Primary objectives: - To examine how environmental exposures influence the prevalence, 5-year incidence and progression of cardiometabolic and chronic respiratory disease in the general population. - To determine the mediation effect of lifestyle…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Glucose metabolism disorders (incl diabetes mellitus)
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The prevalence of (pre) type 2 diabetes
- The 5-year incidence rate of (pre) type 2 diabetes
- The prevalence of chronic lung diseases
- The 5-year incidence rate of chronic lung diseases
- (Change in) lung damage assessed by CT scans, only in the subgroup (n = 350)
Secondary outcome
- Lung function
- Medication use
- Blood pressure
- Respiratory complaints (including dyspnea)
- Psychological complications
- Quality of life
- Occurrence of cardiovascular disease
- All-cause and cause-specific mortality
- Fatigue
- Anthropometrics
- Dietary intake
- Physical activity
- (Change in) exhaled breath profile
- (Change in) transcriptome, genome, epigenome, metabolome and microbiome
- Residential environmental exposures, including ambient air pollution and
green space
- Subjective environment and the use of green spaces
- Personal exposome measurements (only in subgroup of 350 participants)
- Willingness to participate in a combined lifestyle intervention (only in
subgroup of 350 participants)
- Reasons for non-participation in the CooL program (only in participants of
the subgroup fulfilling the CooL eligibility criteria) and evaluation of the
experiences of participation in the CooL program
Background summary
Both the development of cardiometabolic and chronic respiratory diseases are
influenced by modifiable risk factors, such as smoking, poor dietary quality
and/or a lack of physical activity. Environmental exposures such as air
pollution have also been shown to be risk factors for the development of both
cardiometabolic and respiratory diseases. However, improved characterization of
how environmental exposures interact with lifestyle factors is needed in order
to better stratify persons into appropriate risk and treatment categories.
Additionally, the effect of combined lifestyle interventions on respiratory
parameters need to be investigated. Because of the shared risk factors in the
development of cardiometabolic and chronic respiratory conditions, this study
aims to examine environmental risk factors for both cardiometabolic and chronic
respiratory diseases in the general population. The results of this study will
contribute to the development of innovative strategies for the prevention of
chronic diseases.
Study objective
Primary objectives:
- To examine how environmental exposures influence the prevalence, 5-year
incidence and progression of cardiometabolic and chronic respiratory disease in
the general population.
- To determine the mediation effect of lifestyle factors and *omics profiles
(i.e., biological mechanisms) in the associations between environmental
exposures and the development and progression of cardiometabolic and chronic
respiratory disease.
- To detect biomarkers and treatable targets for early lung damage and
cardiometabolic diseases.
Study design
Prospective longitudinal observational cohort study.
Study burden and risks
All 3000 participants will be invited for two study visits that will take
approximately four hours: 1) at baseline; 2) after five years of follow-up.
Before the start of these study visits, participants will collect urine and
faeces at home. The following measurements will be performed during the study
visits: anthropometry, blood pressure, lung function, exhaled breath, nasal
sampling, questionnaires, collection of fasting blood samples, and an Oral
Glucose Tolerance Test. After both study visits, participants will complete the
questionnaires at home, they will wear an accelerometer for seven days and
track their nutritional intake through an app on their mobile phone for a
maximum of 12 days. They will also have the opportunity to take a food
intolerance test at baseline. Finally, participants will be requested to fill
out electronic questionnaires once a year at home between the baseline study
visit and study visit at t = 5 years.
We will perform additional measurements in a subgroup of 350 participants.
These measurements (specifically the CT scans and personal exposome
measurements) are invasive and expensive, and will therefore only be performed
in a clearly defined, specific subgroup of the PARASOL study. This subgroup
will be invited for an extra study visit both at baseline and after five years
of follow-up, during which a CT scan of the chest will be performed. Moreover,
personal exposome measurements will be performed in these 350 participants,
which will require six short home visits at baseline and t = 5 years. In
addition to the study visit after five years of follow-up, the subgroup will
also be invited for a study visit after one year, during which the following
measurements will be performed: anthropometry, blood pressure, lung function,
exhaled breath, nasal sampling, questionnaires, and collection of fasting blood
samples (i.e., no CT scan will be performed at t = 1 year). After this study
visit at t = 1 year, participants will again wear an accelerometer for seven
days and track their nutritional intake through an app on their mobile phone.
Finally, participants of the subgroup who have an indication for referral to a
combined lifestyle intervention reimbursed by basic insurance (obesity, or
overweight with a cardiometabolic risk factor) will be informed about the
opportunity to participate in the Coaching on Lifestyle (CooL) program.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Aged 30-55 years;
- Residing in (the vicinity of) Amsterdam or Hoorn;
- Able to provide written informed consent;
- Understanding of the Dutch language.
Exclusion criteria
- Unable to give written informed consent;
- Serious mental impairment, i.e., preventing to understand the study
protocol/aim.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL84012.018.23 |