Clinical trial NCT06793930: A Tailored, Optimised, and Person-centred Programme to Promote Lifestyle Modification in People with Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Primary Prevention of Atherosclerotic Cardiovascular Disease
Keywords: Metabolic syndrome
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Metabolic syndrome reversal
timeFrame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Secondary outcomes:
measure: Health-promoting behaviours
timeFrame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
measure: Defining characteristics of metabolic syndrome
timeFrame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
measure: Health-related quality of life
timeFrame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Local community centres
Study officials:
References: