Healthy DietNCT05660837
Online Social Support Program for Physical and Mental Health of Filipino Migrant Domestic Workers in Hong Kong
A study testing T1: Mixed mode social support group and T2: Online mode social support group in people with Healthy Diet and Mental Health Wellness, run by Hong Kong University of Science and Technology at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Mental Health Wellness
- What is being tested?
- T1: Mixed mode social support group and T2: Online mode social support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Oct 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Filipino
- Migrant domestic worker working in Hong Kong
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong University of Science of Technology
Hong Kong
Yaeeun Han, +85253004009, yehan@ust.hk
Anirban Mukhopadhyay, +85223587708, anirban.mukhopadhyay@ust.hk
About this study
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.
- Does an online social support program that provides informational and emotional support improve diet, anthropometry, and mental health?
- 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?
- 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?
- Online bonding
- Group identity
- Quality of relationship
Read the detailed description
Study design: Randomized controlled trial
- 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.
- 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.
- 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.
- Conditions
- Healthy Diet, Mental Health Wellness
- Being tested
- T1: Mixed mode social support group, T2: Online mode social support group
- Keywords
- social support, weight management, emotional support, online support groups, eating behavior, mental health, informational support
- Medical subject headings
- Feeding Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1: Mixed mode social support groupBehavioural
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 groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| T1: Mixed mode social support group | Experimental | 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 Receives: Behavioral: T1: Mixed mode social support group |
| Online social support group | Experimental | This group will receive the same program as mixed mode social support group. The key differences would be delivery of all program components online. Receives: Behavioral: T2: Online mode social support group |
| Control | No intervention | This is the control group. Control group will only participate in baseline and follow-up survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition knowledge score (change)
Questions to test nutrition knowledge, survey questionnaire (score range 0-17, higher score means better outcome)
Measured: Change from baseline nutrition knowledge at approximately 3-6 months.
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.
Measured: Change from baseline perceived social support at approximately 3-6 months.
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
Measured: Change from baseline diet practices at approximately 3-6 months.
Stress (change)
Screen for stress using DASS-21 questionnaire, survey questionnaire (score range (0-42), higher score means worse outcome
Measured: Change from baseline mental health at approximately 3-6 months.
Anxiety (change)
Screen for anxiety using DASS-21 questionnaire, survey questionnaire, score range (0-42), higher score means worse outcome
Measured: Change from baseline mental health at approximately 3-6 months.
Depression (change)
Screen for depression using DASS-21 questionnaire, survey questionnaire, score range (0-42), higher score means worse outcome
Measured: Change from baseline mental health at approximately 3-6 months.
Secondary outcomes (7)
Body mass index (change)
kg/m2, anthropometry measurements
Measured: Change from baseline BMI at approximately 3-6 months.
Waist-to-hip ratio (change)
waist circumference (cm) /hip circumference (cm), anthropometry measurements
Measured: Change from baseline waist-to-hip ratio at approximately 3-6 months.
Waist-to-stature ratio (change)
Waist circumference (cm)/Height (cm), anthropometry measurements
Measured: Change from baseline waist-to-stature ratio at approximately 3-6 months.
Self-efficacy (change)
four questions, General self-efficacy scale (GSE) survey questionnaire, score range 0-30, higher score means better outcome
Measured: Change from baseline self-efficacy at approximately 3-6 months.
Group identity
4 questions: 5 point scale (strongly agree to strongly disagree) , survey questionnaire
Measured: measured at end-line only ( 3-6 months after baseline survey)
Online bonding
10 questions: 5 point scale (strongly agree to strongly disagree), survey questionnaire
Measured: measured at end-line only (3-6 months after baseline survey)
Peer pressure
10 questions: 5 point scale (strongly agree to strongly disagree), survey questionnaire
Measured: measured at end-line only (3-6 months after baseline survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start31 Oct 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anirban MUKHOPADHYAY, Hong Kong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660837
- Sponsor's protocol ID
- HREP-2022-0170
- Status last verified
- Dec 2022
- First submitted
- 7 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Social Support Program for Physical and Mental Health of Filipino Migrant Domestic Workers in Hong Kong
- ClinicalTrials.gov ID
- NCT05660837
- Acronym / sponsor ID
- HREP-2022-0170
- Conditions
- Healthy Diet, Mental Health Wellness
- Keywords
- social support, weight management, emotional support, online support groups, eating behavior, mental health, informational support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hong Kong University of Science and TechnologyUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Does an online social support program that provides informational and emotional support improve diet, anthropometry, and mental health?
- 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?
- 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?
- Online bonding
- Group identity
- Quality of relationship
Detailed description
Study design: Randomized controlled trial
- 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.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| T1: Mixed mode social support group | Experimental | Behavioral: T1: Mixed mode social support groupThis 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 |
| Online social support group | Experimental | Behavioral: T2: Online mode social support groupThis group will receive the same program as mixed mode social support group. The key differences would be delivery of all program components online. |
| Control | No intervention | –This is the control group. Control group will only participate in baseline and follow-up survey |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Filipino
- Migrant domestic worker working in Hong Kong
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1: Mixed mode social support groupThis 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 | Behavioural | T1: Mixed mode social support group |
| T2: Online mode social support groupThis 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 | Behavioural | Online social support group |
Primary outcome
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)
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.
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
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
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
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
7 secondary outcomes
Body mass index (change)
Time frame: 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-to-stature ratio (change)
Time frame: 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.
Group identity
Time frame: 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)
Peer pressure
Time frame: measured at end-line only (3-6 months after baseline survey)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1: Mixed mode social support group and T2: Online mode social support group in people with Healthy Diet and Mental Health Wellness, run by Hong Kong University of Science and Technology at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaeeun Han (+85253004009, yehan@ust.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition knowledge score (change) (time frame: Change from baseline nutrition knowledge at approximately 3-6 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.