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RECRUITING

NCT07372729

Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1400

Start Date

2026-03-15

Completion Date

2027-03-15

Last Updated

2026-04-06

Healthy Volunteers

Yes

Conditions

Prehypertension Borderline Dyslipidemia Overweight , Obesity Prediabetes

Interventions

BEHAVIORAL

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 measures include smartwatch-based indicator monitoring and risk warning, diet and exercise reporting, monitoring, and goal setting/planning, community interaction, collaborative management by medical staff and family members.In addition, routine health education will be provided during face-to-face visits at baseline, 3 months, and 6 months.

BEHAVIORAL

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.

Inclusion Criteria: 1. Age \>= 18 years, no gender restriction; 2. 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; 3. 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. Exclusion Criteria: 1. Secondary obesity diagnosed by doctors in secondary or higher-level medical institutions; 2. 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; 3. Diseases seriously affecting survival, such as malignant tumors, AIDS, hepatic and renal failure; 4. Pregnancy, lactation period, or women who may become pregnant within one year; 5. History of severe neuropsychiatric diseases with potential cognitive or communication impairments, such as dementia, Alzheimer's disease, Parkinson's syndrome; 6. Individuals with limited daily mobility; 7. Individuals undergoing or planning to receive weight loss through surgery, medication, or other methods; 8. Currently participating in other lifestyle intervention-related trials.

Locations (3)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Health Community Group of Yuhuan People's Hosptial

Yuhuan, Zhejiang, China