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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT03678766
Eligibility Criteria:
Inclusion Criteria:
1. All participants will be Veterans between the ages of 18-65 meeting criteria for overweight, with a 45≥ BMI ≥25.
2. Participants will meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for BED or subclinical BED
3. Participants will be willing and able to participate in assessment visits and treatment sessions at University of California, San Diego (UCSD).
4. Participants will be able to provide data in English through interviews and questionnaires and understand treatment materials in English.
5. Participants will be willing to maintain contact with the investigators for 11 months.
6. Participants will be free of serious or unstable medical (current symptoms of angina, stroke, heart disease or other serious medical condition that would make physical activity unsafe or impossible at a moderate level) or psychiatric illness (i.e., active suicidal ideation, history of suicide attempt within 1 year, current unmanaged psychosis, manic episode, anorexia nervosa, bulimia nervosa, or substance abuse within the past year) or psychosocial instability (e.g., homelessness) that could compromise study participation.
7. Participants will be free from conditions in which exercise or weight loss will be detrimental to the participant's health (e.g., pregnancy); pharmacotherapy for obesity or binge eating disorder (e.g., Orlistat or Meridia) or bariatric surgery within the past 6 months or planning to start such treatments in the next 11 months.
8. Participants will not be moving out of the San Diego area for the duration of their study enrollment (11 months).
9. Participants will not be pregnant, planning to get pregnant in the 11-month study period or lactating.
10. Participants will not be participating in group or individual psychotherapy for binge eating or weight management.
11. Participants with medical or psychological problems or taking medications that could make adherence with the study protocol difficult or dangerous will not be included.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03678766
Study Brief:
Protocol Section:
NCT03678766