- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07594275
Interoception and Illness Perception Before and After Bariatric Surgery: Impact on Disordered Eating (Interoceptiv-BAR)
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
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
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maria Rosaria Magurano, PC
- Número de teléfono: +393663940248
- Correo electrónico: mariarosaria.magurano@policlinicogemelli.it
Ubicaciones de estudio
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Lazio
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Rome, Lazio, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Contacto:
- Maria Rosaria Magurano, PC
- Número de teléfono: +393663940248
- Correo electrónico: mariarosaria.magurano@policlinicogemelli.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Periodo de tiempo: Baseline to 24 months after bariatric surgery
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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.
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Baseline to 24 months after bariatric surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R)
Periodo de tiempo: Baseline to 24 months after bariatric surgery
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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
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Anthropometrics
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in body weight from baseline to 12 and 24 months after bariatric surgery.
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Baseline, 12 months, and 24 months after bariatric surgery
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Changes in Depression
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)from baseline to follow-up.
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Baseline, 12 months, and 24 months after bariatric surgery
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Changes in Disordered Eating Behaviors
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in disordered eating behaviors assessed by the Eating Disorder Examination Questionnaire 6.0 (EDE-Q6)
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Baseline, 12 months, and 24 months after bariatric surgery
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Changes in Psychological Functioning
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in general psychological functioning assessed by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM).
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Baseline, 12 months, and 24 months after bariatric surgery
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Changes in Health-Related Quality of Life
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in health-related quality of life assessed by the Short Form-36 Health Survey (SF-36).
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Baseline, 12 months, and 24 months after bariatric surgery
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Anthropometrics
Periodo de tiempo: Time frame: baseline, 12, 24 months
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Change in body mass index (BMI) from baseline to 12 and 24 months after bariatric surgery.
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Time frame: baseline, 12, 24 months
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Changes Anxiety Symptoms
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in depressive symptoms assessed by the anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7) from baseline to follow-up.
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Baseline, 12 months, and 24 months after bariatric surgery
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Changes in Disordered Eating Behaviors 1
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in disordered eating behaviors assessed by the Binge Eating Scale (BES).
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Baseline, 12 months, and 24 months after bariatric surgery
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Changes in Disordered Eating Behaviors 2
Periodo de tiempo: Baseline, 12 months, and 24 months after bariatric surgery
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Change in disordered eating behaviors assessed by the Clinical Impairment Assessment (CIA).
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Baseline, 12 months, and 24 months after bariatric surgery
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Maria Rosaria Magurano, Fondazione Policlinico A. Gemelli IRCCS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ID 27168 - Interoceptiv-BAR
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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