Circadian Misalignment, Night Shift Work, Obesity & Overweight
Conditions
Keywords
Lifestyle, Stress, Sleep, Diet, Physical Activity
Brief 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. 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.
Interventions
BEHAVIORALCombined 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.
Sponsors
Wageningen University
University of Bremen
Medical University of Lodz
Erasmus Medical Center
Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Although blinding of participants and investigators is not possible due to the nature of the intervention, outcome assessments will be conducted using objective measures (e.g., actigraphy for sleep duration) and standardized procedures to reduce the risk of measurement bias.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep duration | From enrollment to the end of intervention (24 weeks) | Total sleep time (min/24h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | From enrollment to end of intervention (24 weeks) | (kg) |
| BMI | From enrollment to end of intervention (24 weeks) | (kg/m2) |
| Objective sleep quality | From enrollment to end of intervention (24 weeks) | Wake after sleep onset (min spent awake/main sleep episode), derived from actigraphy data |
| Overall diet quality | 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). |
| Physical activity level | From enrollment to end of intervention (24 weeks) | Light, moderate, vigorous activity (min), Sedentary time (min) as measured with an actigraphy (Motionwatch) |
| Perceived stress | 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. |
| Subjective sleep quality (Insomina) | 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 |
| Subjective leep quality (pattern) | [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 |
| Chrono-nutrition patterns | 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. |
| Food preferences | 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). |
| Occupational physical activity | From enrollment to end of intervention (24 weeks) | OSPAQ (min) |
| Work-related sense of coherence | 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. |
| Satisfaction With Life | [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 |
Countries
Germany, Netherlands, Poland
Outcome results
None listed