Shift Workers' Health Behavior Action Program Across Europe (SHAPE)
2026年8月18日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
400
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bremen、德国
- 招聘中
- Uni Bremen
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接触：
- U. Klink
- 电话号码：0049 421 218 68980
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Bremerhaven、德国
- 尚未招聘
- TTZ
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Lodz、波兰
- 尚未招聘
- Lodz
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接触：
- M. Wrzesińska
- 电话号码：0048 42 272 58 13
- 邮箱：prorektor.int@umed.lodz.pl
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Rotterdam、荷兰
- 招聘中
- Erasmus Medical Centre
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接触：
- H. Lammers-van der Holst
- 电话号码：0031 10 704 0704
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Wageningen、荷兰
- 招聘中
- Wageningen University & Research
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接触：
- M. Mensink
- 电话号码：0031 (0)317 480 100
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sleep duration
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body weight
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：[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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：[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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Body composition
大体时间：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
大体时间：[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
大体时间：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
大体时间：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
大体时间：[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
大体时间：[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
大体时间：[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
大体时间：[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
大体时间：[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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月15日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年5月1日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.