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:
  1. 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]
  2. 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]