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

NCT ID: NCT04621266

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-13
• Study Completion Date: 2024-01-18

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Online Home-based peer support intervention

Participants will receive intervention on top of standard usual care.

Group Type: EXPERIMENTAL

Online Home-based peer support

Intervention Type: 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.

Standard usual care

Participants will receive standard usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kris YW Lok, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 39043588 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BFPS1

Identifier Type: -

Identifier Source: org_study_id