Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147089
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-01-24
Brief Title:
Shift Work Intervention Strategies for Night Shift Workers
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Biomarker Based Intervention Strategies to Combat Adverse Effects of Shift Work
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRIP
Brief 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 intervention Participants will wear smart devices do a alertnessperformance 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
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 alertnessperformance 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 hygieneenvironment 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 parametersendpoints 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
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 hygieneenvironment 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 parametersendpoints 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8264907822 | OTHER | Erasmus Medical Center | None |