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

ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

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.

Time frame
Baseline to 24 months after bariatric surgery

Secondary outcomes

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).

Time frame
Baseline to 24 months after bariatric surgery
2

Anthropometrics

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

Time frame
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.

Time frame
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)

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

Other outcomes

Sponsors and contacts

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