Status:
ACTIVE_NOT_RECRUITING
Mastering Diabetes Study
Lead Sponsor:
Ohio University
Collaborating Sponsors:
Memorial Health System
Conditions:
Diabetes Mellitus, Type 2
PreDiabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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, foc...
Detailed Description
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 well...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04454957
Start Date
August 24 2020
End Date
June 30 2025
Last Update
November 22 2024
Active Locations (1)
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1
Ohio University
Athens, Ohio, United States, 45701