Shift Work Intervention Strategies for Night Shift Workers

NCT06147089 | Completed

• 2 other identifiers: MEC-82649NL82649.078.22
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Shift-Work Related Sleep Disturbance

Keywords

night shift work; sleep; nutrition; personalised intervention; biomarker; alertness; performance

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  Baseline, 1 month and 3-5 months after start intervention

• Change in Sustained Attention after 1 month and 3-5 months of intervention

  Baseline, 1 month and 3-5 months after start intervention

Study Arms (3)

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.

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.

Behavioral: Nutritional intervention

Interventions

Sleep Intervention BEHAVIORAL

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.

Sleep intervention

Nutritional intervention BEHAVIORAL

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.

Nutritional Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• National Institute for Public Health and the Environment (RIVM): collaborator
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (1)

• van 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.

  PMID: 39300419 DERIVED

Study Officials

• Heidi M Lammers-van der Holst, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: There are three study arms: control group, personalised sleep intervention, and personalised nutritional intervention

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: November 27, 2023
• Study Start: February 9, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)