NCT06793930

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

The Effects of a Tailored, Optimised, and Person-centred Critical Pathway to Promote Lifestyle Modification in People With Metabolic Syndrome: A Mixed-methods Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome
• Primary Prevention of Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
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
OTHER	Brief advice	once-off brief lifestyle advice lasting for 15 minutes

Timeline

• Start date: 2024-10-14
• Primary completion: 2026-03-02
• Completion: 2026-03-02
• First posted: 2025-01-27
• Last updated: 2026-02-02

Locations

1 site across 1 country: Hong Kong