Intervention in the Surgical Treatment of Obesity

NCT ID: NCT06033690

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-08

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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multidisciplinary guide

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

Group Type EXPERIMENTAL

multidisciplinary guide

Intervention Type BEHAVIORAL

use of the food guide for education, clarification of doubts

Control

Consultations with a multidisciplinary team

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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multidisciplinary guide

use of the food guide for education, clarification of doubts

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

not signing the informed consent form.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Izabele Vian

Role: STUDY_DIRECTOR

Cardiology Institute

Locations

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Izabele Vian

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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UP5815/20

Identifier Type: -

Identifier Source: org_study_id

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