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NCT Number: NCT06275009

Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina)

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Xue Feng, MD PhD

CONTACT

[email protected]

+86-15601378512

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the composite end point of new major adverse cardiovascular events

    Time frame: 10 years

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

Secondary outcomes

  1. new incidence of each major adverse cardiovascular events

    Time frame: 10 years

    new incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, unstable angina requiring hospitalization and other major adverse cardiovascular events

  2. new incidence of cancer

    Time frame: 10 years

    new incidence of cancer and all-cause death

  3. new incidence of all-cause death

    Time frame: 10 years

    new incidence of all-cause death

  4. level of systolic pressure

    Time frame: 10 years

    The level of systolic pressure measured at each follow-up evaluation time point

  5. level of diastolic pressure

    Time frame: 10 years

    The level of diastolic pressure measured at each follow-up evaluation time point

  6. level of blood lipid

    Time frame: 10 years

    The level of blood lipid measured at each follow-up evaluation time point

  7. level of BMI

    Time frame: 10 years

    The level of BMI (weight and height will be combined to report BMI in kg/m^2) measured at each follow-up evaluation time point

  8. level of maximal oxygen uptake (VO2max)

    Time frame: 10 years

    The level of VO2max which is obtained by submaximal exercise testing on cycle ergometer with two-stage workload to assess cardiorespiratory fitness measured at each follow-up evaluation time point

  9. level of metabolic equivalents (METs)

    Time frame: 10 years

    The level of METs which is obtained by submaximal exercise testing on cycle ergometer with two-stage workload to assess cardiorespiratory fitness measured at each follow-up evaluation time point

Study contacts

Contact information is provided by the study sponsor or research team.

Hongyi Du, MD PhD

CONTACT

[email protected]

86-10-88396087

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Effects of Lifestyle and Physical Fitness on Cardiovascular Health: a Cohort Study in Chinese Occupational Population

Acronym: LiFitChina

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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