ObesityNCT00125073
Postoperative Dietary Counseling After Bariatric Surgery
A study testing Postoperative nutritional counseling in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Postoperative nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Pennsylvania Weight and Eating Disorder Program
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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
- Being tested
- Postoperative nutritional counseling
- Keywords
- Standard Care, Nutritional Counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative nutritional counselingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- David S Sarwer, Ph.D., Principal investigator, The University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125073
- Sponsor's protocol ID
- DK67885
- Other IDs
- R03DK067885
- Status last verified
- Jun 2010
- First submitted
- 28 Jul 2005
- Last updated
- 28 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Dietary Counseling After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00125073
- Acronym / sponsor ID
- DK67885
- Conditions
- Obesity
- Keywords
- Standard Care, Nutritional Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 29 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative nutritional counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Sarwer, Ph.D. principal investigator
The University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative nutritional counseling in people with Obesity, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2010.