- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098719
GISMO - Geographical Information Support for Healthy Mobility (GISMO)
Study Overview
Detailed Description
The World Health Organization recommends a minimum of 150 minutes per week of moderate activity as a minimum for a healthy daily routine. The average employee in Austria works on 5 days a week and covers the distance from his place of residence to his place of work twice. This distance can be actively traveled (e.g., bicycle) or passively (e.g., car).
Due to a moderate physical activity (intensity 4-6 METs, corresponding to 4-6 times resting energy conversion) of 15 minutes in one direction, only the active minimum requirement for everyday activity would be achieved by active mobility to and from the workplace.
Design:
2: 1 randomized controlled trial (intervention group: control group)
Activities:
Motivation of the employees by health care professionals of a sample company (Salzburger Landeskrankenanstalten AG, SALK) to use the public transport as well as the bicycle or footpath on the way from and to the workplace.
Intervention A: Change from car to bicycle for at least 50% of the routes, n = 20-25 Employees who have previously traveled exclusively by car and are living within a radius of ≤10 kilometers from the workplace are motivated by the GVPs to switch to a bicycle. In the case of appropriate proximity, employees can travel the entire path without motorized mobility. The greatest health benefit is to be expected by largely dispensing with motorized mobility at work. In the case of bad weather, cold or similar obstacles, a public transport or car can be used occasionally and exceptionally.
Intervention B: Exit from public transport one or more stations earlier or enter one or more station later, n = 20-25 By extending the path to and from a stop, which is to be actively pursued, a health effect is expected. In the context of this intervention, the availability of time tickets will provide incentives for switching from car to public transport. In addition, the employees are motivated to use the next stop in order to extend the active distance. Access routes can also be covered on foot.
Control group: Maintaining the mobility as before n = 20-25
Method:
Before and after the intervention phase of 1 year (to take into account seasonal effects or fluctuations), parameters relevant to health are collected. Finally, the results of the initial examination are compared with those of the final examination in order to examine the effects of healthy mobility on the workplace on cardiovascular risk profile, everyday activity, physical performance, quality of life, mobility behavior, body composition.
The aim of this project is to generate data on the health effects of a healthy mobility.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Salzburg, Austria, 5020
- Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- employees of SALK (possibly also employees of other companies), age 18-70 voluntary participation in the study, consent in German language, desire to change the currently prevailing passive mobility behavior.
Exclusion Criteria:
physical or psychological condition that makes the participation and completion of the study unlikely. i.e.:
- Participation in further clinical trials at the same time, or at least four weeks time
- Pregnancy or lactation
- Well-known diseases of the movement apparatus, which could influence healthy mobility
- Subjects with known endogenous or reactive depression or other psychiatric disorders such as panic disorder, schizophrenia, organic mental disorder, delirious, psychotic, phobic, or other psychiatric disorder in the last five years prior to study inclusion
- Subjects with osteoporosis requiring treatment
- Severe general disease (e.g., neoplasia, tuberculosis, heart failure)
- Subjects with chronic infections
- subjects with alcohol or drug abuse or dependency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
see detailed discription
|
|
No Intervention: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiorespiratory Fitness, i.e. metaboloic equivalents (METs)
Time Frame: 1 year
|
Ergometry
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular Risk
Time Frame: 1 year
|
Heart Score of the European Society of Cardiology
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GISMO-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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