Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients

This study has been completed.
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Nintendo of Europe GmbH
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier:
NCT01735643
First received: November 22, 2012
Last updated: November 27, 2012
Last verified: November 2012

November 22, 2012
November 27, 2012
January 2011
September 2012   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01735643 on ClinicalTrials.gov Archive Site
weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Device: interactive videogame Wii Fit Plus
    Use of the interactive videogame Wii Fit Plus für 12 weeks.
    Other Name: Wii Fit Plus
  • Other: waiting
    waiting for 12 weeks
  • Experimental: interactive videogame intervention
    Intervention: Device: interactive videogame Wii Fit Plus
  • Experimental: waiting group
    Intervention: Other: waiting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01735643
Wii study
Yes
Stephan Martin, West German Center of Diabetes and Health
West German Center of Diabetes and Health
  • Novartis Pharmaceuticals
  • Nintendo of Europe GmbH
Principal Investigator: Stephan Martin, MD West German Center of Diabetes and Health
West German Center of Diabetes and Health
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP