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NCT01329692 · ClinicalTrials.gov registry record · NA
Early Intervention for Morbidly Obese Patients After Roux-en-Y Gastric Bypass (RYGB) Surgery
A NA study, sponsored by Duke University.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01329692 is a NA study that was terminated before completion, run by Duke University. The registered enrollment target is 8 participants.
The verdict
NCT01329692, a NA study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Lifestyle counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01329692
The ClinicalTrials.gov registry entry for NCT01329692 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lifestyle counseling is the first listed.
NCT01329692 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01329692 about?
NCT01329692 is a clinical study titled "Early Intervention for Morbidly Obese Patients After Roux-en-Y Gastric Bypass (RYGB) Surgery". 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 ...
What is the current status of trial NCT01329692?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2010-12. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01329692?
The interventions under investigation include: Lifestyle counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01329692?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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