A Feasibility Randomised Controlled Study of an Innovative Postnatal Breastfeeding Peer Counselling Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Home-based peer counselling intervention
Women planning to breastfeed who meet the study's inclusion criteria
干预措施: Home-based peer counselling (web-based) intervention (Other)
Standard usual care
Women planning to breastfeed who meet the study's inclusion criteria
结局指标
主要结局
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
时间窗: 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.
次要结局
- 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)