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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Behavioral: Lifestyle counseling

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Durham Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle counseling; This is a seven-week group education, counseling, nutrition, exercise, and journaling program of the Duke Metabolic and 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. 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.	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.
No Intervention: RYGB regular post-op care; Regular care and follow-up after RYGB surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 7, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: follow-up; Intervention; RYGB; morbidly obese; standard-of-care; Back on Track program; poor weight loss
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: Pro00025927