Anthropometric and Laboratory Data
The data for each registered patient was weight loss (kg), measured
using a calibrated digital scale, body mass index (BMI), and height and
weight measurements were recorded twice at each visit to increase
accuracy and reliability); bag size, measured using the graduation
endoscope in relation to length (all bags that allowed the device to be
retrovisioned were considered wide).
All outcome variables, except blood tests (total plasma cholesterol,
high density lipoprotein cholesterol (HDL) and HbA1c) were determined at
randomization and in the second, fourth and sixth months after
randomization.
Statistical analysis
The statistical analysis of the
data has performed by an external collaborator (Dr. Idiberto José
Zotarelli Filho) and interpreted by the principal investigator (Dr.
Ricardo Fittipaldi-Fernandez). For data analysis, a database has built
on the Microsoft Excel spreadsheet which has exported to the Minitab
18® statistical program (version 18, Minitab, LLC,
State College, Pennsylvania, USA) (Minitab®)[22]and OriginPro ® 9 (DPR Group, Inc., Northampton, Massachusetts,
USA).[23] A common descriptive statistical
analysis has performed, obtaining the values of total “n”, mean and
standard deviation, confidence interval (CI), and percentage for all the
variables. Normality test has performed for all variables. One-Way test
(ANOVA) has applied, adopting the α-level less than 0.05 with a
statistical difference for 95% CI. The R-sq (R2)
value has also analyzed.