Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
interactive videogame Wii Fit Plus
waiting
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, physical activity, lifestyle change, motivation, patient empowerment
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- West German Center of Diabetes and Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
interactive videogame intervention
waiting group
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
weight
Full Information
NCT ID
NCT01735643
First Posted
November 22, 2012
Last Updated
November 27, 2012
Sponsor
West German Center of Diabetes and Health
Collaborators
Novartis Pharmaceuticals, Nintendo of Europe GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01735643
Brief Title
Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients
Official Title
Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel "Wii Fit Plus" Bei Personen Mit Typ-2-Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
Novartis Pharmaceuticals, Nintendo of Europe GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Patients with type 2 diabetes were recruited via treating physicians or articles in magazines and newspapers. Participants were randomized in an intervention and a control group. The intervention group was sent the Wii, the balance board and the interactive video game Wii Fit Plus and were instructed to use these items 30 minutes each day during the next 12 weeks. The control group got the items 12 weeks later. At begin and after 12 weeks of intervention participants (and additionally for the control group: after 12 weeks of waiting phase) sent their health parameters, which had been measured in the context of the disease management program type 2 diabetes as well as questionnaires about physical activity and quality of life to the study center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
type 2 diabetes mellitus, physical activity, lifestyle change, motivation, patient empowerment
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interactive videogame intervention
Arm Type
Experimental
Arm Title
waiting group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
interactive videogame Wii Fit Plus
Other Intervention Name(s)
Wii Fit Plus
Intervention Description
Use of the interactive videogame Wii Fit Plus für 12 weeks.
Intervention Type
Other
Intervention Name(s)
waiting
Intervention Description
waiting for 12 weeks
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
weight
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Martin, MD
Organizational Affiliation
West German Center of Diabetes and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
West German Center of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24321337
Citation
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.
Results Reference
derived
Links:
URL
http://www.vkkd-kliniken.de
Description
Affiliation homepage
Learn more about this trial
Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients
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