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

NCT04741425 | Completed DMC

• 1 other identifier: 2020.577
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding, Exclusive; Self Efficacy

Outcome Measures

Primary Outcomes (3)

• 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

  The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.

  At 2 months postpartum (immediately post-intervention)

• 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

  The self-developed postnatal questionnaires are reviewed and commented by 3 lactation consultants and 2 midwives and revised accordingly.

  At 6 months postpartum

• 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

  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)

  At baseline, 2 months (immediately post-intervention) and 6 months postpartum

Secondary Outcomes (5)

• 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

• Breastfeeding initiation rate (number of mothers initiate breastfeeding within 1st hour of delivery) by self-developed postnatal questionnaire

  At 2 months postpartum

• Exclusive breastfeeding duration (total length of time on exclusive breastfeeding) by self-developed postnatal questionnaires

  At 2 months and 6 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

Study Arms (2)

REST intervention

EXPERIMENTAL

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.

Other: REST intervention

Usual care

NO INTERVENTION

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.

Interventions

REST intervention 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.

REST intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Primiparous women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Natural Parenting Network

Hong Kong, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 39865520 DERIVED

• 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.

  PMID: 36189735 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate, registered nurse, registered midwife

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: February 9, 2021
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

HK (1)