Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)
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
- 否
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
Participation in 3D virtual environment for DSMT/S for a period of 12 months.
干预措施: LIVE (Behavioral)
Website
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)
