The primary objective of this study is to compare lifestyle factors, dietary behaviours, environmental factors and pre-obesity risk markers between shift workers and non-shift workers from the industrial sector and the health care sector.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
circadiane verstoring
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are lifestyle factors (sociodemographic background &
environment, shift schedules & work activities, sleeping behaviour, diet,
quality of life, lifestyle and physical activity, health, literacy, and
interests in ways to change lifestyle), body composition, biomarkers (urine,
faeces, blood, hair), smell and taste ability, food preferences and perceptions
and dietary behaviour. The biomarker hs-CRP is taken is primary outcome for the
sample size estimation.
Secondary outcome
Not applicable
Background summary
Multiple studies have recently shown that working rotating night shifts is
associated with an increased BMI and a higher risk for developing overweight
and obesity. In addition, there is growing evidence that chrono-disruption and
mis-timed eating have deleterious effects on metabolic health and consequently,
shift work is linked to the risk of chronic diseases such as cardiovascular
disease, type 2 diabetes and several types of cancer. Disruption of the
internal circadian timing system and concomitant sleep disturbances is thought
to play a critical role in the development of these health problems, but also
other factors may play a role. To further address how night shift work impacts
metabolic health population-based mechanistic study data is needed. The
European Shift2Health project will focus on providing population-based
mechanistic data on a wide range of biomarkers of metabolic disease risk that
will advance our knowledge on the short- and long-term health effects related
to night shift and eventually will help in designing and applying efficient
prevention policies.
Study objective
The primary objective of this study is to compare lifestyle factors, dietary
behaviours, environmental factors and pre-obesity risk markers between shift
workers and non-shift workers from the industrial sector and the health care
sector.
Study design
The PROMIS study is a cross-sectional study comparing lifestyle factors and
pre-obesity marker between shift workers and non-shift workers. In addition,
the shift workers are nested in an additional mechanistic component of the
study investigating differences in pre-obesity marker between different shifts.
Study burden and risks
All participants will have a study day at the location of employment before a
day shift (shift workers) or at the start of a regular working day (non-shift
workers). This study day will take approximately 1 hour and 30 minutes. Prior
to the study day participants will complete a baseline questionnaire (±45
minutes), collect morning spot urine and faeces samples, which will be handed
in on the study day. During the study day, participants* body composition will
be measured, a fasting blood sample, and hair sample will be collected. Hair
sampling is painless but venapunctures can occasionally cause a local hematoma
or bruise and some participants may report pain or discomfort. All participants
will perform a food preference and perception task as well as an identification
test for smell and taste. After having breakfast, participants will complete
one final questionnaire (±5 minutes). At the end of the study day, participants
will be invited to report their food intake via Traqq®; shift workers will
complete a total of six 2hR-days and non-shift workers a total of three
2hR-days, within a two-week period. Responding to the 2hR prompts will take on
average 5 minutes.
The shift workers will have some additional measurements, i.e., collection of
two 24-hour urine samples; once the day before the study day, and once during
the night shift measurement day. During the study day (before the day shift),
they will collect a dried blood spot and tongue swap, which will be repeated
after the day shift. Within the following two weeks there will be another
measurement day, during a night shift, where the night shift workers repeat the
dried blood spot collection and tongue swap. In addition, they will once more
complete the short questionnaire from the study day (±5 minutes). Between the
study day and the night shift day, the shift workers wear a MotionWatch to
assess physical activity and sleep.
Stippeneng 4
Wageningen 6700 AA
NL
Stippeneng 4
Wageningen 6700 AA
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for shift workers:
• Health care sector or industrial shift worker
• Employed or self-employed
• 21 years or older
• Working hours: >= 28 h/ week
• Shift work duration > 3 years and currently doing night shifts
• 4 or more rotating night shifts/month (night shift defined as a work schedule
that involves working at least 3 hours between 00:00 and 5:00), at least 2
consecutive nights/month
Inclusion criteria non-shift workers:
• Health care sector or industrial work
• Employed or self-employed
• 21 years or older
• Working hours: >= 28 h/ week
• No night shift or rotating shift work in the last 10 years
• No history of night shift or rotating shift work for more than 5 years
Exclusion criteria
Exclusion criteria for shift workers and non-shift workers
• Pregnancy
• Lactation period
• BMI of 40 or above
• Present treatment of a disease e.g. cancer radio- or chemotherapy
• Chronic diseases if in an ongoing therapy but not after a remission (renal
failure, active hepatitis, cirrhosis, myocardial infarction, chronic
obstructive pulmonary disease and cancer)
• Immunodeficiency syndrome, any acute episode of auto-immune or
auto-inflammatory diseases (e.g., type-1 diabetes, multiple sclerosis, lupus,
rheumatoid arthritis) and acute episodes of atopic diseases (atopic dermatitis,
asthma, type 1 allergies such as hay fever)
• Bariatric surgery
• Antibiotics in the last month
• Participation in another human trial
• No literacy in Dutch (not able to speak and read Dutch)
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 | NL86146.091.24 |