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临床试验/NCT02040038
NCT02040038已完成不适用

Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)

Duke University2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
212
试验地点
2
主要终点
Change in Physical Activity

研究概览

简要总结

The purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based DSMT/S.

研究设计

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

入排标准

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

入选标准

  • Live in close proximity to Duke University Medical Center (DUMC) or NYU Endocrinology Clinic, or Faculty Practice and Bellevue Medical Center to facilitate follow-up research appointments
  • Diagnosis of Type 2 Diabetes (T2D)
  • >= 21 years old
  • able to read and understand English
  • access to a computer with broad band internet connection in a private location
  • reachable by telephone
  • no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (e.g.
  • Are able to travel to a clinical lab for blood work

排除标准

  • 未提供

研究组 & 干预措施

LIVE Arm

Experimental

Participation in 3D virtual environment for DSMT/S for a period of 12 months.

干预措施: LIVE (Behavioral)

Website

Active Comparator

Participation in 2D website for DSMT/S for a period of 12 months.

干预措施: Website (Behavioral)

结局指标

主要结局

Change in Physical Activity

时间窗: 18 months

Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months.

Change in Dietary Intake

时间窗: 18 months

Dietary (fat intake, fruit and vegetable intake) will be assessed at start of the study and at 3, 6, 12 and 18 months

次要结局

  • Change in HbA1C level(18 months)
  • Change in Waist Circumference(18 months)
  • Change in BMI(18 months)
  • Change in Blood Pressure(18 months)
  • Change in Lipid Levels(18 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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