Shift Workers' Health Behavior Action Program Across Europe (SHAPE)
18 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
400
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bremen, Allemagne
- Recrutement
- Uni Bremen
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Contact:
- U. Klink
- Numéro de téléphone: 0049 421 218 68980
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Bremerhaven, Allemagne
- Pas encore de recrutement
- TTZ
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Rotterdam, Pays-Bas
- Recrutement
- Erasmus Medical Centre
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Contact:
- H. Lammers-van der Holst
- Numéro de téléphone: 0031 10 704 0704
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Wageningen, Pays-Bas
- Recrutement
- Wageningen University & Research
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Contact:
- M. Mensink
- Numéro de téléphone: 0031 (0)317 480 100
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Lodz, Pologne
- Pas encore de recrutement
- Lodz
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Contact:
- M. Wrzesińska
- Numéro de téléphone: 0048 42 272 58 13
- E-mail: prorektor.int@umed.lodz.pl
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention
Intervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops.
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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.
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Aucune intervention: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sleep duration
Délai: From enrollment to the end of intervention (24 weeks)
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Total sleep time (min/24h)
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From enrollment to the end of intervention (24 weeks)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body weight
Délai: From enrollment to end of intervention (24 weeks)
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(kg)
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From enrollment to end of intervention (24 weeks)
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BMI
Délai: From enrollment to end of intervention (24 weeks)
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(kg/m2)
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From enrollment to end of intervention (24 weeks)
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Objective sleep quality
Délai: From enrollment to end of intervention (24 weeks)
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Wake after sleep onset (min spent awake/main sleep episode), derived from actigraphy data
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From enrollment to end of intervention (24 weeks)
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Overall diet quality
Délai: From enrollment to end of intervention (24 weeks)
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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).
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From enrollment to end of intervention (24 weeks)
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Physical activity level
Délai: From enrollment to end of intervention (24 weeks)
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Light, moderate, vigorous activity (min), Sedentary time (min) as measured with an actigraphy (Motionwatch)
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From enrollment to end of intervention (24 weeks)
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Perceived stress
Délai: From enrollment to end of intervention (24 weeks)
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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.
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From enrollment to end of intervention (24 weeks)
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Subjective sleep quality (Insomina)
Délai: From enrollment to end of intervention (24 weeks)
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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
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From enrollment to end of intervention (24 weeks)
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Subjective leep quality (pattern)
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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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
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Chrono-nutrition patterns
Délai: From enrollment to end of intervention (24 weeks)
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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.
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From enrollment to end of intervention (24 weeks)
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Food preferences
Délai: From enrollment to end of intervention (24 weeks)
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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).
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From enrollment to end of intervention (24 weeks)
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Occupational physical activity
Délai: From enrollment to end of intervention (24 weeks)
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OSPAQ (min)
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From enrollment to end of intervention (24 weeks)
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Work-related sense of coherence
Délai: From enrollment to end of intervention (24 weeks)
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Work-related sense of coherence Work-Soc (5-point Likert scale), a 9-scale assessing individuals' perceived comprehensibility, manageability, and meaningfulness at work.
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From enrollment to end of intervention (24 weeks)
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Satisfaction With Life
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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Satisfaction With Life Scale (SWLS): a 5-item questionnaire evaluating global life satisfaction (66).
Items are rated on a 7-point scale
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body composition
Délai: From enrollment to end of intervention (24 weeks)
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body Fat percentage (%) measured with bio-impedance analysis (BIA)
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From enrollment to end of intervention (24 weeks)
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waist to hip circumference
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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ratio of waist and hip circumference (cm/cm)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Behavior assessment
Délai: From enrollment to end of intervention (24 weeks)
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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.
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From enrollment to end of intervention (24 weeks)
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Stress biomarker
Délai: From enrollment to end of intervention (24 weeks)
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Hair cortisol concentraition (HCC), pg/mg hair
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From enrollment to end of intervention (24 weeks)
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glucose
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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fasted blood glucose (mM)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Insulin
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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fasted plasma insulin (pmol/L)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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blood lipids
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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fasted blood lipids (mmol/L)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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blood pressure
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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Diastolic and systolic blood pressure in fasted state (mmHg)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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circadian biomarker
Délai: [Time Frame: From enrollment to end of intervention (24 weeks)]
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urinary melatonin (ng/mL)
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[Time Frame: From enrollment to end of intervention (24 weeks)]
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Participant satisfaction and feasibility
Délai: end of intervention (week 24)
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assessed using a study-specific questionnaire evaluating participants' experiences with the intervention content, delivery, usability, and perceived burden of the intervention
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end of intervention (week 24)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 mai 2026
Achèvement primaire (Estimé)
1 juillet 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
1 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 août 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NL-010791
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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