Night Shift WorkSHAPENCT07631767
Shift Workers' Health Behavior Action Program Across Europe
A study testing Combined Lifestyle Intervention in people with Night Shift Work and Obesity & Overweight, run by Wageningen University at 5 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Night Shift Work, Obesity & Overweight, Circadian Misalignment
- What is being tested?
- Combined Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 15 May 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Uni Bremen
Bremen
U. Klink, 0049 421 218 68980
- Not yet recruiting
TTZ
Bremerhaven
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medical Centre
Rotterdam
H. Lammers-van der Holst, 0031 10 704 0704
- Recruiting
Wageningen University & Research
Wageningen
M. Mensink, 0031 (0)317 480 100
Poland1 site, 1 recruiting
- Not yet recruiting
Lodz
Lodz
M. Wrzesińska, 0048 42 272 58 13, prorektor.int@umed.lodz.pl
About this study
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.
- Being tested
- Combined Lifestyle Intervention
- Keywords
- Lifestyle, Stress, Sleep, Diet, Physical Activity
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Lifestyle InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops. Receives: Behavioral: Combined Lifestyle Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration
Total sleep time (min/24h)
Measured: From enrollment to the end of intervention (24 weeks)
Secondary outcomes (13)
Body weight
(kg)
Measured: From enrollment to end of intervention (24 weeks)
BMI
(kg/m2)
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: [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.
Measured: 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).
Measured: From enrollment to end of intervention (24 weeks)
Occupational physical activity
OSPAQ (min)
Measured: 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.
Measured: 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
Measured: [Time Frame: From enrollment to end of intervention (24 weeks)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 May 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Night Shift WorkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bremen, Medical University of Lodz, Erasmus Medical Center, Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.
- Responsible party
- Principal investigator, Marco Mensink, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631767
- Sponsor's protocol ID
- NL-010791
- Acronym
- SHAPE
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shift Workers' Health Behavior Action Program Across Europe
- ClinicalTrials.gov ID
- NCT07631767
- Acronym / sponsor ID
- SHAPE / NL-010791
- Keywords
- Lifestyle, Stress, Sleep, Diet, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- University of Bremen, Medical University of Lodz, Erasmus Medical Center, Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.
- Study start
- 15 May 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Combined Lifestyle InterventionIntervention group receives access to the 24-week combined lifestyle intrevention, which includes the mobile intervention app and four interactive workshops. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Lifestyle InterventionThe 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. | Behavioural | Intervention |
Primary outcome
Sleep duration
Time frame: From enrollment to the end of intervention (24 weeks)
Total sleep time (min/24h)
13 secondary outcomes
Body weight
Time frame: From enrollment to end of intervention (24 weeks)
BMI
Time frame: From enrollment to end of intervention (24 weeks)
Objective sleep quality
Time frame: From enrollment to end of intervention (24 weeks)
Overall diet quality
Time frame: From enrollment to end of intervention (24 weeks)
Physical activity level
Time frame: From enrollment to end of intervention (24 weeks)
Perceived stress
Time frame: From enrollment to end of intervention (24 weeks)
Subjective sleep quality (Insomina)
Time frame: From enrollment to end of intervention (24 weeks)
Subjective leep quality (pattern)
Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]
Chrono-nutrition patterns
Time frame: From enrollment to end of intervention (24 weeks)
Food preferences
Time frame: From enrollment to end of intervention (24 weeks)
Occupational physical activity
Time frame: From enrollment to end of intervention (24 weeks)
Work-related sense of coherence
Time frame: From enrollment to end of intervention (24 weeks)
Satisfaction With Life
Time frame: [Time Frame: From enrollment to end of intervention (24 weeks)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Lifestyle Intervention in people with Night Shift Work and Obesity & Overweight, run by Wageningen University at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration (time frame: From enrollment to the end of intervention (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.