Postoperative Dietary Counseling After Bariatric Surgery

June 25, 2010 updated by: University of Pennsylvania
This study aims to assess the changes in physical characteristics, food intake, eating behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are put into one of two conditions; they will either receive standard postoperative care or biweekly counseling sessions with a dietician that will help them with the postoperative diet. Patients who receive dietary counseling are anticipated to experience greater weight loss and report less consumption of sugar and fat as compared to patients who do not receive dietary counseling. Moreover, patients who receive dietary counseling are predicted to report less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not receive postoperative dietary counseling. This is predicted to result as a consequence of increased dietary adherence evidenced by the former group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to assess the changes in physical characteristics, food intake, eating behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are put into one of two conditions; they will either receive standard postoperative care or biweekly counseling sessions with a dietician that will help them with the postoperative diet. Patients who receive dietary counseling are anticipated to experience greater weight loss and report less consumption of sugar and fat as compared to patients who do not receive dietary counseling. Moreover, patients who receive dietary counseling are predicted to report less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not receive postoperative dietary counseling. This is predicted to result as a consequence of increased dietary adherence evidenced by the former group.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The University of Pennsylvania Weight and Eating Disorder Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI): 40 to 60 kg(squared) or greater than or equal to 35kg(squared) in the presence of co-morbid medical condition.
  • Subjects must live within 30 minutes of the University of Pennsylvania and drive or have ready access to public transportation.
  • Subjects must be able to ambulate without assistance.
  • Subjects will be free of contraindications to bariatric surgery and will have been approved for surgery by both the medical staff and their insurance carrier.
  • Subjects must be able to communicate with the investigator, be legally competent, and provide written informed consent.

Exclusion Criteria:

  • Evidence of significant psychiatric distress that impairs daily functioning, as suggested by a Beck Depression Inventory-II (BDI-II) greater than or equal to 25. (Individuals with BDI-II scores greater than or equal to 25 will be referred for appropriate help, as per the requirements of the law in the state of Pennsylvania.)
  • Any current substance abuse or dependence disorder.
  • Concurrent psychiatric treatment for any DSM-IV condition
  • Persons who binge eat and report purging behavior (i.e., vomiting, laxative or diuretic abuse, etc.) will be excluded from the study and referred to an eating disorders specialist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: David S Sarwer, Ph.D., The University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

July 28, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

July 29, 2005

Study Record Updates

Last Update Posted (Estimate)

June 28, 2010

Last Update Submitted That Met QC Criteria

June 25, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DK67885
  • R03DK067885 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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