Shift Workers' Health Behavior Action Program Across Europe

NCT07631767 | Not Yet Recruiting

• 1 other identifier: NL-010791
• Study Type: interventional
• Target: 400
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Night Shift Work; Obesity & Overweight; Circadian Misalignment

Keywords

Lifestyle; Stress; Sleep; Diet; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Sleep duration

  Total sleep time (min/24h)

  From enrollment to the end of intervention (24 weeks)

Secondary Outcomes (13)

• Body weight

  From enrollment to end of intervention (24 weeks)

• BMI

  From enrollment to end of intervention (24 weeks)

• Objective sleep quality

  From enrollment to end of intervention (24 weeks)

• Overall diet quality

  From enrollment to end of intervention (24 weeks)

• Physical activity level

  From enrollment to end of intervention (24 weeks)

Other Outcomes (10)

• Body composition

  From enrollment to end of intervention (24 weeks)

• waist to hip circumference

  [Time Frame: From enrollment to end of intervention (24 weeks)]

• Behavior assessment

  From enrollment to end of intervention (24 weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops.

Behavioral: Combined Lifestyle Intervention

Control

NO INTERVENTION

The control group receives informational brochures with general advice on the four life-style domains, without active behavioral support. The control group receives access to the combined lifestyle intrevention after the intervention period has ended.

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.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years
• Work ≥ 24 hours per week
• Shift work duration \> 3 years and currently doing night shifts
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• 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

Study Sites (5)

Uni Bremen

Bremen, Germany

Location

TTZ

Bremerhaven, Germany

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

Wageningen University & Research

Wageningen, Netherlands

Location

Lodz

Lodz, Poland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although blinding of participants and investigators is not possible due to the nature of the intervention, outcome assessments will be conducted using objective measures (e.g., actigraphy for sleep duration) and standardized procedures to reduce the risk of measurement bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: June 8, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-05

Locations

NL (2); PL (1); DE (2)