Clinical trial NCT04193384: Predictive Factors of Regain in Bariatric Patients Without Outpatients Care Regular.
Official title: Analysis of Weight Regain Rate and Predictive Factors in Patients Submitted to Bariatric Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery
Keywords: Obesity
Bariatric Surgery
Weight Gain
Predictive Factors
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-bariatric patients without care by health professional with more than one year of surgery.

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.

Eligibility criteria: Inclusion Criteria:

- Bariatric patients without regular medical follow-up

Exclusion Criteria:

* Pregnancy
* Bariatric patients under one year of surgery

Primary outcomes:
measure: Analysis of the association between weight regain and alcohol abuse disorder
timeFrame: through study completion, an average of 1 year
measure: Analysis of the association between weight regain and general psychopathology
timeFrame: through study completion, an average of 1 year
measure: Analysis of the association between weight regain and physical activity level
timeFrame: through study completion, an average of 1 year
measure: Analysis of the association between weight regain and quality of life indicators
timeFrame: through study completion, an average of 1 year
measure: Analysis of the association between weight regain and eating Disorder
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Laboratory for Clinical and Experimental Research on Vascular Biology, Rio de Janeiro State University
state: Rio De Janeiro, Brazil
Study officials:
References:
citation: 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.