Recruiting
Not applicable
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Condition(s) studied
PrehypertensionBorderline DyslipidemiaOverweight , ObesityPrediabetes
Investigational drug(s) / intervention(s)
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 ManualsFace-to-face health education sessions
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.
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Change in Life's Essential 8 risk score — Baseline and 6 months after intervention
The primary outcome is change in Life's Essential 8 risk score from baseline and 6 months following intervention.
The Life's Essential 8 (LE8) is a cardiovascular health score that uses a 0-100 scale. The score is calculated based on a participant's adherence to eight healthy lifestyle components: diet, physical activity, smoking habits, body mass index, non-HDL cholesterol, blood sugar, blood pressure, and sleep. Each component has scoring algorithm ranging from 0 to 100 points, allowing generation of a composite cardiovascular health score (the unweighted average of all components) that also varies from 0 to 100 points. 0 will indicate the lowest cardiovascular health scores and 100 will indicate the highest cardiovascular health scores.
Trial sites (3)
| Facility | City | Region | Status |
|---|
| Beijing Chao Yang Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| Cangzhou Central Hospital |
Cangzhou |
Hebei |
Recruiting |
| Health Community Group of Yuhuan People's Hosptial |
Yuhuan |
Zhejiang |
Recruiting |
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