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Набор скоро начнётся NCT07594275

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

Наблюдательное Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Obesity. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA) [Срок оценки: Baseline to 24 months after bariatric surgery]
Вторичные конечные точки (10)
  • Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R) [Срок оценки: Baseline to 24 months after bariatric surgery]
  • Anthropometrics [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]
  • Changes in Depression [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]
  • Changes in Disordered Eating Behaviors [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]
  • Changes in Psychological Functioning [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]
  • Changes in Health-Related Quality of Life [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]
  • Anthropometrics [Срок оценки: Time frame: baseline, 12, 24 months]
  • Changes Anxiety Symptoms [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]
  • Changes in Disordered Eating Behaviors 1 [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]
  • Changes in Disordered Eating Behaviors 2 [Срок оценки: Baseline, 12 months, and 24 months after bariatric surgery]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome

Идентификаторы

NCT: NCT07594275 · ID 27168 - Interoceptiv-BAR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