Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Recruiting · NCT07372729 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Anzhen Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Face-to-face health education sessionsSmartwatch-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
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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:
- 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
- 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.
Where it is running
3 locations listed.
- 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