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| Name | Class |
|---|---|
| University of Bremen | OTHER |
| Medical University of Lodz | OTHER |
| Erasmus Medical Center | OTHER |
| Verein zur Fƶrderung des Technologietransfers an der Hochschule Bremerhaven e.V. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Lifestyle Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep duration | Total sleep time (min/24h) | From enrollment to the end of intervention (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | (kg) | From enrollment to end of intervention (24 weeks) |
| BMI | (kg/m2) | From enrollment to end of intervention (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | body Fat percentage (%) measured with bio-impedance analysis (BIA) | From enrollment to end of intervention (24 weeks) |
| waist to hip circumference | ratio of waist and hip circumference (cm/cm) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uni Bremen | Bremen | Germany | ||||
| TTZ |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| UNKNOWN |
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Although blinding of participants and investigators is not possible due to the nature of the intervention, outcome assessments will be conducted using objective measures (e.g., actigraphy for sleep duration) and standardized procedures to reduce the risk of measurement bias.
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| Objective sleep quality | 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 | Diet quality score: Eetscoreā¢, 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 | Light, moderate, vigorous activity (min), Sedentary time (min) as measured with an actigraphy (Motionwatch) | From enrollment to end of intervention (24 weeks) |
| Perceived stress | 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) | 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) | 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 | 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 | 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 | OSPAQ (min) | From enrollment to end of intervention (24 weeks) |
| Work-related sense of coherence | 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 | 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)] |
| [Time Frame: From enrollment to end of intervention (24 weeks)] |
| Behavior assessment | 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 | Hair cortisol concentraition (HCC), pg/mg hair | From enrollment to end of intervention (24 weeks) |
| glucose | fasted blood glucose (mM) | [Time Frame: From enrollment to end of intervention (24 weeks)] |
| Insulin | fasted plasma insulin (pmol/L) | [Time Frame: From enrollment to end of intervention (24 weeks)] |
| blood lipids | fasted blood lipids (mmol/L) | [Time Frame: From enrollment to end of intervention (24 weeks)] |
| blood pressure | Diastolic and systolic blood pressure in fasted state (mmHg) | [Time Frame: From enrollment to end of intervention (24 weeks)] |
| circadian biomarker | urinary melatonin (ng/mL) | [Time Frame: From enrollment to end of intervention (24 weeks)] |
| Participant satisfaction and feasibility | 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) |
| Bremerhaven |
| Germany |
| Erasmus Medical Centre | Rotterdam | Netherlands |
| Wageningen University & Research | Wageningen | Netherlands |
| Lodz | Lodz | Poland |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |