Intervention in the Surgical Treatment of Obesity | NCT06033690

Studies
Intervention in the Surgical Treatment of Obesity

NCT06033690

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Status

Completed

Last Update Posted

Sep 13, 2023Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Obesity, Morbid

Interventions

multidisciplinary guide

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2021Actual

Primary Completion Date

Dec 12, 2021Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 21, 2023

First Submission Date that Met QC Criteria

Sep 10, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
multidisciplinary guide	Behavioral	use of the food guide for education, clarification of doubts	multidisciplinary guide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
behavior	participants' scores in a pre- and post-intervention food assessment questionnaire	40 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

not signing the informed consent form.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Izabele Vian	Cardiology Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Izabele Vian		Porto Alegre	Rio Grande do Sul	91000000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided