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AzTrials

ObesityBARI-SCLNCT07780058

Longitudinal Study of the Psychological Impact of Bariatric Surgery

An observational study of Obesity, run by University of Alicante at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity
How many people
70 participants
Where
2 sitesSpain
Study dates
2 Sep 2025to 28 Oct 2028
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lorena Andreu Lucena, MSc contact

+34667508676

lorenapsicologiabariatrica@gmail.com

Ana M Santos, PhD contact

+34 965 90 3960

anasantos@gcloud.ua.es

Spain2 sites, 2 recruiting

  • Hospital Universitario Virgen de los Lirios

    Alcoy, Alicante, 03804

    Cristian Marco, endocrino, +34 965 53 74 00, marco_criala@gva.es

    Nieves Pérez, cirugía, +34 965 53 74 00, perez_nie@gva.es

    Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, Alicante, 03010

    Rahma Amrani, nutrición, +34965 93 30 00, raramma@gmail.com

    Ángel L Abad, endocrino, +34965 93 30 00, angeluis1024@gmail.com

    Recruiting

Other trials in Spain

About this study

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

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.

Conditions
Obesity
Keywords
psychological well-being, bariatric surgery, hair cortisol, morbid obesity, follow-up
Medical subject headings
Obesity, Psychological Well-Being, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07780058
Study groupRoleWhat they receive
Bariatric Surgery GroupPatients with severe obesity who are candidates for bariatric surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (11)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start2 Sep 2025
  3. Primary completion28 Sep 2028 (estimated)
  4. Study completion28 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780058
Sponsor's protocol ID
B/2025/15
Other IDs
B/2025/15
Acronym
BARI-SCL
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of Alicante at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lorena Andreu Lucena, MSc (+34667508676, lorenapsicologiabariatrica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Severity Index (GSI) score 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07780058, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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