A Tailored, Optimised, and Person-centred Programme to Promote Lifestyle Modification in People With Metabolic Syndrome (TOP-S)

January 29, 2026 updated by: Chan Shinyi, The University of Hong Kong

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:

1) 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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)
  2. aged ≥18
  3. community-dwelling
  4. independent in daily living
  5. possessed a digital device with an internet connection

Exclusion Criteria:

  1. Has established atherosclerotic cardiovascular diseases (coronary heart disease, cerebrovascular disease and peripheral arterial disease)
  2. Has psychiatric diseases
  3. Cannot read Chinese
  4. Has impaired communication or cognitive function (as indicated by an Abbreviated Mental Test Score of ≤6)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Will receive a 12-week tailored, optimised and person-centred programme for sustainable lifestyle modification
Behavioral: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification
The TOP-S programme is a nurse-led intervention promoting the maintenance of lifestyle modification
Sham Comparator: Control group
Will receive an once-off 15-minute structured education
Other: Brief advice
once-off brief lifestyle advice lasting for 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-promoting behaviours
Time Frame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
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.
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
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.
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
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.
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).
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)
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

March 2, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-306
  • HKUCTR-3030 (Registry Identifier: HKU Clinical Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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