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Recruiting
NCT07631767
Shift Workers' Health Behavior Action Program Across Europe
Conditions: Night Shift Work, Obesity & Overweight, Circadian Misalignment
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 400
Sponsor: Wageningen University
Location: Uni Bremen Bremen
Summary
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.
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
Source: ClinicalTrials.gov (NCT07631767). StuddyBuddy aggregates publicly available trial information.