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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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

300

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Maria Rosaria Magurano、Fondazione Policlinico A. Gemelli IRCCS

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月13日

一次修了 (推定)

2027年5月13日

研究の完了 (推定)

2028年5月13日

試験登録日

最初に提出

2026年5月7日

QC基準を満たした最初の提出物

2026年5月14日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月3日

QC基準を満たした最後の更新が送信されました

2026年9月2日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • ID 27168 - Interoceptiv-BAR

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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