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Postoperative Dietary Counseling After Bariatric Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00125073
First received: July 28, 2005
Last updated: June 25, 2010
Last verified: June 2010

July 28, 2005
June 25, 2010
July 2005
August 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00125073 on ClinicalTrials.gov Archive Site
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Postoperative Dietary Counseling After Bariatric Surgery
Postoperative Dietary Counseling After Bariatric Surgery

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.

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.

Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Behavioral: Postoperative nutritional counseling
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2005
August 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00125073
DK67885, R03DK067885
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University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: David S Sarwer, Ph.D. The University of Pennsylvania
University of Pennsylvania
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP