Intervention in the Surgical Treatment of Obesity

Sponsor

Instituto de Cardiologia do Rio Grande do Sul (Other)

Overall Status

Completed

CT.gov ID

NCT06033690

Collaborator

(none)

Enrollment

Location

Arms

16.8

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid	Behavioral: multidisciplinary guide	N/A

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

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

the two groups were randomized by online program, into intervention group and control group

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 8, 2021

Actual Primary Completion Date :

Dec 12, 2021

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: multidisciplinary guide Consultation and multidisciplinary guide with guidance on physical activity and healthy eating.	Behavioral: multidisciplinary guide use of the food guide for education, clarification of doubts
No Intervention: Control Consultations with a multidisciplinary team

Arm

Intervention/Treatment

Experimental: multidisciplinary guide

Consultation and multidisciplinary guide with guidance on physical activity and healthy eating.

Behavioral: multidisciplinary guide

use of the food guide for education, clarification of doubts

No Intervention: Control

Consultations with a multidisciplinary team

Outcome Measures

Primary Outcome Measures

behavior [40 minutes]
participants' scores in a pre- and post-intervention food assessment questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

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

Exclusion criteria:

not signing the informed consent form.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Izabele Vian	Porto Alegre	Rio Grande Do Sul	Brazil	91000000

Sponsors and Collaborators

Instituto de Cardiologia do Rio Grande do Sul

Investigators

Study Director: Izabele Vian, Cardiology Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Cardiologia do Rio Grande do Sul

ClinicalTrials.gov Identifier:

NCT06033690

Other Study ID Numbers:

UP5815/20

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul

Additional relevant MeSH terms:

Obesity

Obesity, Morbid

Study Results

No Results Posted as of Sep 13, 2023