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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Primary Prevention of Atherosclerotic Cardiovascular Disease; Metabolic Syndrome

Treatments: Other: Brief advice; Behavioral: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT06793930

HKUCTR-3030 (Registry Identifier)

UW 24-306

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

152 participants in 2 patient groups

Intervention group

Experimental group

Description:

Will receive a 12-week tailored, optimised and person-centred programme for sustainable lifestyle modification

Treatment:

Behavioral: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification

Control group

Sham Comparator group

Description:

Will receive an once-off 15-minute structured education

Treatment:

Other: Brief advice