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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT06440551
Eligibility Criteria:
Inclusion criteria:
1. Male of Puerto Rican descent over 35 years.
2. BMI ≥25 by anthropometrically measured weight and height.
3. Physically able to exercise (via the EASY tool \[106, 107\]; Appendix 2). If responses to the EASY indicate that medical clearance is needed, then able to receive medical clearance to participate in the study.
4. Has access to secure computer or tablet in a private location with reliable internet connection to support video streaming
5. Ability to understand and speak English. For those without a high-speed internet and private space to exercise, we will work with our community partners to identify a space with access to videoconferencing so they can attend the telehealth class.
Exclusion:
1. Does not understand/speak English.
2. Plans to move from the Illinois area during the study.
3. Currently in a formal weight management program.
4. Current or planned use of weight control or loss medication prescribed by a doctor.
5. Currently exercising \>1 time/week.
6. Unable to attend study times.
7. Serious medical problems or medications that would make protocol compliance difficult or dangerous, e.g., unable to engage in moderate \& eventually vigorous exercise, uncontrolled diabetes (A1C \> 9) or hypertension (systolic \>160 or diastolic \>100), hypoglycemia, heart attack in the past six months, unstable angina, life-threatening arrhythmias, cancer that required treatment in the last 5 years (except non-melanoma skin cancers that have been cured). Patients who have been treated for cancer in the past 5 years may require different diet and PA recommendations than individuals without treatment for cancer in the past 5 years.
8. In the EASY interview, if participant answers yes to the question that indicates they fall or always use an assisted device while walking.
9. Current alcohol abuse (\>35 alcoholic drinks/week); score of yes to \> 2 questions on the CAGE alcohol scale (Appendix 1) \[108\].
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
35 Years
Study:
NCT06440551
Study Brief:
Protocol Section:
NCT06440551