Shift-Work Related Sleep DisturbanceGRIPNCT06147089
Shift Work Intervention Strategies for Night Shift Workers
A study testing Sleep Intervention and Nutritional intervention in people with Shift-Work Related Sleep Disturbance, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this intervention study is to test behavioral interventions in night shift workers. The main question it aims to answer is: Can personalized sleep or nutrition intervention strategies help against the negative health effects of night shift work? Participants will be followed before and after the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Related Sleep Disturbance
- What is being tested?
- Sleep Intervention and Nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Feb 2023to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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, irritable bowel disease, chronic obstructive pulmonary disease.
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Based Intervention Strategies to Combat Adverse Effects of Shift Work
The goal of this intervention study is to test behavioral interventions in night shift workers. The main question it aims to answer is:
- Can personalized sleep or nutrition intervention strategies help against the negative health effects of night shift work?
Participants will be followed before and after the intervention. Participants will wear smart devices, do a alertness/performance test and complete questionnaires. Blood samples will be collected.
Researchers will compare the intervention groups to the control group (which receives no intervention) to see if the sleep and nutrition interventions affected the health of night shift workers.
Read the detailed description
Rationale: 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.
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. Study population: The study population consists of employees who work at least 4 night shifts a month on average, with at least 1 year prior experience with shift work. Employees are aged 18-60 years and without a diagnosis of major disease. Each arm of the study will include 25 participants. There are three study arms: control group (no advice), personalised sleep intervention, and personalised nutritional intervention.
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.
Main study parameters/endpoints: The primary outcomes are the quality and quantity of sleep and stability and levels of (continuous) glucose patterns. 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 mixed-meal challenge test (PhenFlex) test. The outcomes will be compared, pre- and post-intervention.
- Conditions
- Shift-Work Related Sleep Disturbance
- Being tested
- Sleep Intervention, Nutritional intervention
- Keywords
- night shift work, sleep, nutrition, personalised intervention, biomarker, alertness, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep InterventionBehavioural
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.
Nutritional interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive no behavioral intervention and is instructed to continue with their normal sleep and nutritional habits. |
| Sleep intervention | Experimental | The sleep intervention group will receive personalised sleep advice to promote better sleep during night shift periods. This intervention will last 3 months. Receives: Behavioral: Sleep Intervention |
| Nutritional Intervention | Experimental | The nutritional intervention group will receive personalised nutrition advice to promote better metabolic health during night shift periods. This intervention will last 3 months. Receives: Behavioral: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total sleep time (TST) after1 month and 5 months intervention
The TST is calculated as minutes of sleep in the main sleep episode plus the minutes of sleep during any naps between the consecutive shifts, derived from actigraphy data collected in 60 s epochs. The investigators will use a commercial software package to score the sleep.
Measured: Baseline, 1 month and 5 months after start intervention
Change in Fragmentation index (FI) with actigraphy, and calculated using commercial software. Change in Fragmentation Index (FI) after 1 month and 5 months intervention
FI will be calculated as the number of times that sleep was terminated after 1 minute, expressed as a percentage of total estimated sleep time, using actigraphy data and commercial software to calculate it.
Measured: Baseline, 1 month and 3-5 months after start intervention
Change in Wake after sleep onset (WASO) after 1 month and 3-5 months intervention
WASO is an objective sleep quality measure and will be calculated as the duration (in minutes) of all awakenings during the main sleep episode measured with actigraphy, and calculated using commercial software.
Measured: Baseline, 1 month and 3-5 months after start intervention
Change in 24h glucose levels after 1 month and 3-5 months of intervention
24h interstitial glucose levels were recorded for 14 days around scheduled transition from day to night shifts, using the Freestyle Libre-Pro.
Measured: Baseline, 1 month and 3-5 months after start intervention
Secondary outcomes (2)
Change in Subjective Alertness via Karolinska Sleepiness Scale (KSS) after 1 month and 3-5 months of intervention
Participants will complete the Karolinska Sleepiness Scale (KSS) as a measure of subjective alertness at the beginning and end of 2 night shifts. The KSS is a Likert scale ranging from 1, extremely alert, to 9, extremely sleepy.beginning and end of 2 consecutive night shifts, to be performed on a mobile phone.
Measured: Baseline, 1 month and 3-5 months after start intervention
Change in Sustained Attention after 1 month and 3-5 months of intervention
The psychomotor vigilance task (PVT) is a test of visual reaction time (RT) in which the participant is asked to maintain the fastest possible RTs to a simple visual stimulus for several minutes. The inter-stimulus interval varies randomly between 2-10 seconds. While there are a number of standard performance metrics that can be obtained from each PVT, we will use the number of lapses of attention (RT > 500msec) as our outcome.
Measured: Baseline, 1 month and 3-5 months after start intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start9 Feb 2023
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shift-Work Related Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are three study arms: control group, personalised sleep intervention, and personalised nutritional intervention
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), Netherlands Organisation for Scientific Research
- Responsible party
- Principal investigator, Dr. Heidi Lammers-van der Holst PhD, Erasmus Medical Center
- Investigators
- Heidi M Lammers-van der Holst, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147089
- Sponsor's protocol ID
- MEC-82649
- Other IDs
- NL82649.078.22
- Acronym
- GRIP
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Rhee M, van den Broek TJ, Chaves I, Dolle MET, van Kerkhof LWM, Burdorf A, Lammers-Van der Holst HM, Oosterman JE, Wopereis S. A personalized nutrition intervention advances meal timing and is associated with reduced postprandial lipid and inflammatory responses in night shift workers. Front Nutr. 2026 Oct 8;13:1912094. doi: 10.3389/fnut.2026.1912094. eCollection 2026.
