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BreastfeedingBFPSNCT04621266

Home Based Peer Support Program for Mothers With Low Breastfeeding Self-efficacy

A study testing Online Home-based peer support in people with Breastfeeding, run by The University of Hong Kong at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An online home-based breastfeeding peer support programme is proposed to support mothers who are giving birth to their first-born. This study aims to evaluate the effectiveness of this programme in improving breastfeeding practices among women with low breastfeeding self-efficacy. 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?
Online Home-based peer support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
442 participants
Where
2 sitesHong Kong
Study dates
13 Aug 2021to 18 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Primiparous mothers
  • Intend to breastfeed
  • Have low breastfeeding self-efficacy (between 14 to 32)
  • Have singleton pregnancy and live birth
  • Have term infant (37-42 weeks gestational)
  • Cantonese speaking
  • Hong Kong resident
  • Have no serious medical or obstetrical complications

Who cannot join

  • Infant is <37 week gestation
  • Infant has Apgar score <8 at five minutes
  • Infant has birthweight <2,500 grams
  • Infant has any severe medical conditions or congenital malformations
  • Infant is placed in the special care baby unit for more than 48 hours after birth
  • Infant is placed in the neonatal intensive care unit at any time after birth

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Effectiveness of a Home-based Peer Support Program for Chinese Mothers With Low Breastfeeding Self-efficacy to Increase the Exclusivity and Duration of Breastfeeding: a Randomized Controlled Trial

An online home-based breastfeeding peer support programme is proposed to support mothers who are giving birth to their first-born. This study aims to evaluate the effectiveness of this programme in improving breastfeeding practices among women with low breastfeeding self-efficacy. It is hypothesized that participants who received online home-based peer support will exclusively breastfeed for longer duration, have higher breastfeeding self-efficacy, and lower post-partum depression symptoms when compared to those receiving only standard care.

Read the detailed description

Primiparous mothers who plan to breastfeed but did not go on to breastfeed often face high levels of emotional and psychological challenges in their transition to parenthood. This can adversely affect their breastfeeding experiences and general well-being, and is associated with stress, anxiety, and postnatal depression. While family psycho-education and other supportive group programmes are available in health services, they require face-to-face education sessions over a long interval, high engagement, and trusting relationships, and thus often result in low attendance and high drop outs.

Mothers have expressed the need for psychological support of peer counsellors, which would allow them to support each other. The first month postpartum is a critical period for sustaining exclusive breastfeeding and the time when mothers are at high risk of postpartum depression. For Chinese mothers in Hong Kong, however, they are often housebound during this period due to the tradition of "doing the month", and thus often find it difficult to attend support groups or seek help. In view of these challenges and the pandemic wave faced by primiparous mothers, they are reluctant with home visits, therefore an online delivery of the home-based peer support programme is proposed.

This randomized control trial adopts a two-arm design to examine the effectiveness of an online home-based peer support programme for women with low breastfeeding self-efficacy. It is hypothesized that those receiving the intervention, when compared to the controls, will have (1) longer period of exclusive breastfeeding, (2) higher postnatal breastfeeding self-efficacy, and (3) lower post-partum depressive symptoms.

Conditions
Breastfeeding
Being tested
Online Home-based peer 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.

  • Online Home-based peer supportBehavioural

    Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes.

Study groups in NCT04621266
Study groupRoleWhat they receive
Online Home-based peer support interventionExperimentalParticipants will receive intervention on top of standard usual care.
Receives: Behavioral: Online Home-based peer support
Standard usual careNo interventionParticipants will receive standard usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infant Feeding Status: Exclusive Breastfeeding

    Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum.

    Measured: At 1 month postpartum

  2. Infant Feeding Status: Exclusive Breastfeeding

    Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum.

    Measured: At 2 months postpartum

  3. Infant Feeding Status: Exclusive Breastfeeding

    Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum.

    Measured: At 4 months postpartum

  4. Infant Feeding Status: Exclusive Breastfeeding

    Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum.

    Measured: At 6 months postpartum

Secondary outcomes (7)

  1. Women's Self-efficacy in Breastfeeding

    Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.

    Measured: At baseline, 2 months and 4 months postpartum

  2. Women's Self-efficacy in Breastfeeding at Baseline

    Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.

    Measured: At baseline

  3. Women's Self-efficacy in Breastfeeding at 2 Months Postpartum

    Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.

    Measured: At 2 months postpartum

  4. Women's Self-efficacy in Breastfeeding at 4 Months Postpartum

    Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.

    Measured: At 4 months postpartum

  5. Women's Postpartum Depression at Baseline

    The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.

    Measured: At baseline

  6. Women's Postpartum Depression at 1 Month Postpartum

    The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.

    Measured: At 1 month postpartum

  7. Women's Postpartum Depression at 2 Month Postpartum

    The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.

    Measured: At 2 month postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start13 Aug 2021
  3. Primary completion18 Jan 2024
  4. Study completion18 Jan 2024

Resources

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
Participant
Enrolment
442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04621266
Sponsor's protocol ID
BFPS1
Acronym
BFPS
Status last verified
Aug 2023
First submitted
29 Oct 2020
Last updated
17 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lok KYW, Ip CHL, Dai Y, Chan YF, Choi MSL, Lam C, Wong SK, Ho LF, Chau PH, Chang YS, Bick D. Video-Based Peer Support and Exclusive Breastfeeding and Maternal Self-Efficacy: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2614490. doi: 10.1001/jamanetworkopen.2026.14490.

    PubMed 42201735

  • Lok KYW, Choi MSL, Ko RWT, Chau PPH, Lam CCO, Chang YS, Bick D. Effectiveness of a home-based peer support programme for Chinese mothers with low breastfeeding self-efficacy to increase the exclusivity and duration of breastfeeding: study protocol of a randomised control trial. BMJ Open. 2024 Jul 23;14(7):e081897. doi: 10.1136/bmjopen-2023-081897.

    PubMed 39043588

Questions about this trial

What is this clinical trial studying?

A study testing Online Home-based peer support 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 8 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 17 Feb 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?

Yes. Results are posted in the registry (first posted 20 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Status: Exclusive Breastfeeding (time frame: At 1 month postpartum). The study lists 4 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 NCT04621266, 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 17 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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