Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >= 18 years, no gender restriction;
Overweight and obesity: Body Mass Index (BMI) 24.0-32.4 kg/m², or waist circumference >= 90 cm for males and >= 85 cm for females;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
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
BehavioralThe 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.
Face-to-face health education sessions
BehavioralAt 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.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Smartwatch-Based Comprehensive InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and 6 months after interventionSecondary outcomes
1
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.
Time frame
Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention2
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.
Time frame
Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention3
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%
Time frame
Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention4
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.
Time frame
Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Anzhen Hospital
Lead sponsor
Beijing Chao Yang Hospital
Collaborator
Cangzhou Central Hospital
Collaborator
Health Community Group of Yuhuan People's Hosptial
Collaborator
Source ClinicalTrials.gov