Clinical trial NCT06275009: Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina)
Official title: Effects of Lifestyle and Physical Fitness on Cardiovascular Health: a Cohort Study in Chinese Occupational Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lifestyle
Physical Fitness
Cardiovascular Diseases
Keywords: Lifestyle
physical fitness
Cardiovascular Diseases
cohort
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-02-23
Enrollment: 18512
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: occupational person free of cardiovascular disease at baseline in China

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the composite end point of new major adverse cardiovascular events
timeFrame: 10 years
Secondary outcomes:
measure: new incidence of each major adverse cardiovascular events
timeFrame: 10 years
measure: new incidence of cancer
timeFrame: 10 years
measure: new incidence of all-cause death
timeFrame: 10 years
measure: level of systolic pressure
timeFrame: 10 years
measure: level of diastolic pressure
timeFrame: 10 years
measure: level of blood lipid
timeFrame: 10 years
measure: level of BMI
timeFrame: 10 years
measure: level of maximal oxygen uptake (VO2max)
timeFrame: 10 years
measure: level of metabolic equivalents (METs)
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References: