Shift Workers' Health Behavior Action Program Across Europe (SHAPE)
18 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
400
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bremen, Alemanha
- Recrutamento
- Uni Bremen
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Contato:
- U. Klink
- Número de telefone: 0049 421 218 68980
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Bremerhaven, Alemanha
- Ainda não está recrutando
- TTZ
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Rotterdam, Holanda
- Recrutamento
- Erasmus Medical Centre
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Contato:
- H. Lammers-van der Holst
- Número de telefone: 0031 10 704 0704
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Wageningen, Holanda
- Recrutamento
- Wageningen University & Research
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Contato:
- M. Mensink
- Número de telefone: 0031 (0)317 480 100
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Lodz, Polônia
- Ainda não está recrutando
- Lodz
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Contato:
- M. Wrzesińska
- Número de telefone: 0048 42 272 58 13
- E-mail: prorektor.int@umed.lodz.pl
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sleep duration
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body weight
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: [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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: [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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body composition
Prazo: 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
Prazo: [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
Prazo: 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
Prazo: 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
Prazo: [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
Prazo: [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
Prazo: [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
Prazo: [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
Prazo: [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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de maio de 2026
Conclusão Primária (Estimado)
1 de julho de 2027
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
1 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de agosto de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NL-010791
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