Health BehaviorGISMONCT03098719
GISMO - Geographical Information Support for Healthy Mobility
A study testing Active Mobility in people with Health Behavior, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
GISMO combines spatial information with findings on the health effects of sustainable, active forms of mobility in the work environment in order to derive evidence-based decision-making bases for a health-promoting, operational mobility management. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Active Mobility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 20 Mar 2017to 30 Oct 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Severe general disease (e.g., neoplasia, tuberculosis, heart failure)
- Subjects with chronic infections
- subjects with alcohol or drug abuse or dependency
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Salzburg, 5020
About this study
GISMO combines spatial information with findings on the health effects of sustainable, active forms of mobility in the work environment in order to derive evidence-based decision-making bases for a health-promoting, operational mobility management. Existing approaches - with regard to spatial information systems, decision-support systems and health effects of active mobility - are considered and supplemented by our developments and investigations. Achieved non-personal results are provided through standardized web interfaces, ensuring integration into existing and prospective tools of an innovative and health-promoting mobility management.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Active Mobility
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active MobilityBehavioural
see detailed discription
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Active Mobility |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness, i.e. metaboloic equivalents (METs)
Ergometry
Measured: 1 year
Secondary outcomes (1)
Cardiovascular Risk
Heart Score of the European Society of Cardiology
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start20 Mar 2017
- Primary completion30 Jun 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salzburg
- Responsible party
- Principal investigator, Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098719
- Sponsor's protocol ID
- GISMO-1
- Acronym
- GISMO
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2017
- Last updated
- 4 Mar 2020
- 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 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GISMO - Geographical Information Support for Healthy Mobility
- ClinicalTrials.gov ID
- NCT03098719
- Acronym / sponsor ID
- GISMO / GISMO-1
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- University of Salzburg
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 4 Apr 2017 (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.
GISMO combines spatial information with findings on the health effects of sustainable, active forms of mobility in the work environment in order to derive evidence-based decision-making bases for a health-promoting, operational mobility management. Existing approaches - with regard to spatial information systems, decision-support systems and health effects of active mobility - are considered and supplemented by our developments and investigations. Achieved non-personal results are provided through standardized web interfaces, ensuring integration into existing and prospective tools of an innovative and health-promoting mobility management.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Active Mobility |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- physical or psychological condition that makes the participation and completion of the study unlikely. i.e.:
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 |
|---|---|---|
| Active Mobilitysee detailed discription | Behavioural | Intervention |
Primary outcome
Cardiorespiratory Fitness, i.e. metaboloic equivalents (METs)
Time frame: 1 year
Ergometry
1 secondary outcome
Cardiovascular Risk
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Mobility in people with Health Behavior, run by Paracelsus Medical University 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 4 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness, i.e. metaboloic equivalents (METs) (time frame: 1 year). 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 4 Mar 2020.