Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

A Smart Wearable Devices-based Comprehensive Intervention Through a Cluster Randomized Controlled Trial to Improve Cardiovascular Health in Overweight/Obese Individuals With Cardiometabolic Preconditions

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.

Study Overview

• Status: Recruiting
• Conditions: Prehypertension; Prediabetes; Overweight , Obesity; Borderline Dyslipidemia
• Intervention / Treatment: 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; Behavioral: Face-to-face health education sessions

Detailed Description

This study plans to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among Overweight/Obese Individuals with Cardiometabolic Preconditions through a cluster randomized controlled trial. The study is designed as a prospective, multicenter, parallel-group, open-label cluster randomized controlled trial. The objective is to compare the effects of a comprehensive behavioral intervention model versus usual care on improving cardiovascular health among community-dwelling individuals who are overweight/obese and have at least one of the following conditions: prehypertension, prediabetes, or borderline dyslipidemia. The trial plans to include approximately 40 clusters across three regions (covering both urban and rural areas), with an expected recruitment of more than 35 eligible participants per cluster, resulting in a total sample size of around 1,400 participants. Participants in the intervention group will receive a comprehensive behavioral intervention during the intensive phase (first 6 months), led by smartwatches and a WeChat mini-program (WMP), supported by primary healthcare providers and an integrated management platform, along with face-to-face health education. During the maintenance phase (subsequent 6 months), they will receive only self-management support via smartwatches and the , supplemented by face-to-face health education. Participants in the control group will receive only face-to-face health education throughout the study period. All participants will undergo follow-up assessments at 3, 6 and 12 months from baseline. The primary outcome is the change in Life's Essential 8 components (diet, physical activity, smoking, sleep, BMI, blood lipids, blood glucose, and blood pressure) at 6 months of intervention. Secondary outcomes include changes in the primary outcome at 12 months and improvements in each component of Life's Essential 8.

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wei wang, PhD; Phone Number: 01081997731; Email: wangw917@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100013
      • Recruiting
      • Beijing Chao Yang Hospital
      • Contact: Hongjiang Wang; Phone Number: +86 15810239667; Email: wanghongjiang@126.com
  • Hebei
    • Cangzhou, Hebei, China, 061012
      • Recruiting
      • Cangzhou Central Hospital
      • Contact: Xiaoyang Sun; Phone Number: +86 18330292831; Email: s18330292831@163.com
  • Zhejiang
    • Yuhuan, Zhejiang, China, 317608
      • Recruiting
      • Health Community Group of Yuhuan People's Hosptial
      • Contact: Gaofeng Zhang; Phone Number: +86 13967668068; Email: 173235071@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartwatch-Based Comprehensive Intervention; 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; 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.
Active Comparator: Usual Care; Participants in the control group will receive only face-to-face health education sessions.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (Individual Life's Essential 8 components)	Changes in the individual risk factors of Life's Essential 8 (LE8), including changes in blood pressure (both systolic and diastolic), will be assessed at baseline, 3 months, 6 months, and 12 months. Data will be derived from the Electronic Data Capture (EDC) system. For the primary outcome composite score: 100 points: <120/<80 mm Hg; 0 points: ≥160 mm Hg or ≥100 mm Hg.	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)	Changes in the individual risk factors of Life's Essential 8, including changes in non-HDL cholesterol, will be assessed at baseline, 3 months, 6 months, and 12 months after intervention. Data will be derived from the Electronic Data Capture (EDC) system. For the primary outcome composite score: 100 points: <3.36 mmol/L; 0 points: ≥5.69 mmol/L.	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)	Changes in the individual risk factors of Life's Essential 8, including changes in blood glucose, will be assessed at baseline, 3 months, 6 months, and 12 months after intervention. Data will be derived from the Electronic Data Capture (EDC) system. For the primary outcome composite score: 100 points: No history of diabetes and hemoglobin A1c <5.7%; 0 points: Diabetes with hemoglobin A1c ≥10.0%	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)	Changes in the individual risk factors of Life's Essential 8, including changes in body mass index, will be assessed at baseline, 3 months, 6 months, and 12 months after intervention. Data will be derived from the Electronic Data Capture (EDC) system. For the primary outcome composite score: 100 points: <23 kg/m²; 0 points: ≥35 kg/m².	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)	Changes in the individual risk factors of Life's Essential 8, including changes in physical activity, will be assessed at baseline, 3 months, 6 months, and 12 months after intervention. Data will be derived from the Electronic Data Capture (EDC). For the primary outcome composite score: 100 points: ≥150 minutes of moderate or vigorous activities per week; 0 points: 0 minutes.	Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention
Sleep (Individual Life's Essential 8 components)	Changes in the individual risk factors of Life's Essential 8, including changes in sleep, will be assessed at baseline, 3 months, 6 months, and 12 months after intervention. Data will be derived from the Electronic Data Capture (EDC) system. For the primary outcome composite score: 100 points: 7-<9 hours of sleep per night; 0 points: <4 hours of sleep per night.	Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention
Smoking habits (Individual Life's Essential 8 components)	Changes in the individual risk factors of Life's Essential 8, including changes in smoking habits, will be assessed at baseline, 3 months, 6 months, and 12 months after intervention. Data will be derived from the Electronic Data Capture (EDC) system. For the primary outcome composite score: 100 points: Never smoker; 0 points: Current smoker.	Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention
Health diet pattern (Individual Life's Essential 8 components)	Changes in the individual risk factors of Life's Essential 8, including changes in diet patterns, will be assessed at baseline, 3 months, 6 months, and 12 months after intervention. Data will be derived from the Electronic Data Capture (EDC) system. For the primary outcome composite score: 100 points: DASH diet score of 8; 0 points: DASH diet score of 0 to 1.	Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention
Change in Life's Essential 8 risk score	the change in the Life's Essential 8 risk score from baseline to 3 months and 12 months after intervention.	Baseline and 3 months after intervention; Baseline and 12 months after intervention

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Beijing Chao Yang Hospital; Cangzhou Central Hospital; Health Community Group of Yuhuan People's Hosptial
• Investigators: Principal Investigator: yue qi, PhD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Prediabetic State; Prehypertension; Therapeutics; Nutrition Therapy; Diet Therapy
• Other Study ID Numbers: BJAZH-SWITCH-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No