About this trial
Studying the mechanisms of weight regain (WR) may provide much needed insight into sustained obesity management. The aim of this five-year, prospective, multicenter study is to evaluate the association among eating patterns (specifically maladaptive behaviors), certain psychological variables and weight trajectory in the short- and long-term after bariatric surgery (BS). The study will include 2 groups: 1.- Candidates to primary BS undergoing laparoscopic gastric bypass (LGBP) or laparoscopic sleeve gastrectomy (LSG) from September 2020 to September 2021. This group will be evaluated prior to surgery, at 4 months, 1 year, 3 years and 5 years after BS, and 2.- a control group of subjects with obesity not candidates to BS matched with the intervention group for age, sex and BMI prior to BS. They will be evaluated once. The primary variable will be: body weight: total weight lost (%), excess weight lost (%), total weight regained (%), excess of weight regain (%). Information regarding the psychological and behavioral variables will be collected using questionnaires that have been validated in our setting and will be completed by the patients themselves online.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Candidate to primary BS from 09/2020 to 09/2021.
Subjects with obesity (>40 kg/m2) not candidates to BS.
Internet users.
Primary BS: LGBP and LSG.
Disqualifiers
Second time and/or revisional BS.
Pregnancy.
Presence of intellectual impairment impeding the administration of the psychometric tools.
Type 1 diabetes.
Trial population
Candidates to primary BS undergoing laparoscopic gastric bypass (LGBP) or laparoscopic sleeve gastrectomy (LSG) from September 2020 to September 2021 and a control group of subjects with obesity not candidates to BS matched with the intervention group for age, sex and BMI prior to BS.
Trial design
Case-control
Prospective
Treatments tested in this trial
Questionnaire
BehavioralPsychological and behavioral variables will be collected using questionnaires that have been validated in our setting and will be completed by the patients themselves online.
Treatment groups
Trial outcomes
Primary outcomes
Total weight lost percent (%).
Total weight lost \> 25 percent.
Excess weight lost: percent (%),
Excess weight lost \> 50 percent
Total weight regained: percent (%)
Total weight regained \> 15%
Excess of weight regain: percent (%).
EWR \> 15 percent will be considered as significant
Sponsors and contacts
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