The Effects of a Tailored, Optimised, and Person-centred Critical Pathway to Promote Lifestyle Modification in People With Metabolic Syndrome: A Mixed-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Metabolic syndrome reversal
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •community-dwelling
- •independent in daily living
- •possessed a digital device with an internet connection
排除标准
- •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)
研究组 & 干预措施
Intervention group
Will receive a 12-week tailored, optimised and person-centred programme for sustainable lifestyle modification
干预措施: A tailored, optimised, and person-centred critical pathway to promote sustainable lifestyle modification (Behavioral)
Control group
Will receive an once-off 15-minute structured education
干预措施: Brief advice (Other)
结局指标
主要结局
Metabolic syndrome reversal
时间窗: 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.
次要结局
- Health-related quality of life(From enrollment to the end of the active phase of programme at 12 weeks and 20 weeks)
- 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)
- 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).)
研究者
Chan Shinyi
PhD Candidate
The University of Hong Kong