A Multicentre Randomized Controlled Trial of the Effectiveness of a Lifestyle Intervention Programme Using Mobile Application vs Booklet for Adults With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The study aims to compare the effect of a lifestyle intervention programme (LIP) using mobile application (MetS app) vs using booklet for MetS adults living in the community.
详细描述
The study aims to compare the effect of a lifestyle intervention programme (LIP) using mobile application (MetS app) vs using booklet for MetS adults living in the community.
Methods A multi-site randomized controlled trial (RCT) with three arms, namely, MetS app group (Group A), booklet group (Group B), and control group (group C). Three hundred and sixty subjects will be recruited from six community centers and randomized into either one arm. Inclusion criteria are those MetS adult, able to use a smart phone. Group a participants will receive a 30-minute educational session and a MetS app while Group B will receive same educational session and a MetS booklet and the control group receive a placebo booklet only. The MetS app or booklet, has been well developed by the team with the support of internal grant, aims to support MetS individual's self- monitoring and record of health measures (body weight, blood pressure, waist circumference) and exercise. The primary outcomes of this study include the body weight and total physical exercise (GSLTPAQ). The secondary outcomes include cardiometabolic risk factors, cardiovascular endurance, self-efficacy for exercise (SEE) and stress level (PSS-10). Data will be collected at baseline (T1), 4 week (T2) and week 12 (T3) and week 24 (T4). SPSS and Generalized Estimating equations (GEE) model will be employed for data analysis.
Significance This study will provide empirical evidence and inform about the effective way to enhance patient's self-management of MetS, exercise sustainability that will be beneficial to clients' health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
A computer-generated randomizer will be used to decide the random allocation. Each eligible subject will be assigned a number generated by the computer. By using random numbers, subjects will be randomly allocated to different groups. This randomization ensure equal sample size in the study groups.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ethnic Chinese client who has a smart phone.
- •Adult age 18 or over
- •MetS Clients with central obesity (male >90 cm , female > 80cm ) plus two items of the followings :
- •Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality
- •Reduced HDL cholesterol < 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females or treatment for this lipid abnormality
- •Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension (HT)
- •Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (DM) -
排除标准
- •Clients with physical, mental, visual, or cognitive impairments with regular medical follow-ups and treatment, and those who have musculoskeletal disorders or other disabling diseases that may limit the practice of walking exercise will be excluded. Client receiving prescription of medication for weight reduction will be excluded as well.
结局指标
主要结局
Body weight
时间窗: 24 weeks
change in body weight will be measured at the same scale in the follow up centre
次要结局
- hospitalization(24 weeks)
- Chinese version of Self-Efficacy for Exercise (SEE-C)(24 weeks)
- Cardiovascular endurance test.(24 weeks)
- app usage(24 weeks)
- booklet usage(24 weeks)
- Fasting blood glucose(24 weeks)
- Total physical exercise(24 weeks)
- blood pressure(24 weeks)
- Perceived stress scale (PSS-10)(24 weeks)
- Lipid level(24 weeks)
- Waist circumference (cm)(24 weeks)
研究者
Dr Eliza Wong
Principal Research Fellow
The Hong Kong Polytechnic University