Clinical trial NCT01735643: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
physical activity
lifestyle change
motivation
patient empowerment
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: Nintendo of Europe GmbH
First posted: 2012-11-28
Enrollment: 220
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West German Center of Diabetes and Health
Study officials:
affiliation: West German Center of Diabetes and Health
name: Stephan Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.