Obesity, MorbidNCT06033690
Intervention in the Surgical Treatment of Obesity
A study testing multidisciplinary guide in people with Obesity, Morbid, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
The worldwide prevalence of obesity reaching epidemic levels, and directly associated with several non-communicable chronic diseases, being considered the sixth leading cause of death in the world. In Brazil, estimated that one third of the population is overweight. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- multidisciplinary guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Referred for bariatric surgery Having or not comorbidity associated with obesity.
Who cannot join
- not signing the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Beyond Multidisciplinarity in the Surgical Treatment of Obesity Randomized Clinical Trial
The worldwide prevalence of obesity reaching epidemic levels, and directly associated with several non-communicable chronic diseases, being considered the sixth leading cause of death in the world. In Brazil, estimated that one third of the population is overweight. Currently, bariatric surgery the fastest and most effective method to control the disease. However, most patients do not follow the postoperative follow-up protocol, causing weight regain. Intervention in the literature that goes beyond multidisciplinary and can prevent weight relapse. The develop and apply an interdisciplinary manual, based on the guidelines of the Food Guide for the Brazilian Population, as a support in the prophylactic treatment of weight relapse patients and bariatric surgery
Read the detailed description
The objective of this randomized clinical study is to compare the eating behavior of obese participants who underwent the dietary guide after bariatric surgery treatment. The main questions are:
- Can an interdisciplinary intervention through a dietary guide promote a change in eating behavior in participants undergoing surgical treatment for obesity?
- Participants will participate in consultations and receive a food guidance guide and lectures with guidance.
- Researchers will compare intervention and control groups to see if there will be changes in eating behavior
- Conditions
- Obesity, Morbid
- Being tested
- multidisciplinary guide
- Keywords
- obesity, bariatric surgery, food guide, interdisciplinarity
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary guideBehavioural
use of the food guide for education, clarification of doubts
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary guide | Experimental | Consultation and multidisciplinary guide with guidance on physical activity and healthy eating. Receives: Behavioral: multidisciplinary guide |
| Control | No intervention | Consultations with a multidisciplinary team |
What is being measured
The primary outcome is the main question the study is designed to answer.
behavior
participants' scores in a pre- and post-intervention food assessment questionnaire
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start8 Aug 2021
- Primary completion12 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Izabele Vian, Study director, Cardiology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033690
- Sponsor's protocol ID
- UP5815/20
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Beyond Multidisciplinarity in the Surgical Treatment of Obesity Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06033690
- Acronym / sponsor ID
- UP5815/20
- Conditions
- Obesity, Morbid
- Keywords
- obesity, bariatric surgery, food guide, interdisciplinarity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Sep 2023 (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 worldwide prevalence of obesity reaching epidemic levels, and directly associated with several non-communicable chronic diseases, being considered the sixth leading cause of death in the world. In Brazil, estimated that one third of the population is overweight. Currently, bariatric surgery the fastest and most effective method to control the disease. However, most patients do not follow the postoperative follow-up protocol, causing weight regain. Intervention in the literature that goes beyond multidisciplinary and can prevent weight relapse. The develop and apply an interdisciplinary manual, based on the guidelines of the Food Guide for the Brazilian Population, as a support in the prophylactic treatment of weight relapse patients and bariatric surgery
Detailed description
The objective of this randomized clinical study is to compare the eating behavior of obese participants who underwent the dietary guide after bariatric surgery treatment. The main questions are:
- Can an interdisciplinary intervention through a dietary guide promote a change in eating behavior in participants undergoing surgical treatment for obesity?
- Participants will participate in consultations and receive a food guidance guide and lectures with guidance.
- Researchers will compare intervention and control groups to see if there will be changes in eating behavior
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary guide | Experimental | Behavioral: multidisciplinary guideConsultation and multidisciplinary guide with guidance on physical activity and healthy eating. |
| Control | No intervention | –Consultations with a multidisciplinary team |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred for bariatric surgery Having or not comorbidity associated with obesity.
Key exclusion criteria (1 listed)
- not signing the informed consent form.
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 |
|---|---|---|
| multidisciplinary guideuse of the food guide for education, clarification of doubts | Behavioural | multidisciplinary guide |
Primary outcome
behavior
Time frame: 40 minutes
participants' scores in a pre- and post-intervention food assessment questionnaire
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 13 Sep 2023.
- 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.
Izabele Vian study director
Cardiology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary guide in people with Obesity, Morbid, run by Instituto de Cardiologia do Rio Grande do Sul 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 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 13 Sep 2023. 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?
behavior (time frame: 40 minutes). 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 13 Sep 2023.