Longitudinal Study of the Psychological Impact of Bariatric Surgery

Psychological Impact of Bariatric Surgery in Patients With Morbid Obesity: a Longitudinal Study Protocol

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07780058

Acronym

BARI-SCL

Enrollment

Registered

2026-08-21

Start date

2025-09-02

Completion date

2028-10-28

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

psychological well-being, bariatric surgery, hair cortisol, morbid obesity, follow-up

Brief summary

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.

Detailed description

Objective: To evaluate the impact of bariatric surgery on mental health and hair cortisol concentrations in patients with morbid obesity over a 3-year follow-up. Methods: This is a prospective observational study in candidates for bariatric surgery. Assessments will include sociodemographic data, anthropometric measures, clinical, nutritional and lifestyle variables, hair cortisol concentrations, and psychological variables, including psychopathological symptoms, stress levels, impulsivity, emotional eating, and health-related quality of life. Evaluations will be performed at five time points: preoperative (T0), 1 month (T1), 1 year (T2), 2 years (T3), and 3 years (T4). The study will describe psychological and weight changes after surgery and identify possible needs for psychological support before surgery and during mid- and long-term follow-up.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Patients with previous bariatric surgery and pregnant women during follow-up will be excluded.

Design outcomes

Primary

Measure	Time frame	Description
Global Severity Index (GSI) score of the Symptom Checklist-90-Revised (SCL-90-R)	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in overall psychological distress assessed using the Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R).

Secondary

Measure	Time frame	Description
Perceived Stress Scale (PSS-14) score	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in perceived stress assessed using the 14-item Perceived Stress Scale (PSS-14). Outcome measure: total PSS-14 score.
UPPS-P Short Version score	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in impulsivity assessed using the 20-item UPPS-P Short Version questionnaire. Outcome measure: total UPPS-P score and subscale scores.
Hair cortisol concentration	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in hair cortisol concentration measured in hair samples, expressed as pg/mg of hair.
Moorehead-Ardelt Quality of Life Questionnaire II score	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in health-related quality of life assessed using the Moorehead-Ardelt Quality of Life Questionnaire II. Outcome measure: total questionnaire score.
Eating Disorder Examination Questionnaire (EDE-Q) score	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in eating disorder symptoms assessed using the Eating Disorder Examination Questionnaire (EDE-Q). Outcome measure: total EDE-Q score.
Emotional Eating Questionnaire (EEQ) score	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in emotional eating assessed using the Emotional Eating Questionnaire (EEQ). Outcome measure: total EEQ score.
Body weight	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery	Change in body weight measured in kilograms (kg).
Body Mass Index (BMI)	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in body mass index calculated as weight divided by height squared, expressed in kg/m².
Mediterranean Diet Adherence Screener (MEDAS) score	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in adherence to the Mediterranean diet assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS). Outcome measure: total MEDAS score (0-14).
Sleep quality	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in self-reported sleep quality assessed using the study-specific questionnaire. Outcome measure: sleep quality score.
Physical activity	Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.	Change in self-reported physical activity assessed using the study-specific questionnaire.

Countries

Spain

Contacts

CONTACTLorena Andreu Lucena, MSc

lorenapsicologiabariatrica@gmail.com+34667508676

CONTACTAna M Santos, PhD

anasantos@gcloud.ua.es+34 965 90 3960

STUDY_DIRECTORCristian Marco, MD, PhD

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

STUDY_CHAIRRahma Amrani, MSc