Shift Workers' Health Behavior Action Program Across Europe (SHAPE)
18 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
400
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bremen, Duitsland
- Werving
- Uni Bremen
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Contact:
- U. Klink
- Telefoonnummer: 0049 421 218 68980
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Bremerhaven, Duitsland
- Nog niet aan het werven
- TTZ
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Rotterdam, Nederland
- Werving
- Erasmus Medical Centre
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Contact:
- H. Lammers-van der Holst
- Telefoonnummer: 0031 10 704 0704
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Wageningen, Nederland
- Werving
- Wageningen University & Research
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Contact:
- M. Mensink
- Telefoonnummer: 0031 (0)317 480 100
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Lodz, Polen
- Nog niet aan het werven
- Lodz
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Contact:
- M. Wrzesińska
- Telefoonnummer: 0048 42 272 58 13
- E-mail: prorektor.int@umed.lodz.pl
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sleep duration
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Body weight
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: [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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: [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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Body composition
Tijdsspanne: 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
Tijdsspanne: [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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: [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
Tijdsspanne: [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
Tijdsspanne: [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
Tijdsspanne: [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
Tijdsspanne: [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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 mei 2026
Primaire voltooiing (Geschat)
1 juli 2027
Studie voltooiing (Geschat)
1 december 2027
Studieregistratiedata
Eerst ingediend
1 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 juni 2026
Eerst geplaatst (Werkelijk)
8 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
18 augustus 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NL-010791
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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