RecruitingNot ApplicableNCT06793930

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


Sponsor

The University of Hong Kong

Enrollment

152 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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)

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Interventions

BEHAVIORALA 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

OTHERBrief advice

once-off brief lifestyle advice lasting for 15 minutes


Locations(1)

Local community centres

Hong Kong, Hong Kong

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NCT06793930


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