Home-based Breastfeeding Peer Counselling Programme

Overview

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.

Full Title of Study: “A Feasibility Randomised Controlled Study of an Innovative Postnatal Breastfeeding Peer Counselling Programme”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2019

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).

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Home-based peer counselling intervention
    • Women planning to breastfeed who meet the study’s inclusion criteria
  • No Intervention: Standard usual care
    • Women planning to breastfeed who meet the study’s inclusion criteria

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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
  • Exclusive Breastfeeding Duration
    • Time Frame: At 1, 2, 4 and 6 months postpartum
    • Exclusive breastfeeding duration is measured using time in weeks
  • 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.
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The University of Hong Kong
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kris YW Dr Lok, PhD, Principal Investigator, The University of Hong Kong

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