NCT06275009

Brief Summary

The incidence and prevalence of metabolic risk factors such as obesity, hypertension, diabetes, and dyslipidemia, as well as cardiovascular diseases (CVD), are continuously rising among the occupational population in China, primarily comprising the middle-aged and young adults. Unhealthy lifestyles and declining physical fitness are independent risk factors affecting cardiovascular health. Additionally, the level of physical fitness is influenced by postnatal lifestyles. Lifestyle factors related to cardiovascular health in the occupational population encompass various aspects, including smoking, physical activity, diet, sleep, psychological stress, etc. These factors may interact or have a synergistic effect, necessitating a comprehensive assessment. This project proposes a prospective cohort study design to establish a monitoring cohort for lifestyle and physical fitness among the occupational population. The study will track and follow individuals with or without any CVD metabolic risk factors, collecting information on general status, lifestyle, physical fitness, and health examination data. Exposure factors such as lifestyle and physical fitness will be measured annually, and the occurrence of CVD-related health outcomes will be observed. The aim is to develop a comprehensive evaluation index for cardiovascular health lifestyle, analyze the direct and indirect impacts of lifestyle and physical fitness on the occurrence and development of CVD, and explore potential mediating and moderating effects of physical fitness in the association between lifestyle and cardiovascular health.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
18,512

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress80%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 11, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2026

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

February 17, 2024

Last Update Submit

February 26, 2024

Conditions

Keywords

Lifestylephysical fitnessCardiovascular Diseasescohort

Outcome Measures

Primary Outcomes (1)

  • the composite end point of new major adverse cardiovascular events

    including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina pectoris requiring hospitalization

    10 years

Secondary Outcomes (9)

  • new incidence of each major adverse cardiovascular events

    10 years

  • new incidence of cancer

    10 years

  • new incidence of all-cause death

    10 years

  • level of systolic pressure

    10 years

  • level of diastolic pressure

    10 years

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

occupational person free of cardiovascular disease at baseline in China

You may qualify if:

  • adults between 18-59 years of age
  • occupational staff
  • willing to accept long-term follow-up

You may not qualify if:

  • participants with previous CVD history such as myocardial infarction, stroke and severe aortic stenosis;
  • with cancer;
  • with congenital genetic diseases, or cannot cooperate with the investigation and follow-up due to acquired diseases, such as congenital heart disease, paralysis, deafness, dementia, mental abnormality, developmental retardation, etc.;
  • with exercise contraindications;
  • duration of pregnancy;
  • refuse to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Hongyi Du, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2024

First Posted

February 23, 2024

Study Start

December 11, 2023

Primary Completion (Estimated)

December 11, 2026

Study Completion (Estimated)

December 11, 2026

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations