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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel "Wii Fit Plus" Bei Personen Mit Typ-2-Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735643
• Other study ID #: Wii study
• Status: Completed
• Phase: Phase 0
• First received: November 22, 2012
• Last updated: November 27, 2012
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• interactive videogame Wii Fit Plus
Use of the interactive videogame Wii Fit Plus für 12 weeks.

Other:
• waiting
waiting for 12 weeks

Locations

Country	Name	City	State
Germany	West German Center of Diabetes and Health	Düsseldorf

Sponsors (3)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	Nintendo of Europe GmbH, Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		12 weeks	No
Secondary	weight		12 weeks	No

External Links

•   Affiliation homepage