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Not yet recruiting NCT07631767

Shift Workers' Health Behavior Action Program Across Europe

No phase Interventional Night Shift Work Obesity & Overweight Circadian Misalignment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined Lifestyle Intervention.
Who it may be relevant to
Registry conditions: Night Shift Work, Obesity & Overweight, Circadian Misalignment. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Netherlands, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Behavioral Combined Lifestyle Intervention
    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.

Primary outcome measures

  • Sleep duration [Time frame: From enrollment to the end of intervention (24 weeks)]
Secondary outcome measures (12)
  • Body weight [Time frame: From enrollment to end of intervention (24 weeks)]
  • BMI [Time frame: From enrollment to end of intervention (24 weeks)]
  • Objective sleep quality [Time frame: From enrollment to end of intervention (24 weeks)]
  • Overall diet quality [Time frame: From enrollment to end of intervention (24 weeks)]
  • Physical activity level [Time frame: From enrollment to end of intervention (24 weeks)]
  • Perceived stress [Time frame: From enrollment to end of intervention (24 weeks)]
  • Subjective sleep quality (Insomina) [Time frame: From enrollment to end of intervention (24 weeks)]
  • Subjective leep quality (pattern) [Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]]
  • Chrono-nutrition patterns [Time frame: From enrollment to end of intervention (24 weeks)]
  • Food preferences [Time frame: From enrollment to end of intervention (24 weeks)]
  • Occupational physical activity [Time frame: From enrollment to end of intervention (24 weeks)]
  • Work-related sense of coherence [Time frame: From enrollment to end of intervention (24 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Germany · 2 centers
  • Uni Bremen — Bremen
  • TTZ — Bremerhaven
Netherlands · 2 centers
  • Erasmus Medical Centre — Rotterdam
  • Wageningen University & Research — Wageningen
Poland · 1 center
  • Lodz — Lodz

Identifiers

NCT: NCT07631767 · NL-010791

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