Natural Parenting Network
Hong Kong
NCT Number: NCT04741425
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Hong Kong
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The breastfeeding talk will be conducted by Zoom at the third trimester about breastfeeding benefits and other practical advices. There is also a sharing session by a successful breastfeeding mother and a group discussion with different breastfeeding scenarios.
Once the mothers return home after delivery, individualized breastfeeding coaching will be provided by PI through a daily Zoom videoconference within 24 hours upon hospital discharge till Day 7 after delivery.
During the last breastfeeding videoconference, mothers will be reminded to have weekly telephone follow-ups by PI from week 2 to 2 months postpartum.
Women who are randomised into the intervention group will receive REST in addition to the standard antenatal and postnatal care (described at below) by the Obstetrics Department of their delivery hospitals.
Time frame: At 2 months postpartum (immediately post-intervention)
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Time frame: At 6 months postpartum
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Time frame: At baseline, 2 months (immediately post-intervention) and 6 months postpartum
BSES-SF is a 14-item scale with 5-point Likert scale. Total score ranged from 14 to 70 and higher score indicates higher breastfeeding self-efficacy. and the results will be presented as BSES-SF mean scores which are measured by Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) (Dennis, 2003)
Time frame: At 2 months and 6 months postpartum
The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Time frame: At 2 months postpartum
The self-developed postnatal questionnaire are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Time frame: At 2 months and 6 months postpartum
The self-developed postnatal questionnaire are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Time frame: At 2 months and 6 months postpartum
Maternal postnatal depression is one kind of mood disorder, which commonly occurs after the birth of a baby.
In EPDS, there are 10 questions with a total score of 0 to 30. Risk of postnatal depression was defined as EPDS score ≥10, and higher score indicates higher risk of a women suffering from postnatal depression.
Time frame: At 2 months and 6 months postpartum
The medical diseases to be estimated for these morbidities are limited to infectious diseases including respiratory, ear and gastrointestinal infection.
The self-developed postnatal questionnaire are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.
Chinese University of Hong Kong
Other
Effects of an Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes: A Randomised Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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