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

2 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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 de estudio

De observación

Inscripción (Estimado)

300

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Lazio
      • Rome, Lazio, Italia, 00168

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de mayo de 2026

Finalización primaria (Estimado)

13 de mayo de 2027

Finalización del estudio (Estimado)

13 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

7 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de mayo de 2026

Publicado por primera vez (Actual)

18 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de septiembre de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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