Breast Feeding, ExclusiveNCT05109988
Father-involvement Telephone Support Intervention on Breastfeeding: RCT
A study testing Breastfeeding telephone support in people with Breast Feeding, Exclusive and Parents, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The World Health Organization advocates for breastfeeding as the best source of food for optimal infant development, which reduces the risk of infant mortality and morbidity. The objectives of this study are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Feeding, Exclusive, Parents
- What is being tested?
- Breastfeeding telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Apr 2022to 28 Jul 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or above;
- giving birth to a single healthy baby at term
- ability to speak and read the Chinese language
Who cannot join
- psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Father-involvement Breastfeeding Telephone Support Intervention on Exclusive and Sustained Breastfeeding: A Randomized Controlled Trial.
The World Health Organization advocates for breastfeeding as the best source of food for optimal infant development, which reduces the risk of infant mortality and morbidity. The objectives of this study are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding. The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. We expect that women who receive the intervention will have a higher rate and longer duration of exclusive breastfeeding, fewer depressive symptoms and better parent-child relationship. The knowledge gained from this study can provide direction for the development of flexible, accessible and culturally sensitive interventions to promote breastfeeding and mental health in Chinese society.
Read the detailed description
Exclusive breastfeeding is recommended as the most beneficial form of infant nutrition during the first 6 months of life, which protects infants against childhood illness and reduces the risk of infant mortality and morbidity. The aim of this study is to implement and evaluate a breastfeeding telephone support intervention that involves mothers and fathers during the postpartum period. The objectives are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding.
Hypothesis to be tested:
- Mothers who receive the father-involvement telephone support intervention will have a higher rate and a longer duration of exclusive breastfeeding at 1, 2, 4 and 6 months postpartum than those who receive the standard postpartum care.
- Mothers and fathers who receive the intervention will have: (a) fewer depressive symptoms, and (b) better parent-infant bonding at 2 and 6 months postpartum than those who receive the standard postpartum care.
Design and subjects: Randomized controlled trial. A sample of postpartum mothers (n = 738) and fathers (n = 738) will be randomly assigned to either the experimental or the control groups.
Study instruments: Edinburgh Postnatal Depression Scale (EPDS) and Postpartum Bonding Questionnaire (PBQ).
Intervention: The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.
Main outcome measures: The prevalence and duration of exclusive breastfeeding will be collected at 1, 2, 4 and 6 months postpartum. Postnatal depression and parent-infant boding will be assessed by the EPDS and the PBQ, respectively, at 2 and 6 months postpartum.
Data analysis: Generalized linear mixed models and survival analysis will be conducted to compare differences in the outcomes between two groups.
Potential application: The implementation of a simple, brief telephone-based intervention for breastfeeding families is most likely to be taken up in the primary health care setting. The results may better equip policy makers and health professionals to design health promotion programs for breastfeeding families, thus reducing the public health burden of childhood illness.
- Conditions
- Breast Feeding, Exclusive, Parents
- Being tested
- Breastfeeding telephone support
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding telephone supportBehavioural
The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. Receives: Behavioral: Breastfeeding telephone support |
| Control | No intervention | Standard postpartum care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of exclusive breastfeeding
The prevalence/proportion of infants younger than 1 month who are exclusively breastfed is calculated as the number of infants younger than 1 month who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 1 month.
Measured: 1 month
Secondary outcomes (11)
Prevalence of exclusive breastfeeding
The prevalence of infants younger than 1 month who are exclusively breastfed is calculated as the number of infants younger than 1 month who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 1 month.
Measured: 2 months
Prevalence of exclusive breastfeeding
The prevalence of infants younger than 4 months who are exclusively breastfed is calculated as the number of infants younger than 4 months who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 4 months.
Measured: 4 months
Prevalence of exclusive breastfeeding
The prevalence of infants younger than 6 months who are exclusively breastfed is calculated as the number of infants younger than 6 months who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 6 months.
Measured: 6 months
Duration of exclusive breastfeeding
The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.
Measured: 1 month
Duration of exclusive breastfeeding
The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.
Measured: 2 months
Duration of exclusive breastfeeding
The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.
Measured: 4 months
Duration of exclusive breastfeeding
The duration of exclusive breastfeeding is measured as the infant's age in weeks when the women first introduce infant formula.
Measured: 6 months
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale is a 10-item self-report instrument used to assess the presence of depressive symptoms during the postnatal period. Each item is scored on a 4-point scale and total scores ranging from 0 to 30, with higher scores indicating more depressive symptoms.
Measured: 2 months
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale is a 10-item self-report instrument used to assess the presence of depressive symptoms during the postnatal period. Each item is scored on a 4-point scale and total scores ranging from 0 to 30, with higher scores indicating more depressive symptoms.
