Shift Work Intervention Strategies for Night Shift Workers — GRIP  

Shift-Work Related Sleep Disturbance Clinical Trial

Official title: Biomarker Based Intervention Strategies to Combat Adverse Effects of Shift Work

Status Recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Shift-Work Related Sleep Disturbance

• NCT number: NCT06147089
• Study type: Interventional
• Source: Erasmus Medical Center
• Contact: Heidi M Lammers-van der Holst, PhD
• Phone: +31107043721
• Email: h.lammers-vanderholst@erasmusmc.nl
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Completion date: June 1, 2026