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AzTrials

ObesityNCT00899964

IT-based Training in Obesity

A study testing Physical activity in people with Obesity and Inactivity, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Though possibly cost-saving, there is little scientific evidence for the effectiveness and reasonable modality of internet-delivered physical activity interventions in primary prevention. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Inactivity
What is being tested?
Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteGermany
Study dates
May 2009to Nov 2009
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 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Physical activity of less than once per week
  • Body-Mass-Index 28-35 kg/m2
  • Age 35-65
  • Men and women

Who cannot join

  • CHD
  • Diabetes
  • Other chronic diseases with conditions prohibiting regular physical activity
  • Drug abuse
  • BMI < 28 or > 35
  • Regular physical activity
  • Pregnancy
  • Mental illness

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Prevention and Sports Medicine

    München, Bavaria, 80809

Other trials in Germany

About this study

Official title: Influence of a Combined Personal and IT-based Physical Activity Intervention in an Obese, Sedentary Population on Daily Activity and Metabolic Risk Profile

Though possibly cost-saving, there is little scientific evidence for the effectiveness and reasonable modality of internet-delivered physical activity interventions in primary prevention. The aim of the study is to compare the influence of different personal and IT-based service levels on the activity outcome of obese, sedentary persons to evaluate the minimum level of service necessary for a maximum increase in activity and weight reduction.

Conditions
Obesity, Inactivity
Being tested
Physical activity
Medical subject headings
Obesity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activityBehavioural

    6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules

Study groups in NCT00899964
Study groupRoleWhat they receive
1Active comparatorautomated tailored feedback per E-mail
Receives: Behavioral: Physical activity
2Active comparator1 + active contact per E-mail possible
Receives: Behavioral: Physical activity
3Active comparator2 + active contact by trainer in case of exercise-related problems
Receives: Behavioral: Physical activity
4Active comparator3 + regular active contact by trainer
Receives: Behavioral: Physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported physical activity evaluated by questionnaire

    Measured: 6 months

Secondary outcomes (6)

  1. Body-Mass-Index

    Measured: 6 months

  2. Body weight

    Measured: 6 months

  3. Technology acceptance evaluated by questionnaire

    Measured: 6 months

  4. Motivation analysis

    Measured: 6 months

  5. Time spent on the internet

    Measured: 6 months

  6. Metabolic equivalents

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionSep 2009
  4. Study completionNov 2009

Resources

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
Participant
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00899964
Sponsor's protocol ID
2372/09
Status last verified
Mar 2014
First submitted
5 May 2009
Last updated
7 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • Bretschneider, U.; Ebner, W.; Leimeister, J. M.; Krcmar, H. (2007): Internetbasierte Ideenwettbewerbe als Instrument der Integration von Kunden in das Innovationsmanagement von Software-Unternehmen. In: Virtuelle Organisationen und Neue Medien 2007 /Workshop GeNeMe 2007: Gemeinschaften in neuen Medien. Herausgeber / Editor: Engelien, M.; Homann, J. Erscheinungsort / Published in: Lohmar, Köln Erscheinungsjahr / Year: 2007 Verlag / Publisher: Joseph Eul Verlag

  • Dannecker, A., Konana, P., Leimeister, J. M.; Rajagopalan, B. (2007): Towards a Research Agenda for Virtual Communities. In: Proceedings of the Americas Conference on Information Systems (AMCIS 2007), Keystone

  • Esch, S.; Knebel, U.; Leimeister, J. M.; Krcmar, H.: Referenzmodell für einen IT-gestützten mobilen Gesundheitscoach. In: Mobiles Computing in der Medizin, Proceedings zum 7. Workshop der GMDS-Arbeitsgruppe Mobiles Computing in der Medizin. Herausgeber: Leimeister, J.M.; Mauro, C.; Krcmar, H.; Eymann, T.; Koop, A., Shaker Verlag, Aachen, 2007

  • Hörmann, C.; Klapdor, S.; Leimeister, J. M.; Krcmar, H. (2007): IT-Management in deutschen Kranken-häusern - eine empirische Untersuchung unter IT-Entscheidern. Arbeitspapier Nr. 27, Lehrstuhl für Wirtschaftsinformatik, Technische Universität München, März 2007

  • Hoffmann, H.; Leimeister, J. M.; Krcmar, H. (2007): A Framework for Developing Personalizeable Mobile Services in Automobiles. In: XVth European Conference on Information Systems (ECIS 2007). Hrsg.: Österle, H.; Schelp, J.; Winter, R. University of St. Gallen, St. Gallen 2007, S. 938-949

