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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT00902694
Eligibility Criteria:
Age 18 and older;
* Overweight, defined by Body Mass Index at least 25.0 kg/m2;
* Able and willing to give informed consent and participate in the intervention;
* On the same psychiatric medications within the 30 days before baseline weight (dose changes allowed;)
* Able to attend at least 2 intervention sessions per week during initial 6-month phase;
Exclusion criteria
* Contraindication to weight loss
* Receiving active cancer treatment (radiation/chemotherapy)
* Liver failure
* History of anorexia nervosa;
* Cardiovascular event (unstable angina, myocardial infarction) within previous 6 months;
* Prior or planned bariatric surgery;
Use of prescription weight loss medication or over-the-counter orlistat within 3 months
if participant does not agree to stop taking it;
* Twenty pound or greater weight loss in 3 months prior to baseline, as documented by staff measurement;
* Inability to walk to participate in exercise class;
* Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician;
* Alcohol or substance use disorder either: 1) active and determined to be incompatible with participation in the intervention through discussion with program staff; or 2) new abstinence from alcohol or substance use disorder in past 30 days;
* Planning to leave rehabilitation center within 6 months or move out of geographic area within 18 months;
* Investigator judgment (e.g., for concerns over safety, adherence or follow-up);
* Weight greater than 400 pounds.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00902694
Study Brief:
Protocol Section:
NCT00902694