The current study aims to investigate two types of preventive interventions in night shift workers: a personalised sleep intervention and a personalised nutritional intervention. It will assess the effects of the two interventions on sleep and on (…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
- Sleep disorders and disturbances
Synonym
Health condition
slaap, vermoeidheid, wellbevinden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are the quality and quantity of sleep and stability and
levels of (continuous) glucose patterns.
Secondary outcome
Secondary outcomes include a set of relevant clinical biomarkers (of metabolic
health, epigenetic DNA methylation profiles in blood, and stress markers in
hair, and anthropometrics), and alertness during night shifts. For the
nutritional intervention, metabolic flexibility and inflammatory resilience
will be measured with the PhenFlex test.
Background summary
Night work interferes with the timing of daily activities and disturbs the
circadian rhythms of multiple physiological processes in the human body. This
is associated with detrimental health effects, such as disturbances in sleep
(shorter, less consolidated sleep) and insulin regulation (due to altered
eating behaviour). Night shift work is prevalent and difficult to limit in
many job types, yet there is currently limited evidence on effective
interventions to prevent the health consequence of shift work in a real life
context. Therefore more research on tools for the prevention of negative health
effects is warranted.
Study objective
The current study aims to investigate two types of preventive interventions in
night shift workers: a personalised sleep intervention and a personalised
nutritional intervention. It will assess the effects of the two interventions
on sleep and on (continuous) glucose patterns.
Study design
A non-blinded controlled intervention study, consisting of a run-in period with
baseline levels, an intervention of ~ 3 months including measurements at the
start of the intervention, a post-intervention measurement and a follow up
after 12 months. There are three study arms: control group (no advice),
personalised sleep intervention, and personalised nutritional intervention.
The total participation during the study for the sleep intervention and control
group consists of: 3 visits to the Erasmus MC with 3 fasting blood draws (3x 30
mL). The total burden during the study for participants in the nutritional
intervention group consist of: 3 visits to the Erasmus MC, where a fasting
blood draw will be taken during each visit (3x 30 mL blood) and a PhenFlex test
will be done in addition during 2 out of 3 visits (2x 60 mL additional sampling
of blood, resulting in a total of 90 mL of blood drawn). Furthermore, all
participants will log their food intake during 3 consecutive days, during 3
periods. All participants will wear the CGM and an actigraphy watch for a
duration of 14 days during 3 periods. All participants will wear a wearable
activity tracker during the whole study period, will be requested 4 times to
fil in multiple questionnaires, and will complete a 5-min alertness test during
6 night shifts.
Intervention
Participants in the sleep intervention receive advice on: sleep
hygiene/environment, sleep timing, naps, and exposure to light. These advices
will be tailored to the personal situation of the participant, as measured
during the run-in period. Participants in the nutritional intervention receive
personalised advice on the distribution of calories and nutrients over 24 hrs,
and on specific food products based on the outcomes of the continuous glucose
measurements (CGM) during the run-in period. The guidelines will include room
for personal dietary preferences. The control group is asked to carry on with
their normal sleep and nutritional habits.
Study burden and risks
Venipuncture for blood samples might be experienced as painful. We expect no
discomfort from wearing the activity trackers, glucose monitor or responding to
questionnaires. These activities are a minimal burden to the participants and
with low risks. For the PhenFlex test, participants will drink a high caloric
and sweet drink, which may be experienced as unpleasant or nauseating. For
people with (undiagnosed) type 2 diabetes there is a small risk of
hyperglycemia. Experienced medical professionals are present during these
PhenFlex tests and will closely monitor the participants. Participants will
receive a personalised sleep or nutritional advice (based on their own personal
situation) or no advice (control). Based on previous findings we expect that
these advices may have a beneficial effect on the participants* health and
provide valuable insight into the effectiveness of the interventions.
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
• Age 18 to 60 years.
• Work at least 4 night shifts a month on average.
• Shift workers, working rotating shifts (morning, evening and night shifts) or
working predominantly night shifts. Night shift defined as work at least 1
hours between 0:00- and 6:00.
• Work at least 2 night shifts in a row
• Work >= 20 work hours per week.
• Having a shift duration of 6 h-12 h.
• History of >= 1 year of working rotating shift work or night shifts prior to
the study.
Exclusion criteria
• Taking medication that the investigator believes would interfere with the
objectives of the study. For example, sleep medication, medication that
interferes with glucose homeostasis, and/or anti-inflammatory drugs.
• Pregnant or have a wish to become pregnant during the study period.
• Planned surgery during the entire study period
• Alcohol consumption > 21 units/week
• Severe psychiatric disease and/or any mental or physical disability that will
hinder participation in the interventions
• Severe cardiovascular disease, to the discretion of the study doctor
• Having a chronic inflammatory disease, including asthma, rheumatic fever,
IBD, COPD
• Other bowel diseases, including Chron*s disease and Colitis Ulcerosa.
• A disease or condition with higher bleeding risk (/risk of hemorrhage), under
which a blood sample may lead to complications.
• Participation in any clinical trial including blood sampling and/or
administration of substances up to 90 days before Day 01 of this study
• Recent blood donation (<1 month prior to the start of the study)
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 | NL82649.078.22 |