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

NCT06793930 | Recruiting

• 2 other identifiers: UW 24-306HKUCTR-3030
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Primary Prevention of Atherosclerotic Cardiovascular Disease

Keywords

Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Metabolic syndrome reversal

  The reversal of metabolic syndrome will be determined using the Harmonizing the metabolic syndrome criteria. To be classified as the reversal of metabolic syndrome, participants must have ≤2 of the following: (1) a waist circumference of ≥85 cm in men and ≥80 cm in women; (2) triglycerides \<1.7mmol/L and/or on drug treatment as an alternate indicator; (3) HDL \<1.0 mmol/L in men and \<1.3 mmol/L in women and/or on drug treatment as an alternate indicator; (4) systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg and/or on antihypertensive drug treatment as an alternate indicator; and (5) fasting blood glucose ≥5.6 mmol/L and/or on drug treatment as an alternate indicator.

  From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks

Secondary Outcomes (4)

• Health-promoting behaviours

  From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks

• Metabolic syndrome components

  From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks

• Health-related quality of life

  From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks

• Blood lipid measures

  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).

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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

Control group

SHAM COMPARATOR

Will receive an once-off 15-minute structured education

Other: Brief advice

Interventions

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

The TOP-S programme is a nurse-led intervention promoting the maintenance of lifestyle modification

Intervention group

Brief advice OTHER

once-off brief lifestyle advice lasting for 15 minutes

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Local community centres

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Bernice Chan

CONTACT

852-9752-7530; bernices@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 27, 2025
• Study Start: October 14, 2024
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)