Postoperative Dietary Counseling After Bariatric Surgery

NCT ID: NCT00125073

Last Updated: 2010-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2005-08-31

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 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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Postoperative nutritional counseling

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Principal Investigators

David S Sarwer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Pennsylvania

Locations

The University of Pennsylvania Weight and Eating Disorder Program

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R03DK067885

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK67885

Identifier Type: -

Identifier Source: org_study_id