Longitudinal Study of the Psychological Impact of Bariatric Surgery
ConditionObesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversity of Alicante
About this trial
This prospective observational study evaluates the effect of bariatric surgery on mental health and hair cortisol in patients with morbid obesity over a 3-year follow-up. Assessments will be performed before surgery and at 1 month, 1 year, 2 years, and 3 years to analyze psychological changes, weight changes, and the need for psychological support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged 18 to 70 years who are candidates for gastric bypass, sleeve gastrectomy, or single-anastomosis duodeno-ileal bypass (SADI-S), with a body mass index of at least 40 kg/m² or at least 35 kg/m² with comorbidities, and who are able to provide informed consent.
Disqualifiers
Patients with previous bariatric surgery and pregnant women during follow-up will be excluded.
Trial population
Patients with morbid obesity who are candidates for bariatric surgery and will be treated and followed at the participating hospital/center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 1 trial groupGroup A: Bariatric Surgery Group
Trial outcomes
Primary outcomes
1
Global Severity Index (GSI) score of the Symptom Checklist-90-Revised (SCL-90-R)
Change in overall psychological distress assessed using the Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R).
Time frame
Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.Secondary outcomes
1
Perceived Stress Scale (PSS-14) score
Change in perceived stress assessed using the 14-item Perceived Stress Scale (PSS-14). Outcome measure: total PSS-14 score.
Time frame
Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.2
UPPS-P Short Version score
Change in impulsivity assessed using the 20-item UPPS-P Short Version questionnaire. Outcome measure: total UPPS-P score and subscale scores.
Time frame
Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.3
Hair cortisol concentration
Change in hair cortisol concentration measured in hair samples, expressed as pg/mg of hair.
Time frame
Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.4
Moorehead-Ardelt Quality of Life Questionnaire II score
Change in health-related quality of life assessed using the Moorehead-Ardelt Quality of Life Questionnaire II. Outcome measure: total questionnaire score.
Time frame
Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alicante
Lead sponsor
Instituto de Investigación Sanitaria y Biomédica de Alicante
Collaborator
FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)
Collaborator
Source ClinicalTrials.gov