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Completed

NCT Number: NCT01735643

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

West German Center of Diabetes and Health

Düsseldorf, 40591, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interactive videogame Wii Fit Plus

Device

Use of the interactive videogame Wii Fit Plus für 12 weeks.

Other names: Wii Fit Plus

waiting

Other

waiting for 12 weeks

Primary outcomes

  1. HbA1c

    Time frame: 12 weeks

Secondary outcomes

  1. weight

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

  • Nintendo of Europe GmbH
  • Novartis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2012
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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