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Clinical Trials/NCT01735643
NCT01735643CompletedEarly Phase 1

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

West German Center of Diabetes and Health2 sites in 1 country220 target enrollmentStarted: January 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Sponsor
Enrollment
220
Locations
2
Primary Endpoint
HbA1c

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • change of smoking status during the past 6 months or during the study
  • participation in other studies during the past 6 months

Outcomes

Primary Outcomes

HbA1c

Time Frame: 12 weeks

Secondary Outcomes

  • weight(12 weeks)

Investigators

Sponsor
West German Center of Diabetes and Health
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephan Martin

MD

West German Center of Diabetes and Health

Study Sites (2)

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