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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05489835
Other study ID # EK 34-147 ex 21/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 11, 2023
Est. completion date December 30, 2024

Study information

Verified date January 2023
Source Medical University of Graz
Contact Andreas Baranyi, M.D.
Phone 0043-316-385-86241
Email an.baranyi@medunigraz.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

New working environments (digitalization, flexibilization) can lead to increased levels of stress. A balanced work-life balance is therefore important in order to prevent negative effects of stress on mental health. This study investigates, 1. how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions. 2. how standardized nutritional training affects individual body composition (measured using Bioelectrical Impedance Analyses, BIA), stress perception, burn-out symptoms and sleep.


Description:

The ways of working must adapt to the challenges and opportunities of the digital world. Work 4.0 describes the process of change in the working environment in the digital age. Adapting to rapidly changing and sometimes uncertain living and working conditions in times of digitization, dislocated working (including "home office") and altered work processes demands a considerable effort of resources from numerous employees. Previously established work environments and behaviors are being evaluated and adapted to the new circumstances and requirements. Such times of change often cause uncertainty and result in increased stress levels. Stress, in turn, leads to a variety of symptoms in many areas of life and work, which can limit the ability to work. As a result, successful adaptation to the challenges of the new work reality of Work 4.0 can fail. Research Questions: This study investigates, 1. how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions and central characteristics of work 4.0. 2. how standardized nutritional training based on the Austrian Food Pyramid affects individual body composition (measured using Bioelectrical Impedance Analyses, BIA), stress perception, burn-out symptoms and sleep.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - employees in austrian companies affected by digitalization - Informed consent Exclusion Criteria: - no informed consent

Study Design


Intervention

Behavioral:
Nutritional counseling
Nutritional counseling

Locations

Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stress Stress-Erholungsfragebogen (RESTQ); minimum value: 0, maximum value: 294; High scores reflect high subjective stress. 3 months
Secondary Sleep Insomnis severity index: minimum value: 0, maximum value: 28; High scores reflect the presence of sleeping disorders 3 months
Secondary Body mass index Body mass index (BMI); BMI= body weight / (body height)² 3 months
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