Severe ObesityFPQNCT02124993
The Effect of Sleeve Gastrectomy on Food Preference
An observational study of Severe Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Questionnaire
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Sep 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dr. Drake Bellanger sleeve gastrectomy surgery
Who may be able to join
- Male or Female, 18 years or over, who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger.
Who cannot join
- Women who are pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.
Read the detailed description
Participants that will undergo the sleeve gastrectomy surgery by Dr. Drake Bellanger's, will be asked to participant in a questionnaire survey. Once given the consent to participate, a food preference questionnaire (FPQ) will be administered at a pre-operative visit and then a six-week follow up visit at Dr. Drake Bellanger's office.
- Conditions
- Severe Obesity
- Being tested
- Questionnaire
- Keywords
- Gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Food Preference questionnaire (FPQ)
Dr. Ballanger's office will administer a FPQ upon approval of an informed consent. Subjects will be asked to complete the questionnaire at a pre-operative visit and six weeks post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy surgery Participants | Male or female who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants food preferences before sleeve gastrectomy surgery and after surgery.
A list of food items are on a questionnaire asking food preferences, Breads, Cereals, Grain products, Fruits and Juices, Fats and oils, Milk, etc. which allows the subjects to select their food preferences before and after the surgery.
Measured: Change from Baseline in preferences after follow-up six weeks
Secondary outcomes (1)
Participants weight change before sleeve gastrectomy surgery and after surgery focusing on specific macronutrient.
A participant is weighted at baseline visit and follow-up visit 6 weeks after the surgery.
Measured: Change from Baseline in weight after follow-up six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124993
- Sponsor's protocol ID
- PBRC 13029
- Acronym
- FPQ
- Status last verified
- Jan 2016
- First submitted
- 22 Apr 2014
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleeve Gastrectomy on Food Preference
- ClinicalTrials.gov ID
- NCT02124993
- Acronym / sponsor ID
- FPQ / PBRC 13029
- Conditions
- Severe Obesity
- Keywords
- Gastrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Apr 2014 (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 is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.
Detailed description
Participants that will undergo the sleeve gastrectomy surgery by Dr. Drake Bellanger's, will be asked to participant in a questionnaire survey. Once given the consent to participate, a food preference questionnaire (FPQ) will be administered at a pre-operative visit and then a six-week follow up visit at Dr. Drake Bellanger's office.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy surgery Participants | – | Other: QuestionnaireMale or female who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dr. Drake Bellanger sleeve gastrectomy surgery
Key inclusion criteria (1 listed)
- Male or Female, 18 years or over, who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger.
Key exclusion criteria (1 listed)
- Women who are pregnant or nursing.
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 |
|---|---|---|
| QuestionnaireAlso: Food Preference questionnaire (FPQ)Dr. Ballanger's office will administer a FPQ upon approval of an informed consent. Subjects will be asked to complete the questionnaire at a pre-operative visit and six weeks post-operatively. | Other | Sleeve gastrectomy surgery Participants |
Primary outcome
Participants food preferences before sleeve gastrectomy surgery and after surgery.
Time frame: Change from Baseline in preferences after follow-up six weeks
A list of food items are on a questionnaire asking food preferences, Breads, Cereals, Grain products, Fruits and Juices, Fats and oils, Milk, etc. which allows the subjects to select their food preferences before and after the surgery.
1 secondary outcome
Participants weight change before sleeve gastrectomy surgery and after surgery focusing on specific macronutrient.
Time frame: Change from Baseline in weight after follow-up six weeks
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 11 Jan 2016.
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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.
Frank Greenway, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Obesity, run by Pennington Biomedical Research Center 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 1 inclusion and 1 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 11 Jan 2016. 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.
What does the primary outcome measure?
Participants food preferences before sleeve gastrectomy surgery and after surgery. (time frame: Change from Baseline in preferences after follow-up six weeks). It is what the study was designed to measure, not a finding.
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 11 Jan 2016.