Metabolic Syndrome, Primary Prevention of Atherosclerotic Cardiovascular Disease
Conditions
Keywords
Metabolic syndrome
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.
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
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic syndrome reversal | From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-promoting behaviours | From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks | The 52-item HPLP-II (Chinese version) will be used to measure health promoting behaviour. It comprises six subscales measuring health-promoting lifestyle, health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. Each item of health behaviour is rated according to the frequency that the respondents practice on a four-point Likert Scale, with 1 indicating 'never', 2 indicating 'sometimes', 3 indicating 'often', and 4 indicating 'routinely'. The total score is the mean of all responses to the 52 items, with sub-scale scores representing the mean of all responses to the corresponding items under each subscale. A higher score indicates better reported health promoting behaviours. |
| Metabolic syndrome components | From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks | Metabolic syndrome components include systolic and diastolic blood pressure (mmHg), triglycerides (mmol/L), high-density lipoprotein (HDL in mmol/L) , fasting blood glucose(mmol/L), and waist circumference (cm).Systolic and diastolic blood pressure will be measured using a digital automatic blood pressure monitor with an appropriate size cuff. Participants will be asked to relax and sit quietly for 3-5 minutes before the blood pressure measurement. They will be seated with their arm supported at heart level for the measurement. The measurement of waist circumference will be taken at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Capillary blood samples will be taken in the morning after fasting for 12 hours using the finger prick method. A portable point-of-care analyser (CardioChek Plus) will be used to measure circulating HDL, triglycerides, and fasting blood glucose. BMI (kg/m2)will be calculated as weight (kg)/height (m)\^2. |
| Health-related quality of life | From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks | The 12-item Chinese (HK) SF-12v2 will be used to measure HRQoL. The SF-12v2 consists of eight subscales that form two summary scores, physical summary score and mental summary score, to reflect people's physical and mental health state. The total score ranges from 0 to 100, with a higher score indicating the better health state. |
| 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). | A portable point-of-care analyser (CardioChek Plus) will be used to measure circulating cholesterol (total cholesterol, HDL and LDL). Approximately 15uL of capillary blood sample will be collected at each measurement. (The amendment of the study outcome has been approved by the HKU/HA HKW Institutional Review Board) |
Countries
Hong Kong
Contacts
CONTACTBernice Chan
Outcome results
None listed