NCT04621266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
442

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 20, 2025

Completed
Last Updated

February 17, 2026

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

October 29, 2020

Results QC Date

September 11, 2024

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Infant Feeding Status: Exclusive Breastfeeding

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

    At 1 month postpartum

  • Infant Feeding Status: Exclusive Breastfeeding

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

    At 2 months postpartum

  • Infant Feeding Status: Exclusive Breastfeeding

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

    At 4 months postpartum

  • Infant Feeding Status: Exclusive Breastfeeding

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

    At 6 months postpartum

Secondary Outcomes (7)

  • Women's Self-efficacy in Breastfeeding

    At baseline, 2 months and 4 months postpartum

  • Women's Self-efficacy in Breastfeeding at Baseline

    At baseline

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

    At 2 months postpartum

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

    At 4 months postpartum

  • Women's Postpartum Depression at Baseline

    At baseline

  • +2 more secondary outcomes

Study Arms (2)

Online Home-based peer support intervention

EXPERIMENTAL

Participants will receive intervention on top of standard usual care.

Behavioral: Online Home-based peer support

Standard usual care

NO INTERVENTION

Participants will receive standard usual care.

Interventions

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.

Online Home-based peer support intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Dr Kris Lok
Organization
The University of Hong Kong

Study Officials

  • Kris YW Lok, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 9, 2020

Study Start

August 13, 2021

Primary Completion

January 18, 2024

Study Completion

January 18, 2024

Last Updated

February 17, 2026

Results First Posted

January 20, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations