antenatal human milk expression (AME) as breastfeeding intervention to improve breastfeeding for GDM women. The efficacy of AME practice on the breastfeeding exclusivity will also be investigated. It is hypothesized that AME will increase breastfeeding exclusivity compare with women receiving standard care, and will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth.
Detailed description
The incidence of GDM has been increasing worldwide and varied globally. Women with previous GDM have a 7-fold higher risk of developing diabetes mellitus over their lifetime. It has emerged global public health concern. Studies found that women with GDM breastfeed her baby significantly reduce the risk of Type 2 Diabetes and cardiometabolic disease, and improve postpartum glucose metabolism. However, evidence shows that GDM women have breastfeeding challenges and barriers. Women with diabetes experience delay in lactogenesis and infant have increased risk hypoglycaemia, they require blood monitoring and are often admit to the neonatal unit. As a result, the infants are more likely to have early receiving of formula supplementation. Besides, evidence indicated that low maternal confidence, increase depressive symptoms and breastfeeding self-efficacy among GDM women. Therefore, early lactation support was necessary. Greater support for GDM women reduces the risks of hypoglycaemia, formula supplementation and early weaning. It has been proposed that hand expression of breast milk in pregnancy may promote breastfeeding. Mothers with diabetes can express colostrum antenatally for use rather than infant formula if necessary.
Though Antenatal Milk Expression (AME) advises women at risk of early lactation problems, very limited evidence regarding the safety and efficacy of the practice. Also, very limited evidence investigated the AME for diabetes women for improving infant outcomes. Few studies found that AME increased confidence and contributed to better preparation on breastfeeding, but AME on depressive symptoms is under examined.
In Hong Kong, AME is not widely practice with inconsistent advice. It may raise concern on culture diversity regarding conservative culture in Chinese. There is lack of local article on the feasibility and acceptability of AME practice for GDM women in Hong Kong. Local clinical protocol on the implementation of AME and instructions on the practice is also absent. Given cultural differences in breastfeeding motivation and self-regulation as compared with those of oversea countries, the motivation of Hong Kong pregnant women engages in antenatal education and receiving social and breastfeeding support may be differ from women in the West. Thus, it is important to evaluate the efficacy and experience of AME on Hong Kong Chinese to assess cultural acceptability and effectiveness in supporting baby-friendly hospital practice and breastfeeding continuation.
Limited qualitative study compares breastfeeding self-efficacy on GDM women and positive impacts of the self-efficacy on breastfeeding prevalence and duration. Besides, qualitative study on the experiences and perceptions of GDM women on breastfeeding, and the experience on the collection and storage of expressed colostrum are very rare.
This blocked randomized, parallel-armed controlled trial with mixed method study design which integrating with quantitative and qualitative study will be conducted to examine (1) the acceptability and feasibility of AME as breastfeeding intervention to improve breastfeeding for GDM women, how and why AME works or does not work using qualitative research; (2) to understand the experience and perceptions of antenatal milk expression among the GDM women and (3) to investigate the efficacy of AME practice on the breastfeeding exclusivity. The secondary aims are determining whether AME as mediating variables in the effect on the breastfeeding self-efficacy among Hong Kong GDM women in Hong Kong.
The study hypotheses are (1) Antenatal human milk expression (AME) will increase breastfeeding exclusivity on hospital discharge, at 4 weeks and 8 weeks postpartum compare women receiving standard care (2) AME will improve the breastfeeding self-efficacy and reduce depressive symptoms of women after birth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care plus an antenatal milk expression education | Experimental | Behavioral: Antenatal milk expression and breastfeeding self-efficacy enhancementParticipants will have one face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation and telephone follow-up weekly till delivery. |
| Standard hospital antenatal care | No intervention | –Participants will receive standard care include prenatal breastfeeding education at gestation of 24-36 weeks same as intervention group. They will not discuss about antenatal milk expression, breastfeeding self-efficacy and the effects of breastfeeding on GDM women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- diagnosed gestational diabetes without on insulin
- can read and speak Chinese
- Hong Kong resident and stay in Hong Kong after delivery
- no serious medical or obstetrical complications
- no mental health illness or history
Key exclusion criteria (5 listed)
- do not have Hong Kong Identify Card
- breastfeeding elder child at pregnancy
- cannot understand the study
- give birth <37 weeks of gestation
- a known fetal anomaly or any suspicion of fetal compromise
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 |
|---|---|---|
| Antenatal milk expression and breastfeeding self-efficacy enhancementA face-to-face breastfeeding education in lactation clinic at 37 weeks of gestation will be arranged. The session will approximately last for 45minutes. GDM leaflet and GAME fact sheet are used to facilitate the teaching. The benefits of breastfeeding for women with GDM will be addressed. Maternal metabolic control, calories consumed, and weight loss are addressed for the extra benefits of breastfeeding for GDM women. The possible challenges of GDM on breastfeeding will be supported. The antenatal human milk expression will be taught by International Board-Certified Lactation Consultant. Participants will be encouraged to express colostrum twice daily for up to 10 minutes until admitted to hospital to give birth. They will receive a weekly phone follows up from 38 weeks before delivery and they can contact the researcher by phone in the information sheet if any questions. | Behavioural | Standard care plus an antenatal milk expression education |
Primary outcome
Infant Feeding pattern
Time frame: At 4 weeks postpartum
Exclusive breastfeeding prevalence
Infant Feeding pattern
Time frame: At 8 weeks postpartum
Exclusive breastfeeding prevalence
4 secondary outcomes
Women's self-determination toward breastfeeding
Time frame: At baseline, 4 weeks and 8 weeks postpartum
Women's self-efficacy in breastfeeding
Time frame: At baseline, 4 weeks and 8 weeks postpartum
Women's perinatal/postnatal depression
Time frame: At baseline, 4 weeks and 8 weeks postpartum
Women's prevalence of Impaired Glucose Tolerance
Time frame: At 6 weeks 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 19 Sep 2024.
- Derived from this study: PubMed 42592109Leung YN, Chau PH, Dai Y, Lam CCO, Leung WC, Lok KYW. The Gestational Diabetes Antenatal Milk Expression (GAME) trial: effects on breastfeeding outcomes and maternal mental health-A randomised controlled trial. EClinicalMedicine. 2026 Aug 5;98:104130. doi: 10.1016/j.eclinm.2026.104130. eCollection 2026 Aug.
- 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.
Yu Ngai Ms Leung, MPH principal investigator
Department of Obstetrics and Gynaecology, Kwong Wah Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal milk expression and breastfeeding self-efficacy enhancement 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 10 inclusion and 5 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 19 Sep 2024. 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?
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?
Infant Feeding pattern (time frame: At 4 weeks 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?
On the ClinicalTrials.gov record for NCT05851651, which also lists 1 linked publication.
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 19 Sep 2024.