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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03572218
Eligibility Criteria:
Inclusion Criteria:
* Eligible participants will be men and women ages 18-65 years.
* Participants must have obesity (defined as a BMI ≥ 30 kg/m2); report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview; and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview.
* Participants must be seeking weight loss.
* If currently taking medications, dosages must be stable for at least 3 months.
* Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables.
* Participants taking anti-depressant medication will be eligible if their dose has been stable for a minimum of 3 months.
Eligible female patients will be:
* non-pregnant, evidenced by a negative urine dipstick pregnancy test
* non-lactating
* surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study
Participants must:
* have a PCP who is responsible for providing routine care
* have reliable telephone service with which to participate in conference calls
* understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Exclusion Criteria:
Applicants will be excluded if they have:
* a diagnosis of type I or II diabetes;
* uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg);
* experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months;
* lost ≥ 5% of their initial weight in the last 6 months;
* or have participated in individual or group psychotherapy in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). Applicants who have recently participated in or are currently receiving counseling for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; caregiver support) may be eligible per Principal Investigator's discretion.
* Applicants with severe symptoms of mood (for example, BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program. Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion.
* Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated.
* Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area.
* Applicants will not be eligible if they have a history of bariatric surgery.
* Women who are nursing, pregnant, or planning to become pregnant in the next 12 months are not eligible to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03572218
Study Brief:
Protocol Section:
NCT03572218