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.

Condition	Intervention
Standard Care Nutritional Counseling	Behavior: Postoperative nutritional counseling

Further Study Details: 

Expected Total Enrollment:  100

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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. -They must live within 30 minutes of the University of Pennsylvania and drive or have ready access to public transportation. -They 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. -The patient must be able to communicate with the investigator, be legally competant, and provide written, informed consent.

Exclusion Criteria: -Evidence of significant psychiatric distress that impairs daily functioning, as suggested by a Beck Depression Inventory-II greather 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125073

Alec W Baker, B.A.      215-746-1281    bakera@mail.med.upenn.edu
Ali Infield, B.A.      215-898-3184    infieldl@mail.med.upenn.edu

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

Study chairs or principal investigators

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

Study ID Numbers:  DK67885
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125073
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02