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

This study has been terminated.
(The PI has left Duke-the primary study site and the sponsor retreat the support)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01329692
First received: April 4, 2011
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Weight Loss
Obesity
Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Early Intervention in Patients With Predicted Poor Long-term Outcome Following Laparoscopic Roux-en-Y Gastric Bypass: a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • First quartile excess weight loss(0-11% EWL)at one month predicted first quartile EWL at 12-month and 36-month follow-up. [ Time Frame: 1-7 week intervention, 3,6, and 12 months follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329692

Locations
United States, North Carolina
Durham Regional Hospital
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01329692     History of Changes
Other Study ID Numbers: Pro00025927
Study First Received: April 4, 2011
Last Updated: February 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
RYGB
Intervention
follow-up
standard-of-care
Back on Track program
poor weight loss
morbidly obese

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014