Actively Recruiting
Mental Health, Dysfunctional Eating Pattern and Weight Trajectory in Subjects Undergoing Bariatric Surgery
Led by GOSEEN Obesity group of the Spanish Endocrinology Society · Updated on 2020-08-26
500
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how eating habits, especially unhealthy behaviors, and certain psychological factors relate to weight changes after bariatric surgery over both short and long periods. It is a five-year, prospective, multicenter observational study including people with obesity undergoing primary bariatric surgery and a control group of obese individuals not undergoing surgery but matched by age, sex, and BMI. The study includes two groups: those having primary laparoscopic gastric bypass or sleeve gastrectomy surgeries between September 2020 and September 2021, who will be evaluated before surgery and at 4 months, 1 year, 3 years, and 5 years after surgery; and a control group of obese subjects not eligible for surgery who will be evaluated once. Psychological and behavioral data will be collected through validated online questionnaires completed by participants. Participants will provide information about their weight changes, psychological states, eating patterns, mood, stress, impulsivity, substance use, personality traits, depression, economic status, physical activity, social support, and quality of life. Food intake will be recorded over three days for analysis. The primary outcomes include percentages of total weight lost, excess weight lost, total weight regained, and excess weight regained over five years. Data on demographics, comorbidities, and anthropometric measures will also be collected to support the analysis.
CONDITIONS
Brief Title
Eating Behavior and Weight Trajectory After Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate to primary bariatric surgery from September 2020 to September 2021.
- Adults aged 18 to 70 years.
- Obesity with body mass index over 40 kg/m2.
- Internet users able to complete online questionnaires.
- Acceptance to participate and provide signed informed consent.
- Undergoing primary laparoscopic gastric bypass or sleeve gastrectomy.
You will not qualify if you...
- Undergoing second time or revisional bariatric surgery.
- Pregnancy.
- Intellectual impairment preventing questionnaire completion.
- Diagnosis of type 1 diabetes.
- Dyslexia.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 year before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or online) for eligibility assessment
Duration - Surgery date plus initial recovery period
Participants undergo primary bariatric surgery (laparoscopic gastric bypass or sleeve gastrectomy) and receive immediate post-operative care.
Surgery day plus initial recovery visits as per routine care
Duration - 5 years post-surgery
Participants complete online questionnaires and have weight and psychological assessments prior to surgery and at 4 months, 1 year, 3 years, and 5 years after surgery.
5 follow-up assessments (1 pre-surgery and 4 post-surgery) completed online
Duration - Single timepoint
Participants with obesity not undergoing bariatric surgery complete a one-time evaluation matched to surgical participants' baseline characteristics.
1 visit (online) for assessment
Trial Site Locations
Total: 1 location
1
Hospital Clinic
Barcelona, Spain, 08036
Actively Recruiting
Research Team
L
Lilliam Flores, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here