PubMed 42923332van der Rhee M, Oosterman JE, Wopereis S, van der Horst GTJ, Chaves I, Dolle MET, Burdorf A, van Kerkhof LWM, der Holst HML. Personalized sleep and nutritional strategies to combat adverse effects of night shift work: a controlled intervention protocol. BMC Public Health. 2024 Sep 19;24(1):2555. doi: 10.1186/s12889-024-20022-w.
PubMed 39300419
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Based Intervention Strategies to Combat Adverse Effects of Shift Work
- ClinicalTrials.gov ID
- NCT06147089
- Acronym / sponsor ID
- GRIP / MEC-82649
- Conditions
- Shift-Work Related Sleep Disturbance
- Keywords
- night shift work, sleep, nutrition, personalised intervention, biomarker, alertness, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), Netherlands Organisation for Scientific Research
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this intervention study is to test behavioral interventions in night shift workers. The main question it aims to answer is:
- Can personalized sleep or nutrition intervention strategies help against the negative health effects of night shift work?
Participants will be followed before and after the intervention. Participants will wear smart devices, do a alertness/performance test and complete questionnaires. Blood samples will be collected.
Researchers will compare the intervention groups to the control group (which receives no intervention) to see if the sleep and nutrition interventions affected the health of night shift workers.
Detailed description
Rationale: 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.
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. Study population: The study population consists of employees who work at least 4 night shifts a month on average, with at least 1 year prior experience with shift work. Employees are aged 18-60 years and without a diagnosis of major disease. Each arm of the study will include 25 participants. There are three study arms: control group (no advice), personalised sleep intervention, and personalised nutritional intervention.
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.
Main study parameters/endpoints: The primary outcomes are the quality and quantity of sleep and stability and levels of (continuous) glucose patterns. 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 mixed-meal challenge test (PhenFlex) test. The outcomes will be compared, pre- and post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three study arms: control group, personalised sleep intervention, and personalised nutritional intervention
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive no behavioral intervention and is instructed to continue with their normal sleep and nutritional habits. |
| Sleep intervention | Experimental | Behavioral: Sleep InterventionThe sleep intervention group will receive personalised sleep advice to promote better sleep during night shift periods. This intervention will last 3 months. |
| Nutritional Intervention | Experimental | Behavioral: Nutritional interventionThe nutritional intervention group will receive personalised nutrition advice to promote better metabolic health during night shift periods. This intervention will last 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep InterventionParticipants 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. | Behavioural | Sleep intervention |
| Nutritional interventionParticipants 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. | Behavioural | Nutritional Intervention |
Primary outcome
Change in Total sleep time (TST) after1 month and 5 months intervention
Time frame: Baseline, 1 month and 5 months after start intervention
The TST is calculated as minutes of sleep in the main sleep episode plus the minutes of sleep during any naps between the consecutive shifts, derived from actigraphy data collected in 60 s epochs. The investigators will use a commercial software package to score the sleep.
Change in Fragmentation index (FI) with actigraphy, and calculated using commercial software. Change in Fragmentation Index (FI) after 1 month and 5 months intervention
Time frame: Baseline, 1 month and 3-5 months after start intervention
FI will be calculated as the number of times that sleep was terminated after 1 minute, expressed as a percentage of total estimated sleep time, using actigraphy data and commercial software to calculate it.
Change in Wake after sleep onset (WASO) after 1 month and 3-5 months intervention
Time frame: Baseline, 1 month and 3-5 months after start intervention
WASO is an objective sleep quality measure and will be calculated as the duration (in minutes) of all awakenings during the main sleep episode measured with actigraphy, and calculated using commercial software.
Change in 24h glucose levels after 1 month and 3-5 months of intervention
Time frame: Baseline, 1 month and 3-5 months after start intervention
24h interstitial glucose levels were recorded for 14 days around scheduled transition from day to night shifts, using the Freestyle Libre-Pro.
2 secondary outcomes
Change in Subjective Alertness via Karolinska Sleepiness Scale (KSS) after 1 month and 3-5 months of intervention
Time frame: Baseline, 1 month and 3-5 months after start intervention
Change in Sustained Attention after 1 month and 3-5 months of intervention
Time frame: Baseline, 1 month and 3-5 months after start intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 42923332van der Rhee M, van den Broek TJ, Chaves I, Dolle MET, van Kerkhof LWM, Burdorf A, Lammers-Van der Holst HM, Oosterman JE, Wopereis S. A personalized nutrition intervention advances meal timing and is associated with reduced postprandial lipid and inflammatory responses in night shift workers. Front Nutr. 2026 Oct 8;13:1912094. doi: 10.3389/fnut.2026.1912094. eCollection 2026.
- Derived from this study: PubMed 39300419van der Rhee M, Oosterman JE, Wopereis S, van der Horst GTJ, Chaves I, Dolle MET, Burdorf A, van Kerkhof LWM, der Holst HML. Personalized sleep and nutritional strategies to combat adverse effects of night shift work: a controlled intervention protocol. BMC Public Health. 2024 Sep 19;24(1):2555. doi: 10.1186/s12889-024-20022-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi M Lammers-van der Holst, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Intervention and Nutritional intervention in people with Shift-Work Related Sleep Disturbance, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total sleep time (TST) after1 month and 5 months intervention (time frame: Baseline, 1 month and 5 months after start intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147089, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.