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:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT02382458
Eligibility Criteria:
Inclusion Criteria:
* Are actively engaged as patients in the medical practices of University Specialty Clinics (under the direction of Dr. Victor Hirth) or Eau Claire Cooperative Health Care System (under the direction of Dr. Stuart Hamilton) or has physician consent
* Are ≥21 years of age;
* Are willing and able to participate fully in the study for a period of one year; and
* Are able to obtain travel to and from the intervention classes at the designated time.
Exclusion Criteria:
* Serious, unstable co-morbidity that would make participation in a diet and physical activity intervention difficult or risky including renal disease retinopathy, peripheral vascular disease or neuropathy;
* Any medications that are known to influence CRP levels such as chronic steroid (e.g., prednisone) use;
* Diagnoses of congestive heart failure, chronic renal failure, chronic liver disease (including alcoholic cirrhosis), cancer within the past year (except for non-melanoma skin cancer);
* Actively receiving cancer treatment;
* Have had any major surgeries in the past 3 months;
* Poor performance status according to the World Health Organization definitions (i.e., Level 3: symptomatic, \>50% in bed, capable of only limited self-care; or Level 4: bedbound); or
* Life expectancy \<3 years, on hospice, nursing home or other institutionalized care.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02382458
Study Brief:
Protocol Section:
NCT02382458