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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01980758
Eligibility Criteria:
Inclusion Criteria:
* Age 14 - 19.
* At physical maturity.
* BMI of greater than or equal to 35 kg/m2 with major comorbidities, or BMI of greater than 40 kg/m2 with other weight related comorbidities.
* Must have undergone comprehensive pre-surgical assessments by a multi-disciplinary team.
* Must have at least 6 months of medically observed and attempted non-surgical weight loss.
* Must have demonstrated suboptimal weight loss following participation in a lifestyle intervention.
* Must have parents involved in all phases of recruitment and intervention.
Exclusion Criteria:
* Underlying genetic or endocrine disorder, which would preclude weight loss through behavioral and surgical techniques.
* Less than six months of participation in a medically-supervised weight management efforts.
* Active untreated, unstable psychopathology (to include active psychosis, severe depression, or significant eating pathology), as determined by psychological evaluation.
* Active suicidal ideation, as determined by psychological evaluation.
* Inadequate social support, as determined by psychological evaluation.
* Inability to provide informed consent/assent, as evidenced by clinical interview and cognitive assessments.
* Severe mental retardation, as evidenced by clinical interview and cognitive assessments.
* Demonstrated pattern of poor adherence to medical regimen and lifestyle modification.
* Active substance abuse, including tobacco use, as demonstrated by clinical interview and psychological evaluation. Inadequate knowledge of risks and patient responsibilities, as determined by clinical interview and knowledge quiz.
* Reported pregnancy within the past year, current pregnancy, or planning to become pregnant in the next three years.
* History or clinical symptoms of severe gastrointestinal reflux disease (GERD)
* Person is not deemed for medical reasons to be a surgical candidate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
19 Years
Study:
NCT01980758
Study Brief:
Protocol Section:
NCT01980758