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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT05227105
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 - 75 at the time of enrollment
* Either overweight/obese (Body Mass Index (BMI) ≥ 25) or diabetic (hemoglobin A1c ≥ 5.7%)
* Physically inactive (defined as \< 90 min/week of self-reported structured physical activity)
* Able to speak, read, and understand the English language
* Resides in a rural area of Pennsylvania with a Rural Urban Continuum Code (RUCC) 4 - 9 or Rural-Urban Commuting Area (RUCA) code 4 - 10
* Must be able to provide and understand informed consent
* Primary care patient of one of the participating providers
* Self-report ability to walk ¼ mile
* Access to a telephone
Exclusion Criteria:
* Cardiac exclusion criteria: Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, acute pericarditis, acute endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, or acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
* Mental impairment leading to inability to cooperate, provide informed consent, or follow study instructions
* Evidence in the electronic medical record of an absolute contraindication for physical activity
* Severe or advanced orthopedic conditions
* Use of assistive devices for ambulation
* Resides outside of a rural area of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)
* Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05227105
Study Brief:
Protocol Section:
NCT05227105