NCT05660837

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. 1.Does an online social support program that provides informational and emotional support improve diet, anthropometry, and mental health?
  2. 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. 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?
  4. 4.Online bonding
  5. 5.Group identity
  6. 6.Quality of relationship

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

November 7, 2022

Last Update Submit

December 14, 2022

Conditions

Keywords

social supportweight managementemotional supportonline support groupseating behaviormental healthinformational support

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (7)

  • Body mass index (change)

    Change from baseline BMI at approximately 3-6 months.

  • Waist-to-hip ratio (change)

    Change from baseline waist-to-hip ratio at approximately 3-6 months.

  • Waist-to-stature ratio (change)

    Change from baseline waist-to-stature ratio at approximately 3-6 months.

  • Self-efficacy (change)

    Change from baseline self-efficacy at approximately 3-6 months.

  • Group identity

    measured at end-line only ( 3-6 months after baseline survey)

  • +2 more secondary outcomes

Other Outcomes (6)

  • Weight (change)

    Change from baseline weight at approximately 3-6 months.

  • Waist circumference (change)

    Change from baseline waist circumference at approximately 3-6 months

  • Hip circumference (change)

    Change from baseline hip circumference at approximately 3-6 months.

  • +3 more other outcomes

Study Arms (3)

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

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.

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

Interventions

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

T1: Mixed 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

Online social support group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale will be eligible to participate. Participant eligibility is based on self-representation.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Filipino
  • Migrant domestic worker working in Hong Kong

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong University of Science of Technology

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Feeding BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorPersonal Satisfaction

Central Study Contacts

Yaeeun Han

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Baseline survey, follow-up survey, and anthropometry measurement will be collected through assessor masked to assignment details.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2022

First Posted

December 21, 2022

Study Start

October 31, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Immediately after the study is accepted for publication, and available for 5 years
Access Criteria
Those who want access will be asked to contact the Principal Investigator via email.

Locations