ClinicalTrials.gg
RecruitingNCT07780058BARI-SCLUpdated Aug 21, 2026

Longitudinal Study of the Psychological Impact of Bariatric Surgery

An observational study in Obesity, sponsored by University of Alicante. Recruiting at 2 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Primary conditionObesity, MorbidRegistry: ObesityReclassifiedWhy we changed it
Registry
Obesity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity, Morbid
Why
  1. The study's title name Obesity, Morbid, a narrower term within Obesity.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Alicante · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • psychological well-being
  • bariatric surgery
  • hair cortisol
  • morbid obesity
  • follow-up
03

In context

Obesity, Morbid Reclassified

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's planned enrollment of 70 is below the median of 80 across 311 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

University of Alicante is the lead sponsor of 28 studies on the registry; 7 are open to participants now.

Compared within Obesity, Morbid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with morbid obesity who are candidates for bariatric surgery and will be treated and followed at the participating hospital/center.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 of at least 40 kg/m² or at least 35 kg/m² with comorbidities, and who are able to provide .

Exclusion criteria

Exclusion Criteria:

  • Patients with previous bariatric surgery and pregnant women during follow-up will be excluded.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Bariatric Surgery Group

    Patients with severe obesity who are candidates for bariatric surgery.

06

What researchers measure

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.

  5. Eating Disorder Examination Questionnaire (EDE-Q) score

    Change in eating disorder symptoms assessed using the Eating Disorder Examination Questionnaire (EDE-Q). Outcome measure: total EDE-Q score.

    Time frame: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

  6. Emotional Eating Questionnaire (EEQ) score

    Change in emotional eating assessed using the Emotional Eating Questionnaire (EEQ). Outcome measure: total EEQ score.

    Time frame: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

  7. Body weight

    Change in body weight measured in kilograms (kg).

    Time frame: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery

  8. Body Mass Index (BMI)

    Change in body mass index calculated as weight divided by height squared, expressed in kg/m².

    Time frame: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

  9. Mediterranean Diet Adherence Screener (MEDAS) score

    Change in adherence to the Mediterranean diet assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS). Outcome measure: total MEDAS score (0-14).

    Time frame: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

  10. Sleep quality

    Change in self-reported sleep quality assessed using the study-specific questionnaire. Outcome measure: sleep quality score.

    Time frame: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

  11. Physical activity

    Change in self-reported physical activity assessed using the study-specific questionnaire.

    Time frame: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

07

Study locations

2 of 2 sites recruiting
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References and documents

Publications

  • Sarwer DB, Wadden TA, Ashare R, Spitzer JC, McCuen-Wurst C, LaGrotte C, Williams N, Soans R, Tewksbury C, Wu J, Tajeu G, Allison KC. Psychopathology, disordered eating, and impulsivity as predictors of weight loss 24 months after metabolic and bariatric surgery. Surg Obes Relat Dis. 2024 Jul;20(7):634-642. doi: 10.1016/j.soard.2024.01.019. Epub 2024 Feb 7. PubMed 38480031 ↗
  • van Reekum EA, Darcy M, Drage J, Xu J, Ng K, Forestell B, Santesso N, Joundi RA, Wong J, Doumouras A, Taylor VH, Yusuf S, Van Lieshout R. Psychiatric and Cognitive Functioning After Metabolic and Bariatric Surgery: A Systematic Review and Meta-Analysis. Obes Rev. 2025 Nov;26(11):e13968. doi: 10.1111/obr.13968. Epub 2025 Jun 22. PubMed 40545266 ↗
  • Martinez Gonzalez A, Gonzalez Nunes M, Pena Pineiro N, Argibay Ulloa M, Fraile Amador FJ, Llopiz Castedo J, Jaimes Jaimes SM, Rodriguez Pulian J, Rodriguez Castineira TC, Silva Sousa JI, Sieiro Pena CE, Gonzalez Valladares MG. [Long-term effectiveness of bariatric surgery: weight and metabolic outcomes after 10 years of follow-up]. Nutr Hosp. 2025 Sep 4;42(4):686-694. doi: 10.20960/nh.05876. Spanish. PubMed 40576229 ↗
  • Budin AJ, Brown WA, MacCormick AD, Caterson I, Sumithran P. Depressive symptoms at short-, medium-, and long-term follow-up after bariatric surgical procedures: A systematic review and meta-analysis. Obes Rev. 2025 Aug;26(8):e13927. doi: 10.1111/obr.13927. Epub 2025 Apr 13. PubMed 40222815 ↗

Individual participant data

Plan to share: No — Individual patient data will not be shared with other researchers. The data will be used solely for the purposes of this study and will be presented in aggregate form, ensuring confidentiality and protecting participants' identities.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07780058
Lead sponsor
University of Alicante
Collaborators
Instituto de Investigación Sanitaria y Biomédica de Alicante, FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)
Responsible party
Sponsor
First posted
Aug 21, 2026
Start date
Sep 2, 2025
Primary completion
Sep 28, 2028 (estimated)
Completion
Oct 28, 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Lorena Andreu Lucena, MSc
Contact
lorenapsicologiabariatrica@gmail.com
+34667508676
Ana M Santos, PhD
Contact
anasantos@gcloud.ua.es
+34 965 90 3960
Cristian Marco, MD, PhD
study director · Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Rahma Amrani, MSc
study chair · Instituto de Investigación Sanitaria y Biomédica de Alicante
Nieves Pérez, MD
study chair · Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Trinidad M Castillo, MSc
study chair · Instituto de Investigación Sanitaria y Biomédica de Alicante
Ángel L Abad, MD
study chair · Instituto de Investigación Sanitaria y Biomédica de Alicante
Myriam Sánchez, MD
study chair · Instituto de Investigación Sanitaria y Biomédica de Alicante
Dolores M Fernández, PhD
study chair · Instituto de Investigación Sanitaria y Biomédica de Alicante

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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