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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT02671292
Eligibility Criteria:
Adolescent Inclusion Criteria:
1. Age between 12 and 17 years (at the start of the study)
2. BMI at or above the 85th percentile for age and sex
3. English-speaking
4. Ability to complete study procedures, including the ability to participate in a group
5. \> 1 episode of LOC eating during the 3 months prior to assessment
6. Must have a parent(s) enrolled in TRICARE at the time of study initiation
Parent Inclusion Criteria:
1.The consenting parent or caregiver must be able to comprehend English.
Adolescent Exclusion Criteria:
1. Presence of a chronic major medical illness: renal, hepatic, gastrointestinal, endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication).
2. Presence of a documented, obesity-related medical complication that would require a more aggressive weight loss intervention approach: type 2 diabetes, hyperlipidemia, hypertension, fasting hyperglycemia, or nonalcoholic steatohepatitis.
3. Self-reported current pregnancy, current breast-feeding, or recently pregnant girls (within 1 year of delivery).
4. Current, regular use of prescription medications that affect appetite, mood, or body weight: currently prescribed SSRI's, neuroleptics, tricyclics, stimulants, or any other medication known to affect appetite, mood, or body weight. For girls, oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting the prevention groups. Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.
5. Current involvement in psychotherapy or a structured weight loss program.
6. Weight loss during the past two months for any reason exceeding 3% of body weight.
7. Current anorexia nervosa or bulimia nervosa as determined by documented medical history or if uncovered during K-SADS semi-structured interview. Current binge eating disorder (BED) will be permitted, although adolescents will be informed that they have an eating disorder and have the option to participate in the study or seek outside treatment (and not participate in the study).
8. Individuals who have major depressive disorder, psychoses, current substance or alcohol abuse, conduct disorder, as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) semi-structured interview and as defined by criteria outlined in the DSM-5, or any other DSM psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.
Parent Exclusion Criteria:
1\. None
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02671292
Study Brief:
Protocol Section:
NCT02671292