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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT00288132
Eligibility Criteria:
Inclusion Criteria:
* All participants must have a confirmed physician diagnosis of type 2 diabetes supported by American Diabetes Association diagnostic criteria for blood glucose levels or
* Current use of oral hypoglycemic agents or insulin as confirmed by brief medical record review.
* All adults (\> 21 years of age) who have a A1c value \> 7.0 will be eligible.
Exclusion Criteria:
* Exclusion criteria applies to individuals with limitations that could limit safe participation in the study,
* such as metastatic cancer,
* multiple or recent (within six months) myocardial infarction (MI) or stroke,
* dialysis for end stage renal disease,
* severe psychiatric disease or dementia, or
* inability to walk without an assistive device.
* We will also exclude women who are pregnant at the time of study recruitment (based on self report only) because of the unique needs related to diabetes self-management during pregnancy.
* We will, however, retain women in the study should they become pregnant during the course of the project.
* Individuals will be excluded if they plan to move out of the area.
* Additional exclusions may include inability to complete baseline tasks to the satisfaction of the lead interventionist or other more subjective assessment suggesting inability or unwillingness to adhere reasonably to the intervention based on interventionist review.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00288132
Study Brief:
Protocol Section:
NCT00288132