试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
This is a randomized, controlled comparison study that will evaluate the effectiveness of WellStart, a virtual intensive therapeutic lifestyle change program to control type 2 diabetes.
详细描述
Purpose: To test the efficacy of WellStart Health program to to arrest and / or reverse type 2 diabetes.
Future comparative studies between programs programs are anticipated, utilizing this data to help identify the strengths and weaknesses of different programs, as well as identify subpopulations that might benefit from one program as opposed to another.
Data from this study will be shared via posters and papers among the lifestyle medicine community / publications to help contribute to better lifestyle interventions.
Pilot programs reported on the WellStart web page report reduction in hemoglobin A1c (HBA1c) and weight during the 12 week program.
The web site states:
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of type 2 diabetes (T2DM)
- •Between the ages of 18 and 65 years-old
- •Own and willing to use a smart phone or computer, and have daily internet access
- •Have an email account
- •Have access to resources (finances and transportation) that allow for regular acquisition (at least once weekly) of groceries, including produce
- •Access to resources that allow for food preparation at home (refrigeration, basic kitchen appliances and supplies)
- •Willingness to attempt changes in food preparation and consumption, and physical activity.
- •Scoring at least a 7/10 in both readiness for change and confidence of success; 1= not ready / no confidence; 10 = extremely ready / extremely confident of success -
排除标准
- •Advanced renal disease (stage 4 or 5) with or without hemodialysis
- •Congestive Heart Failure
- •Taking warfarin
- •Pregnancy or plans for pregnancy
- •Current smoker of tobacco cigarettes
- •Adults who have a physical limitation to prepare their own food or incorporate movement into their lifestyle (based on questionnaire answer)
- •Brittle diabetes and/or history of hospitalization for high or low blood sugar
- •Difficult-to-control hypertension and / or on 4 or more medications for high blood pressure.
- •Does not speak or understand English
- •Inability to use email or the Internet
结局指标
主要结局
Hemoglobin A1c
时间窗: 6 months
glycosylated hemoglobin, measure of diabetes control over last 3 months
Weight
时间窗: 6 months
risk factor for diabetes
次要结局
- Diastolic Blood Pressure(6 months)
- Total cholesterol(6 months)
- Systolic Blood Pressure(6 months)
- Short Form Health Survey - 36 Questions (SF-36)(6 months)
- Low density lipoprotein cholesterol (calculated)(6 months)
- High density lipoprotein cholesterol(6 months)
- Triglycerides(6 months)
- Days per week of exercise(6 months)
- Minutes per day of exercise(6 months)