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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT06574035
Eligibility Criteria:
Inclusion Criteria:
* African American/Black males
* age 18 years or older
* ambulatory status
* diagnosis of Type 2 Diabetes (T2D) for one year duration or longer
* be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year
* be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)
* have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks
* live in the Wayne or Washtenaw County\\
* have reliable transportation to in-person events
Exclusion Criteria:
* stage 2 hypertension as defined by Joint National Committee (JNC) VIII
* recent cardiac events
* recent laser surgery for proliferative retinopathy
* history of stroke
* lower limb amputation
* peripheral neuropathy
* severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)
* class III or IV heart failure
* medical instability.
Per American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:
* ongoing unstable angina
* uncontrolled cardiac arrhythmia with hemodynamic compromise
* active endocarditis
* symptomatic severe aortic stenosis
* acute myocarditis or pericarditis
* acute aortic dissection
* acute pulmonary embolism
* pulmonary infarction
* deep venous thrombosis
* physical disability that precludes safe and adequate testing
* chest discomfort with exertion
* unreasonable breathlessness, or dizziness, fainting, or blackouts.
As part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included.
If you are interested in the study, please complete our screening survey: https://redcapproduction.umms.med.umich.edu/surveys/?s=JNPPEDANX7KLPPF9. Thank you so much!
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06574035
Study Brief:
Protocol Section:
NCT06574035