Intervention in the Surgical Treatment of Obesity

Obesity, Morbid Clinical Trial

Official title:

Intervention Beyond Multidisciplinarity in the Surgical Treatment of Obesity Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06033690
• Other study ID #: UP5815/20
• Status: Completed
• Phase: N/A
• Start date: August 8, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2022
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

Referred for bariatric surgery Having or not comorbidity associated with obesity.

Exclusion criteria:

not signing the informed consent form.

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Behavioral:
• multidisciplinary guide
use of the food guide for education, clarification of doubts

Locations

Country	Name	City	State
Brazil	Izabele Vian	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	behavior	participants' scores in a pre- and post-intervention food assessment questionnaire	40 minutes