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Recruiting NCT06793930

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

No phase Interventional Metabolic Syndrome Primary Prevention of Atherosclerotic Cardiovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification, Brief advice.
Who it may be relevant to
Registry conditions: Metabolic Syndrome, Primary Prevention of Atherosclerotic Cardiovascular Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Metabolic syndrome reversal [Time frame: From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks]
Secondary outcome measures (4)
  • Health-promoting behaviours [Time frame: 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]
  • Health-related quality of life [Time frame: 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).]

Eligibility criteria

Inclusion criteria

  • 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)
  • aged ≥18
  • community-dwelling
  • independent in daily living
  • possessed a digital device with an internet connection

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • Local community centres — Hong Kong

Identifiers

NCT: NCT06793930 · UW 24-306 · HKUCTR-3030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