RECRUITING Not applicable ClinicalTrials.gov

Shift Workers' Health Behavior Action Program Across Europe

Sponsor: Wageningen University • ClinicalTrials.gov ID: NCT07631767

Registry updated: 2026-08-20

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Description

This study evaluates the effects of a Combined Lifestyle Intervention Program (CLIP) on sleep, lifestyle behaviors, obesity risk and health in night-shift workers. The primary objective is to assess the effect of the CLIP on objectively measured sleep duration. Secondary objectives include behavioral outcomes related to sleep, diet, physical activity, and stress, as well as body weight and metabolic outcomes, . It is hypothesized that CLIP participants will show a greater increase in sleep duration than controls, alongside favorable changes in lifestyle and health outcomes.

Interventions

Combined Lifestyle Intervention (Behavioral)
The 24-week lifestyle intervention is structured in four 6-week blocks focusing on sleep and stress management or diet and physical activity. Lifestyle advice and behavior change techniques are delivered via a mobile application, complemented by workshops.

Eligibility criteria

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

Conditions

Night Shift Work Obesity & Overweight Circadian Misalignment

Locations

Uni Bremen — Bremen, Germany
TTZ — Bremerhaven, Germany
Erasmus Medical Centre — Rotterdam, Netherlands
Wageningen University & Research — Wageningen, Netherlands
Lodz — Lodz, Poland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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