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Completed
NCT04454957
Mastering Diabetes Study
Conditions: Diabetes Mellitus, Type 2, PreDiabetes
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 89
Sponsor: Ohio University
Location: Ohio University Athens Ohio
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT04454957). StuddyBuddy aggregates publicly available trial information.