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

2. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

300

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Mai 2026

Primärer Abschluss (Geschätzt)

13. Mai 2027

Studienabschluss (Geschätzt)

13. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

18. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. September 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ID 27168 - Interoceptiv-BAR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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