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

Obesity Clinical Trial

— Back on Track  

Official title:

Early Intervention in Patients With Predicted Poor Long-term Outcome Following Laparoscopic Roux-en-Y Gastric Bypass: a Prospective Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329692
• Other study ID #: Pro00025927
• Status: Terminated
• Phase: N/A
• First received: April 4, 2011
• Last updated: February 7, 2012
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

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

Exclusion Criteria:

• Younger than Age 18 years

• Patient is disabled and unable to participate in an exercise program

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Lifestyle counseling
Weeks 1 and 2 consist primarily of a review of current dietary habits with initiation of a food journal; a basic review of macronutrients and metabolism; and the beginning of a weekly exercise regimen. Weeks 3, 4, & 5 introduces counseling, with specific emphasis on emotional aspects of eating and behavioral modification strategies. Week 6 focuses on the metabolic impact of exercise, and includes an exercise session with a personal trainer. Week 7 incorporates a question and answer session with a sharing of discoveries, as well as an option for additional individual follow-up as needed. During this period, patients will also be given access to an interactive web-based tool providing additional emphasis on the aforementioned components and clinician follow-up.

Locations

Country	Name	City	State
United States	Durham Regional Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First quartile excess weight loss(0-11% EWL)at one month predicted first quartile EWL at 12-month and 36-month follow-up.	Weeks 1 and 2 consist primarily of a review of current dietary habits. Weeks 3, 4, & 5 introduces counseling, with specific emphasis on emotional aspects of eating and behavioral modification strategies. Week 6 focuses on the metabolic impact of exercise, and includes an exercise session with a personal trainer. Week 7 incorporates a question and answer session with a sharing of discoveries, as well as an option for additional individual follow-up as needed.	1-7 week intervention, 3,6, and 12 months follow-up	No