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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Device: interactive videogame Wii Fit Plus; Other: waiting	Early Phase 1

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel "Wii Fit Plus" Bei Personen Mit Typ-2-Diabetes Mellitus
Study Start Date :	January 2011
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	September 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: interactive videogame intervention	Device: interactive videogame Wii Fit Plus; Use of the interactive videogame Wii Fit Plus für 12 weeks.; Other Name: Wii Fit Plus
Experimental: waiting group	Other: waiting; waiting for 12 weeks

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. HbA1c [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. weight [ Time Frame: 12 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
West German Center of Diabetes and Health
Düsseldorf, Germany, 40591

Sponsors and Collaborators

West German Center of Diabetes and Health

Novartis Pharmaceuticals

Nintendo of Europe GmbH

Investigators

Principal Investigator:	Stephan Martin, MD	West German Center of Diabetes and Health

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Affiliation homepage 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Stephan Martin, MD, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier:	NCT01735643 History of Changes
Other Study ID Numbers:	Wii study
First Posted:	November 28, 2012
Last Update Posted:	November 28, 2012
Last Verified:	November 2012

Keywords provided by Stephan Martin, West German Center of Diabetes and Health:

type 2 diabetes mellitus; physical activity; lifestyle change; motivation; patient empowerment

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases