- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621266
Home Based Peer Support Program for Mothers With Low Breastfeeding Self-efficacy (BFPS)
Effectiveness of a Home-based Peer Support Program for Chinese Mothers With Low Breastfeeding Self-efficacy to Increase the Exclusivity and Duration of Breastfeeding: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primiparous mothers who plan to breastfeed but did not go on to breastfeed often face high levels of emotional and psychological challenges in their transition to parenthood. This can adversely affect their breastfeeding experiences and general well-being, and is associated with stress, anxiety, and postnatal depression. While family psycho-education and other supportive group programmes are available in health services, they require face-to-face education sessions over a long interval, high engagement, and trusting relationships, and thus often result in low attendance and high drop outs.
Mothers have expressed the need for psychological support of peer counsellors, which would allow them to support each other. The first month postpartum is a critical period for sustaining exclusive breastfeeding and the time when mothers are at high risk of postpartum depression. For Chinese mothers in Hong Kong, however, they are often housebound during this period due to the tradition of "doing the month", and thus often find it difficult to attend support groups or seek help. In view of these challenges and the pandemic wave faced by primiparous mothers, they are reluctant with home visits, therefore an online delivery of the home-based peer support programme is proposed.
This randomized control trial adopts a two-arm design to examine the effectiveness of an online home-based peer support programme for women with low breastfeeding self-efficacy. It is hypothesized that those receiving the intervention, when compared to the controls, will have (1) longer period of exclusive breastfeeding, (2) higher postnatal breastfeeding self-efficacy, and (3) lower post-partum depressive symptoms.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Queen Mary Hospital
-
Hong Kong, Hong Kong
- Queen Elizabeth Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primiparous mothers
- Intend to breastfeed
- Have low breastfeeding self-efficacy (between 14 to 32)
- Have singleton pregnancy and live birth
- Have term infant (37-42 weeks gestational)
- Cantonese speaking
- Hong Kong resident
- Have no serious medical or obstetrical complications
Exclusion Criteria:
- Infant is <37 week gestation
- Infant has Apgar score <8 at five minutes
- Infant has birthweight <2,500 grams
- Infant has any severe medical conditions or congenital malformations
- Infant is placed in the special care baby unit for more than 48 hours after birth
- Infant is placed in the neonatal intensive care unit at any time after birth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online Home-based peer support intervention
Participants will receive intervention on top of standard usual care.
|
Online Home-based peer support will be provided to support participants' breastfeeding.
There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants.
Each session will last approximately 30 minutes.
|
|
No Intervention: Standard usual care
Participants will receive standard usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infant Feeding Status: Exclusive Breastfeeding
Time Frame: At 1 month postpartum
|
Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum.
|
At 1 month postpartum
|
|
Infant Feeding Status: Exclusive Breastfeeding
Time Frame: At 2 months postpartum
|
Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum.
|
At 2 months postpartum
|
|
Infant Feeding Status: Exclusive Breastfeeding
Time Frame: At 4 months postpartum
|
Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum.
|
At 4 months postpartum
|
|
Infant Feeding Status: Exclusive Breastfeeding
Time Frame: At 6 months postpartum
|
Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum.
|
At 6 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Women's Self-efficacy in Breastfeeding
Time Frame: At baseline, 2 months and 4 months postpartum
|
Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy.
The 14-item scale is on a 5-point Likert scale.
Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy.
A cut-off score of 46 is applied after rounding up to the nearest integer.
|
At baseline, 2 months and 4 months postpartum
|
|
Women's Self-efficacy in Breastfeeding at Baseline
Time Frame: At baseline
|
Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy.
The 14-item scale is on a 5-point Likert scale.
Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy.
A cut-off score of 46 is applied after rounding up to the nearest integer.
|
At baseline
|
|
Women's Self-efficacy in Breastfeeding at 2 Months Postpartum
Time Frame: At 2 months postpartum
|
Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy.
The 14-item scale is on a 5-point Likert scale.
Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy.
A cut-off score of 46 is applied after rounding up to the nearest integer.
|
At 2 months postpartum
|
|
Women's Self-efficacy in Breastfeeding at 4 Months Postpartum
Time Frame: At 4 months postpartum
|
Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy.
The 14-item scale is on a 5-point Likert scale.
Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy.
