Intervention in the Surgical Treatment of Obesity

NCT06033690 | Completed

• 1 other identifier: UP5815/20
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity, Morbid

Keywords

obesity; bariatric surgery; food guide; interdisciplinarity

Outcome Measures

Primary Outcomes (1)

• behavior

  participants' scores in a pre- and post-intervention food assessment questionnaire

  40 minutes

Study Arms (2)

multidisciplinary guide

EXPERIMENTAL

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

Behavioral: multidisciplinary guide

Control

NO INTERVENTION

Consultations with a multidisciplinary team

Interventions

multidisciplinary guide BEHAVIORAL

use of the food guide for education, clarification of doubts

multidisciplinary guide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• not signing the informed consent form.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Izabele Vian

Porto Alegre, Rio Grande do Sul, 91000000, Brazil

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Izabele Vian

  Cardiology Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the two groups were randomized by online program, into intervention group and control group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: September 13, 2023
• Study Start: August 8, 2021
• Primary Completion: December 12, 2021
• Study Completion: December 31, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)