The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Glycated hemoglobin
研究概览
简要总结
This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Data will also be analyzed to see if participation in the program results in reductions glycated hemoglobin levels, body weight, and cholesterol levels.
详细描述
This study aims to assess the feasibility and implementation of an online, plant-based, diabetes reversal program in a community setting. The study will also assess changes in glycated hemoglobin, body weight, and plasma lipids with an online 12-week, plant-based, nutrition education program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere, in addition to their value for the individual research participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •U.S. Men and women meeting the age of majority, defined as follows: Age 19 or older in Nebraska and Alabama; Age 21 or older in Mississippi; Age 18 or older in all other states
- •Prior diagnosis of type 2 diabetes mellitus
排除标准
- •Use of recreational drugs in the past 6 months
- •Pregnancy or intention to become pregnant during the study period, as verified by self-report
- •Unstable medical or psychiatric illness
- •Lack of English fluency
- •Inability to maintain current medication regimen
- •Inability or unwillingness to participate in all components of the study
结局指标
主要结局
Glycated hemoglobin
时间窗: 12 weeks
A1c will be measured before and after the study period
次要结局
- body weight(12 weeks)
- total cholesterol(12 weeks)
- LDL cholesterol(12 weeks)
- medication usage(12 weeks)
研究者
Vanita Rahman
Clinic Director
Physicians Committee for Responsible Medicine