Obesity Clinical Trial
— ObesityOfficial title:
Analysis of Weight Regain Rate and Predictive Factors in Patients Submitted to Bariatric Surgery.
NCT number | NCT04193384 |
Other study ID # | BAREG |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | January 1, 2020 |
Verified date | March 2022 |
Source | Rio de Janeiro State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Bariatric patients without regular medical follow-up Exclusion Criteria: - Pregnancy - Bariatric patients under one year of surgery |
Country | Name | City | State |
---|---|---|---|
Brazil | Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University | Rio De Janeiro | Rio De Janeiro, Brazil |
Lead Sponsor | Collaborator |
---|---|
Rio de Janeiro State University |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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