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Construction of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model and Optimization of Health Evaluation Pathways in Overweight/Obese Individuals with Cardiometabolic Preconditions: A Mixed-Methods Study

Construction of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model and Optimization of Health Evaluation Pathways in Overweight/Obese Individuals with Cardiometabolic Preconditions: A Mixed-Methods Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114426
Enrollment
Unknown
Registered
2025-12-11
Start date
2025-12-14
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Interventions

Smartwatch-Based Comprehensive Intervention Group:Participants receive mHealth-based multi-faceted behavioral intervention via a closed-loop management pathway formed by the intervention tools of "sma
for overweight/obese individuals with cardiometabolic preconditions, a customized combination of implementation strategies is provided. Intervention measures include smartwatch-based indicator monitor

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion 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 2-hour postprandial glucose (2hPG) 7.8-11.0 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 1 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

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.

Design outcomes

Primary

MeasureTime frame
Adoption rate;Fidelity;Acceptability;

Secondary

MeasureTime frame
Safety;Equity;

Countries

China

Contacts

Public ContactQi Yue

Beijing Anzhen Hospital , Capital Medical University

qiyue_bjcn@163.com+86 138 1110 6169

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026