Metabolic SyndromeNCT06169943
Mhealth Social Support for People at Risk of Metabolic Syndrome
A study testing mHealth social support program in people with Metabolic Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong at 3- and 6-month follow-ups. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- mHealth social support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2024to 31 Aug 2025
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese adults aged ≥ 45 years
- With central obesity according to IDF criteria
- Being treated of hypertension, dyslipidemia, or diabetes
- Able to give informed consent
- Attain at least 6 years of formal education
- Have a smartphone with internet connection and able to use WhatsApp
Who cannot join
- Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program
- Known history of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Shatin, Not Applicabnle.
About this study
Official title: A Mhealth Social Support Program on Health Behaviors Among People at Risk of Metabolic Syndrome: a Feasibility Randomized Controlled Trial
This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong at 3- and 6-month follow-ups.
Read the detailed description
Metabolic syndrome is a cluster of unhealthy conditions that affects more than 1 billion people in the world. Lifestyle modifications can reduce the risk to develop metabolic syndrome, while the report showed that over 95% of people in Hong Kong did not practice healthy lifestyle. This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong. Eighty eligible participants will be recruited from community centers and be randomized into intervention group or control group. Participants in the control group will receive a mobile app with limited function, while those in the intervention group will receive a theory-guided mhealth social support program. Data will be collected at baseline, 3 months, and 6 months on the outcomes of feasibility, acceptability, and lifestyle modifications. Data will be analyzed using a generalized estimating equation based on the intention-to-treat principle. The findings of this study will provide valuable information for a full randomized controlled trial.
- Conditions
- Metabolic Syndrome
- Being tested
- mHealth social support program, Control
- Keywords
- mhealth, metabolic syndrome, lifestyle modifications
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth social support programOther
This is a 3-month program comprises mobile app, group discussion, individual telephone contact, and reminders.
ControlOther
The same mobile app as the intervention group but with limited function.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Participants in the control group will receive the same mobile app as the intervention group but with limited function. Receives: Other: Control |
| Intervention | Experimental | Participants in the intervention group will receive the mHealth social support program. Receives: Other: mHealth social support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Total exercise amount will be quantified with a modified version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire.
Measured: Baseline, 3, and 6 months
Secondary outcomes (8)
Healthy eating
Diet subscale of the Chinese version of Health Promoting Lifestyle Profile II. The subscale includes eight items measuring healthy eating on a 4-point Likert scale (1=never to 4=routinely), ranged from 8-32. The higher sum score indicates more adoption of healthy eating.
Measured: Baseline, 3, and 6 months
Metabolic syndrome knowledge
Chinese version of metabolic syndrome knowledge scale. 10 items cover three domains: definition and diagnosis (5 items), complications (2 items), and preventions (3 items); a higher sum score indicates better understanding of metabolic syndrome.
Measured: Baseline, 3, and 6 months
Perceived social support
Chinese version of multidimensional scale of perceived social support. 12 items measuring perceived support from family and friends; 7-point Likert scale (1=strongly disagree to 7=strongly agree), ranged from 12 -84; a higher sum score indicates more social support is perceived.
Measured: Baseline, 3, and 6 months
Self-efficacy
Nutrition and Exercise subscale of the Chinese version of Self-rated Abilities for Health Practices.
7 items measuring diet self-efficacy and 7 items measuring PA self-efficacy; five-point Likert scale (0=not confident to 4=very confident) that a higher score indicates higher confidence to adopt lifestyle modifications in daily life.
Measured: Baseline, 3, and 6 months
Blood pressure
Both systolic blood pressure and diastolic blood pressure will be measured by a validated and reliable upper-arm automated system (in mmHg) after resting for 20 minutes; an average of two measurements with 1-minute apart is recorded.
Measured: Baseline, 3, and 6 months
Waist circumference
Measured in the nearest 0.1 centimeter.
Measured: Baseline, 3, and 6 months
Body weight
Measured in the nearest 0.1 kilogram.
Measured: Baseline, 3, and 6 months
Body fat mass percentage
Body fat mass percentage will be assessed by a calibrated digital body composition monitor.
Measured: Baseline, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Nov 2024
- Primary completion30 Jun 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Intervention group Control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Lon Tam, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169943
- Sponsor's protocol ID
- RS-2023-AT
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mhealth Social Support Program on Health Behaviors Among People at Risk of Metabolic Syndrome: a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06169943
- Acronym / sponsor ID
- RS-2023-AT
- Conditions
- Metabolic Syndrome
- Keywords
- mhealth, metabolic syndrome, lifestyle modifications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 14 Dec 2023 (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.
This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong at 3- and 6-month follow-ups.
Detailed description
Metabolic syndrome is a cluster of unhealthy conditions that affects more than 1 billion people in the world. Lifestyle modifications can reduce the risk to develop metabolic syndrome, while the report showed that over 95% of people in Hong Kong did not practice healthy lifestyle. This trial is to examine the feasibility, acceptability, and preliminary effect of a mHealth social support program on lifestyle modifications among people at risk of metabolic syndrome in Hong Kong. Eighty eligible participants will be recruited from community centers and be randomized into intervention group or control group. Participants in the control group will receive a mobile app with limited function, while those in the intervention group will receive a theory-guided mhealth social support program. Data will be collected at baseline, 3 months, and 6 months on the outcomes of feasibility, acceptability, and lifestyle modifications. Data will be analyzed using a generalized estimating equation based on the intention-to-treat principle. The findings of this study will provide valuable information for a full randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group Control group
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlParticipants in the control group will receive the same mobile app as the intervention group but with limited function. |
| Intervention | Experimental | Other: mHealth social support programParticipants in the intervention group will receive the mHealth social support program. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chinese adults aged ≥ 45 years
- With central obesity according to IDF criteria
- Being treated of hypertension, dyslipidemia, or diabetes
- Able to give informed consent
- Attain at least 6 years of formal education
Key exclusion criteria (2 listed)
- Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program
- Known history of psychiatric disorders
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 |
|---|---|---|
| mHealth social support programThis is a 3-month program comprises mobile app, group discussion, individual telephone contact, and reminders. | Other | Intervention |
| ControlThe same mobile app as the intervention group but with limited function. | Other | Control |
Primary outcome
Physical activity level
Time frame: Baseline, 3, and 6 months
Total exercise amount will be quantified with a modified version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire.
8 secondary outcomes
Healthy eating
Time frame: Baseline, 3, and 6 months
Metabolic syndrome knowledge
Time frame: Baseline, 3, and 6 months
Perceived social support
Time frame: Baseline, 3, and 6 months
Self-efficacy
Time frame: Baseline, 3, and 6 months
Blood pressure
Time frame: Baseline, 3, and 6 months
Waist circumference
Time frame: Baseline, 3, and 6 months
Body weight
Time frame: Baseline, 3, and 6 months
Body fat mass percentage
Time frame: Baseline, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth social support program in people with Metabolic Syndrome, run by Chinese University of Hong Kong 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 16 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: Baseline, 3, and 6 months). 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 16 Oct 2026.