A cut-off score of 46 is applied after rounding up to the nearest integer.
|
At 4 months postpartum
|
|
Women's Postpartum Depression at Baseline
Time Frame: At baseline
|
The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms.
It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30.
In general, a higher score indicates more severe depressive symptoms.
|
At baseline
|
|
Women's Postpartum Depression at 1 Month Postpartum
Time Frame: At 1 month postpartum
|
The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms.
It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30.
In general, a higher score indicates more severe depressive symptoms.
|
At 1 month postpartum
|
|
Women's Postpartum Depression at 2 Month Postpartum
Time Frame: At 2 month postpartum
|
The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms.
It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30.
In general, a higher score indicates more severe depressive symptoms.
|
At 2 month postpartum
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kris YW Lok, PhD, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BFPS1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breastfeeding
-
Uludag UniversityCompletedVirtual Reality | Breastfeeding Education | Breastfeeding Duration | Breastfeeding Self-Efficacy | Metaverse | Breastfeeding Motivation | Digital Museum | Breastfeeding Problems AssessmentTurkey (Türkiye)
-
Marmara UniversityNot yet recruitingBreastfeeding | Breastfeeding Support
-
Halic UniversityCompletedBreastfeeding | Breastfeeding, ExclusiveTurkey
-
University of Ontario Institute of TechnologyDurham Region Health DepartmentUnknown
-
University of California, DavisUniversity of California, San Francisco; Public Hospital Roatan, HondurasCompletedBreastfeeding | Breastfeeding, ExclusiveHonduras
-
T.C. ORDU ÜNİVERSİTESİCompletedBreastfeeding Education | Breastfeeding Attitude | Breastfeeding Self-EfficacyTurkey
-
Semmelweis UniversityNot yet recruitingLactation | Breastfeeding | Breastfeeding Mothers | Breastfeeding Education | Lactating Mother
-
Fundacion Profesor Novoa SantosNot yet recruitingGrowth & Development | Breastfeeding, Exclusive | Breastfeeding Rate | Breastfeeding Outcomes | Breastfeeding Duration | Breastfeeding After Discharge From Hospital Following Childbirth, Yes/no | Breastfeeding Attitude | Breastfeeding Support System | Breastfeeding Consultancy Training | Breastfeeding...Spain
-
Celal Bayar UniversityManisa Celal Bayar UniversityCompletedBreastfeeding | Breastfeeding, ExclusiveTurkey
-
Benten Technologies, Inc.National Institute on Minority Health and Health Disparities (NIMHD); George... and other collaboratorsEnrolling by invitationBreastfeeding | Exclusive BreastfeedingUnited States
Clinical Trials on Online Home-based peer support
-
University of British ColumbiaUniversity of CopenhagenCompleted
-
Universitätsklinikum Hamburg-EppendorfUniversity of UlmActive, not recruitingSevere Mental Health Condition With Indication of Hospital AdmissionGermany
-
University College, LondonCompletedDepression | Anxiety | Loneliness | Anxiety Disorder | Low MoodUnited Kingdom
-
University of TorontoUnknownSocial Support | Affect | Ventilators, MechanicalCanada
-
Lighthouse TrustUniversity of North Carolina, Chapel Hill; World Health Organization; Kamuzu... and other collaboratorsUnknown
-
University of NottinghamUnknownDepression | AnxietyUnited Kingdom
-
McGill University Health Centre/Research Institute...Canadian Institutes of Health Research (CIHR); University of AlbertaCompletedParent-Child Relations | Autism Spectrum Disorder | Parenting | Mental Health Wellness 1 | Parent-child Problem | Child Development Disorder | Child Developmental DelayCanada
-
Jewish General HospitalUniversity Health Network, Toronto; McGill University Health Centre/Research... and other collaboratorsCompletedHealth Attitude | Low Anterior Resection Syndrome | Patient Satisfaction | Colo-rectal Cancer | Health Knowledge, Attitudes, Practice | Patient Empowerment | Peer GroupCanada
-
British Columbia Cancer AgencyUniversity of British Columbia; McMaster University; University of Calgary; Tom... and other collaboratorsUnknown
-
Centre for Addiction and Mental HealthBreaking Free Online (BFO); Community Addictions Peer Support Association (CAPSA)CompletedSubstance Use DisordersCanada