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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT00907660
Eligibility Criteria:
Inclusion Criteria:
* Patients from the University Medicine Denver, University Medicine Anschutz, and A.F. Williams clinics meeting the following criteria
* Age 18 or older
* Able to keep a food record for 3 days prior to study entry
* Able to give informed consent
* Willing to accept randomization to either treatment condition, to attend all sessions, and to complete study-related assessments
* Body mass index (BMI) ≥ 30 kg/m2 and \< 50 kg/m2
* Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
* Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
* Elevated blood pressure (≥130/85), including hypertension (≥140/90); individuals taking anti-hypertensive medication qualify automatically
* Hypertriglyceridemia (TG ≥ 150); individuals taking lipid-lowering medications qualify automatically
* Decreased high-density lipoprotein (HDL) cholesterol (\< 40 for men, \< 50 for women)
* Obstructive sleep apnea
Exclusion Criteria:
* Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
* Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
* Weight gain or loss of ≥5% of weight in the past 6 months; patients who have not been weight stable may be re-screened in 3 months
* Concurrent use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
* Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
* Prior or planned bariatric surgery
* Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00907660
Study Brief:
Protocol Section:
NCT00907660