Postoperative Dietary Counseling After Bariatric Surgery
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jul 2005
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 28, 2005
CompletedFirst Posted
Study publicly available on registry
July 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJune 28, 2010
June 1, 2010
1 month
July 28, 2005
June 25, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Pennsylvania Weight and Eating Disorder Program
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David S Sarwer, Ph.D.
The University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 28, 2005
First Posted
July 29, 2005
Study Start
July 1, 2005
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
June 28, 2010
Record last verified: 2010-06