GISMO - Geographical Information Support for Healthy Mobility (GISMO)

March 3, 2020 updated by: Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Behavioral: Active Mobility
see detailed discription
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiorespiratory Fitness, i.e. metaboloic equivalents (METs)
Time Frame: 1 year
Ergometry
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paracelsus Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Salzburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GISMO-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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