Overweight and ObesityNCT04614961
Database Concerning Patients Consulting the Obesity Clinic
An observational study of Overweight and Obesity and Bariatric Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Bariatric Surgery
- What is being tested?
- Lifestyle therapy - individual, Lifestyle therapy - group and Medical therapy
- Type of treatment
- Surgery or procedure
- How many people
- 999,999 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Nov 2019to 31 Dec 2099
- How long will I take part?
- 100 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects with overweight, obesity or after bariatric surgery
Who may be able to join
- Signed informed consent
- Age 18 years or older
- Subjects with overweight, obesity or after bariatric surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Obesity Clinic University Hospitals Leuven
Leuven, 3000
Bart Van der Schueren, MD, PhD, +32 16 34 69 94, bart.vanderschueren@uzleuven.be
About this study
Official title: Database Concerning Patients Consulting the Obesity Clinic of University Hospitals Leuven
A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.
Read the detailed description
A registry/database is constructed with data of the individuals that visit the Obesity Clinic of the University Hospitals of Leuven. Data will be obtained from the screening visits and all follow-up visits in terms of sociodemographics, treatment and treatment outcomes, disease impact, biochemistry, questionnaires, QoL, …
- Conditions
- Overweight and Obesity, Bariatric Surgery
- Being tested
- Lifestyle therapy - individual, Lifestyle therapy - group, Medical therapy, Bariatric surgery
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle therapy - individualOther
Individual therapy
Lifestyle therapy - groupOther
Group therapy
Medical therapyOther
Medical therapy
Bariatric surgeryProcedure or surgery
Surgical and endoscopic therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with overweight, obesity or after bariatric surgery | Patients with overweight, obesity or after bariatric surgery Receives: Other: Lifestyle therapy - individual; Other: Lifestyle therapy - group; Other: Medical therapy; Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...)
The objective is to develop an Obesity Clinic registry to collect routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...) using the electronic medical record to improve the knowledge on obesity, the treatment of obesity and its outcomes.
Measured: up to 100 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start12 Nov 2019
- Primary completion31 Dec 2099 (estimated)
- Study completion31 Dec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 999,999 participants (estimated)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614961
- Sponsor's protocol ID
- S62590
- Status last verified
- Jul 2024
- First submitted
- 5 Oct 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Database Concerning Patients Consulting the Obesity Clinic of University Hospitals Leuven
- ClinicalTrials.gov ID
- NCT04614961
- Acronym / sponsor ID
- S62590
- Conditions
- Overweight and Obesity, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 999,999 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 31 Dec 2099 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 4 Nov 2020 (actual)
- 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.
A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.
Detailed description
A registry/database is constructed with data of the individuals that visit the Obesity Clinic of the University Hospitals of Leuven. Data will be obtained from the screening visits and all follow-up visits in terms of sociodemographics, treatment and treatment outcomes, disease impact, biochemistry, questionnaires, QoL, …
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with overweight, obesity or after bariatric surgery | – | Other: Lifestyle therapy - individual, Other: Lifestyle therapy - group, Other: Medical therapy, Procedure: Bariatric surgeryPatients with overweight, obesity or after bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with overweight, obesity or after bariatric surgery
Key inclusion criteria (3 listed)
- Signed informed consent
- Age 18 years or older
- Subjects with overweight, obesity or after bariatric surgery
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle therapy - individualIndividual therapy | Other | Patients with overweight, obesity or after bariatric surgery |
| Lifestyle therapy - groupGroup therapy | Other | Patients with overweight, obesity or after bariatric surgery |
| Medical therapyMedical therapy | Other | Patients with overweight, obesity or after bariatric surgery |
| Bariatric surgerySurgical and endoscopic therapy | Procedure or surgery | Patients with overweight, obesity or after bariatric surgery |
Primary outcome
Routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...)
Time frame: up to 100 years
The objective is to develop an Obesity Clinic registry to collect routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...) using the electronic medical record to improve the knowledge on obesity, the treatment of obesity and its outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Overweight and Obesity and Bariatric Surgery, run by Universitaire Ziekenhuizen 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 3 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: looking for participants now, as of the sponsor's last update on 3 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart Van der Schueren, MD, Phd (+32 16 34 69 94, bart.vanderschueren@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Routine treatment data (sociodemographics, treatment and treatment outcome, disease impact, biochemistry, questionnaires, ...) (time frame: up to 100 years). 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 3 Jul 2024.