Early Intervention for Morbidly Obese Patients After Roux-en-Y Gastric Bypass (RYGB) Surgery

Stopped early · Not applicable

Conditions studied: Weight Loss, Obesity

In brief

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.

Key facts

Study ID

NCT01329692

Run by

Duke University

People needed

8

Starts

2010-12-01

Expected to finish

2011-10-01

Last updated by the study team

2012-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older
• Patient is scheduled and consented for laparoscopic Roux-en-Y gastric bypass as part of their routine medical care

You may not qualify if…

• Younger than Age 18 years
• Patient is disabled and unable to participate in an exercise program

Where it is running

• Durham Regional Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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