mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health
Engaging the Whole Family to Support Expectant Mothers: A Family-based mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health
1 other identifier
interventional
1,578
1 country
2
Brief Summary
The proposed study is to test the effectiveness of a culturally-attuned, family-based mobile health (mHealth) intervention in reducing symptoms of postnatal depression and promoting health among expectant mothers in Hong Kong. Using a family perspective, the proposed mHealth intervention will engage family members, including expectant fathers and grandparents, in providing support to expectant mothers. Expectant mothers and their family members will be recruited at antenatal clinics at two public hospitals in Hong Kong and randomized to receive the family-based mHealth intervention (experimental), the mother-only mHealth intervention (experimental), or the health education (control). Maternal depression, anxiety and stress, perceived social support, health-related quality of life, and perceived family cohesion will be assessed at recruitment and four weeks after childbirth. For family members, symptoms of anxiety and stress, health-related quality of life, and perceived family cohesion will be measured.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
March 11, 2022
CompletedStudy Start
First participant enrolled
June 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 22, 2022
August 1, 2022
1 year
March 2, 2022
August 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Postnatal depression symptoms
Symptoms of maternal depression at four weeks postpartum will be assessed with the validated Chinese version of the 10-item Edinburgh Postnatal Depression Scale (EPDS).
24 weeks after start of intervention
Secondary Outcomes (4)
Perceived social support levels of expectant mothers
24 weeks after start of intervention
Anxiety and stress levels of all participants
24 weeks after start of intervention
Health-related quality of life (QoL) of all participants
24 weeks after start of intervention
Perceived family cohesion levels of all participants
24 weeks after start of intervention
Study Arms (3)
family-based mHealth intervention
EXPERIMENTALThe expectant mothers and their family members (fathers and grandparents) in this group will receive health education and support and family support via a smartphone app.
mother-only mHealth intervention
EXPERIMENTALThe expectant mothers in this group will receive health education and support via a smartphone app.
Health education
ACTIVE COMPARATORThe expectant mothers in the control group will receive health education via a smartphone app.
Interventions
The intervention consists of three versions: mother, father, and grandparent. The app consists of health information about pregnancy, postnatal care, and infant care in the form of brief texts and short videos. Each versions have their unique features, such as a platform to ask questions in mother version, a quiz game to promote fathers' knowledge related to father's involvement, educational materials tailored for grandparents. An obstetrician and a social worker will respond to the questions. Details please refer to the proposal.
The expectant mothers in this group will receive information about pregnancy, postnatal care, and infant care in the form of brief texts and short videos via a smartphone app. The expectant mothers will also have access to a platform in the smartphone app to ask questions about their pregnancy. An obstetrician will respond to the questions.
The expectant mothers in the control group will receive information about pregnancy, postnatal care, and infant care in the form of brief texts and short videos via a smartphone app.
Eligibility Criteria
You may qualify if:
- Expectant mothers (18 years old or above) attending the antenatal clinics at two public hospitals, Kwong Wah Hospital and Tsan Yuk Hospital in Hong Kong and their family members.
- Possession of a smartphone and a personal email address for receiving and sending information relevant to the study.
- Willing to accept the study arrangements.
You may not qualify if:
- Not able to understand written or spoken Chinese.
- Expectant mothers whose EPDS score is equal to or high than the cut-off score of 10.
- Not willing or not able to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hong Kong Polytechnic Universitylead
- Kwong Wah Hospitalcollaborator
- The University of Hong Kongcollaborator
- University of Glasgowcollaborator
- Tsan Yuk Hospital, Hong Kongcollaborator
Study Sites (2)
Kwong Wah Hospital
Hong Kong, Hong Kong
Tsan Yuk Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 2, 2022
First Posted
March 11, 2022
Study Start
June 16, 2022
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
August 22, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share