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

Healthy Diet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660837
• Other study ID #: HREP-2022-0170
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2022
• Source: Hong Kong University of Science and Technology
• Contact: Yaeeun Han
• Phone: +85253004009
• Email: yehan[@]ust.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Filipino

• Migrant domestic worker working in Hong Kong

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Healthy Diet
• Mental Health Wellness

Intervention

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 In person get to know your group member activities Nutrition information through WhatsApp Tips and advice to maintain good mental health through WhatsApp Motivational messages through WhatsApp Reminder through WhatsApp In-person baking class x 1 session
• 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. Online get to know your group member activities Nutrition information through WhatsApp Tips and advice to maintain good mental health through WhatsApp Motivational messages through WhatsApp Reminder through WhatsApp Online baking class x 1 session through WhatsApp

Locations

Country	Name	City	State
Hong Kong	Hong Kong University of Science of Technology	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong University of Science and Technology

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight (change)	measured in kg	Change from baseline weight at approximately 3-6 months.
Other	Waist circumference (change)	measured in cm	Change from baseline waist circumference at approximately 3-6 months
Other	Hip circumference (change)	measured in cm	Change from baseline hip circumference at approximately 3-6 months.
Other	Depression (change)	Created dummy variable (moderate or above) from depression score using DASS-21 questionnaire, survey questionnaire	Change from baseline at approximately 3-6 months.
Other	Anxiety (change)	Created dummy variable (moderate or above) from anxiety score using DASS-21 questionnaire, survey questionnaire	Change from baseline at approximately 3-6 months.
Other	Stress (change)	Created dummy variable (moderate or above) from stress score using DASS-21 questionnaire, survey questionnaire	Change from baseline at approximately 3-6 months.
Primary	Nutrition knowledge score (change)	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.
Primary	Perceived social support (change)	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.
Primary	Healthy diet practices (change)	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.
Primary	Stress (change)	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.
Primary	Anxiety (change)	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.
Primary	Depression (change)	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	Body mass index (change)	kg/m2, anthropometry measurements	Change from baseline BMI at approximately 3-6 months.
Secondary	Waist-to-hip ratio (change)	waist circumference (cm) /hip circumference (cm), anthropometry measurements	Change from baseline waist-to-hip ratio at approximately 3-6 months.
Secondary	Waist-to-stature ratio (change)	Waist circumference (cm)/Height (cm), anthropometry measurements	Change from baseline waist-to-stature ratio at approximately 3-6 months.
Secondary	Self-efficacy (change)	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.
Secondary	Group identity	4 questions: 5 point scale (strongly agree to strongly disagree) , survey questionnaire	measured at end-line only ( 3-6 months after baseline survey)
Secondary	Online bonding	10 questions: 5 point scale (strongly agree to strongly disagree), survey questionnaire	measured at end-line only (3-6 months after baseline survey)
Secondary	Peer pressure	10 questions: 5 point scale (strongly agree to strongly disagree), survey questionnaire	measured at end-line only (3-6 months after baseline survey)