Metabolic SyndromeTOP-SNCT06793930
A Tailored, Optimised, and Person-centred Programme to Promote Lifestyle Modification in People With Metabolic Syndrome
A study testing A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification and Brief advice in people with Metabolic Syndrome and Primary Prevention of Atherosclerotic Cardiovascular Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a mixed-methods study comprising a 2-arm randomised controlled trial and a qualitative study. This study aims to evaluate the effects of a lifestyle modification on the control of metabolic syndrome, with assessments measured at baseline, immediately at the end of the active phase of intervention (12 weeks)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome, Primary Prevention of Atherosclerotic Cardiovascular Disease
- What is being tested?
- A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification and Brief advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Oct 2024to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese adults with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five defining characteristics (i.e., raised blood pressure, raised triglycerides, lowered high-density lipoprotein, raised fasting blood glucose, and central obesity)
- aged ≥18
- community-dwelling
- independent in daily living
- possessed a digital device with an internet connection
Who cannot join
- Has established atherosclerotic cardiovascular diseases (coronary heart disease, cerebrovascular disease and peripheral arterial disease)
- Has psychiatric diseases
- Cannot read Chinese
- Has impaired communication or cognitive function (as indicated by an Abbreviated Mental Test Score of ≤6)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Local community centres
Hong Kong
Bernice Chan, 852-9752-7530, bernices@connect.hku.hk
About this study
Official title: The Effects of a Tailored, Optimised, and Person-centred Critical Pathway to Promote Lifestyle Modification in People With Metabolic Syndrome: A Mixed-methods Study
This is a mixed-methods study comprising a 2-arm randomised controlled trial and a qualitative study. This study aims to evaluate the effects of a lifestyle modification on the control of metabolic syndrome, with assessments measured at baseline, immediately at the end of the active phase of intervention (12 weeks) and 8 weeks thereafter (20 weeks). It will be conducted in multiple community centres in Hong Kong. Individuals fulfilling the following eligibility criteria will be recruited:
- Chinese people with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five components (i.e., raised blood pressure, raised triglycerides, lowered HDL, raised fasting blood glucose, and central obesity)[1]; 2) aged ≥18; 3) community-dwelling; 4) independent in daily living, and 5) possessed a digital device with internet connection. Participants will be randomly allocated in a 1:1 ratio to receive the TOP critical pathway (intervention group) or once-off brief lifestyle advice (control group).
Evaluation outcomes will be measured at baseline (T0), 12 weeks (T1) and 20 weeks (T2) thereafter. The outcome assessment includes Health-Promoting Lifestyle Profile-II (HPLP-II), reversal of metabolic syndrome, defining characteristics of metabolic syndrome (body mass index, systolic and diastolic blood pressure, triglycerides, high-density lipoprotein, fasting blood glucose and waist circumference) and the 12-item Short-Form Health Survey version 2 (SF-12v2). Triglycerides, high-density lipoprotein and fasting blood glucose will be measured using a portable point-of-care analyser.
- Being tested
- A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification, Brief advice
- Keywords
- Metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modificationBehavioural
The TOP-S programme is a nurse-led intervention promoting the maintenance of lifestyle modification
Brief adviceOther
once-off brief lifestyle advice lasting for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Will receive a 12-week tailored, optimised and person-centred programme for sustainable lifestyle modification Receives: Behavioral: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification |
| Control group | Sham comparator | Will receive an once-off 15-minute structured education Receives: Other: Brief advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic syndrome reversal
The reversal of metabolic syndrome will be determined using the Harmonizing the metabolic syndrome criteria. To be classified as the reversal of metabolic syndrome, participants must have ≤2 of the following: (1) a waist circumference of ≥85 cm in men and ≥80 cm in women; (2) triglycerides <1.7mmol/L and/or on drug treatment as an alternate indicator; (3) HDL <1.0 mmol/L in men and <1.3 mmol/L in women and/or on drug treatment as an alternate indicator; (4) systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg and/or on antihypertensive drug treatment as an alternate indicator; and (5) fasting blood glucose ≥5.6 mmol/L and/or on drug treatment as an alternate indicator.
Measured: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Secondary outcomes (4)
Health-promoting behaviours
The 52-item HPLP-II (Chinese version) will be used to measure health promoting behaviour. It comprises six subscales measuring health-promoting lifestyle, health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. Each item of health behaviour is rated according to the frequency that the respondents practice on a four-point Likert Scale, with 1 indicating 'never', 2 indicating 'sometimes', 3 indicating 'often', and 4 indicating 'routinely'. The total score is the mean of all responses to the 52 items, with sub-scale scores representing the mean of all responses to the corresponding items under each subscale. A higher score indicates better reported health promoting behaviours.
Measured: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Metabolic syndrome components
Metabolic syndrome components include systolic and diastolic blood pressure (mmHg), triglycerides (mmol/L), high-density lipoprotein (HDL in mmol/L) , fasting blood glucose(mmol/L), and waist circumference (cm).Systolic and diastolic blood pressure will be measured using a digital automatic blood pressure monitor with an appropriate size cuff. Participants will be asked to relax and sit quietly for 3-5 minutes before the blood pressure measurement. They will be seated with their arm supported at heart level for the measurement. The measurement of waist circumference will be taken at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Capillary blood samples will be taken in the morning after fasting for 12 hours using the finger prick method. A portable point-of-care analyser (CardioChek Plus) will be used to measure circulating HDL, triglycerides, and fasting blood glucose. BMI (kg/m2)will be calculated as weight (kg)/height (m)^2.
