Online Social Support Program for Physical and Mental Health of Filipino Migrant Domestic Workers in Hong Kong

December 14, 2022 updated by: Anirban MUKHOPADHYAY, Hong Kong University of Science and Technology

The goal of this study is to test the effect of informational and emotional social support (via nutrition education, mental health support, and/or baking classes) through two different communication modalities (online vs. mixed mode / hybrid) on physical and mental health outcomes

Our research questions are the following.

  1. Does an online social support program that provides informational and emotional support improve diet, anthropometry, and mental health?
  2. Does a mixed-mode social support program that provides informational, emotional support through both online and face-to-face mode improve diet, anthropometry, and mental health?

  3. Is a mixed mode social support program more effective in improving outcomes? Does meeting the group members face-to-face change the dynamics of online communication? If yes, what are the mechanisms? Are there differences in the following outcomes by communication modality?

    1. Online bonding
    2. Group identity
    3. Quality of relationship

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design: Randomized controlled trial

  1. Study description

    Filipino Migrant Domestic workers (MDWs) working in Hong Kong will be eligible to apply. The investigators will advertise in Newspapers and Facebook commonly read by Filipino MDWs in Hong Kong. The investigators will recruit 400 MDWs over two phases and randomly assign them across three arms, T1) mixed-mode social support program; T2) Online social support program; and C) Control. Online social support program will be delivered through WhatsApp group chat. MDWs will self-fill surveys at Caritas office, but surveys will be assisted by survey enumerators as a group.

  2. Logistics

    Due to administrative constraints delivering interventions to 400 participants at the same time, the investigators will deliver interventions over two cohorts.

    Cohort 1 (~200 participants)

    • Oct 31st-Dec 18th 2022 Baseline survey
    • Jan 8th-March 18th 2023 Intervention (10 weeks)
    • March 26th -April 16th 2023 Follow-up survey

    Cohort 2 (~200 participants)

    • Feb 5th-March 19th 2023 Baseline survey
    • March 20th-May 27th Intervention (10 weeks)
    • May 28th - June 25th follow-up survey

    Note 1: The investigators will enroll participants until the scheduled date for baseline survey or until the investigators recruit target sample size, whichever comes earlier.

    Note 2: The investigators will keep the intervention design exactly the same for cohort 1 and cohort 2, and will not analyze data until data collection for both cohort 1 and cohort 2 is complete. Cohort 1 and cohort 2 will be analyzed as one sample.

  3. Statistical analysis model - Estimation of treatment effect

In this section, the investigators outline the basic estimation approach to measuring the effect of the treatments on various outcomes.

Our basic treatment effects specification estimates the following equation:

y= β₀ + β₁T1 + β₂T2+ β₃X+ ε where y is the outcome of interest.

T1 and T2 are dummy variables equal to 1 if the participant was randomly assigned to the T1 and T2 group, respectively, and 0 otherwise. β₁ and β₂ represent the effect of being assigned to the specific treatment arm. X is a vector of baseline outcome and individual's characteristics including age, marital status, years working as migrant domestic workers, level of education, received food allowance. ε is an error term. The primary outcome variable, y, include nutrition knowledge, perceived social support, healthy diet, stress, anxiety, and depression. To compare the difference between T1 and T2, we will use F-test coefficient of equality.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yaeeun Han
  • Phone Number: +85253004009
  • Email: yehan@ust.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong University of Science of Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Filipino
  • Migrant domestic worker working in Hong Kong

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T1: Mixed mode social support group
This group will receive programs in both online and off-line setting. There will be one face-to-face group session to get to know participant's peer group members. After the in-person group meeting, participants will meet in WhatsApp group. In WhatsApp group, facilitator will provide the following program
Behavioral: T1: Mixed mode social support group

This group will receive programs in both online and off-line setting. There will be one face-to-face group session to get to know participant's peer group members. After the in-person group meeting, participants will meet in WhatsApp group. In WhatsApp group, facilitator will provide the following program

  1. In person get to know your group member activities
  2. Nutrition information through WhatsApp
  3. Tips and advice to maintain good mental health through WhatsApp
  4. Motivational messages through WhatsApp
  5. Reminder through WhatsApp
  6. In-person baking class x 1 session
Experimental: Online social support group
This group will receive the same program as mixed mode social support group. The key differences would be delivery of all program components online.
Behavioral: T2: Online mode social support group

This group will receive the same program as mixed mode social support group. The key differences would be delivery of all program components online.

  1. Online get to know your group member activities
  2. Nutrition information through WhatsApp
  3. Tips and advice to maintain good mental health through WhatsApp
  4. Motivational messages through WhatsApp
  5. Reminder through WhatsApp
  6. Online baking class x 1 session through WhatsApp
No Intervention: Control

This is the control group.

