Home-based Breastfeeding Peer Counselling Programme

May 10, 2023 updated by: The University of Hong Kong

A Feasibility Randomised Controlled Study of an Innovative Postnatal Breastfeeding Peer Counselling Programme

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Peer counselling and support has been shown to be effective in improving breastfeeding (BF) initiation, duration and exclusiveness. Peer counselling is being introduced into different country settings worldwide as an intervention to support women to achieve successful commencement and maintenance of breastfeeding, given the range of health benefits for the woman and her infant. Findings from one Cochrane review suggested that postnatal contacts in the home may reduce infant health service utilisation in the weeks following the birth, and that more home visits may encourage more women to exclusively breastfeed.

The planned study A feasibility randomized controlled trial (RCT) 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 BF 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 RCT, the investigators need to know if women would be willing to be recruited and randomised to an intervention or standard care.

This study is important for several reasons. Chinese women are expected to be housebound during the first month postnatally due to the tradition of 'doing the month', when problems with infant feeding and/or infants failing to thrive due to poor feeding could result in a decision to stop breastfeeding. The innovative home-based intervention the investigators will undertake will address an important service gap in Hong Kong to promote and sustain exclusive breastfeeding, and could be an effective strategy which reflects Chinese culture. The Health Care and Promotion Scheme grant review panel recommended that although an evaluation of a home-based peer counselling project is a high priority, a small-scale feasibility study was needed before a definitive RCT application is submitted.

Peer counsellors will be recruited from those who passed the UNICEF and La Leche League Peer Counselling Training programme. Additional training tailored to issues that they may encounter in home-based contacts with women who are breastfeeding, for example solving problems of exclusive breastfeeding and correct breastfeeding technique will be needed and conducted by team leaders for the peer counsellors. Women planning to breastfeed who meet the study's inclusion criteria will be recruited from hospital postnatal ward and randomly allocated using opaque, sealed envelopes, by an independent research assistant not involved in participant recruitment, data collection or analysis to the intervention group (n=10, home-based peer counselling intervention and standard usual care) and control groups (n=10, standard usual care).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Home-based peer counselling intervention
Women planning to breastfeed who meet the study's inclusion criteria
Other: Home-based peer counselling (web-based) intervention
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.
No Intervention: Standard usual care
Women planning to breastfeed who meet the study's inclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
Time Frame: through study completion, an average of 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Exclusively Breastfeed
Time Frame: At 1, 2, 4 and 6 months postpartum
The number of participants who exclusive breastfeed at each follow-up time-points
At 1, 2, 4 and 6 months postpartum
Exclusive Breastfeeding Duration
Time Frame: At 1, 2, 4 and 6 months postpartum
Exclusive breastfeeding duration is measured using time in weeks
At 1, 2, 4 and 6 months postpartum
Women's Self-efficacy in Breastfeeding
Time Frame: At baseline, 2 and 4 months postpartum
Breastfeeding Self-efficacy Scale measures maternal breastfeeding self-efficacy. It consists of 14 items measured on a 5-point likert scale. On scale 1 indicates "not at all confident" and 5 indicates "always confident". Total scores range from 14 to 70 with higher scores indicating greater breastfeeding confidence and self-efficacy.
At baseline, 2 and 4 months postpartum
Women's Attitude in Breastfeeding
Time Frame: At baseline, 2 and 4 months postpartum
Iowa Infant Feeding Attitude Scale is a measure of attitudes towards feeding. It consists of 17 items that are scored on a 5-point Likert scale, which ranges from 1 (strongly disagree) to 5 (strongly agree). Eight items are worded in a favourable manner towards breastfeeding, while nine are favourable towards formula feeding. Items favouring formula feeding are reverse-scored (i.e. 1=5, 2=4, 4=2 and 5=1). The total attitude scores range from 17 (indicating positive bottle feeding attitudes) to 85 (reflecting positive breastfeeding attitudes). Total scores are grouped into the following three categories: (1) positive towards breastfeeding (70-85); (2) neutral (49-69); and (3) positive towards formula feeding (17-48).
At baseline, 2 and 4 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Kris YW Dr Lok, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

September 2, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BFPC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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