NCT07372729

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Prehypertension
• Borderline Dyslipidemia
• Overweight , Obesity
• Prediabetes

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-09-15
• Completion: 2027-03-15
• First posted: 2026-01-28
• Last updated: 2026-04-06

Locations

3 sites across 1 country: China