Intervention in the Surgical Treatment of Obesity
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
multidisciplinary guide
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Morbid focused on measuring obesity, bariatric surgery, food guide, interdisciplinarity
Eligibility Criteria
Inclusion criteria: Referred for bariatric surgery Having or not comorbidity associated with obesity. Exclusion criteria: not signing the informed consent form.
Sites / Locations
- Izabele Vian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
multidisciplinary guide
Control
Arm Description
Consultation and multidisciplinary guide with guidance on physical activity and healthy eating.
Consultations with a multidisciplinary team
Outcomes
Primary Outcome Measures
behavior
participants' scores in a pre- and post-intervention food assessment questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT06033690
First Posted
June 21, 2023
Last Updated
September 10, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT06033690
Brief Title
Intervention in the Surgical Treatment of Obesity
Official Title
Intervention Beyond Multidisciplinarity in the Surgical Treatment of Obesity Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2021 (Actual)
Primary Completion Date
December 12, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
obesity, bariatric surgery, food guide, interdisciplinarity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
the two groups were randomized by online program, into intervention group and control group
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multidisciplinary guide
Arm Type
Experimental
Arm Description
Consultation and multidisciplinary guide with guidance on physical activity and healthy eating.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Consultations with a multidisciplinary team
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary guide
Intervention Description
use of the food guide for education, clarification of doubts
Primary Outcome Measure Information:
Title
behavior
Description
participants' scores in a pre- and post-intervention food assessment questionnaire
Time Frame
40 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Referred for bariatric surgery Having or not comorbidity associated with obesity.
Exclusion criteria:
not signing the informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Izabele Vian
Organizational Affiliation
Cardiology Institute
Official's Role
Study Director
Facility Information:
Facility Name
Izabele Vian
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91000000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intervention in the Surgical Treatment of Obesity
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