Effects of an Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
The group allocation is determined by the recruitment sequence into the study. Sealed, opaque envelopes with random codes (A and B) in blocks will be generated by a research assistant, who is blinded to the study group to maintain the randomization concealment, and the participant list with the group allocation will be prepared by another research assistant.
Outcome assessment will be blinded by using online questionnaires.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
REST intervention
There will be one session of online antenatal breastfeeding talk, 5 sessions of daily online postnatal individualized breastfeeding coaching, and 7 weekly postnatal telephone follow-ups.
Intervention: REST intervention (Other)
Usual care
Standard antenatal and postnatal care provided by midwives and lactation consultants in the hospitals through by Zoom or by online self-learning through watching videos and reading pamphlets. Participants can also attend other breastfeeding talks or breastfeeding support groups provided by the non-governmental organizations for maternal care.
After delivery, mothers will be taught about baby care at bedside. Breastfeeding skills will also be taught and assessed by the midwives and lactation consultants individually or in group-based breastfeeding talk in the postnatal ward.
Upon discharge, a breastfeeding and postnatal hotline will be provided to all women for advices, and a telephone follow-up will be arranged for all the mothers within 3 to 4 days after delivery by midwives or lactation consultants. The mother-baby dyads will be suggested to follow up in MCHCs for baby growth and breastfeeding support.
Outcomes
Primary Outcomes
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
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.
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
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)
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
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.
Secondary Outcomes
- 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(At 2 months and 6 months postpartum)
- Exclusive breastfeeding duration (total length of time on exclusive breastfeeding) by self-developed postnatal questionnaires(At 2 months and 6 months postpartum)
- Breastfeeding initiation rate (number of mothers initiate breastfeeding within 1st hour of delivery) by self-developed postnatal questionnaire(At 2 months postpartum)
- Maternal postnatal depression score by the Chinese version of Edinburgh Postnatal Depression Scale (EPDS)(At 2 months and 6 months postpartum)
- Infant's morbidity (total number of infants getting sick and the types of infectious diseases that requires medical checkup) by self-developed postnatal questionnaires(At 2 months and 6 months postpartum)
Investigators
WONG Mei Sze
PhD candidate, registered nurse, registered midwife
Chinese University of Hong Kong