Shift Workers' Health Behavior Action Program Across Europe

ConditionsNight Shift Work Obesity & Overweight Circadian Misalignment

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorWageningen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Sleep duration

Total sleep time (min/24h)

Time frame

From enrollment to the end of intervention (24 weeks)

Secondary outcomes

Body weight

(kg)

Time frame

From enrollment to end of intervention (24 weeks)

BMI

(kg/m2)

Time frame

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

Time frame

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).

Time frame

From enrollment to end of intervention (24 weeks)

Other outcomes

Body composition

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

Time frame

From enrollment to end of intervention (24 weeks)

waist to hip circumference

ratio of waist and hip circumference (cm/cm)

Time frame

[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.

Time frame

From enrollment to end of intervention (24 weeks)

Stress biomarker

Hair cortisol concentraition (HCC), pg/mg hair

Time frame

From enrollment to end of intervention (24 weeks)