Shift Workers' Health Behavior Action Program Across Europe
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorWageningen University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Combined Lifestyle Intervention
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wageningen University
Lead sponsor
University of Bremen
Collaborator
Medical University of Lodz
Collaborator
Erasmus Medical Center
Collaborator
Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.
Collaborator
Source ClinicalTrials.gov