Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05275413
Other study ID # KC/KE-20-0119/ER-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 16, 2022
Est. completion date December 31, 2023

Study information

Verified date August 2022
Source The Hong Kong Polytechnic University
Contact Camilla Kin Ming LO, Phd
Phone 2766 5760
Email camilla.lo@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1578
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Behavioral:
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.
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.
Other:
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.

Locations

Country Name City State
Hong Kong Kwong Wah Hospital Hong Kong
Hong Kong Tsan Yuk Hospital Hong Kong

Sponsors (5)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Kwong Wah Hospital, The University of Hong Kong, Tsan Yuk Hospital, Hong Kong, University of Glasgow

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Perceived social support levels of expectant mothers Perceived social support levels of expectant mothers will be assessed with the Chinese version of the 12-item Multidimensional Scale of Perceived Social Support (MSPSS). 24 weeks after start of intervention
Secondary Anxiety and stress levels of all participants Anxiety and stress levels of all participants (including the expectant mothers, fathers, and grandparents) will be assessed with the Anxiety and Stress subscales of the Chinese version of the Depression Anxiety Stress Scale (DASS21). 24 weeks after start of intervention
Secondary Health-related quality of life (QoL) of all participants Health-related quality of life (QoL) of all participants will be measured with the validated Chinese version of the Short-form-12 Health survey (SF-12 v2), which consists of 12 items to be computed as two composite scores: physical component score and mental component score. 24 weeks after start of intervention
Secondary Perceived family cohesion levels of all participants Perceived family cohesion levels of all participants will be assessed using the nine-item Family Cohesion subscale of the Chinese version of the Family Environment Scale. 24 weeks after start of intervention
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A