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

This study has been completed.
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Nintendo of Europe GmbH
Information provided by (Responsible Party):
Stephan Martin, West German Center of Diabetes and Health
ClinicalTrials.gov Identifier:
NCT01735643
First received: November 22, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Device: interactive videogame Wii Fit Plus
Other: waiting
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by West German Center of Diabetes and Health:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735643

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

Additional Information:
Affiliation homepage  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: November 22, 2012
Last Updated: November 27, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on May 19, 2013