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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT07219667
Eligibility Criteria:
Inclusion Criteria:
Aim 1 (Qualitative Component):
* South Asian ethnicity based on self-report information
* 18 years of age or older
* Residing in NYC
* Willingness and capacity to provide consent
Aim 3: Pilot Intervention:
* South Asian ethnicity based on patient demographic information
* 18 to 75 years of age
* Appointment for routine non-emergent primary care in the past 12 months
* Diagnosis of Type 2 diabetes
* Patient Health Questionnaire-9 (PHQ-9) score of ≥5 (mild to severe depression)
* Residing in NYC
* Willingness and capacity to provide consent
Exclusion Criteria:
Aim 1 (Qualitative Component):
• Diagnosed cognitive deficits or limited decision-making capacity
Aim 3: Pilot Intervention:
* Pregnant at the time of screening
* Type 1 diabetes or diabetes secondary to other conditions (e.g., steroid-induced, pancreatic insufficiency)
* Malignancy or life-threatening illness with a life expectancy of \<5 years
* Inability to perform unsupervised physical activity
* Diagnosed cognitive deficits or limited decision-making capacity
* Currently taking anti-depressant medication or receiving counseling services.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07219667
Study Brief:
Protocol Section:
NCT07219667