Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

Официальное название

A Smart Wearable Devices-based Comprehensive Intervention Through a Cluster Randomized Controlled Trial to Improve Cardiovascular Health in Overweight/Obese Individuals With Cardiometabolic Preconditions

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
  The intervention model integrates multiple functions including data collection, intelligent analysis, and personalized intervention, and delivers targeted management for the target population. Among these, the intervention content includes the smartwatch-based comprehensive behavioral intervention model adopted in the model construction phase; for overweight/obese individuals with cardiometabolic preconditions, a customized combination of implementation strategies is provided. Intervention measu
• Поведенческое Face-to-face health education sessions
  At baseline, 3 months, and 6 months, participants will attend follow-up visits at primary healthcare institutions in the project areas and receive usual care based on guideline-recommended health education manuals, which provide comprehensive lifestyle intervention advice.

Первичные конечные точки

• Change in Life's Essential 8 risk score [Срок оценки: Baseline and 6 months after intervention]

Вторичные конечные точки (9)

• Blood pressure (Individual Life's Essential 8 components) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Baseline and 3 months after intervention; Baseline and 12 months after intervention]

Критерии участия

Критерии включения

• 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; 4. Local permanent residents who will reside in the area for at least 12 month after enrollment; 5. Have basic reading, writing, and comprehension abilities; proficient in using internet-connected smartphones; able to independently complete basic operations of the application; 6. Written informed consent provided.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 3 центра

• Beijing Chao Yang Hospital — Пекин
• Cangzhou Central Hospital — Cangzhou
• Health Community Group of Yuhuan People's Hosptial — Yuhuan

Идентификаторы

NCT: NCT07372729 · BJAZH-SWITCH-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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