Obesity (Class II to III) Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Consecutive adult patients with obesity at three Portuguese tertiary care outpatient centers specialized in the surgical treatment of obesity, namely Hospital do Espírito Santo de Évora, Hospital de São Bernardo de Setúbal, and Centro Hospitalar Universitário de São João for bariatric surgery, following the criteria defined in the Portuguese National Health Service: 1. Body mass index (BMI) greater than 40 kg/m2 with or without associated comorbidities or greater than 35 Kg/m2 in the presence of at least 1 comorbidity (type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea syndrome, obese hypoventilation syndrome, arterial hypertension or osteoarticular degenerative pathology, with marked functional limitation). 2. Age between 18 and 65 years 3. Failure of non-surgical interventions for weight reduction, for at least one year, obesity that is not secondary to an identified endocrine disease 4. Ability to understand the surgical procedure and to adhere to a long-term follow-up program 5. Absence of psychiatric disorders, absence of alcohol or drug dependence 6. Balanced relationship between operative risk and clinical risk
Exclusion criteria
Exclusion criteria: 1. Active acute respiratory infection 2. Active neurological or psychiatric disease 3. Active gastrointestinal, hepatic or pancreatic disease 4. Illicit substance use or alcohol abuse 5. Illiteracy or otherwise not understanding instructions for the study 6. Prior major gastrointestinal surgery 7. Intra-gastric balloon 8. History of food allergies 9. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary response (dependent) variable: Weight change from baseline [%WL = (weight lost/baseline weight)*100] assessed up to 18 months after surgery Main explanatory (independent) variables: 1. Mean intensity and pleasantness ratings given to four concentrations of sucrose (sweet) as assessed with general labeled magnitude scales (gLMS) at baseline up to 18 months after surgery 2. Hedonic hunger assessed with the Power of Food Scale assessed at baseline and up to 18 months after surgery 3. Addiction-like feeding behavior assessed with the Yale Food Addiction Scale assessed up to 18 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary explanatory (independent) variables: 1. Intensity and pleasantness ratings given to four concentrations of citric acid (sour) as assessed with a gLMS at baseline up to 18 months after surgery 2. Intensity and pleasantness ratings given to four concentrations of sodium chloride (salty) as assessed with a gLMS at baseline up to 18 months after surgery 3. Intensity and pleasantness ratings given to four concentrations of quinine hydrochloride (bitter) as assessed with a gLMS at baseline up to 18 months after surgery 4. Acuity in tastant identification (sour, salt, sweet and bitter) assessed in a multiple forced choice test, at baseline and up to 18 months after surgery 5. Taste thresholds assessed with electrogustometry at baseline and up to 18 months after surgery 6. Feeding behavior traits assessed by the Dutch Eating Behavior Questionnaire (DEBQ) assessed at baseline and up to 18 months after surgery 7. Food acceptance assessed by the Food Action Rating Scale (FARS) assessed at baseline and up to 18 months after surgery 8. Depressive symptom severity assessed with the Beck Depression Inventory II (BDI-II) assessed up to 18 months after surgery | — |
Countries
Portugal