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PrehypertensionNCT07372729

Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

A study testing 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 and Face-to-face health education sessions in people with Prehypertension and Borderline Dyslipidemia, run by Beijing Anzhen Hospital at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
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 and Face-to-face health education sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,400 participants
Where
3 sitesChina
Study dates
24 Mar 2026to 15 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

wei wang, PhD contact

01081997731

wangw917@126.com

China3 sites, 3 recruiting
  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality, 100013

    Hongjiang Wang, +86 15810239667, wanghongjiang@126.com

    Recruiting
  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061012

    Xiaoyang Sun, +86 18330292831, s18330292831@163.com

    Recruiting
  • Health Community Group of Yuhuan People's Hosptial

    Yuhuan, Zhejiang, 317608

    Gaofeng Zhang, +86 13967668068, 173235071@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
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, Face-to-face health education sessions
Medical subject headings
Prehypertension, Overweight, Obesity, Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 ManualsBehavioural

    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.

  • Face-to-face health education sessionsBehavioural

    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.

Study groups in NCT07372729
Study groupRoleWhat they receive
Smartwatch-Based Comprehensive InterventionExperimentalParticipants 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)".
Receives: 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 CareActive comparatorParticipants in the control group will receive only face-to-face health education sessions.
Receives: Behavioral: Face-to-face health education sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6 months after intervention

Secondary outcomes (9)
  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.

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

  2. 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.

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

  3. 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%

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

    Measured: Baseline and 3 months after intervention; Baseline and 12 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start24 Mar 2026
  3. Primary completion24 Sep 2026 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07372729
Sponsor's protocol ID
BJAZH-SWITCH-2026
Status last verified
Jan 2026
First submitted
12 Jan 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 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 and Face-to-face health education sessions in people with Prehypertension and Borderline Dyslipidemia, run by Beijing Anzhen Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact wei wang, PhD (01081997731, wangw917@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Life's Essential 8 risk score (time frame: Baseline and 6 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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