- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maria Rosaria Magurano, PC
- Phone Number: +393663940248
- Email: mariarosaria.magurano@policlinicogemelli.it
Study Locations
-
-
Lazio
-
Rome, Lazio, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS
-
Contact:
- Maria Rosaria Magurano, PC
- Phone Number: +393663940248
- Email: mariarosaria.magurano@policlinicogemelli.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 24 months after bariatric surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Baseline to 24 months after bariatric surgery
|
|
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.
|
Baseline, 12 months, and 24 months after bariatric surgery
|
|
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.
|
Baseline, 12 months, and 24 months after bariatric surgery
|
|
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)
|
Baseline, 12 months, and 24 months after bariatric surgery
|
|
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).
|
Baseline, 12 months, and 24 months after bariatric surgery
|
|
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).
|
Baseline, 12 months, and 24 months after bariatric surgery
|
|
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.
|
Time frame: baseline, 12, 24 months
|
|
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.
|
Baseline, 12 months, and 24 months after bariatric surgery
|
|
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).
|
Baseline, 12 months, and 24 months after bariatric surgery
|
|
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).
|
Baseline, 12 months, and 24 months after bariatric surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maria Rosaria Magurano, Fondazione Policlinico A. Gemelli IRCCS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID 27168 - Interoceptiv-BAR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.