Breastfeeding
Conditions
Brief 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. 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.
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.
Interventions
BEHAVIORALOnline 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.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Feeding Status: Exclusive Breastfeeding | At 1 month postpartum | Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Women's Self-efficacy in Breastfeeding | At baseline, 2 months and 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. |
| Women's Self-efficacy in Breastfeeding at Baseline | 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. |
| Women's Self-efficacy in Breastfeeding at 2 Months Postpartum | 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. |
| Women's Self-efficacy in Breastfeeding at 4 Months Postpartum | 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. |
| Women's Postpartum Depression at Baseline | 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. |
| Women's Postpartum Depression at 1 Month Postpartum | 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. |
| Women's Postpartum Depression at 2 Month Postpartum | 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. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORKris YW Lok, PhD
The University of Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 224 |
| Standard Usual Care Participants will receive standard usual care. | 218 |
| Total | 442 |
Baseline characteristics
| Characteristic | Online Home-based Peer Support Intervention | Standard Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 224 Participants | 218 Participants | 442 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 224 Participants | 218 Participants | 442 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 224 | 0 / 218 |
| other Total, other adverse events | 0 / 224 | 0 / 218 |
| serious Total, serious adverse events | 0 / 224 | 0 / 218 |
Outcome results
Primary
Infant Feeding Status: Exclusive Breastfeeding
Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum.
Time frame: At 2 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Home-based Peer Support Intervention | Infant Feeding Status: Exclusive Breastfeeding | 54 Participants |
| Standard Usual Care | Infant Feeding Status: Exclusive Breastfeeding | 38 Participants |
Primary
Infant Feeding Status: Exclusive Breastfeeding
Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum.
Time frame: At 4 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Home-based Peer Support Intervention | Infant Feeding Status: Exclusive Breastfeeding | 47 Participants |
| Standard Usual Care | Infant Feeding Status: Exclusive Breastfeeding | 42 Participants |
Primary
Infant Feeding Status: Exclusive Breastfeeding
Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum.
Time frame: At 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Home-based Peer Support Intervention | Infant Feeding Status: Exclusive Breastfeeding | 37 Participants |
| Standard Usual Care | Infant Feeding Status: Exclusive Breastfeeding | 29 Participants |
Primary
Infant Feeding Status: Exclusive Breastfeeding
Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum.
Time frame: At 1 month postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Home-based Peer Support Intervention | Infant Feeding Status: Exclusive Breastfeeding | 46 Participants |
| Standard Usual Care | Infant Feeding Status: Exclusive Breastfeeding | 39 Participants |
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.
Time frame: At 1 month postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Home-based Peer Support Intervention | Women's Postpartum Depression at 1 Month Postpartum | 9.0 score on a scale | Standard Deviation 4.5 |
| Standard Usual Care | Women's Postpartum Depression at 1 Month Postpartum | 8.8 score on a scale | Standard Deviation 4.7 |
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.
Time frame: At 2 month postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Home-based Peer Support Intervention | Women's Postpartum Depression at 2 Month Postpartum | 7.8 score on a scale | Standard Deviation 4.8 |
| Standard Usual Care | Women's Postpartum Depression at 2 Month Postpartum | 7.6 score on a scale | Standard Deviation 4.7 |
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.
Time frame: At baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Home-based Peer Support Intervention | Women's Postpartum Depression at Baseline | 8.2 score on a scale | Standard Deviation 4.9 |
| Standard Usual Care | Women's Postpartum Depression at Baseline | 7.9 score on a scale | Standard Deviation 4.4 |
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.
Time frame: At baseline, 2 months and 4 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Home-based Peer Support Intervention | Women's Self-efficacy in Breastfeeding | 45 score on a scale | Standard Deviation 12.9 |
| Standard Usual Care | Women's Self-efficacy in Breastfeeding | 40.7 score on a scale | Standard Deviation 11.3 |
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.
Time frame: At 2 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Home-based Peer Support Intervention | Women's Self-efficacy in Breastfeeding at 2 Months Postpartum | 40.6 score on a scale | Standard Deviation 12.4 |
| Standard Usual Care | Women's Self-efficacy in Breastfeeding at 2 Months Postpartum | 38.7 score on a scale | Standard Deviation 6.6 |
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.
Time frame: At 4 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Home-based Peer Support Intervention | Women's Self-efficacy in Breastfeeding at 4 Months Postpartum | 45 score on a scale | Standard Deviation 12.9 |
| Standard Usual Care | Women's Self-efficacy in Breastfeeding at 4 Months Postpartum | 38.7 score on a scale | Standard Deviation 6.6 |
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.
Time frame: At baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Home-based Peer Support Intervention | Women's Self-efficacy in Breastfeeding at Baseline | 37 score on a scale | Standard Deviation 6.6 |
| Standard Usual Care | Women's Self-efficacy in Breastfeeding at Baseline | 37 score on a scale | Standard Deviation 6.6 |