Shift Workers' Health Behavior Action Program Across Europe (SHAPE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight; Circadian Misalignment; Night Shift Work
• Intervention / Treatment: Behavioral: Combined Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bremen, Germany
    • Uni Bremen
  • Bremerhaven, Germany
    • TTZ
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Centre
  • Wageningen, Netherlands
    • Wageningen University & Research
• Poland
  • Lodz, Poland
    • Lodz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops.	Behavioral: Combined Lifestyle Intervention; 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep duration	Total sleep time (min/24h)	From enrollment to the end of intervention (24 weeks)

Secondary Outcome Measures

Outcome Measure	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)
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: 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).	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)]

Other Outcome Measures

Outcome Measure	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)	[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)

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Erasmus Medical Center; Medical University of Lodz; University of Bremen; Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Stress; Sleep; Diet; Lifestyle
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Motor Activity
• Other Study ID Numbers: NL-010791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No