Measured: 6 months
Postpartum Bonding Questionnaire
to assess parent-infant relationship
Measured: 2 months
Postpartum Bonding Questionnaire
to assess parent-infant relationship
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start18 Apr 2022
- Primary completion28 Jul 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngai Fei Wan, The Hong Kong Polytechnic University
- Investigators
- Fei Wan Ngai, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109988
- Sponsor's protocol ID
- 18191141
- Status last verified
- Dec 2025
- First submitted
- 17 Oct 2021
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Father-involvement Breastfeeding Telephone Support Intervention on Exclusive and Sustained Breastfeeding: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05109988
- Acronym / sponsor ID
- 18191141
- Conditions
- Breast Feeding, Exclusive, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 5 Nov 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.
The World Health Organization advocates for breastfeeding as the best source of food for optimal infant development, which reduces the risk of infant mortality and morbidity. The objectives of this study are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding. The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. We expect that women who receive the intervention will have a higher rate and longer duration of exclusive breastfeeding, fewer depressive symptoms and better parent-child relationship. The knowledge gained from this study can provide direction for the development of flexible, accessible and culturally sensitive interventions to promote breastfeeding and mental health in Chinese society.
Detailed description
Exclusive breastfeeding is recommended as the most beneficial form of infant nutrition during the first 6 months of life, which protects infants against childhood illness and reduces the risk of infant mortality and morbidity. The aim of this study is to implement and evaluate a breastfeeding telephone support intervention that involves mothers and fathers during the postpartum period. The objectives are to evaluate the effect of a father-involvement breastfeeding telephone support intervention on prevalence and duration of exclusive breastfeeding, postnatal depression and parent-infant bonding.
Hypothesis to be tested:
- Mothers who receive the father-involvement telephone support intervention will have a higher rate and a longer duration of exclusive breastfeeding at 1, 2, 4 and 6 months postpartum than those who receive the standard postpartum care.
- Mothers and fathers who receive the intervention will have: (a) fewer depressive symptoms, and (b) better parent-infant bonding at 2 and 6 months postpartum than those who receive the standard postpartum care.
Design and subjects: Randomized controlled trial. A sample of postpartum mothers (n = 738) and fathers (n = 738) will be randomly assigned to either the experimental or the control groups.
Study instruments: Edinburgh Postnatal Depression Scale (EPDS) and Postpartum Bonding Questionnaire (PBQ).
Intervention: The intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers.
Main outcome measures: The prevalence and duration of exclusive breastfeeding will be collected at 1, 2, 4 and 6 months postpartum. Postnatal depression and parent-infant boding will be assessed by the EPDS and the PBQ, respectively, at 2 and 6 months postpartum.
Data analysis: Generalized linear mixed models and survival analysis will be conducted to compare differences in the outcomes between two groups.
Potential application: The implementation of a simple, brief telephone-based intervention for breastfeeding families is most likely to be taken up in the primary health care setting. The results may better equip policy makers and health professionals to design health promotion programs for breastfeeding families, thus reducing the public health burden of childhood illness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Breastfeeding telephone supportThe intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. |
| Control | No intervention | –Standard postpartum care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or above;
- giving birth to a single healthy baby at term
- ability to speak and read the Chinese language
Key exclusion criteria (1 listed)
- psychiatric illness
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 |
|---|---|---|
| Breastfeeding telephone supportThe intervention consists of four weekly 20-30 minutes telephone-administered counselling sessions on breastfeeding, delivered individually in the first month postpartum for mothers and fathers. | Behavioural | Intervention |
Primary outcome
Prevalence of exclusive breastfeeding
Time frame: 1 month
The prevalence/proportion of infants younger than 1 month who are exclusively breastfed is calculated as the number of infants younger than 1 month who are exclusively breastfed in the last 24 hours divided by the total number of infants younger than 1 month.
11 secondary outcomes
Prevalence of exclusive breastfeeding
Time frame: 2 months
Prevalence of exclusive breastfeeding
Time frame: 4 months
Prevalence of exclusive breastfeeding
Time frame: 6 months
Duration of exclusive breastfeeding
Time frame: 1 month
Duration of exclusive breastfeeding
Time frame: 2 months
Duration of exclusive breastfeeding
Time frame: 4 months
Duration of exclusive breastfeeding
Time frame: 6 months
Edinburgh Postnatal Depression Scale
Time frame: 2 months
Edinburgh Postnatal Depression Scale
Time frame: 6 months
Postpartum Bonding Questionnaire
Time frame: 2 months
Postpartum Bonding Questionnaire
Time frame: 6 months
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 30 Dec 2025.
- 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.
Fei Wan Ngai, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding telephone support in people with Breast Feeding, Exclusive and Parents, run by The Hong Kong Polytechnic University 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 3 inclusion and 1 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 30 Dec 2025. 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?
Prevalence of exclusive breastfeeding (time frame: 1 month). 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 30 Dec 2025.