Table 1.
Inclusion Criteria | Exclusion Criteria |
---|---|
– 14–18 yrs old at time of enrollment | – History of prior bariatric surgery or intent to have additional bariatric surgery in the next year |
– BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 and at least 1 comorbidity | – History of GI tract anomalies, severe cardiopulmonary disease, coagulopathy, hepatic insufficiency or cirrhosis |
– Obesity for at least 5 yrs with documented attempts at diet and medical management | – History of gastric or esophageal surgery |
– Bone age at least 13.5 (F) and 14.5 (M) | – History of chronic aspirin and/or NSAID use |
– Emotional maturity | – Pregnancy or intent to become pregnant in the next year |
– Use of appropriate contraception (F) | – Eating disorders with self-induced vomiting |
– Understanding and willingness to comply with protocol | – Inability to understand the intervention and followup |
(F): female; (M): male; NSAID: non-steroidal anti-inflammatory drug.