Online Theory-based Educational Programme for Primiparous Women on Improving Breastfeeding Related Outcomes

NCT ID: NCT04741425

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-09

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Breastfeeding, Exclusive Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

REST intervention

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REST intervention

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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WONG Mei Sze

PhD candidate, registered nurse, registered midwife

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Natural Parenting Network

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Wong MS, Chien WT. Effects of an Online Theory-Based Educational Programme for Primiparous Women on Improving Breastfeeding-Related Outcomes: A Randomised Controlled Trial. Scand J Caring Sci. 2025 Mar;39(1):e13320. doi: 10.1111/scs.13320.

Reference Type DERIVED
PMID: 39865520 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36189735 (View on PubMed)

Other Identifiers

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2020.577

Identifier Type: -

Identifier Source: org_study_id

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