Measured: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Health-related quality of life
The 12-item Chinese (HK) SF-12v2 will be used to measure HRQoL. The SF-12v2 consists of eight subscales that form two summary scores, physical summary score and mental summary score, to reflect people's physical and mental health state. The total score ranges from 0 to 100, with a higher score indicating the better health state.
Measured: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Blood lipid measures
A portable point-of-care analyser (CardioChek Plus) will be used to measure circulating cholesterol (total cholesterol, HDL and LDL). Approximately 15uL of capillary blood sample will be collected at each measurement. (The amendment of the study outcome has been approved by the HKU/HA HKW Institutional Review Board)
Measured: At baseline (T0), immediately at the end of the active intervention phase (12 weeks after baseline)(T1), and 8 weeks thereafter (20 weeks after baseline) (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start14 Oct 2024
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Mar 2026 (estimated)
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 The 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Shinyi, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793930
- Sponsor's protocol ID
- UW 24-306
- Other IDs
- HKUCTR-3030
- Acronym
- TOP-S
- Status last verified
- Jan 2026
- First submitted
- 10 Jan 2025
- Last updated
- 2 Feb 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Tailored, Optimised, and Person-centred Critical Pathway to Promote Lifestyle Modification in People With Metabolic Syndrome: A Mixed-methods Study
- ClinicalTrials.gov ID
- NCT06793930
- Acronym / sponsor ID
- TOP-S / UW 24-306
- Keywords
- Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 27 Jan 2025 (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 is a mixed-methods study comprising a 2-arm randomised controlled trial and a qualitative study. This study aims to evaluate the effects of a lifestyle modification on the control of metabolic syndrome, with assessments measured at baseline, immediately at the end of the active phase of intervention (12 weeks) and 8 weeks thereafter (20 weeks). It will be conducted in multiple community centres in Hong Kong. Individuals fulfilling the following eligibility criteria will be recruited:
- Chinese people with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five components (i.e., raised blood pressure, raised triglycerides, lowered HDL, raised fasting blood glucose, and central obesity)[1]; 2) aged ≥18; 3) community-dwelling; 4) independent in daily living, and 5) possessed a digital device with internet connection. Participants will be randomly allocated in a 1:1 ratio to receive the TOP critical pathway (intervention group) or once-off brief lifestyle advice (control group).
Evaluation outcomes will be measured at baseline (T0), 12 weeks (T1) and 20 weeks (T2) thereafter. The outcome assessment includes Health-Promoting Lifestyle Profile-II (HPLP-II), reversal of metabolic syndrome, defining characteristics of metabolic syndrome (body mass index, systolic and diastolic blood pressure, triglycerides, high-density lipoprotein, fasting blood glucose and waist circumference) and the 12-item Short-Form Health Survey version 2 (SF-12v2). Triglycerides, high-density lipoprotein and fasting blood glucose will be measured using a portable point-of-care analyser.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modificationWill receive a 12-week tailored, optimised and person-centred programme for sustainable lifestyle modification |
| Control group | Sham comparator | Other: Brief adviceWill receive an once-off 15-minute structured education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese adults with metabolic syndrome defined by the 'Harmonising the metabolic syndrome' (HMS) criteria by three or more abnormal findings out of five defining characteristics (i.e., raised blood pressure, raised triglycerides, lowered high-density lipoprotein, raised fasting blood glucose, and central obesity)
- aged ≥18
- community-dwelling
- independent in daily living
- possessed a digital device with an internet connection
Key exclusion criteria (4 listed)
- Has established atherosclerotic cardiovascular diseases (coronary heart disease, cerebrovascular disease and peripheral arterial disease)
- Has psychiatric diseases
- Cannot read Chinese
- Has impaired communication or cognitive function (as indicated by an Abbreviated Mental Test Score of ≤6)
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 |
|---|---|---|
| A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modificationThe TOP-S programme is a nurse-led intervention promoting the maintenance of lifestyle modification | Behavioural | Intervention group |
| Brief adviceonce-off brief lifestyle advice lasting for 15 minutes | Other | Control group |
Primary outcome
Metabolic syndrome reversal
Time frame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
The reversal of metabolic syndrome will be determined using the Harmonizing the metabolic syndrome criteria. To be classified as the reversal of metabolic syndrome, participants must have ≤2 of the following: (1) a waist circumference of ≥85 cm in men and ≥80 cm in women; (2) triglycerides <1.7mmol/L and/or on drug treatment as an alternate indicator; (3) HDL <1.0 mmol/L in men and <1.3 mmol/L in women and/or on drug treatment as an alternate indicator; (4) systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg and/or on antihypertensive drug treatment as an alternate indicator; and (5) fasting blood glucose ≥5.6 mmol/L and/or on drug treatment as an alternate indicator.
4 secondary outcomes
Health-promoting behaviours
Time frame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Metabolic syndrome components
Time frame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Health-related quality of life
Time frame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Blood lipid measures
Time frame: At baseline (T0), immediately at the end of the active intervention phase (12 weeks after baseline)(T1), and 8 weeks thereafter (20 weeks after baseline) (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification and Brief advice in people with Metabolic Syndrome and Primary Prevention of Atherosclerotic Cardiovascular Disease, run by The 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Feb 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernice Chan (852-9752-7530, bernices@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic syndrome reversal (time frame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks). 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 2 Feb 2026.