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NCT Number: NCT07631767

Shift Workers' Health Behavior Action Program Across Europe

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uni Bremen, Bremen, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sleep duration

    Time frame: From enrollment to the end of intervention (24 weeks)

    Total sleep time (min/24h)

Secondary outcomes

  1. Body weight

    Time frame: From enrollment to end of intervention (24 weeks)

    (kg)

  2. BMI

    Time frame: From enrollment to end of intervention (24 weeks)

    (kg/m2)

  3. Objective sleep quality

    Time frame: From enrollment to end of intervention (24 weeks)

    Wake after sleep onset (min spent awake/main sleep episode), derived from actigraphy data

  4. Overall diet quality

    Time frame: From enrollment to end of intervention (24 weeks)

    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).

  5. Physical activity level

    Time frame: From enrollment to end of intervention (24 weeks)

    Light, moderate, vigorous activity (min), Sedentary time (min) as measured with an actigraphy (Motionwatch)

  6. Perceived stress

    Time frame: From enrollment to end of intervention (24 weeks)

    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.

  7. Subjective sleep quality (Insomina)

    Time frame: From enrollment to end of intervention (24 weeks)

    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

  8. Subjective leep quality (pattern)

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    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

  9. Chrono-nutrition patterns

    Time frame: From enrollment to end of intervention (24 weeks)

    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.

  10. Food preferences

    Time frame: From enrollment to end of intervention (24 weeks)

    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).

  11. Occupational physical activity

    Time frame: From enrollment to end of intervention (24 weeks)

    OSPAQ (min)

  12. Work-related sense of coherence

    Time frame: From enrollment to end of intervention (24 weeks)

    Work-related sense of coherence Work-Soc (5-point Likert scale), a 9-scale assessing individuals' perceived comprehensibility, manageability, and meaningfulness at work.

  13. Satisfaction With Life

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    Satisfaction With Life Scale (SWLS): a 5-item questionnaire evaluating global life satisfaction (66). Items are rated on a 7-point scale

Other outcomes

  1. Body composition

    Time frame: From enrollment to end of intervention (24 weeks)

    body Fat percentage (%) measured with bio-impedance analysis (BIA)

  2. waist to hip circumference

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    ratio of waist and hip circumference (cm/cm)

  3. Behavior assessment

    Time frame: From enrollment to end of intervention (24 weeks)

    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.

  4. Stress biomarker

    Time frame: From enrollment to end of intervention (24 weeks)

    Hair cortisol concentraition (HCC), pg/mg hair

  5. glucose

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    fasted blood glucose (mM)

  6. Insulin

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    fasted plasma insulin (pmol/L)

  7. blood lipids

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    fasted blood lipids (mmol/L)

  8. blood pressure

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    Diastolic and systolic blood pressure in fasted state (mmHg)

  9. circadian biomarker

    Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]

    urinary melatonin (ng/mL)

  10. Participant satisfaction and feasibility

    Time frame: end of intervention (week 24)

    assessed using a study-specific questionnaire evaluating participants' experiences with the intervention content, delivery, usability, and perceived burden of the intervention

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

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

Registry information

Acronym: SHAPE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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