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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT03202420
Eligibility Criteria:
Inclusion Criteria:
* Participants must be patients of the DOC.
* BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).
Exclusion Criteria:
* Mental illness that would cause disruptions to group meetings
* Cognitive impairment that would preclude participants from understanding the program
* Type 2 diabetics on insulin or sulfonylureas without provider approval
* untreated hyper- or hypothyroidism
* current cancer diagnosis
* history of cancer (other than skin cancer)
* gastrointestinal disorders affecting food intake
* use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
* women currently pregnant or lactating, planning to become pregnant, or less than 6 months post-partum
* weight loss of \> 5% in past 6 months
* major psychiatric disorder
* current moderate to severe symptoms of depression
* eating disorders
* current alcohol or substance abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03202420
Study Brief:
Protocol Section:
NCT03202420