Psychological StressNCT05489835
Work-Health-Life-Balance - Mental Resilience, Stability & Healthy Nutrition
An observational study of Psychological Stress and Nutritional Quality, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychological Stress, Nutritional Quality, Burn-out Syndrome
- What is being tested?
- Nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 11 Jan 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: employees in austrian companies affected by digitalization
Who may be able to join
- employees in austrian companies affected by digitalization
- Informed consent
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Melanie Schweinzer contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8036
Andreas Baranyi, Prof. MD, +4331638586241, an.baranyi@medunigraz.at
About this study
Official title: Work-Health-Life-Balance 4.0 - Mental Resilience, Stability & Healthy Nutrition in a New Work Reality
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,
- how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions.
- how standardized nutritional training affects individual body composition (measured using Bioelectrical Impedance Analyses, BIA), stress perception, burn-out symptoms and sleep.
Read the detailed 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,
- how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions and central characteristics of work 4.0.
- 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.
- Being tested
- Nutritional counseling
- Medical subject headings
- Stress, Psychological, Burnout, Psychological, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional counselingBehavioural
Nutritional counseling
| Study group | Role | What they receive |
|---|---|---|
| Employees | Employees in Austrian companies affected by digitalization Receives: Behavioral: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Stress-Erholungsfragebogen (RESTQ); minimum value: 0, maximum value: 294; High scores reflect high subjective stress.
Measured: 3 months
Secondary outcomes (2)
Sleep
Insomnis severity index: minimum value: 0, maximum value: 28; High scores reflect the presence of sleeping disorders
Measured: 3 months
Body mass index
Body mass index (BMI); BMI= body weight / (body height)²
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start11 Jan 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Baranyi, Medical University of Graz
- Investigators
- Andreas Baranyi, M.D., Principal investigator, Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489835
- Sponsor's protocol ID
- EK 34-147 ex 21/22
- Status last verified
- Jan 2023
- First submitted
- 29 Jun 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-Health-Life-Balance 4.0 - Mental Resilience, Stability & Healthy Nutrition in a New Work Reality
- ClinicalTrials.gov ID
- NCT05489835
- Acronym / sponsor ID
- EK 34-147 ex 21/22
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 11 Jan 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Aug 2022 (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.
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,
- how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions.
- how standardized nutritional training affects individual body composition (measured using Bioelectrical Impedance Analyses, BIA), stress perception, burn-out symptoms and sleep.
Detailed 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,
- how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions and central characteristics of work 4.0.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Employees | – | Behavioral: Nutritional counselingEmployees in Austrian companies affected by digitalization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- employees in austrian companies affected by digitalization
Key inclusion criteria (2 listed)
- employees in austrian companies affected by digitalization
- Informed consent
Key exclusion criteria (1 listed)
- no informed consent
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 |
|---|---|---|
| Nutritional counselingNutritional counseling | Behavioural | Employees |
Primary outcome
Stress
Time frame: 3 months
Stress-Erholungsfragebogen (RESTQ); minimum value: 0, maximum value: 294; High scores reflect high subjective stress.
2 secondary outcomes
Sleep
Time frame: 3 months
Body mass index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Psychological Stress
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
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. This study is not recruiting at the moment.
Melanie Schweinzer contact
Andreas Baranyi, M.D. principal investigator
Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress and Nutritional Quality, run by Medical University of Graz at 1 site in Austria.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Baranyi, M.D. (0043-316-385-86241, an.baranyi@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: 3 months). 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 11 Jan 2023.