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

Early Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: waiting; Device: interactive videogame Wii Fit Plus

• Registration Number: NCT01735643
• Lead Sponsor: West German Center of Diabetes and Health

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-11
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Study First Posted: 2012-11-28
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
waiting group	waiting	-
interactive videogame intervention	interactive videogame Wii Fit Plus	-

Primary Outcome Measures

Name	Time	Method
HbA1c	12 weeks

Secondary Outcome Measures

Name	Time	Method
weight	12 weeks

Trial Locations

Locations (1)

West German Center of Diabetes and Health; 🇩🇪 Düsseldorf, Germany