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Status:

COMPLETED

Postoperative Dietary Counseling After Bariatric Surgery

Lead Sponsor:

University of Pennsylvania

Collaborating Sponsors:

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

Conditions:

Obesity

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

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 c...

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 c...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2005

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00125073

Start Date

July 1 2005

End Date

August 1 2005

Last Update

June 28 2010

Active Locations (1)

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1

The University of Pennsylvania Weight and Eating Disorder Program

Philadelphia, Pennsylvania, United States, 19104