Clinical trial NCT05660837: Online Social Support Program for Physical and Mental Health of Filipino Migrant Domestic Workers in Hong Kong
Official title: Online Social Support Program for Physical and Mental Health of Filipino Migrant Domestic Workers in Hong Kong
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Diet
Mental Health Wellness
Keywords: social support
weight management
emotional support
online support groups
eating behavior
mental health
informational support
Lead sponsor: Hong Kong University of Science and Technology
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators are providing informational and emotional social support (nutrition, mental health, baking classes) through two different communication modalities (online vs. mixed mode) whose effects will be contrasted against each other and a third, control, condition.

Treatment 1: Mixed-mode social support group Treatment 2: Online social support group Control: No intervention
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* Filipino
* Migrant domestic worker working in Hong Kong

Exclusion Criteria:

* None

Primary outcomes:
measure: Nutrition knowledge score (change)
timeFrame: Change from baseline nutrition knowledge at approximately 3-6 months.
measure: Perceived social support (change)
timeFrame: Change from baseline perceived social support at approximately 3-6 months.
measure: Healthy diet practices (change)
timeFrame: Change from baseline diet practices at approximately 3-6 months.
measure: Stress (change)
timeFrame: Change from baseline mental health at approximately 3-6 months.
measure: Anxiety (change)
timeFrame: Change from baseline mental health at approximately 3-6 months.
measure: Depression (change)
timeFrame: Change from baseline mental health at approximately 3-6 months.
Secondary outcomes:
measure: Body mass index (change)
timeFrame: Change from baseline BMI at approximately 3-6 months.
measure: Waist-to-hip ratio (change)
timeFrame: Change from baseline waist-to-hip ratio at approximately 3-6 months.
measure: Waist-to-stature ratio (change)
timeFrame: Change from baseline waist-to-stature ratio at approximately 3-6 months.
measure: Self-efficacy (change)
timeFrame: Change from baseline self-efficacy at approximately 3-6 months.
measure: Group identity
timeFrame: measured at end-line only ( 3-6 months after baseline survey)
measure: Online bonding
timeFrame: measured at end-line only (3-6 months after baseline survey)
measure: Peer pressure
timeFrame: measured at end-line only (3-6 months after baseline survey)
Other outcomes:
measure: Weight (change)
timeFrame: Change from baseline weight at approximately 3-6 months.
measure: Waist circumference (change)
timeFrame: Change from baseline waist circumference at approximately 3-6 months
measure: Hip circumference (change)
timeFrame: Change from baseline hip circumference at approximately 3-6 months.
measure: Depression (change)
timeFrame: Change from baseline at approximately 3-6 months.
measure: Anxiety (change)
timeFrame: Change from baseline at approximately 3-6 months.
measure: Stress (change)
timeFrame: Change from baseline at approximately 3-6 months.
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong University of Science of Technology
Study officials:
References: