Predictive Factors of Regain in Bariatric Patients Without Outpatients Care Regular.

NCT04193384 | Completed

• 1 other identifier: BAREG
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. The purpose of this study is to identify the rate of weight regain and predictive factors of regain in bariatric patients without outpatients care regular.

Conditions

Obesity; Bariatric Surgery

Keywords

Obesity; Bariatric Surgery; Weight Gain; Predictive Factors

Outcome Measures

Primary Outcomes (5)

• Analysis of the association between weight regain and alcohol abuse disorder

  Analysis of the association between weight regain (weight in kg) and Alcohol abuse (avaliated by Alcohol Use Disorders Identification Test) in the first clinical evaluation

  through study completion, an average of 1 year

• Analysis of the association between weight regain and general psychopathology

  Analysis of the association between weight regain (weight in kg) and general psychopathology (avaliated by Beck Depression Inventory) in the first clinical evaluation

  through study completion, an average of 1 year

• Analysis of the association between weight regain and physical activity level

  Analysis of the association between weight regain (weight in kg) and physical activity (avaliated by International Physical Activity Questionnaire and the ActiGraph accelerometer) in the first clinical evaluation

  through study completion, an average of 1 year

• Analysis of the association between weight regain and quality of life indicators

  Analysis of the association between weight regain (weight in kg) and quality of life (avaliated by the 36-Item Short-Form Health Survey Questionnaire) in the first clinical evaluation

  through study completion, an average of 1 year

• Analysis of the association between weight regain and eating Disorder

  Analysis of the association between weight regain (weight in kg) and eating disorder (avaliated by Eating Disorder Examination-Questionnaire and Repetitive eating questionnaire) in the first clinical evaluation

  through study completion, an average of 1 year

Study Arms (2)

Group 1≤ (G1≤)

Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year

Group 1> (G1>)

Group 1\> (G1\>) - patients that performed bariatric surgery for \> 1 year

Eligibility Criteria

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

Study Population

Post-bariatric patients without care by health professional with more than one year of surgery.

You may qualify if:

• \- Bariatric patients without regular medical follow-up

You may not qualify if:

• Pregnancy
• Bariatric patients under one year of surgery

Sponsors & Collaborators

• Rio de Janeiro State University: lead

Study Sites (1)

Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, Brazil, 20550013, Brazil

Location

Related Publications (1)

• Lopes KG, Dos Santos GP, Romagna EC, Mattos DMF, Braga TG, Cunha CB, Maranhao PA, Kraemer-Aguiar LG. Changes in appetite, taste, smell, and food aversion in post-bariatric patients and their relations with surgery time, weight loss and regain. Eat Weight Disord. 2022 Jun;27(5):1679-1686. doi: 10.1007/s40519-021-01304-3. Epub 2021 Sep 23.

  PMID: 34554440 DERIVED

MeSH Terms

Conditions

Obesity; Weight Gain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)