Clinical trial NCT04741425: Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes
Official title: Effects of an Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Self Efficacy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Breastmilk is the best food for babies and exclusive breastfeeding is beneficial to mother-baby dyads.

It is recommended to exclusively breastfeed babies till 6 months of age and continue with complementary food until aged 2 or above. This proposed study aims to establish and evaluate an effective intervention in sustaining exclusive breastfeeding among primiparous women up to 6 months postpartum.

Detailed description: World Health Organization suggests all infants should be exclusively breastfed for 6 months and continue with complementary food till 2 years old. Yet, the global exclusive breastfeeding rate at 6 months is only around 40%. As for Hong Kong, breastfeeding rate dropped substantially from 87% upon discharge to less than a half at 6 months postpartum and only one-third of women still exclusively breastfed their infants.

According to previous studies, women had early breastfeeding initiation or had breastfed their first child for at least 6 months were more likely to exclusively breastfeed the babies for longer time. However, mothers have early weaning easily due to inadequate breastfeeding knowledge/ skills, lack of lactation support or if they have specific characteristics like being hypertensive/ diabetic, primiparous or having complicated birthing experience. It was also found that maternal breastfeeding education, breastfeeding self-efficacy and their intention all affect the initiation and continuation of breastfeeding.

Among various promotional interventions, educational and supportive interventions were found to be effectively increased breastfeeding duration, while self-efficacy based intervention improved breastfeeding self-efficacy in the first 2 months but not on exclusive breastfeeding rates at 6 months postpartum. In addition, overall, there are inconsistent effects on educational and supportive interventions on breastfeeding outcomes, especially exclusive breastfeeding rate at 6 months postpartum. Also, most of the previous reviews did not focus on the primiparous women. And it is unclear the intervention effects on breastfeeding self-efficacy and exclusive breastfeeding rate of the first time mothers over 6-months.

As a result, a systematic review of 13 randomised controlled trials was done to identify effective approaches to educational and supportive interventions to improve breastfeeding in first time mothers up to at least 6-month postpartum. The result showed educational and supportive interventions were effective in increasing exclusive breastfeeding rate at ≤2 months \& 6 months, partial breastfeeding rate as well as breastfeeding self-efficacy at ≤2 months. The key components in breastfeeding promotion interventions, are those involved multicomponent (that is antenatal group education, postnatal individual breastfeeding coaching together with telephone follow-ups), breastfeeding self-efficacy theory-based that delivered across antenatal and postnatal period with ≥ 3 intervention sessions.

With the current COVID-19 pandemic, all face-to-face interventions in the hospitals are constrained. So the proposed study will be conducted by using Zoom platform and telephone follow-ups. There are one session of online antenatal breastfeeding talk, 5 times daily online postnatal breastfeeding coaching and 7 times weekly postnatal telephone follow-ups. The intervention will be guided by Dennis's breastfeeding self-efficacy framework.

This study aims to determine if a real-time online theory-based education and support plus telephone follow-ups programme (REST) for primiparous women in Hong Kong would increase their exclusive rate, breastfeeding self-efficacy, and other breastfeeding outcomes over 6-month postpartum.

Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese residents
* at the third trimester (≥32 weeks of gestation)
* aged ≥18 years
* having singleton pregnancy
* able to understand and write in Chinese and speak Cantonese
* delivered in the local public hospitals
* have access to Internet and able to use computer, smartphone or tablet.

Exclusion Criteria:

* having serious medical or obstetric complications such as hypertension and/or diabetes
* having psychiatric illness such as depression or schizophrenia
* not staying in Hong Kong for at least 6 months post-delivery
* having complicated delivery (e.g., instrumental or operative delivery, and/or postpartum hemorrhage)
* receiving pharmacological pain relief during their labor
* having baby admitted to the hospital during the study.

Primary outcomes:
measure: Exclusive breastfeeding rate (number of Infants who have only received breastmilk or expressed breastmilk, and no other liquids or solids except vitamins, mineral supplement and medicines) by self-developed postnatal questionnaires
timeFrame: At 2 months postpartum (immediately post-intervention)
measure: Exclusive breastfeeding rate (number of Infants who have only received breastmilk or expressed breastmilk, and no other liquids or solids except vitamins, mineral supplement and medicines) by self-developed postnatal questionnaires
timeFrame: At 6 months postpartum
measure: Change of breastfeeding self-efficacy (mothers' confidence in their abilities to breastfeed their babies) by the Chinese Hong Kong version of Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) from baseline to 6 months after delivery
timeFrame: At baseline, 2 months (immediately post-intervention) and 6 months postpartum
Secondary outcomes:
measure: Partial breastfeeding rate (number of infants who have been fed with breastmilk together with formula milk or other food/ liquids) by self-developed postnatal questionnaires
timeFrame: At 2 months and 6 months postpartum
measure: Breastfeeding initiation rate (number of mothers initiate breastfeeding within 1st hour of delivery) by self-developed postnatal questionnaire
timeFrame: At 2 months postpartum
measure: Exclusive breastfeeding duration (total length of time on exclusive breastfeeding) by self-developed postnatal questionnaires
timeFrame: At 2 months and 6 months postpartum
measure: Maternal postnatal depression score by the Chinese version of Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: At 2 months and 6 months postpartum
measure: Infant's morbidity (total number of infants getting sick and the types of infectious diseases that requires medical checkup) by self-developed postnatal questionnaires
timeFrame: At 2 months and 6 months postpartum
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Natural Parenting Network
Study officials:
References:
citation: Wong MS, Chien WT. A Pilot Randomized Controlled Trial of an Online Educational Program for Primiparous Women to Improve Breastfeeding. J Hum Lact. 2023 Feb;39(1):107-118. doi: 10.1177/08903344221125129. Epub 2022 Oct 3.