ObesityNCT02156830
Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery
An observational study of Obesity, run by KU Leuven at 1 site in Belgium.
Trial summary
The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2013to Aug 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The different health care professionals of the obesity team
Who may be able to join
- All the members of the obesity team should be prepared to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery: Qualitative Interviews
The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.
Read the detailed description
The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. We will do a benchmarking and also qualitative analyses of the interviews using Nvivo 10.
This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between multidisciplinary approach in bariatric surgery population in Flanders and the guidelines
We will do a benchmarking and a qualitative research to give an overview of the counseling of obese patients before and after bariatric surgery and to identify the barriers of to a multidisciplinary approach in the counseling of bariatric surgery.
Measured: The interviews will be performed once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
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 KU LeuvenThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ina Gesquiere, KU Leuven
- Investigators
- Veerle Foulon, PhD PharmD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156830
- Sponsor's protocol ID
- INOGMA2
- Status last verified
- Feb 2015
- First submitted
- 19 Aug 2013
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery: Qualitative Interviews
- ClinicalTrials.gov ID
- NCT02156830
- Acronym / sponsor ID
- INOGMA2
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Jun 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.
The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.
Detailed description
The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. We will do a benchmarking and also qualitative analyses of the interviews using Nvivo 10.
This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The different health care professionals of the obesity team
Key inclusion criteria (1 listed)
- All the members of the obesity team should be prepared to participate in the study
Key exclusion criteria (0 listed)
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
Difference between multidisciplinary approach in bariatric surgery population in Flanders and the guidelines
Time frame: The interviews will be performed once
We will do a benchmarking and a qualitative research to give an overview of the counseling of obese patients before and after bariatric surgery and to identify the barriers of to a multidisciplinary approach in the counseling of bariatric surgery.
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 5 Feb 2015.
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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.
Veerle Foulon, PhD PharmD principal investigator
KU Leuven
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 Obesity, run by KU Leuven at 1 site in Belgium.
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 0 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 5 Feb 2015. 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 Belgium. 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?
Difference between multidisciplinary approach in bariatric surgery population in Flanders and the guidelines (time frame: The interviews will be performed once). 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 5 Feb 2015.