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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 high-normal blood pressure, prediabetes, or borderline elevated blood lipids, and without a diagnosis of hypertension, diabetes mellitus, or dyslipidemia:

(1) High-normal BP: Systolic blood pressure (SBP) 120-139 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 it's running

• 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
• Email: wangw917@126.com
• Phone: 01081997731

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.