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临床试验/NCT01735643
NCT01735643已完成早期 1 期

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 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
220
试验地点
2
主要终点
HbA1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

HbA1c

时间窗: 12 weeks

次要结局

  • weight(12 weeks)

研究者

发起方
West German Center of Diabetes and Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan Martin

MD

West German Center of Diabetes and Health

研究点 (2)

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