Clinical trial NCT03705494: Home-based Breastfeeding Peer Counselling Programme
Official title: A Feasibility Randomised Controlled Study of an Innovative Postnatal Breastfeeding Peer Counselling Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding
Peer counsellor
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Number of Participants Who Exclusively Breastfeed
timeFrame: At 1, 2, 4 and 6 months postpartum
measure: Exclusive Breastfeeding Duration
timeFrame: At 1, 2, 4 and 6 months postpartum
measure: Women's Self-efficacy in Breastfeeding
timeFrame: At baseline, 2 and 4 months postpartum
measure: Women's Attitude in Breastfeeding
timeFrame: At baseline, 2 and 4 months postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
Study officials:
affiliation: The University of Hong Kong
name: Kris YW Dr Lok, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.