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Shift Workers' Health Behavior Action Program Across Europe (SHAPE)

18. august 2026 oppdatert av: Marco Mensink, Wageningen University
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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Nederland
      • Rotterdam, Nederland
        • Rekruttering
        • Erasmus Medical Centre
        • Ta kontakt med:
          • H. Lammers-van der Holst
          • Telefonnummer: 0031 10 704 0704
      • Wageningen, Nederland
        • Rekruttering
        • Wageningen University & Research
        • Ta kontakt med:
          • M. Mensink
          • Telefonnummer: 0031 (0)317 480 100
  • Polen
      • Lodz, Polen
        • Har ikke rekruttert ennå
        • Lodz
        • Ta kontakt med:
  • Tyskland
      • Bremen, Tyskland
        • Rekruttering
        • Uni Bremen
        • Ta kontakt med:
          • U. Klink
          • Telefonnummer: 0049 421 218 68980
      • Bremerhaven, Tyskland
        • Har ikke rekruttert ennå
        • TTZ

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
Intervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops.
Atferdsmessig: 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.
Ingen inngripen: Control
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sleep duration
Tidsramme: From enrollment to the end of intervention (24 weeks)
Total sleep time (min/24h)
From enrollment to the end of intervention (24 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body weight
Tidsramme: From enrollment to end of intervention (24 weeks)
(kg)
From enrollment to end of intervention (24 weeks)
BMI
Tidsramme: From enrollment to end of intervention (24 weeks)
(kg/m2)
From enrollment to end of intervention (24 weeks)
Objective sleep quality
Tidsramme: From enrollment to end of intervention (24 weeks)
Wake after sleep onset (min spent awake/main sleep episode), derived from actigraphy data
From enrollment to end of intervention (24 weeks)
Overall diet quality
Tidsramme: From enrollment to end of intervention (24 weeks)
Diet quality score: Eetscore™, a 55-item FFQ which is scored with the Dutch Healthy Diet 2015-index to evaluate adherence to the Dutch food-based dietary guideline; resulting in a total score between zero (no adherence) and 100 (complete adherence).
From enrollment to end of intervention (24 weeks)
Physical activity level
Tidsramme: From enrollment to end of intervention (24 weeks)
Light, moderate, vigorous activity (min), Sedentary time (min) as measured with an actigraphy (Motionwatch)
From enrollment to end of intervention (24 weeks)
Perceived stress
Tidsramme: From enrollment to end of intervention (24 weeks)
Perceived stress score (PSS-10), a 10-item validated questionnaire assessing the extent to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded. Items are rated on a 5-point Likert scale referring to experiences over the past month; higher score mean more stress.
From enrollment to end of intervention (24 weeks)
Subjective sleep quality (Insomina)
Tidsramme: From enrollment to end of intervention (24 weeks)
Insomnia severity (0-28): a 7-item self-administered questionnaire validated in shift workers as a proxy for sleep quality. Items assess the severity of insomnia symptoms, including difficulties with sleep onset, maintenance, and early awakening. Each item is scored 0-4, with total scores ranging from 0 to 28; higher scores indicate more severe insomnia
From enrollment to end of intervention (24 weeks)
Subjective leep quality (pattern)
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
Shift Work Disorder Questionnaire (SWDQ): a 4-item questionnaire assessing sleep patterns, excessive sleepiness, and functional impairment related to shift work (53). Each item is scored 1-4, yielding a total score of 4-16, with higher scores reflecting greater symptom severit
[Time Frame: From enrollment to end of intervention (24 weeks)]
Chrono-nutrition patterns
Tidsramme: From enrollment to end of intervention (24 weeks)
Meal timing, frequency, regularity; using the Chrono nutrition Questionnaire for Shift Workers (CNQ-Shift). The questionnaire contains 20-23 questions, five questions each for morning, afternoon, and night shifts, three split shifts questions (if applicable), and two questions for work-free days.
From enrollment to end of intervention (24 weeks)
Food preferences
Tidsramme: From enrollment to end of intervention (24 weeks)
FFPQ (liking/wanting scores): Participants rate "how pleasant it would be to try a bite of this food," using a 100-point visual analogue scale (explicit liking). A forced choice procedure is then carried used to assess which food participants would "most like to eat now" (implicit wanting).
From enrollment to end of intervention (24 weeks)
Occupational physical activity
Tidsramme: From enrollment to end of intervention (24 weeks)
OSPAQ (min)
From enrollment to end of intervention (24 weeks)
Work-related sense of coherence
Tidsramme: From enrollment to end of intervention (24 weeks)
Work-related sense of coherence Work-Soc (5-point Likert scale), a 9-scale assessing individuals' perceived comprehensibility, manageability, and meaningfulness at work.
From enrollment to end of intervention (24 weeks)
Satisfaction With Life
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
Satisfaction With Life Scale (SWLS): a 5-item questionnaire evaluating global life satisfaction (66). Items are rated on a 7-point scale
[Time Frame: From enrollment to end of intervention (24 weeks)]

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body composition
Tidsramme: From enrollment to end of intervention (24 weeks)
body Fat percentage (%) measured with bio-impedance analysis (BIA)
From enrollment to end of intervention (24 weeks)
waist to hip circumference
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
ratio of waist and hip circumference (cm/cm)
[Time Frame: From enrollment to end of intervention (24 weeks)]
Behavior assessment
Tidsramme: From enrollment to end of intervention (24 weeks)
Action planning, Coping planning, Habit formation, Intention. All items are scored on a either a 5 or 7-point Likert scale ranging from totally disagree to totally agree.
From enrollment to end of intervention (24 weeks)
Stress biomarker
Tidsramme: From enrollment to end of intervention (24 weeks)
Hair cortisol concentraition (HCC), pg/mg hair
From enrollment to end of intervention (24 weeks)
glucose
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
fasted blood glucose (mM)
[Time Frame: From enrollment to end of intervention (24 weeks)]
Insulin
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
fasted plasma insulin (pmol/L)
[Time Frame: From enrollment to end of intervention (24 weeks)]
blood lipids
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
fasted blood lipids (mmol/L)
[Time Frame: From enrollment to end of intervention (24 weeks)]
blood pressure
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
Diastolic and systolic blood pressure in fasted state (mmHg)
[Time Frame: From enrollment to end of intervention (24 weeks)]
circadian biomarker
Tidsramme: [Time Frame: From enrollment to end of intervention (24 weeks)]
urinary melatonin (ng/mL)
[Time Frame: From enrollment to end of intervention (24 weeks)]
Participant satisfaction and feasibility
Tidsramme: end of intervention (week 24)
assessed using a study-specific questionnaire evaluating participants' experiences with the intervention content, delivery, usability, and perceived burden of the intervention
end of intervention (week 24)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Wageningen University

Samarbeidspartnere

Erasmus Medical Center
Medical University of Lodz
University of Bremen
Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. mai 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

1. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NL-010791

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Nei

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