NCT06949306

Brief Summary

The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
56mo left

Started Jul 2025

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Jul 2025Dec 2030

First Submitted

Initial submission to the registry

April 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 29, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

April 13, 2025

Last Update Submit

April 21, 2025

Conditions

HypertensionHyperlipidemia

Keywords

Cardiometabolic abnormalitiesDigital Interventions

Outcome Measures

Primary Outcomes (1)

  • Changes in diastolic blood pressure after 24 weeks

    24 weeks following intervention

Secondary Outcomes (1)

  • Values for changes in Hba1c or BMI or CAI after 24 weeks

    24 weeks following intervention

Study Arms (1)

Cardiovascular digital management group

EXPERIMENTAL

Participants used a bracelet and an APP assistant for lifestyle interventions

Other: Bracelet, assistant, APP: the "golden triangle" of smart life

Interventions

Bracelet, assistant, APP: the "golden triangle" of smart lifeOTHER

The lifestyle intervention was carried out through the bracelet, Little Assistant and Keyhealth APP for 24 weeks, and the daily data synchronization of the APP and weekly AI feedback were performed. After 24 weeks, blood glucose, blood lipid, blood pressure, CAI and other indicators were monitored.

Cardiovascular digital management group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diastolic hypertension (systolic blood pressure \< 140 MMHG and diastolic blood pressure ≥90mmHg)
  • Glycosylated hemoglobin (6.0-6.5)
  • Obesity (BMI≥28kg/m²)
  • Mild hyperlipemia: total cholesterol (TC) ≥5.2 mmol/L and \< 6.2 mmol/L, or low-density lipoprotein cholesterol (LDL-C) ≥3.4 mmol/L and \< 4.1 mmol/L 3. Antihypertensive or lipid-lowering medications have not been started 4. Use a smartphone and volunteer

You may not qualify if:

  • Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease
  • Previous cardiovascular and cerebrovascular events
  • Diastolic blood pressure ≥99mmHg
  • Glycated hemoglobin ≥6.5
  • Other life expectancy such as cancer is less than 5 years
  • Participate in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology,Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China, China

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

Dental Assistants

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dental AuxiliariesAllied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and ServicesDental Staff

Central Study Contacts

Yi Zhang

CONTACT

18917686332yizshcn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of Medicine

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 29, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 29, 2025

Record last verified: 2025-03

Locations

CN(1)