Effectiveness of a Virtual Therapeutic Lifestyle Change Program for Diabetes and Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
This is a program evaluation that will evaluate the effectiveness of Mastering Diabetes, a therapeutic lifestyle change (TLC) program to control prediabetes and type 2 diabetes.
Lifestyle change, focused on dietary change, physical activity, stress management and control of unhealthy substances has been demonstrated effective in preventing the progression of prediabetes, as well as reversal of diabetes and type 2 diabetes mellitus (T2DM).
详细描述
This will be a nonrandomized controlled study. Participants will self select to be a part of this intervention. The control data will be aggregated matched data from participants in the corporate wellness program at Memorial Health System, who choose not to participate in the intervention.
Study participants will have met the inclusion criteria. Potential participants will be provided with a short summary of this program as a potential activity for their participation, with a link leading to a landing page, which will explain the study in more detail, and will include a link to the consent.
If the potential participant is interested, they can click the link to move to the on line consent. If they agree to the consent, they will be taken to an on line HIPAA release form, which will also need an electronic agreement to be enrolled into the study signified by typing in the participant's name and date of birth.
Once this is completed, an email with an enrollment code and link to Mastering Diabetes will be sent the participant.
Mastering Diabetes Program Description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years at enrollment
- •Has a diagnosis of diabetes or prediabetes or a HbA1c of 5.7 or higher.
- •Are able to participate in physical activity.
- •Are willing to use a smartphone or computer to access the online education modules and online community, and have reliable daily Internet access with a device with a webcam
- •Have an email account and an Internet connection at home
- •Are able to purchase and transport fresh produce from a local grocery store to their house on a weekly basis
- •Are able to prepare food in their house or get help preparing food in their house following recipes and meal examples provided in the online course
- •Are open-minded about eating a plant-based diet, performing periodic intermittent fasting (16-24 hours, once a week),
- •Are willing to increase movement of their body 5-6 days per week
- •Are willing to participate in an online community for support and coaching
- •Are willing to participate in biweekly videoconferencing for support and coaching
- •Are willing to be courteous and respectful to others in the online community
排除标准
- •Has been told by a medical provider to not participate in physical activity.
- •Has a medical condition that prevents walking at least a mile a day.
- •Deemed unsuitable to exercise by Dr. Drozek or other members of the wellness team.
- •Has a diagnosis of dementia.
- •Is pregnant or planning to become pregnant during the program
- •Does not speak or understand English
- •Advanced renal disease (stage 4 or 5) with or without hemodialysis
- •Congestive heart failure
- •Has inflammatory bowel disease (Crohns disease, ulcerative colitis)
- •Is fed by a feeding tube
- •Is taking Coumadin or warfarin
- •Inability to use email, a smartphone, or the Internet
结局指标
主要结局
HbA1c
时间窗: up to 20 years
glycosylated hemoglobin measured from venous blood
BMI
时间窗: up to 20 years
Body mass index calculated from height and weight
Healthcare expenditures
时间窗: up to 20 years
Monetary amount spent for healthcare
次要结局
- Total cholesterol(baseline, 12 weeks, 1 yearly, then yearly for up to 20 years)
- Dietary Recall(baseline, 12 weeks, 1 yearly, then yearly for up to 20 years)
- Low density lipoprotein cholesterol(baseline, 12 weeks, 1 yearly, then yearly for up to 20 years)
- High density lipoprotein cholesterol(baseline, 12 weeks, 1 yearly, then yearly for up to 20 years)
- Triglyceride(baseline, 12 weeks, 1 yearly, then yearly for up to 20 years)
- Exercise level(baseline, 12 weeks, 1 yearly, then yearly for up to 20 years)
- Patient Health Questionnaire(baseline, 12 weeks, 1 yearly, then yearly for up to 20 years)
研究者
David Drozek
Associate Professor
Ohio University