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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2026-03-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mhealth Social Support for People at Risk of Metabolic Syndrome

NCT06169943

Metabolic Syndrome

NOT_YET_RECRUITING NA

a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome

NCT03778788

Metabolic Syndrome

COMPLETED NA

Cardiometabolic Syndrome Response to Therapeutic Lifestyle Changes

NCT04093440

Metabolic Syndrome ASCVD Lifestyle Risk Reduction

UNKNOWN NA

The Reversal Intervention for Metabolic Syndrome Study

NCT01043770

Metabolic Syndrome

COMPLETED NA

Intensive Lifestyle Intervention for Remission of Metabolic Syndrome

NCT04116905

Metabolic Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome Primary Prevention of Atherosclerotic Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Control group

Will receive an once-off 15-minute structured education

Group Type SHAM_COMPARATOR

Brief advice

Intervention Type OTHER

once-off brief lifestyle advice lasting for 15 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Brief advice

once-off brief lifestyle advice lasting for 15 minutes

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No