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
  Purpose

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
Obesity
Behavioral: Postoperative nutritional counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postoperative Dietary Counseling After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 100
Study Start Date: July 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125073

Locations
United States, Pennsylvania
The University of Pennsylvania Weight and Eating Disorder Program
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: David S Sarwer, Ph.D. The University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00125073     History of Changes
Other Study ID Numbers: DK67885, R03DK067885
Study First Received: July 28, 2005
Last Updated: June 25, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Standard Care
Nutritional Counseling

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014