Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients
Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel "Wii Fit Plus" Bei Personen Mit Typ-2-Diabetes Mellitus
1 other identifier
interventional
220
1 country
1
Brief Summary
Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes mellitus is increasing. Although in early phases the disease might be successfully treated by lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication a highly motivational system with low inhibition threshold is needed. Therefore, the investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks is able to improve HbA1c and weight in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 type-2-diabetes-mellitus
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 22, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedNovember 28, 2012
November 1, 2012
1.7 years
November 22, 2012
November 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
12 weeks
Secondary Outcomes (1)
weight
12 weeks
Study Arms (2)
interactive videogame intervention
EXPERIMENTALwaiting group
EXPERIMENTALInterventions
Use of the interactive videogame Wii Fit Plus für 12 weeks.
Eligibility Criteria
You may qualify if:
- type 2 diabetes mellitus
- diabetes duration \< 5 years
- age 50-75 years
- body mass index \> or equal to 27 kg/m2
- participating in the disease management programme type 2 diabetes mellitus
- physical and mental able for study participation
You may not qualify if:
- insulin or antidiabetic medication (exception: Metformin and DPP-IV-Inhibitors)
- regular physical activity
- depression
- tumors
- change of smoking status during the past 6 months or during the study
- participation in other studies during the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- West German Center of Diabetes and Healthlead
- Novartis Pharmaceuticalscollaborator
- Nintendo of Europe GmbHcollaborator
Study Sites (1)
West German Center of Diabetes and Health
Düsseldorf, 40591, Germany
Related Publications (1)
Kempf K, Martin S. Autonomous exercise game use improves metabolic control and quality of life in type 2 diabetes patients - a randomized controlled trial. BMC Endocr Disord. 2013 Dec 10;13:57. doi: 10.1186/1472-6823-13-57.
PMID: 24321337DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Martin, MD
West German Center of Diabetes and Health
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 22, 2012
First Posted
November 28, 2012
Study Start
January 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 28, 2012
Record last verified: 2012-11