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NCT Number: NCT07780058

Longitudinal Study of the Psychological Impact of Bariatric Surgery

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.

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Key information

Conditions

Obesity Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen de los Lirios, Alcoy, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Change in overall psychological distress assessed using the Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R).

Secondary outcomes

  1. Perceived Stress Scale (PSS-14) score

    Time frame: 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.

  2. UPPS-P Short Version score

    Time frame: 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.

  3. Hair cortisol concentration

    Time frame: 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.

  4. Moorehead-Ardelt Quality of Life Questionnaire II score

    Time frame: 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.

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

    Time frame: 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.

  6. Emotional Eating Questionnaire (EEQ) score

    Time frame: 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.

  7. Body weight

    Time frame: 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).

  8. Body Mass Index (BMI)

    Time frame: 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.

  9. Mediterranean Diet Adherence Screener (MEDAS) score

    Time frame: 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).

  10. Sleep quality

    Time frame: 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.

  11. Physical activity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana M Santos, PhD

CONTACT

[email protected]

+34 965 90 3960

Lorena Andreu Lucena, MSc

CONTACT

[email protected]

+34667508676

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Collaborators

  • FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community)
  • Instituto de Investigación Sanitaria y Biomédica de Alicante

Registry information

Official study title

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

Acronym: BARI-SCL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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