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SHAPE

SHAPE: Shift workers’ health behavior action program across Europe - SHAPE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58433
Enrollment
200
Registered
2025-09-23
Start date
2026-06-10
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic health, obesity, shift work Obesity and night shift work

Interventions

We aim to recruit&nbsp
100 night shift workers per center (n=200 in the Netherlands, 100 via ErasmusMC, 100 via WUR), aged 21 years or older and working for more than 24 hours per week in either the health care or non-healt
Participants in the intervention group will all follow the 24-week CLIP, designed to improve&nbsp
health behaviors in the four targeted domains. Every 6 weeks participants will focus on two components, where they receive lifestyle advice and behavioral change techniques throughout a mobile app and

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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, or at least one night shift per month followed by another shift In possession of a smartphone and willing to download the study application 

Exclusion criteria

Exclusion criteria: Body Mass Index (BMI) < 18.5 or > 40 kg/m2 Pregnant or lactating Chronic diseases if in ongoing therapy but not after a remission (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 benzodiazepine, first-generation antihistamine, melatonin receptors agonists or similar) Other medication or combinations significantly affecting sleeping patterns Recent or ongoing psychotherapy for sleep disorders Current or recent use of medications affecting with appetite or weight regulation, including: Appetite-enhancing/weight-gain medications (e.g., atypical antipsychotics, corticosteroids 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 medication 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  

Design outcomes

Primary

MeasureTime frame
The primary objective of this randomized controlled trial is to determine the effect of the CLIP on objectively measured sleep duration among night shift workers, compared to the control condition. The primary study parameter is objectively measured sleep duration (TST), expressed as minutes of total sleep time per 24-hour period at the end of the intervention (T2), assessed using actigraphy (MotionWatch 8). 

Secondary

MeasureTime frame
The secondary objective is to explore whether the CLIP improves lifestyle behaviors in shift workers across the four targeted domains. These include: Sleep-related behavior Dietary behaviorPhysical activity Perceived stress To explore the behavioral, lifestyle, and dietary mechanisms underlying the health risks of shift work, physiological outcomes and related biomarkers (e.g. BMI, glucose, and lipid values) are included as tertiary outcomes.

Countries

Netherlands

Contacts

Public ContactM. Schuring

Erasmus MC, Universitair Medisch Centrum Rotterdam

m.schuring@erasmusmc.nl+31 107038460

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026