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

Breastfeeding Clinical Trial

— BFPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621266
• Other study ID #: BFPS1
• Status: Completed
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: January 18, 2024

Study information

• Verified date: August 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant feeding status	Exclusive breastfeeding duration	At 1 month postpartum
Primary	Infant feeding status	Exclusive breastfeeding duration	At 2 months postpartum
Primary	Infant feeding status	Exclusive breastfeeding duration	At 4 months postpartum
Primary	Infant feeding status	Exclusive breastfeeding duration	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.	At baseline, 2 months and 4 months postpartum
Secondary	Women's postpartum depression	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, 1 month and 2 months postpartum