A Smart Wearable Devices-based Comprehensive Intervention Through a Cluster Randomized Controlled Trial to Improve Cardiovascular Health in Overweight/Obese Individuals With Cardiometabolic Preconditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 3
- 主要终点
- Change in Life's Essential 8 risk score
研究概览
简要总结
This study aims to employ a cluster randomized controlled trial to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among Overweight/Obese Individuals with Cardiometabolic Preconditions, thereby providing theoretical foundations and practical guidance for the prevention and management of this population.
详细描述
This study plans to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among Overweight/Obese Individuals with Cardiometabolic Preconditions through a cluster randomized controlled trial. The study is designed as a prospective, multicenter, parallel-group, open-label cluster randomized controlled trial. The objective is to compare the effects of a comprehensive behavioral intervention model versus usual care on improving cardiovascular health among community-dwelling individuals who are overweight/obese and have at least one of the following conditions: prehypertension, prediabetes, or borderline dyslipidemia. The trial plans to include approximately 40 clusters across three regions (covering both urban and rural areas), with an expected recruitment of more than 35 eligible participants per cluster, resulting in a total sample size of around 1,400 participants. Participants in the intervention group will receive a comprehensive behavioral intervention during the intensive phase (first 6 months), led by smartwatches and a WeChat mini-program (WMP), supported by primary healthcare providers and an integrated management platform, along with face-to-face health education. During the maintenance phase (subsequent 6 months), they will receive only self-management support via smartwatches and the , supplemented by face-to-face health education. Participants in the control group will receive only face-to-face health education throughout the study period. All participants will undergo follow-up assessments at 3, 6 and 12 months from baseline. The primary outcome is the change in Life's Essential 8 components (diet, physical activity, smoking, sleep, BMI, blood lipids, blood glucose, and blood pressure) at 6 months of intervention. Secondary outcomes include changes in the primary outcome at 12 months and improvements in each component of Life's Essential 8.
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
- 是
入选标准
- •Age >= 18 years, no gender restriction;
- •Overweight and obesity: Body Mass Index (BMI) 24.0-32.4 kg/m^2, or waist circumference >= 90 cm for males and >= 85 cm for females;
- •Presence of at least one metabolic high-risk state among prehypertension, prediabetes, or borderline elevated blood lipids, and without a diagnosis of hypertension, diabetes mellitus, or dyslipidemia:
- •(1) Prehypertension: Systolic blood pressure (SBP) 130-139 mmHg and/or diastolic blood pressure (DBP) 80-89 mmHg, without regular use of antihypertensive medication in the past month; (2) Prediabetes: Fasting blood glucose (FBG) 6.1-6.9 mmol/L, or glycated hemoglobin (HbA1c) 5.7%-6.4%, without regular use of hypoglycemic medication in the past month; (3) Borderline elevated blood lipids: Total cholesterol (TC) 5.2-6.1 mmol/L, or low-density lipoprotein cholesterol (LDL-C) 3.4-4.0 mmol/L, or triglycerides (TG) 1.7-2.2 mmol/L, or non-high-density lipoprotein cholesterol (non-HDL-C) 4.1-4.8 mmol/L, without regular use of lipid-lowering medication in the past month;
- •Local permanent residents who will reside in the area for at least 12 month after enrollment;
- •Have basic reading, writing, and comprehension abilities; proficient in using internet-connected smartphones; able to independently complete basic operations of the application;
- •Written informed consent provided.
排除标准
- •Secondary obesity diagnosed by doctors in secondary or higher-level medical institutions;
- •Cardiovascular and cerebrovascular diseases, including myocardial infarction, stroke, heart failure, arrhythmia; or having received coronary intervention therapy, cardiac surgery, etc.; or with a 10-year high risk of cardiovascular disease;
- •Diseases seriously affecting survival, such as malignant tumors, AIDS, hepatic and renal failure;
- •Pregnancy, lactation period, or women who may become pregnant within one year;
- •History of severe neuropsychiatric diseases with potential cognitive or communication impairments, such as dementia, Alzheimer's disease, Parkinson's syndrome;
- •Individuals with limited daily mobility;
- •Individuals undergoing or planning to receive weight loss through surgery, medication, or other methods;
- •Currently participating in other lifestyle intervention-related trials.
研究组 & 干预措施
Smartwatch-Based Comprehensive Intervention
Participants receive mHealth-based multi-faceted behavioral intervention via a closed-loop management pathway formed by the intervention tools of "smartwatch - mobile phone - data interaction and processing center - WeChat mini-program (WMP)".
干预措施: Smartwatch-Based Multi-Faceted Behavioral Intervention Model Led by Exercise and Dietary Interventions, Supported by Primary Medical Staff, Along with the Distribution of Health Education Manuals (Behavioral)
Usual Care
Participants in the control group will receive only face-to-face health education sessions.
干预措施: Face-to-face health education sessions (Behavioral)
结局指标
主要结局
Change in Life's Essential 8 risk score
时间窗: Baseline and 6 months after intervention
The primary outcome is change in Life's Essential 8 risk score from baseline and 6 months following intervention. The Life's Essential 8 (LE8) is a cardiovascular health score that uses a 0-100 scale. The score is calculated based on a participant's adherence to eight healthy lifestyle components: diet, physical activity, smoking habits, body mass index, non-HDL cholesterol, blood sugar, blood pressure, and sleep. Each component has scoring algorithm ranging from 0 to 100 points, allowing generation of a composite cardiovascular health score (the unweighted average of all components) that also varies from 0 to 100 points. 0 will indicate the lowest cardiovascular health scores and 100 will indicate the highest cardiovascular health scores.
次要结局
- Blood pressure (Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- non-HDL cholesterol(Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- Blood glucose (Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- Body Mass Index (Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- Physical activity (Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- Sleep (Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- Smoking habits (Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- Health diet pattern (Individual Life's Essential 8 components)(Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention)
- Change in Life's Essential 8 risk score(Baseline and 3 months after intervention; Baseline and 12 months after intervention)