Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT04454957
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04454957
Study Brief:
Protocol Section:
NCT04454957