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NCT Number: NCT07594275

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location contact

Maria Rosaria Magurano, PC

CONTACT

[email protected]

+393663940248

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA)

    Time frame: 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.

Secondary outcomes

  1. Change in illness perception measured by the Illness Perception Questionnaire-Revised (IPQ-R)

    Time frame: 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).

  2. Anthropometrics

    Time frame: Baseline, 12 months, and 24 months after bariatric surgery

    Change in body weight from baseline to 12 and 24 months after bariatric surgery.

  3. Changes in Depression

    Time frame: 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.

  4. Changes in Disordered Eating Behaviors

    Time frame: 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)

  5. Changes in Psychological Functioning

    Time frame: 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).

  6. Changes in Health-Related Quality of Life

    Time frame: 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).

  7. Anthropometrics

    Time frame: Time frame: baseline, 12, 24 months

    Change in body mass index (BMI) from baseline to 12 and 24 months after bariatric surgery.

  8. Changes Anxiety Symptoms

    Time frame: 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.

  9. Changes in Disordered Eating Behaviors 1

    Time frame: Baseline, 12 months, and 24 months after bariatric surgery

    Change in disordered eating behaviors assessed by the Binge Eating Scale (BES).

  10. Changes in Disordered Eating Behaviors 2

    Time frame: Baseline, 12 months, and 24 months after bariatric surgery

    Change in disordered eating behaviors assessed by the Clinical Impairment Assessment (CIA).

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Rosaria Magurano, PC

CONTACT

[email protected]

+393663940248

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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