Smartwatch-Led Behavioral Intervention to Improve Cardiovascular Health in Overweight or Obese Adults with Early Metabolic Risks

What this Trial Is About

Researchers are evaluating a smartwatch-based multi-faceted cardiovascular health intervention among overweight or obese adults with cardiometabolic preconditions such as prehypertension, prediabetes, or borderline dyslipidemia. This prospective, multicenter, parallel-group, open-label cluster randomized controlled trial aims to provide evidence and guidance for preventing and managing cardiovascular risks in this population. The study plans to enroll about 1,400 participants from approximately 40 community clusters in urban and rural regions. Participants will be assigned to either the intervention group or the control group. The intervention group receives a comprehensive behavioral program delivered through smartwatches and a WeChat mini-program, supported by primary healthcare providers and an integrated platform. This includes monitoring, goal setting, community interaction, and face-to-face health education during the first 6 months, followed by 6 months of self-management support. The control group receives only face-to-face health education throughout the 12-month study period. During the study, participants will attend follow-up assessments at 3, 6, and 12 months. Researchers will evaluate changes in Lifes Essential 8 components, which include diet, physical activity, smoking, sleep, BMI, blood lipids, blood glucose, and blood pressure. The main outcome is the change in the Lifes Essential 8 risk score at 6 months, with secondary measurements taken at 3 and 12 months. The study also tracks individual health factors and provides ongoing monitoring and support to participants throughout the year-long trial.

Smartwatch-based Intervention for Cardiovascular Health (SWITCH)