Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

NCT07372729 | Not Yet Recruiting DMC

• 1 other identifier: BJAZH-SWITCH-2026
• Study Type: interventional
• Target: 1,400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prehypertension; Borderline Dyslipidemia; Overweight , Obesity; Prediabetes

Outcome Measures

Primary Outcomes (1)

• Change in Life's Essential 8 risk score

  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.

  Baseline and 6 months after intervention

Secondary Outcomes (9)

• Blood pressure (Individual Life's Essential 8 components)

  Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention

• non-HDL cholesterol(Individual Life's Essential 8 components)

  Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention

• Blood glucose (Individual Life's Essential 8 components)

  Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention

• Body Mass Index (Individual Life's Essential 8 components)

  Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention

• Physical activity (Individual Life's Essential 8 components)

  Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention

Study Arms (2)

Smartwatch-Based Comprehensive Intervention

EXPERIMENTAL

Participants receive mHealth-based multi-faceted behavioral intervention via a closed-loop management pathway formed by the intervention tools of "smartwatch - mobile phone - data interaction and processing center - WeChat mini-program (WMP)".

Behavioral: 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

Usual Care

ACTIVE COMPARATOR

Participants in the control group will receive only face-to-face health education sessions.

Behavioral: Face-to-face health education sessions

Interventions

Face-to-face health education sessions BEHAVIORAL

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.

Usual Care

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 BEHAVIORAL

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.

Smartwatch-Based Comprehensive Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Cangzhou Central Hospital: collaborator
• Health Community Group of Yuhuan People's Hosptial: collaborator

MeSH Terms

Conditions

Prehypertension; Overweight; Obesity; Prediabetic State

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• yue qi, PhD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei wang, PhD

CONTACT

01081997731; wangw917@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share