- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Maria Rosaria Magurano, PC
- Telefonní číslo: +393663940248
- E-mail: mariarosaria.magurano@policlinicogemelli.it
Studijní místa
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Lazio
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Rome, Lazio, Itálie, 00168
- Nábor
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Kontakt:
- Maria Rosaria Magurano, PC
- Telefonní číslo: +393663940248
- E-mail: mariarosaria.magurano@policlinicogemelli.it
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Časové okno: 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.
|
Baseline to 24 months after bariatric surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).
|
Baseline, 12 months, and 24 months after bariatric surgery
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Changes in Health-Related Quality of Life
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Maria Rosaria Magurano, Fondazione Policlinico A. Gemelli IRCCS
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ID 27168 - Interoceptiv-BAR
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