Actively Recruiting
Smart Wearable Device-Based Comprehensive Intervention to Improve Cardiovascular Health in Overweight or Obese Adults With Cardiometabolic Conditions: A Cluster Randomized Controlled Trial
Led by Beijing Anzhen Hospital · Updated on 2026-05-14
1400
Participants Needed
3
Research Sites
24 weeks
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
B
Beijing Chao Yang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a smartwatch-based multi-faceted cardiovascular health intervention among overweight or obese adults with cardiometabolic preconditions such as prehypertension, prediabetes, or borderline dyslipidemia. This prospective, multicenter, parallel-group, open-label cluster randomized controlled trial aims to provide evidence and guidance for preventing and managing cardiovascular risks in this population. The study plans to enroll about 1,400 participants from approximately 40 community clusters in urban and rural regions. Participants will be assigned to either the intervention group or the control group. The intervention group receives a comprehensive behavioral program delivered through smartwatches and a WeChat mini-program, supported by primary healthcare providers and an integrated platform. This includes monitoring, goal setting, community interaction, and face-to-face health education during the first 6 months, followed by 6 months of self-management support. The control group receives only face-to-face health education throughout the 12-month study period. During the study, participants will attend follow-up assessments at 3, 6, and 12 months. Researchers will evaluate changes in Life's Essential 8 components, which include diet, physical activity, smoking, sleep, BMI, blood lipids, blood glucose, and blood pressure. The main outcome is the change in the Life's Essential 8 risk score at 6 months, with secondary measurements taken at 3 and 12 months. The study also tracks individual health factors and provides ongoing monitoring and support to participants throughout the year-long trial.
CONDITIONS
Brief Title
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Body Mass Index (BMI) between 24.0 and 32.4 kg/m², or waist circumference ≥90 cm for males and ≥85 cm for females
- Presence of at least one of the following without diagnosis or regular medication use in the past month: prehypertension, prediabetes, or borderline elevated blood lipids
- Local resident planning to stay in the area for at least 12 months after enrollment
- Basic reading, writing, and comprehension skills; able to use an internet-connected smartphone and complete app operations independently
- Provided written informed consent
You will not qualify if you...
- Diagnosed secondary obesity by a doctor at secondary or higher-level medical institutions
- History of cardiovascular or cerebrovascular diseases such as myocardial infarction, stroke, heart failure, arrhythmia, or prior coronary intervention or cardiac surgery, or high 10-year risk of cardiovascular disease
- Serious life-threatening diseases like malignant tumors, AIDS, liver or kidney failure
- Pregnancy, breastfeeding, or planning pregnancy within one year
- Severe neuropsychiatric diseases with cognitive or communication impairments like dementia, Alzheimer's disease, or Parkinson's syndrome
- Limited mobility in daily life
- Undergoing or planning weight loss treatment by surgery, medication, or other methods
- Currently participating in other lifestyle intervention-related clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a smartwatch-based multi-faceted behavioral intervention including monitoring, personalized exercise and diet plans, and face-to-face health education during the intensive phase.
Face-to-face visits at baseline, 3 months, and 6 months; ongoing smartwatch and app use
Duration - 6 months
Participants continue self-management support via smartwatch and app, supplemented by face-to-face health education during the maintenance phase.
Face-to-face visits at 9 months and 12 months; ongoing smartwatch and app use
Duration - 12 months
Participants in the control group receive face-to-face health education sessions throughout the study period at primary healthcare institutions.
Face-to-face visits at baseline, 3 months, 6 months, 9 months, and 12 months
Trial Site Locations
Total: 3 locations
1
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China, 100013
Actively Recruiting
2
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061012
Actively Recruiting
3
Health Community Group of Yuhuan People's Hosptial
Yuhuan, Zhejiang, China, 317608
Actively Recruiting
Research Team
W
wei wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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