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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT03718832
Eligibility Criteria:
Inclusion Criteria:
* Type II Diabetes and an HbA1c ≥ 8.0 as determined by the most recent measurement in the Geisinger EMR within the prior 12 months
* Food insecure based on a two-question survey instrument
* Age \> 17 \& Age \<86
* Living within geographic reach of the program (Lewistown, PA and Scranton, PA)
Exclusion Criteria:
* Already enrolled in FFF in Shamokin
* Not English speaking (working on changing this as the program evolves)
* On hospice or palliative care
* Acute or chronic psychosis
* Resides in a facility which provides meals
* Active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including:
* Cancer; active treatment
* Steroid dependent asthma/ COPD/ emphysema
* Steroid dependent Colitis
* Chronic Kidney Disease with GFR\< 30 mg/mmol
* Celiac disease
* Cirrhosis
* Steroid dependent arthritis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03718832
Study Brief:
Protocol Section:
NCT03718832