NCT03705494

Brief Summary

A feasibility study is proposed in the current study as women who had given birth to their first babies recruited to a previous project specifically expressed the need for postnatal breastfeeding support from peer counsellors at home and there is evidence that this could be of benefit for women and their infants. Evidence of whether women in Hong Kong who had peer counsellors have better breastfeeding outcomes compared to women who had standard care however is not available. Prior to undertaking a definitive trial, the investigators need to know if women would be willing to be recruited and randomised to an intervention or standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 19, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 24, 2020

Completed
Last Updated

June 6, 2023

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

September 2, 2018

Results QC Date

November 4, 2020

Last Update Submit

May 10, 2023

Conditions

Keywords

BreastfeedingPeer counsellor

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention

    The number of participants who have completed the in-depth qualitative interviews on their views on the peer counselling breastfeeding intervention programme. Participants who are in the intervention group and have received intervention were approached for qualitative interviews after study completion at six months. Eight participants have received intervention, two of which has been lost to follow-up. Thus, six participants were approached for the interview. One participants refused to be interviewed.

    through study completion, an average of 6 months

Secondary Outcomes (4)

  • Number of Participants Who Exclusively Breastfeed

    At 1, 2, 4 and 6 months postpartum

  • Exclusive Breastfeeding Duration

    At 1, 2, 4 and 6 months postpartum

  • Women's Self-efficacy in Breastfeeding

    At baseline, 2 and 4 months postpartum

  • Women's Attitude in Breastfeeding

    At baseline, 2 and 4 months postpartum

Study Arms (2)

Home-based peer counselling intervention

ACTIVE COMPARATOR

Women planning to breastfeed who meet the study's inclusion criteria

Other: Home-based peer counselling (web-based) intervention

Standard usual care

NO INTERVENTION

Women planning to breastfeed who meet the study's inclusion criteria

Interventions

The intervention consists of 5-6 home based visits (web-based) over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme.

Home-based peer counselling intervention

Eligibility Criteria

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

You may qualify if:

  • Primiparous mothers
  • Intention to breastfeed
  • Singleton pregnancy
  • Term infant (37-42 weeks gestational)
  • Cantonese speaking
  • Hong Kong resident
  • Mother with no serious medical or obstetrical complications.

You may not qualify if:

  • infant is \<37 weeks gestation,
  • infant has an Apgar score \<8 at five minutes,
  • infant has a birthweight \<2500 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 (1)

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lok KY, Chow CLY, Shing JSY, Smith R, Lam CCO, Bick D, Chang YS. Feasibility, acceptability, and potential efficacy of an innovative postnatal home-based breastfeeding peer support programme in Hong Kong: a feasibility and pilot randomised controlled trial. Int Breastfeed J. 2021 Apr 13;16(1):34. doi: 10.1186/s13006-021-00381-5.

MeSH Terms

Conditions

Breast Feeding

Interventions

Methods

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr Kris LOK
Organization
The University of Hong Kong

Study Officials

  • Kris YW Dr 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
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2018

First Posted

October 15, 2018

Study Start

February 19, 2019

Primary Completion

October 1, 2019

Study Completion

June 30, 2020

Last Updated

June 6, 2023

Results First Posted

December 24, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations