Smartwatch-based program to improve heart health in adults with overweight and cardiometabolic risk

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

This project will test whether a smartwatch-led exercise, diet, and coaching program can help adults who are overweight or obese with prehypertension, prediabetes, or borderline high cholesterol improve their cardiovascular health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT07372729 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, parallel-group cluster randomized trial will enroll about 1,400 community-dwelling adults across roughly 40 clusters in three regions. The intervention group receives a 6-month intensive program led by smartwatches and a WeChat mini-program—combining exercise and dietary guidance, primary-care support, and face-to-face education—followed by a 6-month maintenance phase of self-management via the devices and periodic in-person education. The control group receives face-to-face health education only. The trial will compare changes in cardiovascular risk factors, metabolic markers, and health behaviors between groups over 12 months.

Who should consider this trial

Good fit: Adults aged 18 or older who are overweight or obese (BMI 24.0–32.4 kg/m2 or elevated waist circumference) and have at least one metabolic high-risk state (prehypertension, prediabetes, or borderline elevated lipids) but no diagnosed hypertension, diabetes, or dyslipidemia are ideal candidates.

Not a fit: People with established hypertension, diabetes, or dyslipidemia who require medication, those with BMI outside the specified range, or individuals unable or unwilling to use a smartwatch or WeChat-based tools are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could help delay or prevent progression to hypertension, diabetes, and worse lipid profiles by improving weight, blood pressure, glucose, and lifestyle behaviors at scale.

How similar studies have performed: Previous mHealth and wearable-based lifestyle interventions have shown modest short-term improvements in weight, blood pressure, and glycemic markers, but large cluster-randomized community trials demonstrating sustained benefit are still limited.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Beijing Chao Yang Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Recruiting)
• Health Community Group of Yuhuan People's Hosptial — Yuhuan, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: yue qi, PhD — Beijing Anzhen Hospital
• Study coordinator: wei wang, PhD

Conditions Prehypertension; Borderline Dyslipidemia; Overweight , Obesity; Prediabetes