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 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT02869659
Eligibility Criteria:
Inclusion Criteria:
* BMI=30-45.0 kg/m2 OR BMI 27-30, if waist circumference is ≥ 40in in men or ≥ 35in in women
* Sedentary for past 6 mos (\<20 min; 2 d/wk of resistance or aerobic exercise)
* Normal cognitive function:
Greater than 12 years education:
Caucasian - MOCA ≥ 24 African American/Hispanic/Other- MOCA ≥ 22
12 years or less education: Caucasian- MOCA ≥22 African American/Hispanic/Other- MOCA ≥20
* No evidence of clinical depression
* Fasting blood glucose 100-125 mg/dl OR Hemoglobin A1c 5.7% - 6.4%
* No contraindications for participation in weight loss
* Able to provide own transportation to study visits and intervention
* Approved for participation by Medical Director
* Negative pregnancy test or confirmed post-menopausal/surgically sterile status (Women Only)
* Not involved in any other research study
* Willing to provide informed consent
Exclusion Criteria:
* Weight loss (±5%) in past 6 months
* Uncontrolled arrhythmias
* Cancer requiring treatment in past year, except non-melanoma skin cancers
* Regular smoker (\>1 cigarette/day) or heavy drinker (\>9 alcoholic drinks/wk) within past year
* Insulin dependent or uncontrolled diabetes (FBG\>126 mg/dl) OR (Hemoglobin A1c 6.5% or greater)
* Uncontrolled hypertension (BP\>160/90 mmHg)
* Elevated triglyceride (TG\>400 mg/dl)
* Clinically evident liver disease, kidney disease, edema or anemia
* Past or current ischemic heart disease, uncontrolled angina, heart failure, PAD, stroke, chronic respiratory disease, endocrine or metabolic disease, neurological or hematological disease
* Regular use growth/steroid hormones, including estrogen replacement, weight loss medications, diabetes medications including insulin and/or blood thinners
* History of any type of bariatric or weight loss surgery or bilateral oophorectomy requiring long term hormone replacement therapy use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02869659
Study Brief:
Protocol Section:
NCT02869659