ObesityObesityNCT04193384
Predictive Factors of Regain in Bariatric Patients Without Outpatients Care Regular.
An observational study of Obesity and Bariatric Surgery, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2018to 1 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post-bariatric patients without care by health professional with more than one year of surgery.
Who may be able to join
- Bariatric patients without regular medical follow-up
Who cannot join
- Pregnancy
- Bariatric patients under one year of surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, Brazil, 20550013
About this study
Official title: Analysis of Weight Regain Rate and Predictive Factors in Patients Submitted to Bariatric Surgery.
The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. The purpose of this study is to identify the rate of weight regain and predictive factors of regain in bariatric patients without outpatients care regular.
Read the detailed description
Post-bariatric patients without care by health professional will be recruited. Patients will be divided, initially, in two groups by time after surgical procedure, as follows: Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year and Group 1> (G1>) - patients that performed bariatric surgery for > 1 year. Patients will be seen in a medical set for the first time at the Policlínica Piquet Carneiro (PPC) for outpatients care, which will consist of anamnesis and physical examination, obtaining demographic, socioeconomic data, medications and clinical history. The TxR will be calculated by [TxR = (current weight - minimum weight reported) x 100 / (weight preoperatively reported - minimum weight related)] and information on predictive variables for weight regain will be obtained by Alcohol Use Disorders Identification Test (AUDIT), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ), ActiGraph GT3X + accelerometer, 36-Item Short-Form Health Survey (SF-36), Eating Disorder Examination-Questionnaire (EDE-Q) and Repetitive eating questionnaire (REP(EAT) Q). The inclusion period of new patients in the PPC Obesity Clinic will be one year.
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Obesity, Bariatric Surgery, Weight Gain, Predictive Factors
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1≤ (G1≤) | Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year | |
| Group 1> (G1>) | Group 1> (G1>) - patients that performed bariatric surgery for > 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the association between weight regain and alcohol abuse disorder
Analysis of the association between weight regain (weight in kg) and Alcohol abuse (avaliated by Alcohol Use Disorders Identification Test) in the first clinical evaluation
Measured: through study completion, an average of 1 year
Analysis of the association between weight regain and general psychopathology
Analysis of the association between weight regain (weight in kg) and general psychopathology (avaliated by Beck Depression Inventory) in the first clinical evaluation
Measured: through study completion, an average of 1 year
Analysis of the association between weight regain and physical activity level
Analysis of the association between weight regain (weight in kg) and physical activity (avaliated by International Physical Activity Questionnaire and the ActiGraph accelerometer) in the first clinical evaluation
Measured: through study completion, an average of 1 year
Analysis of the association between weight regain and quality of life indicators
Analysis of the association between weight regain (weight in kg) and quality of life (avaliated by the 36-Item Short-Form Health Survey Questionnaire) in the first clinical evaluation
Measured: through study completion, an average of 1 year
Analysis of the association between weight regain and eating Disorder
Analysis of the association between weight regain (weight in kg) and eating disorder (avaliated by Eating Disorder Examination-Questionnaire and Repetitive eating questionnaire) in the first clinical evaluation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Nov 2018
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
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.
- 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193384
- Sponsor's protocol ID
- BAREG
- Acronym
- Obesity
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopes KG, Dos Santos GP, Romagna EC, Mattos DMF, Braga TG, Cunha CB, Maranhao PA, Kraemer-Aguiar LG. Changes in appetite, taste, smell, and food aversion in post-bariatric patients and their relations with surgery time, weight loss and regain. Eat Weight Disord. 2022 Jun;27(5):1679-1686. doi: 10.1007/s40519-021-01304-3. Epub 2021 Sep 23.
PubMed 34554440
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Weight Regain Rate and Predictive Factors in Patients Submitted to Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT04193384
- Acronym / sponsor ID
- Obesity / BAREG
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Obesity, Bariatric Surgery, Weight Gain, Predictive Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 10 Dec 2019 (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.
The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. The purpose of this study is to identify the rate of weight regain and predictive factors of regain in bariatric patients without outpatients care regular.
Detailed description
Post-bariatric patients without care by health professional will be recruited. Patients will be divided, initially, in two groups by time after surgical procedure, as follows: Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year and Group 1> (G1>) - patients that performed bariatric surgery for > 1 year. Patients will be seen in a medical set for the first time at the Policlínica Piquet Carneiro (PPC) for outpatients care, which will consist of anamnesis and physical examination, obtaining demographic, socioeconomic data, medications and clinical history. The TxR will be calculated by [TxR = (current weight - minimum weight reported) x 100 / (weight preoperatively reported - minimum weight related)] and information on predictive variables for weight regain will be obtained by Alcohol Use Disorders Identification Test (AUDIT), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ), ActiGraph GT3X + accelerometer, 36-Item Short-Form Health Survey (SF-36), Eating Disorder Examination-Questionnaire (EDE-Q) and Repetitive eating questionnaire (REP(EAT) Q). The inclusion period of new patients in the PPC Obesity Clinic will be one year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1≤ (G1≤) | – | –Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year |
| Group 1> (G1>) | – | –Group 1> (G1>) - patients that performed bariatric surgery for > 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post-bariatric patients without care by health professional with more than one year of surgery.
Key inclusion criteria (1 listed)
- Bariatric patients without regular medical follow-up
Key exclusion criteria (2 listed)
- Pregnancy
- Bariatric patients under one year of surgery
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
Analysis of the association between weight regain and alcohol abuse disorder
Time frame: through study completion, an average of 1 year
Analysis of the association between weight regain (weight in kg) and Alcohol abuse (avaliated by Alcohol Use Disorders Identification Test) in the first clinical evaluation
Analysis of the association between weight regain and general psychopathology
Time frame: through study completion, an average of 1 year
Analysis of the association between weight regain (weight in kg) and general psychopathology (avaliated by Beck Depression Inventory) in the first clinical evaluation
Analysis of the association between weight regain and physical activity level
Time frame: through study completion, an average of 1 year
Analysis of the association between weight regain (weight in kg) and physical activity (avaliated by International Physical Activity Questionnaire and the ActiGraph accelerometer) in the first clinical evaluation
Analysis of the association between weight regain and quality of life indicators
Time frame: through study completion, an average of 1 year
Analysis of the association between weight regain (weight in kg) and quality of life (avaliated by the 36-Item Short-Form Health Survey Questionnaire) in the first clinical evaluation
Analysis of the association between weight regain and eating Disorder
Time frame: through study completion, an average of 1 year
Analysis of the association between weight regain (weight in kg) and eating disorder (avaliated by Eating Disorder Examination-Questionnaire and Repetitive eating questionnaire) in the first clinical evaluation
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 22 Mar 2022.
- Derived from this study: PubMed 34554440Lopes KG, Dos Santos GP, Romagna EC, Mattos DMF, Braga TG, Cunha CB, Maranhao PA, Kraemer-Aguiar LG. Changes in appetite, taste, smell, and food aversion in post-bariatric patients and their relations with surgery time, weight loss and regain. Eat Weight Disord. 2022 Jun;27(5):1679-1686. doi: 10.1007/s40519-021-01304-3. Epub 2021 Sep 23.
- Individual participant dataSharing planned: No
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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.
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 and Bariatric Surgery, run by Rio de Janeiro State University at 1 site in Brazil.
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 2 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 22 Mar 2022. 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 Brazil. 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?
Analysis of the association between weight regain and alcohol abuse disorder (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04193384, 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 22 Mar 2022.