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Interoception and Illness Perception Before and After Bariatric Surgery: Impact on Disordered Eating (Interoceptiv-BAR)

2 settembre 2026 aggiornato da: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Interoception and Illness Perception Before and After Bariatric Surgery: Impact on Disordered Eating Behaviors

Obesity is associated with alterations in the perception and interpretation of internal bodily signals (interoception), which may influence eating behaviors, emotional regulation, and long-term weight outcomes. Bariatric surgery induces profound physiological and neurohormonal changes that may affect interoceptive awareness and illness perception, potentially impacting the risk of disordered eating behaviors after surgery.

This observational study aims to evaluate longitudinal changes in interoceptive awareness and illness perception in adults with severe obesity undergoing bariatric surgery, from the pre-operative phase to long-term follow-up. The study also explores the relationship between these psychological constructs and clinical and behavioral outcomes over time.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

Interoception refers to the ability to perceive, interpret, and integrate internal bodily signals and plays a key role in appetite regulation, emotional processing, and eating behavior. Altered interoceptive processing has been associated with obesity, disordered eating behaviors, and psychological distress. In individuals with severe obesity, bariatric surgery represents the most effective treatment for weight reduction; however, the persistence or recurrence of maladaptive eating behaviors after surgery remains a relevant clinical concern.

Bariatric surgery leads to marked modifications in the gut-brain axis, neuroendocrine signaling, and central processing of internal bodily signals. These changes may influence interoceptive awareness and illness perception, which in turn could affect long-term behavioral, psychological, and clinical outcomes. Despite increasing interest in these mechanisms, longitudinal evidence on subjective interoceptive changes and illness perception before and after bariatric surgery remains limited.

This monocentric, longitudinal, ambispective observational study is conducted in adults with severe obesity evaluated for bariatric surgery at a tertiary referral center. Psychological and clinical data are collected during the pre-operative assessment and during post-surgical follow-up, allowing the evaluation of changes over time in interoceptive awareness, illness perception, psychological functioning, and weight-related outcomes.

The study includes both a retrospective component, based on existing clinical data, and a prospective component with repeated assessments over long-term follow-up. By characterizing trajectories of interoceptive awareness and illness perception before and after bariatric surgery, this study aims to improve the understanding of psychological and behavioral factors involved in post-surgical outcomes and to support the development of more personalized multidisciplinary care pathways for patients with severe obesity.

Tipo di studio

Osservativo

Iscrizione (Stimato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population consists of adults with severe or morbid obesity undergoing pre-operative multidisciplinary evaluation for bariatric surgery at a tertiary referral center. Participants are assessed before surgery and during post-surgical follow-up as part of routine clinical care.

Descrizione

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Diagnosis of severe or morbid obesity (body mass index ≥35 kg/m² with obesity-related comorbidities or ≥40 kg/m²).
  • Undergoing multidisciplinary evaluation with indication for bariatric surgery.
  • Ability to provide informed consent and complete self-administered questionnaires.

Exclusion Criteria:

  • Age younger than 18 years.
  • Presence of neurological disorders associated with cognitive impairment that may interfere with questionnaire completion.
  • Pregnancy or breastfeeding at the time of enrollment.
  • Inability to complete study assessments due to language barriers or other conditions limiting participation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Lasso di tempo: Baseline to 24 months after bariatric surgery
Change from baseline to 24 months in MAIA subscale scores. The MAIA is a validated 32-item self-report questionnaire assessing interoceptive awareness across 8 dimensions. Each item is rated on a Likert scale, and subscale scores are calculated as the mean of corresponding items. Higher scores indicate greater interoceptive awareness.
Baseline to 24 months after bariatric surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R)
Lasso di tempo: Baseline to 24 months after bariatric surgery

Change from baseline to 24 months in cognitive and emotional domains of the IPQ-R.

The IPQ-R includes multiple domains assessing illness representations using Likert scales. Higher scores indicate stronger endorsement of the measured dimension (interpretation depends on domain).
Baseline to 24 months after bariatric surgery
Anthropometrics
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in body weight from baseline to 12 and 24 months after bariatric surgery.
Baseline, 12 months, and 24 months after bariatric surgery
Changes in Depression
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)from baseline to follow-up.
Baseline, 12 months, and 24 months after bariatric surgery
Changes in Disordered Eating Behaviors
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in disordered eating behaviors assessed by the Eating Disorder Examination Questionnaire 6.0 (EDE-Q6)
Baseline, 12 months, and 24 months after bariatric surgery
Changes in Psychological Functioning
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in general psychological functioning assessed by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM).
Baseline, 12 months, and 24 months after bariatric surgery
Changes in Health-Related Quality of Life
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in health-related quality of life assessed by the Short Form-36 Health Survey (SF-36).
Baseline, 12 months, and 24 months after bariatric surgery
Anthropometrics
Lasso di tempo: Time frame: baseline, 12, 24 months
Change in body mass index (BMI) from baseline to 12 and 24 months after bariatric surgery.
Time frame: baseline, 12, 24 months
Changes Anxiety Symptoms
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in depressive symptoms assessed by the anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7) from baseline to follow-up.
Baseline, 12 months, and 24 months after bariatric surgery
Changes in Disordered Eating Behaviors 1
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in disordered eating behaviors assessed by the Binge Eating Scale (BES).
Baseline, 12 months, and 24 months after bariatric surgery
Changes in Disordered Eating Behaviors 2
Lasso di tempo: Baseline, 12 months, and 24 months after bariatric surgery
Change in disordered eating behaviors assessed by the Clinical Impairment Assessment (CIA).
Baseline, 12 months, and 24 months after bariatric surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigatori

  • Investigatore principale: Maria Rosaria Magurano, Fondazione Policlinico A. Gemelli IRCCS

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 maggio 2026

Completamento primario (Stimato)

13 maggio 2027

Completamento dello studio (Stimato)

13 maggio 2028

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 settembre 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ID 27168 - Interoceptiv-BAR

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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