A Tailored, Optimised, and Person-centred Programme to Promote Lifestyle Modification in People with Metabolic Syndrome

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; Primary Prevention of Atherosclerotic Cardiovascular Disease

• Registration Number: NCT06793930
• Lead Sponsor: The University of Hong Kong

Brief 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) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-14
• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-03-02
• Study Completion: 2026-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Metabolic syndrome reversal	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.

Secondary Outcome Measures

Name	Time	Method
Health-promoting behaviours	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.
Defining characteristics of metabolic syndrome	From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks	Systolic and diastolic blood pressure (mmHg), triglycerides (mmol/L), high-density lipoprotein (HDL in mmol/L) , fasting blood glucose(mmol/L), waist circumference (cm), and BMI (kg/m2). BMI will be calculated as weight (kg)/height (m)\^2. 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.
Health-related quality of life	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.

Trial Locations

Locations (1)

Local community centres; 🇭🇰 Hong Kong, Hong Kong