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

NCT ID: NCT04193384

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-01-01

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.

Detailed Description

Post-bariatric patients without care by health professional will be recruited. Patients will be divided, initially, in two groups by time after surgical procedure, as follows: Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year and Group 1> (G1>) - patients that performed bariatric surgery for > 1 year. Patients will be seen in a medical set for the first time at the Policlínica Piquet Carneiro (PPC) for outpatients care, which will consist of anamnesis and physical examination, obtaining demographic, socioeconomic data, medications and clinical history. The TxR will be calculated by [TxR = (current weight - minimum weight reported) x 100 / (weight preoperatively reported - minimum weight related)] and information on predictive variables for weight regain will be obtained by Alcohol Use Disorders Identification Test (AUDIT), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ), ActiGraph GT3X + accelerometer, 36-Item Short-Form Health Survey (SF-36), Eating Disorder Examination-Questionnaire (EDE-Q) and Repetitive eating questionnaire (REP(EAT) Q). The inclusion period of new patients in the PPC Obesity Clinic will be one year.

Conditions

Obesity; Bariatric Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1≤ (G1≤)

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

No interventions assigned to this group

Group 1> (G1>)

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Bariatric patients without regular medical follow-up

Exclusion Criteria

• Pregnancy
• Bariatric patients under one year of surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Luiz Guilherme Kraemer-Aguiar, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Rio de Janeiro, Rio de Janeiro, Brazil, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 34554440 (View on PubMed)

Other Identifiers

BAREG

Identifier Type: -

Identifier Source: org_study_id