Mental Health, Dysfunctional Eating Pattern and Weight Trajectory in Subjects Undergoing Bariatric Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Total weight lost percent (%).
Study Overview
Brief Summary
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.
Detailed Description
The objective of this 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.
Design: Five-year, prospective, multicenter study.
The study will include 2 groups:
- Candidates to primary BS undergoing laparoscopic gastric bypass (LGBP) or laparoscopic sleeve gastrectomy (LSG) from September 2020 to September 2021.The subjects of this group will be followed prior to BS, at 4 months, 1 year, 3 years and 5 years after BS.
- 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.
Inclusion criteria:
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Candidate to primary BS from 09/2020 to 09/
- •Subjects with obesity (>40 kg/m2) not candidates to BS.
- •Internet users.
- •Primary BS: LGBP and LSG.
- •Accept to participate in the study and provide signed informed consent
Exclusion Criteria
- •Second time and/or revisional BS.
- •Pregnancy.
- •Presence of intellectual impairment impeding the administration of the psychometric tools.
- •Type 1 diabetes.
- •Dyslexia.
Outcomes
Primary Outcomes
Total weight lost percent (%).
Time Frame: 5 years.
Total weight lost \> 25 percent.
Excess weight lost: percent (%),
Time Frame: 5 years
Excess weight lost \> 50 percent
Total weight regained: percent (%)
Time Frame: 5 years
Total weight regained \> 15%
Excess of weight regain: percent (%).
Time Frame: 5 years
EWR \> 15 percent will be considered as significant
Secondary Outcomes
No secondary outcomes reported
Investigators
Lilliam Flores
Principal Investigator
GOSEEN Obesity group of the Spanish Endocrinology Society