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Completed

NCT Number: NCT04621266

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Infant Feeding Status: Exclusive Breastfeeding

    Time frame: At 1 month postpartum

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

  2. Infant Feeding Status: Exclusive Breastfeeding

    Time frame: At 2 months postpartum

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

  3. Infant Feeding Status: Exclusive Breastfeeding

    Time frame: At 4 months postpartum

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

  4. Infant Feeding Status: Exclusive Breastfeeding

    Time frame: At 6 months postpartum

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

Secondary outcomes

  1. Women's Self-efficacy in Breastfeeding

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Women's Postpartum Depression at Baseline

    Time frame: 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.

  6. Women's Postpartum Depression at 1 Month Postpartum

    Time frame: 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.

  7. Women's Postpartum Depression at 2 Month Postpartum

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Acronym: BFPS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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