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

1 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

400

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Germania
      • Bremen, Germania
        • Uni Bremen
      • Bremerhaven, Germania
        • TTZ
  • Olanda
      • Rotterdam, Olanda
        • Erasmus Medical Centre
      • Wageningen, Olanda
        • Wageningen University & Research
  • Polonia
      • Lodz, Polonia
        • Lodz

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention
Intervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops.
Comportamentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sleep duration
Lasso di tempo: From enrollment to the end of intervention (24 weeks)
Total sleep time (min/24h)
From enrollment to the end of intervention (24 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body weight
Lasso di tempo: From enrollment to end of intervention (24 weeks)
(kg)
From enrollment to end of intervention (24 weeks)
BMI
Lasso di tempo: From enrollment to end of intervention (24 weeks)
(kg/m2)
From enrollment to end of intervention (24 weeks)
Objective sleep quality
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: [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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From enrollment to end of intervention (24 weeks)
OSPAQ (min)
From enrollment to end of intervention (24 weeks)
Work-related sense of coherence
Lasso di tempo: 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
Lasso di tempo: [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)]

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Body composition
Lasso di tempo: 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
Lasso di tempo: [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
Lasso di tempo: 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
Lasso di tempo: From enrollment to end of intervention (24 weeks)
Hair cortisol concentraition (HCC), pg/mg hair
From enrollment to end of intervention (24 weeks)
glucose
Lasso di tempo: [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
Lasso di tempo: [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
Lasso di tempo: [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
Lasso di tempo: [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
Lasso di tempo: [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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Wageningen University

Collaboratori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

1 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL-010791

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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