NCT07594275

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
May 2026May 2028

First Submitted

Initial submission to the registry

May 7, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

May 30, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 7, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

Bariatric SurgeryIntetoception

Outcome Measures

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.

    Baseline to 24 months after bariatric surgery

Secondary Outcomes (10)

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

    Baseline to 24 months after bariatric surgery

  • Anthropometrics

    Baseline, 12 months, and 24 months after bariatric surgery

  • Changes in Depression

    Baseline, 12 months, and 24 months after bariatric surgery

  • Changes in Disordered Eating Behaviors

    Baseline, 12 months, and 24 months after bariatric surgery

  • Changes in Psychological Functioning

    Baseline, 12 months, and 24 months after bariatric surgery

  • +5 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Rosaria Magurano

    Fondazione Policlinico A. Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 18, 2026

Study Start

May 30, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations