Actively Recruiting

Age: 18Years - 70Years
All Genders
ID04526743

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Your Study Journey

Screening

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

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Observational Assessment for Control Group

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

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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

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