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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT02835495
Eligibility Criteria:
Inclusion Criteria:
* BMI 25-40 kg/m2
* Evidence of Pre-Diabetes: all participants will be required to qualify based on evidence of prediabetes from fasting plasma glucose, oral glucose tolerance test, or hemoglobin A1c (HbA1c) taken in the three months.
* The appropriate ranges for each test are
* Hemoglobin A1c (HbAlc): 5.7 to 6.4%
* Fasting Plasma Glucose: 95-125 mg/dL
* Oral Glucose Tolerance Test: 140-200 mg/dL.
* Blood measures will be collected from the medical record
* Prospective participants must be willing to accept randomization to either the lifestyle intervention or the enhanced usual care condition.
Exclusion Criteria:
* Currently involved in a supervised program for weight loss
* Clinical history of diabetes
* Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure
* Uncontrolled high blood pressure (BP \> 160/100) Potential participants can be re-screened after controlled
* Pregnancy, planning pregnancy and breast feeding (self-report) during screening; Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
* Chronic use of medicine known to significantly affect glucose metabolism (e.g., corticosteroids, protease inhibitors)
* Other conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP Vets, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with HELP Vets.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02835495
Study Brief:
Protocol Section:
NCT02835495