Clinical trial NCT04621266: Home Based Peer Support Program for Mothers With Low Breastfeeding Self-efficacy
Official title: Effectiveness of a Home-based Peer Support Program for Chinese Mothers With Low Breastfeeding Self-efficacy to Increase the Exclusivity and Duration of Breastfeeding: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 442
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: An online home-based breastfeeding peer support programme is proposed to support mothers who are giving birth to their first-born. This study aims to evaluate the effectiveness of this programme in improving breastfeeding practices among women with low breastfeeding self-efficacy. It is hypothesized that participants who received online home-based peer support will exclusively breastfeed for longer duration, have higher breastfeeding self-efficacy, and lower post-partum depression symptoms when compared to those receiving only standard care.

Detailed description: Primiparous mothers who plan to breastfeed but did not go on to breastfeed often face high levels of emotional and psychological challenges in their transition to parenthood. This can adversely affect their breastfeeding experiences and general well-being, and is associated with stress, anxiety, and postnatal depression. While family psycho-education and other supportive group programmes are available in health services, they require face-to-face education sessions over a long interval, high engagement, and trusting relationships, and thus often result in low attendance and high drop outs.

Mothers have expressed the need for psychological support of peer counsellors, which would allow them to support each other. The first month postpartum is a critical period for sustaining exclusive breastfeeding and the time when mothers are at high risk of postpartum depression. For Chinese mothers in Hong Kong, however, they are often housebound during this period due to the tradition of "doing the month", and thus often find it difficult to attend support groups or seek help. In view of these challenges and the pandemic wave faced by primiparous mothers, they are reluctant with home visits, therefore an online delivery of the home-based peer support programme is proposed.

This randomized control trial adopts a two-arm design to examine the effectiveness of an online home-based peer support programme for women with low breastfeeding self-efficacy. It is hypothesized that those receiving the intervention, when compared to the controls, will have (1) longer period of exclusive breastfeeding, (2) higher postnatal breastfeeding self-efficacy, and (3) lower post-partum depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* Primiparous mothers
* Intend to breastfeed
* Have low breastfeeding self-efficacy (between 14 to 32)
* Have singleton pregnancy and live birth
* Have term infant (37-42 weeks gestational)
* Cantonese speaking
* Hong Kong resident
* Have no serious medical or obstetrical complications

Exclusion Criteria:

* Infant is \<37 week gestation
* Infant has Apgar score \<8 at five minutes
* Infant has birthweight \<2,500 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: Infant Feeding Status: Exclusive Breastfeeding
timeFrame: At 1 month postpartum
measure: Infant Feeding Status: Exclusive Breastfeeding
timeFrame: At 2 months postpartum
measure: Infant Feeding Status: Exclusive Breastfeeding
timeFrame: At 4 months postpartum
measure: Infant Feeding Status: Exclusive Breastfeeding
timeFrame: At 6 months postpartum
Secondary outcomes:
measure: Women's Self-efficacy in Breastfeeding
timeFrame: At baseline, 2 months and 4 months postpartum
measure: Women's Self-efficacy in Breastfeeding at Baseline
timeFrame: At baseline
measure: Women's Self-efficacy in Breastfeeding at 2 Months Postpartum
timeFrame: At 2 months postpartum
measure: Women's Self-efficacy in Breastfeeding at 4 Months Postpartum
timeFrame: At 4 months postpartum
measure: Women's Postpartum Depression at Baseline
timeFrame: At baseline
measure: Women's Postpartum Depression at 1 Month Postpartum
timeFrame: At 1 month postpartum
measure: Women's Postpartum Depression at 2 Month Postpartum
timeFrame: At 2 month postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Kris YW Lok, PhD
role: PRINCIPAL_INVESTIGATOR
References: