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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: interactive videogame Wii Fit Plus
* Other: waiting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interactive videogame intervention<br> | Device: interactive videogame Wii Fit Plus<br>* Use of the interactive videogame Wii Fit Plus für 12 weeks.<br>* Other names: Wii Fit Plus;|
| Experimental: waiting group<br> | Other: waiting<br>* waiting for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, physical activity, lifestyle change, motivation, patient empowerment