Trial Outcomes & Findings for Home Based Peer Support Program for Mothers With Low Breastfeeding Self-efficacy (NCT NCT04621266)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

442 participants

Primary outcome timeframe

At 1 month postpartum

Results posted on

2025-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Standard Usual Care Participants will receive standard usual care.
Overall Study STARTED	224	218
Overall Study COMPLETED	214	214
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Online Home-based Peer Support Intervention n=224 Participants 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.	Standard Usual Care n=218 Participants Participants will receive standard usual care.	Total n=442 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=224 Participants	0 Participants n=218 Participants	0 Participants n=442 Participants
Age, Categorical Between 18 and 65 years	224 Participants n=224 Participants	218 Participants n=218 Participants	442 Participants n=442 Participants
Age, Categorical >=65 years	0 Participants n=224 Participants	0 Participants n=218 Participants	0 Participants n=442 Participants
Sex: Female, Male Female	224 Participants n=224 Participants	218 Participants n=218 Participants	442 Participants n=442 Participants
Sex: Female, Male Male	0 Participants n=224 Participants	0 Participants n=218 Participants	0 Participants n=442 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At 1 month postpartum

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

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=224 Participants 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.	Standard Usual Care n=218 Participants Participants will receive standard usual care.
Infant Feeding Status: Exclusive Breastfeeding	46 Participants	39 Participants

PRIMARY outcome

Timeframe: At 2 months postpartum

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

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=224 Participants 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.	Standard Usual Care n=218 Participants Participants will receive standard usual care.
Infant Feeding Status: Exclusive Breastfeeding	54 Participants	38 Participants

PRIMARY outcome

Timeframe: At 4 months postpartum

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

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=224 Participants 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.	Standard Usual Care n=218 Participants Participants will receive standard usual care.
Infant Feeding Status: Exclusive Breastfeeding	47 Participants	42 Participants

PRIMARY outcome

Timeframe: At 6 months postpartum

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

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=224 Participants 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.	Standard Usual Care n=218 Participants Participants will receive standard usual care.
Infant Feeding Status: Exclusive Breastfeeding	37 Participants	29 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=223 Participants 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.	Standard Usual Care n=216 Participants Participants will receive standard usual care.
Women's Self-efficacy in Breastfeeding	45 score on a scale Standard Deviation 12.9	40.7 score on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=223 Participants 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.	Standard Usual Care n=216 Participants Participants will receive standard usual care.
Women's Self-efficacy in Breastfeeding at Baseline	37 score on a scale Standard Deviation 6.6	37 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=223 Participants 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.	Standard Usual Care n=216 Participants Participants will receive standard usual care.
Women's Self-efficacy in Breastfeeding at 2 Months Postpartum	40.6 score on a scale Standard Deviation 12.4	38.7 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=223 Participants 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.	Standard Usual Care n=216 Participants Participants will receive standard usual care.
Women's Self-efficacy in Breastfeeding at 4 Months Postpartum	45 score on a scale Standard Deviation 12.9	38.7 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=223 Participants 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.	Standard Usual Care n=216 Participants Participants will receive standard usual care.
Women's Postpartum Depression at Baseline	8.2 score on a scale Standard Deviation 4.9	7.9 score on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=223 Participants 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.	Standard Usual Care n=216 Participants Participants will receive standard usual care.
Women's Postpartum Depression at 1 Month Postpartum	9.0 score on a scale Standard Deviation 4.5	8.8 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online Home-based Peer Support Intervention n=223 Participants 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.	Standard Usual Care n=218 Participants Participants will receive standard usual care.
Women's Postpartum Depression at 2 Month Postpartum	7.8 score on a scale Standard Deviation 4.8	7.6 score on a scale Standard Deviation 4.7

Adverse Events

Online Home-based Peer Support Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Kris Lok

The University of Hong Kong

Phone: 39176690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place