ObesityNCT01412268
Does Bariatric Surgery Changes Eating Habits and Addiction in Morbid Obesity?
An observational study of Obesity, run by Bezmialem Vakif University.
Trial summary
1. Obesity is a big health problem worldwide. 2. Mostly obese people have food addiction and bad eating habits. 3. Bariatric surgery is a good alternative for patients who failed to loose weight with other measures like behavioral changes, activities and sports, diet, etc.. 4. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obesity
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with BMI > 40 kg/m2 Patients with BMI > 35 kg7m2 < 40 kg/m2 but with comorbidity Patients > 18 years old Patients who sign the inform consent Patients who have no psychiatric disease Patients who have no endocrine disorders
Who may be able to join
- Patients with BMI > 40 kg/m2
- Patients with BMI > 35 kg7m2 < 40 kg/m2 but with comorbidity
- Patients > 18 years old
- Patients who sign the inform consent
- Patients who have no psychiatric disease
- Patients who have no endocrine disorders
Who cannot join
- All obese patients who do not fulfill the criteria above mentioned
About this study
Official title: Study of Eating Habits and Addiction Changes in Short and Long Time Follow-up in Morbidly Obese Patients Who Undergo Bariatric Surgery.
- Obesity is a big health problem worldwide.
- Mostly obese people have food addiction and bad eating habits.
- Bariatric surgery is a good alternative for patients who failed to loose weight with other measures like behavioral changes, activities and sports, diet, etc..
- The investigators know the changes occurred after surgery in eating habits due to restrictive and malabsorptive feature of the surgery performed.
- There is no study in the literature to measure these changes.
- The investigators will try to detect these kind of behavioral changes by a survey before and after surgery.
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Behavioral changes, Eating habits, Eating addiction
- Medical subject headings
- Obesity, Feeding Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Bozkurt, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412268
- Sponsor's protocol ID
- BAVUGC-1
- Status last verified
- Jul 2016
- First submitted
- 8 Aug 2011
- Last updated
- 26 Jul 2016
- Results posted
- No
Publications
Sevincer GM, Konuk N, Bozkurt S, Coskun H. Food addiction and the outcome of bariatric surgery at 1-year: Prospective observational study. Psychiatry Res. 2016 Oct 30;244:159-64. doi: 10.1016/j.psychres.2016.07.022. Epub 2016 Jul 12.
PubMed 27479107
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Eating Habits and Addiction Changes in Short and Long Time Follow-up in Morbidly Obese Patients Who Undergo Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT01412268
- Acronym / sponsor ID
- BAVUGC-1
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Behavioral changes, Eating habits, Eating addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Aug 2011 (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.
- Obesity is a big health problem worldwide.
- Mostly obese people have food addiction and bad eating habits.
- Bariatric surgery is a good alternative for patients who failed to loose weight with other measures like behavioral changes, activities and sports, diet, etc..
- The investigators know the changes occurred after surgery in eating habits due to restrictive and malabsorptive feature of the surgery performed.
- There is no study in the literature to measure these changes.
- The investigators will try to detect these kind of behavioral changes by a survey before and after surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with BMI > 40 kg/m2 Patients with BMI > 35 kg7m2 < 40 kg/m2 but with comorbidity Patients > 18 years old Patients who sign the inform consent Patients who have no psychiatric disease Patients who have no endocrine disorders
Key inclusion criteria (6 listed)
- Patients with BMI > 40 kg/m2
- Patients with BMI > 35 kg7m2 < 40 kg/m2 but with comorbidity
- Patients > 18 years old
- Patients who sign the inform consent
- Patients who have no psychiatric disease
Key exclusion criteria (1 listed)
- All obese patients who do not fulfill the criteria above mentioned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 26 Jul 2016.
- Derived from this study: PubMed 27479107Sevincer GM, Konuk N, Bozkurt S, Coskun H. Food addiction and the outcome of bariatric surgery at 1-year: Prospective observational study. Psychiatry Res. 2016 Oct 30;244:159-64. doi: 10.1016/j.psychres.2016.07.022. Epub 2016 Jul 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Bezmialem Vakif University.
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 6 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 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT01412268, which also lists 1 linked publication.
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 26 Jul 2016.