mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health

NCT ID: NCT05275413

Last Updated: 2022-08-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

1578 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Postnatal depression is a prevalent health issue affecting women. Although empirical evidence has proven the effectiveness of face-to-face antenatal classes in reducing perinatal distress, the availability of such support is often limited and is insufficient to benefit all parents who need it. Another challenge in pregnancy support is the difficulty to engage family members in providing support to expectant mothers. To address these limitations, the proposed project aims to develop and test the effectiveness of a family-based mobile health (mHealth) intervention, which will engage family members, including expectant fathers and grandparents to provide support to expectant mothers.

Specifically, the family-based mHealth intervention consists of a smartphone app with different versions designed for expectant mothers, fathers, and grandparents. The smartphone app will provide a user-friendly platform for users to receive psychoeducation materials related to pregnancy (e.g. antenatal care, postnatal care, and infant care) and an interactive forum for all users to ask questions related to pregnancy and family communication, which will be answered by health and social care professionals. To enhance family's engagement, we will also include other functions in the app to encourage communications among family members and enhance family cohesion. These functions include a platform for family members to send texts and share photos, and a shared schedule with alerts for dates related to pregnancy (e.g. appointments for antenatal check-ups and expected delivery date).

Using a randomized controlled design, the proposed study will evaluate the effectiveness of the family-based mHealth intervention in reducing maternal postnatal depression and promoting health in expectant mothers and their family members (expectant fathers and grandparents). The study will recruit 1,578 expectant mothers and their family members at the antenatal clinics at two selected public hospitals in Hong Kong. The participants will be randomized into three groups (i) family-based mHealth intervention; (ii) mother-only mHealth intervention; and (iii) health information control. Participants will be asked to complete a survey with question items related to their physical and mental health, perceived social support and family cohesion, at recruitment and four weeks after childbirth.

It is hypothesized that the family-based mHealth intervention is more effective in reducing symptoms of postnatal depression, promoting health of expectant mothers and their family members, and promoting family cohesion than the mother-only mHealth intervention and the control.

Conditions

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Postnatal Depression Quality of Life Family Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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family-based mHealth intervention

The 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.

Group Type EXPERIMENTAL

family-based mHealth Intervention

Intervention Type BEHAVIORAL

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.

mother-only mHealth intervention

The expectant mothers in this group will receive health education and support via a smartphone app.

Group Type EXPERIMENTAL

mother-only mHealth Intervention

Intervention Type BEHAVIORAL

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.

Health education

The expectant mothers in the control group will receive health education via a smartphone app.

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type OTHER

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.

Interventions

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family-based mHealth Intervention

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.

Intervention Type BEHAVIORAL

mother-only mHealth Intervention

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.

Intervention Type BEHAVIORAL

Health education

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Possession of a smartphone and a personal email address for receiving and sending information relevant to the study.
3. Willing to accept the study arrangements.

Exclusion Criteria

1. Not able to understand written or spoken Chinese.
2. Expectant mothers whose EPDS score is equal to or high than the cut-off score of 10.
3. Not willing or not able to provide informed consent.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kwong Wah Hospital

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role collaborator

Tsan Yuk Hospital, Hong Kong

UNKNOWN

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Camilla Lo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kwong Wah Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Tsan Yuk Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Camilla Kin Ming LO, Phd

Role: CONTACT

2766 5760

Facility Contacts

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Wing Cheong Leung

Role: primary

Ka Wang Cheung

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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KC/KE-20-0119/ER-2

Identifier Type: -

Identifier Source: org_study_id

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