An interventional study of 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 Overweight , Obesity, Prediabetes and High-normal Blood Pressure, sponsored by Beijing Anzhen Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Prevention
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 metabolically at-risk people with overweight/obesity, thereby providing theoretical foundations and practical guidance for the prevention and management of this population.
This study plans to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among metabolically at-risk people with overweight/obesity 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: high-normal blood pressure, prediabetes, or borderline elevated blood lipids. 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 (LE8) from baseline to 6 months post-intervention.The secondary outcomes include: (1) the change in LE8 from baseline to 3 months and 12 months, respectively, and (2) the change in each of the eight LE8 components (diet, physical activity, smoking, sleep, BMI, blood lipids, blood glucose and BP) from baseline to 3, 6 and 12 months.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(1) High-normal BP: Systolic blood pressure (SBP) 120-139 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 (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 provided.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in the control group will receive only face-to-face health education sessions.
Behavioral: Face-to-face health education sessions
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 metabolically at-risk people with overweight/obesity, 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.
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.
Change in Life's Essential 8 risk score
The primary outcome is the change in Life's Essential 8 (LE8) from baseline to 6 months post-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 intervention
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 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.
Time frame: 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%
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 months after intervention; Baseline and 12 months after intervention
Exploratory outcomes
The exploratory outcomes include the change from baseline to follow-up in lifestyle, quality of life, anxiety, depressive, and cognitive function.
Time frame: Baseline and 3 months after intervention; Baseline and 6 months after intervention; Baseline and 12 months after intervention
Plan to share: Yes — De-identified participant-level data underlying the published analyses will be made available to qualified researchers upon reasonable request after publication of the main trial results. The shared data may include participant-level datasets, the data dictionary, statistical code and other relevant study materials. Identifiable participant information will not be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: IPD and supporting information will become available after publication of the main trial results. Data will remain available according to institutional policies, ethical requirements and applicable regulations.
Access criteria: Access will be provided to qualified researchers upon reasonable request. Requests will be reviewed and approved by the principal investigators and must comply with applicable ethics requirements, data protection regulations and institutional policies. Researchers may access de-identified participant-level data and relevant supporting materials after approval and completion of any required data-use agreement.
Data sharing details ↗ · clinicaltrials.gov
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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