Control group will only participate in baseline and follow-up survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition knowledge score (change)
Time Frame: Change from baseline nutrition knowledge at approximately 3-6 months.
Questions to test nutrition knowledge, survey questionnaire (score range 0-17, higher score means better outcome)
Change from baseline nutrition knowledge at approximately 3-6 months.
Perceived social support (change)
Time Frame: Change from baseline perceived social support at approximately 3-6 months.
Participant's perceived social support score, scale adapted from Oslo social support scale (OSSS-3), survey questionnaire, higher score means better outcome.
Change from baseline perceived social support at approximately 3-6 months.
Healthy diet practices (change)
Time Frame: Change from baseline diet practices at approximately 3-6 months.
Questions adapted from "starting the conversation (STC)" food frequency instrument, scale range 0-50, higher score means better outcome, survey questionnaire
Change from baseline diet practices at approximately 3-6 months.
Stress (change)
Time Frame: Change from baseline mental health at approximately 3-6 months.
Screen for stress using DASS-21 questionnaire, survey questionnaire (score range (0-42), higher score means worse outcome
Change from baseline mental health at approximately 3-6 months.
Anxiety (change)
Time Frame: Change from baseline mental health at approximately 3-6 months.
Screen for anxiety using DASS-21 questionnaire, survey questionnaire, score range (0-42), higher score means worse outcome
Change from baseline mental health at approximately 3-6 months.
Depression (change)
Time Frame: Change from baseline mental health at approximately 3-6 months.
Screen for depression using DASS-21 questionnaire, survey questionnaire, score range (0-42), higher score means worse outcome
Change from baseline mental health at approximately 3-6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index (change)
Time Frame: Change from baseline BMI at approximately 3-6 months.
kg/m2, anthropometry measurements
Change from baseline BMI at approximately 3-6 months.
Waist-to-hip ratio (change)
Time Frame: Change from baseline waist-to-hip ratio at approximately 3-6 months.
waist circumference (cm) /hip circumference (cm), anthropometry measurements
Change from baseline waist-to-hip ratio at approximately 3-6 months.
Waist-to-stature ratio (change)
Time Frame: Change from baseline waist-to-stature ratio at approximately 3-6 months.
Waist circumference (cm)/Height (cm), anthropometry measurements
Change from baseline waist-to-stature ratio at approximately 3-6 months.
Self-efficacy (change)
Time Frame: Change from baseline self-efficacy at approximately 3-6 months.
four questions, General self-efficacy scale (GSE) survey questionnaire, score range 0-30, higher score means better outcome
Change from baseline self-efficacy at approximately 3-6 months.
Group identity
Time Frame: measured at end-line only ( 3-6 months after baseline survey)
4 questions: 5 point scale (strongly agree to strongly disagree) , survey questionnaire
measured at end-line only ( 3-6 months after baseline survey)
Online bonding
Time Frame: measured at end-line only (3-6 months after baseline survey)
10 questions: 5 point scale (strongly agree to strongly disagree), survey questionnaire
measured at end-line only (3-6 months after baseline survey)
Peer pressure
Time Frame: measured at end-line only (3-6 months after baseline survey)
10 questions: 5 point scale (strongly agree to strongly disagree), survey questionnaire
measured at end-line only (3-6 months after baseline survey)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight (change)
Time Frame: Change from baseline weight at approximately 3-6 months.
measured in kg
Change from baseline weight at approximately 3-6 months.
Waist circumference (change)
Time Frame: Change from baseline waist circumference at approximately 3-6 months
measured in cm
Change from baseline waist circumference at approximately 3-6 months
Hip circumference (change)
Time Frame: Change from baseline hip circumference at approximately 3-6 months.
measured in cm
Change from baseline hip circumference at approximately 3-6 months.
Depression (change)
Time Frame: Change from baseline at approximately 3-6 months.
Created dummy variable (moderate or above) from depression score using DASS-21 questionnaire, survey questionnaire
Change from baseline at approximately 3-6 months.
Anxiety (change)
Time Frame: Change from baseline at approximately 3-6 months.
Created dummy variable (moderate or above) from anxiety score using DASS-21 questionnaire, survey questionnaire
Change from baseline at approximately 3-6 months.
Stress (change)
Time Frame: Change from baseline at approximately 3-6 months.
Created dummy variable (moderate or above) from stress score using DASS-21 questionnaire, survey questionnaire
Change from baseline at approximately 3-6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2022

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HREP-2022-0170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The investigators will share the study protocol, analysis plan, informed consent form, and study report for up to 5 years after the study is published.

IPD Sharing Time Frame

Immediately after the study is accepted for publication, and available for 5 years

IPD Sharing Access Criteria

Those who want access will be asked to contact the Principal Investigator via email.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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