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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT01859403
Eligibility Criteria:
Inclusion Criteria:
1. Veterans able to receive care at the VASDHS and planning to start the MOVE! program.
2. Veterans able to understand and consent to the study.
3. BMI equal to or greater than 30 kg/m2.
Exclusion Criteria:
1. Veterans unable to receive care at the VASDHS.
2. Veterans unable to understand the consent process at the discretion of the PI.
3. Active substance abuse or substance dependence disorder
4. Cognitive disorder, psychiatric hospitalization in past 6-months, or presence of suicidal ideation identified on self-report instruments
5. Bradycardia, rapid heart rate or other arrhythmia or active ischemia by EKG.
6. Uncontrolled thyroid disease as measured by a TSH above or below the normal range.
7. Body mass index \< 30 kg/m2.
8. Chronic kidney disease stage III or higher by National Kidney Foundation criteria (GFR = 30-59 ml/min).
9. New York Heart Association's functional classification of congestive heart failure above Class I (not limited with normal physical activity by symptoms; Class II occurs when ordinary physical activity results in fatigue, dyspnea, or other symptoms).
10. Sodium or potassium outside the normal range.
11. Edema requiring the use of daily diuresis with furosemide, bumex or other diuretic (does not include hydrochlorthiazide).
12. The use of high dose oral corticosteroids (above replacement doses).
13. Veterans deficient in 25-OH vitamin D (\<20 units/dl).
14. Veterans with fasting LDL \> 190 mg/dl.
15. Veterans with fasting triglyceride levels \> 1000 mg/dl.
16. Excessive caffeine use (\>6 caffeinated beverages/days).
17. Prior gastrointestinal surgery with the exception of distal appendectomy.
18. Acute infections or current use of antibiotic therapy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01859403
Study Brief:
Protocol Section:
NCT01859403