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ObesityNCT07594275

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

An observational study of Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
How many people
300 participants
Where
1 siteItaly
Study dates
13 May 2026to 13 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maria Rosaria Magurano, PC contact

+393663940248

mariarosaria.magurano@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, Lazio, 00168

    Maria Rosaria Magurano, PC, +393663940248, mariarosaria.magurano@policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Keywords
Bariatric Surgery, Intetoception
Medical subject headings
Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline to 24 months after bariatric surgery

Secondary outcomes (10)

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

    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).

    Measured: Baseline to 24 months after bariatric surgery

  2. Anthropometrics

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

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

  3. Changes in Depression

    Change in depressive symptoms assessed by the Patient Health Questionnaire-9 (PHQ-9)from baseline to follow-up.

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

  4. Changes in Disordered Eating Behaviors

    Change in disordered eating behaviors assessed by the Eating Disorder Examination Questionnaire 6.0 (EDE-Q6)

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

  5. Changes in Psychological Functioning

    Change in general psychological functioning assessed by the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM).

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

  6. Changes in Health-Related Quality of Life

    Change in health-related quality of life assessed by the Short Form-36 Health Survey (SF-36).

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

  7. Anthropometrics

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

    Measured: Time frame: baseline, 12, 24 months

  8. Changes Anxiety Symptoms

    Change in depressive symptoms assessed by the anxiety symptoms assessed by the Generalized Anxiety Disorder-7 (GAD-7) from baseline to follow-up.

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

  9. Changes in Disordered Eating Behaviors 1

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

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

  10. Changes in Disordered Eating Behaviors 2

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

    Measured: Baseline, 12 months, and 24 months after bariatric surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start13 May 2026
  3. Primary completion13 May 2027 (estimated)
  4. Study completion13 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07594275
Sponsor's protocol ID
ID 27168 - Interoceptiv-BAR
Status last verified
May 2026
First submitted
7 May 2026
Last updated
3 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Rosaria Magurano, PC (+393663940248, mariarosaria.magurano@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in interoceptive awareness measured by the Multidimensional Assessment of Interoceptive Awareness (MAIA) (time frame: Baseline to 24 months after bariatric surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07594275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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