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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Home-based peer support intervention | Experimental | Participants will receive intervention on top of standard usual care. |
|
| Standard usual care | No Intervention | Participants will receive standard usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Home-based peer support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum. | At 1 month postpartum |
| Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum. | At 2 months postpartum |
| Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum. | At 4 months postpartum |
| Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum. | At 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kris YW Lok, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Hong Kong | Hong Kong | ||||
| Queen Mary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42201735 | Derived | 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. | |
| 39043588 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Online Home-based Peer Support Intervention | Participants will receive intervention on top of standard usual care. Online Home-based peer support: 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. |
| FG001 | Standard Usual Care | Participants will receive standard usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Online Home-based Peer Support Intervention | Participants will receive intervention on top of standard usual care. Online Home-based peer support: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum. | Posted | Count of Participants | Participants | At 1 month postpartum |
|
1-month, 2-month, 4-month, 6-month
No adverse effect is reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Online Home-based Peer Support Intervention | Participants will receive intervention on top of standard usual care. Online Home-based peer support: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kris Lok | The University of Hong Kong | 39176690 | krislok@hku.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2020 | Dec 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
| At baseline, 2 months and 4 months postpartum |
| 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. | At baseline |
| 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. | At 2 months postpartum |
| 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. | At 4 months postpartum |
| 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. | At baseline |
| 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. | At 1 month postpartum |
| 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. | At 2 month postpartum |
| Hong Kong |
| Hong Kong |
| BG001 | Standard Usual Care | Participants will receive standard usual care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum. | Posted | Count of Participants | Participants | At 2 months postpartum |
|
|
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| Primary | Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum. | Posted | Count of Participants | Participants | At 4 months postpartum |
|
|
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| Primary | Infant Feeding Status: Exclusive Breastfeeding | Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum. | Posted | Count of Participants | Participants | No | At 6 months postpartum |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline, 2 months and 4 months postpartum |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At 2 months postpartum |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At 4 months postpartum |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At 1 month postpartum |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At 2 month postpartum |
|
|
|
| 0 |
| 224 |
| 0 |
| 224 |
| 0 |
| 224 |
| EG001 | Standard Usual Care | Participants will receive standard usual care. | 0 | 218 | 0 | 218 | 0 | 218 |
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