Obesity Clinical Trial
Official title:
Early Intervention in Patients With Predicted Poor Long-term Outcome Following Laparoscopic Roux-en-Y Gastric Bypass: a Prospective Randomized Study
Purpose and objective: To identify in the early post-operative period following laparoscopic
Roux-en-Y gastric bypass patients likely to fail to progressively lose weight in expected
fashion, and to institute intervention and assess for its efficacy.
Study activities and population group: Patients identified to have "poor weight loss" (≤ 11%
of excess weight loss) at 1 month will be randomized into a control versus study group.
Intervention for subjects randomized to the IV arm will be by enrollment in the Back on
Track program. This is a seven-week group education, counseling, nutrition, exercise, and
journaling program of the Duke Weight Loss Surgery Center designed to help postoperative
bariatric surgery patients who are failing to progressively lose weight resume an expected
pattern of weight loss and improved overall outcome.
Data analysis and risk/safety: Data will be collected and analyzed by the identified
investigators. The goal of data analysis is to uncover any difference in the EWL of subjects
who underwent intervention for falling in the lowest EWL quartile when compared with those
who did not undergo intervention, and determine the statistical significance of any such
difference. There are no physical risks associated with this study. There is, however, the
potential risk of loss of confidentiality. Every effort will be made to keep your
information confidential.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
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