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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01138293
Other study ID # MEDIGREIF 001
Secondary ID
Status Completed
Phase Phase 1
First received June 4, 2010
Last updated June 25, 2010
Start date June 2008
Est. completion date March 2009

Study information

Verified date June 2010
Source MEDIGREIF Inselklinik Heringsdorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Aims: During the last decades overweight/obesity has increased markedly. They are associated with a high risk for diabetes and death. Effective intervention is mandatory. Following participation in treatment programmes children/adolescents often fail to reach sufficient long-term weight reduction. The present trial aims to integrate telemedical support in therapy to improve long term outcome.

Methods: All children/adolescents with overweight/obesity were included (n=66,age 13.9±2.6 years, body mass index [BMI] 31.2±5.4kg/m², body mass index standard deviation score [BMI-SDS] 2.41±0.6) admitted to our hospital 04-03/2009. To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone(DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria:

- All children/adolescents with overweight/obesity were included admitted to our hospital

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
motion detection with a motion sensor
To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone (DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.

Locations

Country Name City State
Germany MEDIGREIF Inselklinik Heringsdorf GmbH, Haus Gothensee Heringsdorf

Sponsors (2)

Lead Sponsor Collaborator
MEDIGREIF Inselklinik Heringsdorf Fraunhofer Institut für Graphische Datenverarbeitung (IGD), Rostock, Germany

Country where clinical trial is conducted

Germany, 

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