  • Hoffmann, H.; Leimeister, J. M.; Krcmar, H. (2007): Automotive Service Engineering - Systematische Entwicklung personalisierbarer und interaktiver mobiler Dienste für den Automobilsektor In: Proceedings of Wirtschaftsinformatik 2007 (Vol. 1), Universitätsverlag Karlsruhe, Karlsruhe 2007, S. 327-344

  • Hoffmann, H., Leimeister, J. M., Krcmar, H. (2007): Pilotierung mobiler Dienste im Automobilsektor. In: Mobile Dienste im Auto der Zukunft. Hrsg. / Editors: Reichwald, R., Krcmar, H., Reindl, S. Publisher / Verlag: Eul-Verlag, Erscheinungsort / Published in: Lohmar, Erscheinungsjahr / Year: 2007, Seiten / Pages: 125-203

  • Knebel, U.; Leimeister, J. M.; Krcmar, H. (2007): Personal Mobile Sports Companion: Design and Evaluation of IT-supported Product-Service-Bundles in the Sports Industry. In: XVth European Conference on Information Systems (ECIS 2007). Hrsg.: Österle, H.; Schelp, J.; Winter, R. University of St. Gallen, St. Gallen 2007, S. 81-92

  • Leimeister, J. M.; Knebel, U.; Krcmar, H. (2007): Exploring Mobile Information Systems for Chronically Ill Adolescent Patients. In: International Journal of Web-based Communities (IJWBC), Ausgabe / Number: 4, Vol. 3, Verlag / Publisher: Inderscience, Erscheinungsjahr / Year: 2007

  • Mauro, Ch.; Schweiger, A.; Sunyaev, A.; Leimeister, J. M., A., Krcmar, H. (2007): Single Sign-On Clinic Card-Lösung - Ein Konzept zur zentralen Verwaltung von Gesundheitskarten im stationären Umfeld. In: Proceedings of Informatik 2007, Bremen, GI - Gesellschaft für Informatik, S. 463-468

  • Schweiger, A.; Leimeister, J. M.; Krcmar, H. (2007): Auf dem Weg zur integrierten Versorgungim Gesundheitswesen am Beispiel Krankenhaus: Parallelen aus Sicht der Wirtschaftsinformatik. In: Wissens-management im Krankenhaus. Hrsg. / Editor: Bohnet-Joschko, S. Publisher / Verlag: DUV - Gabler Edition Wissenschaft., Erscheinungsort / Published in: Wiesbaden, Erscheinungsjahr / Year: 2007, Seiten / Pages: 97-110

  • Schweiger, A.; Sunyaev, A.; Leimeister, J. M.; Krcmar, H. (2007): Toward Seamless Healthcare with Software Agents. In: Communications of the Association for Information Systems (CAIS), Vol. 19, Verlag / Publisher: Association for Information Systems, Erscheinungsjahr / Year: 2007. Seiten / Pages 692-709

  • Sunyaev, A.; Leimeister, J. M.; Schweiger, A.; Krcmar, H. (2007): Die elektronische Gesundheitskarte und die Sicherheit: Ein Vorschlag zur entwicklungsbegleitenden Sicherheitsevaluation aus Anwendersicht. In: Proceedings of Informatik 2007, Bremen, GI - Gesellschaft für Informatik, S. 469-474

  • Veith, V.; Leimeister, J. M.; Krcmar, H. (2007): Towards Value-based Management of Flexible IT Envi-ronments. In: XVth European Conference on Information Systems (ECIS 2007). Hrsg.: Österle, H.; Schelp, J.; Winter, R. University of St. Gallen, St. Gallen 2007, S. 1190-1201

  • Köbler, F.; Leimeister, J.M.; Lugmayr, A. (2006): Framework for Systematic and Strategic Planning of Innovation-based Mobile Broadband Services. Paper presented at the 14th Euromicro International Conference on Parallel, Distributed, and Network-Based Processing (PDP'06), Montbéliard, France

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity in people with Obesity and Inactivity, run by Technical University of Munich at 1 site in Germany.

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 4 inclusion and 8 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 7 Mar 2014. 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 Germany. 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?

Self-reported physical activity evaluated by questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00899964, which also lists 21 linked publications.

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 7 Mar 2014.

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