Lifestyle program to improve sleep and health for night shift workers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional program, conducted across Europe, uses a Combined Lifestyle Intervention to address sleep duration, diet, physical activity, and stress in night-shift workers. The study will measure changes in objectively recorded sleep time as the primary outcome, with secondary outcomes including lifestyle behaviors, body weight, and metabolic markers. Eligible participants are adults aged 21 and older who work night shifts at least part-time and plan to continue night work for a year, with smartphone access for the study app. Data will be collected through wearable or device-based sleep tracking and self-reported behavioral measures to assess the impact of the intervention on circadian alignment and obesity risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 21 years
* Work ≥ 24 hours per week
* Shift work duration \> 3 years and currently doing night shifts
* Expected to continue night shiftwork for at least 1 year after inclusion
* On average working ≥ 4 night shifts per month
* Working generally ≥ 2 consecutive night shifts
* In possession of a smartphone and willing to download the study application

Exclusion Criteria:

* Body Mass Index (BMI) \< 18.5 or \> 40 kg/m2
* Pregnant or lactating
* Chronic diseases with ongoing therapy (e.g. renal failure, active hepatitis, cirrhosis, myocardial infarction, chronic obstructive pulmonary disease and cancer)
* Current or recent use of medications interfering with sleep, including: Central nervous system stimulants (e.g., Ritalin, Adderall, Modafinil or similar); Chronic use of sleep agents (e.g., benzodiazepine, non-hypnotic benzodiaze-pine, first-generation antihistamine, melatonin receptors agonists or similar); Other medications or combinations significantly affecting sleeping patterns
* Recent or ongoing psychotherapy for sleep disorders
* Current or recent use of medications affecting appetite or weight regulation, including: Appetite-enhancing/weight-gain medications (e.g., atypical antipsychotics, cor-ticosteroids such as prednisone, mirtazapine or similar); Appetite-suppressing/weight-loss medications (e.g., CNS stimulants such as Ritalin, Adderall, GLP-1 receptors agonists or similar); Other medications or combinations significantly influencing appetite or body weight
* Participation in another human trial, lifestyle program or weight loss intervention within the past 3 months
* Planned surgical procedure during the study period
* History of or planned bariatric surgery/treatment

Where it's running

• Uni Bremen
  Bremen, Germany Recruiting
• Erasmus Medical Centre
  Rotterdam, Netherlands Recruiting
• Wageningen University & Research
  Wageningen, Netherlands Recruiting
• Ttz
  Bremerhaven, Germany Not yet recruiting
• Lodz
  Lodz, Poland Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.