Outcomes
The outcomes evaluated in the present study included safety indicator
(treatment complications) and efficacy indicators such as weight loss
(kg), change in BMI (kg/m2), % total weight loss
(%TWL) and % excess weight loss (% EWL) during balloon use (minimum
270 days). Anthropometric measures were obtained at baseline (day of IGB
insertion) and at the end of the study (day of IGB removal). Height was
measured with a stadiometer accurate to ± 0.5 cm and weight was obtained
with a digital scale accurate to ± 0.1 kg (Filizola S.A., São Paulo, SP,
Brazil), after participants without shoes and wearing light clothing,
attempted to empty their bladder. Body mass index (BMI) was calculated
using the standard equation (kg/m2). BMI cutoff points
were used to classify the participants as overweight (25-29.9), class I
obese (30-34.9), class II obese (35-39.9) and class III obese
(≥40).[10] Excess weight (EW) was determined as
the amount of weight that is in excess of the ideal body weight
(determined as a BMI of 24.9). The success of the treatment was
evaluated according two criteria:
- The percentage of excess weight loss (%EWL): patients who did not
achieved the goal of the treatment (<20%), those with
success of treatment (20-50%) and those who had high success
(>50%). [11]
- And the percentage of total weight loss (%TWL): patients who did not
achieved the goal of the treatment (<10%), and those with
success of treatment (≥10%).[11]