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BreastfeedingNCT03705494

Home-based Breastfeeding Peer Counselling Programme

A study testing Home-based peer counselling (web-based) intervention in people with Breastfeeding, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding
What is being tested?
Home-based peer counselling (web-based) intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteHong Kong
Study dates
19 Feb 2019to 30 Jun 2020
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Queen Elizabeth Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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).

Conditions
Breastfeeding
Being tested
Home-based peer counselling (web-based) intervention
Keywords
Breastfeeding, Peer counsellor
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based peer counselling (web-based) interventionOther

    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.

Study groups in NCT03705494
Study groupRoleWhat they receive
Home-based peer counselling interventionActive comparatorWomen planning to breastfeed who meet the study's inclusion criteria
Receives: Other: Home-based peer counselling (web-based) intervention
Standard usual careNo interventionWomen planning to breastfeed who meet the study's inclusion criteria

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 6 months

Secondary outcomes (4)
  1. Number of Participants Who Exclusively Breastfeed

    The number of participants who exclusive breastfeed at each follow-up time-points

    Measured: At 1, 2, 4 and 6 months postpartum

  2. Exclusive Breastfeeding Duration

    Exclusive breastfeeding duration is measured using time in weeks

    Measured: At 1, 2, 4 and 6 months postpartum

  3. Women's Self-efficacy in Breastfeeding

    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.

    Measured: At baseline, 2 and 4 months postpartum

  4. Women's Attitude in Breastfeeding

    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).

    Measured: At baseline, 2 and 4 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2018
  2. Study start19 Feb 2019
  3. Primary completion1 Oct 2019
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03705494
Sponsor's protocol ID
BFPC1
Status last verified
Sep 2019
First submitted
2 Sep 2018
Last updated
6 Jun 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33849582

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