Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168, Italy
NCT Number: NCT07594275
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 opening soon.
Get Notified18 year and older
All sexes
Observational
Rome, Lazio, 00168, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
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.
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)
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).
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).
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 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.
Time frame: Baseline, 12 months, and 24 months after bariatric surgery
Change in disordered eating behaviors assessed by the Binge Eating Scale (BES).
Time frame: Baseline, 12 months, and 24 months after bariatric surgery
Change in disordered eating behaviors assessed by the Clinical Impairment Assessment (CIA).
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Interoception and Illness Perception Before and After Bariatric Surgery: Impact on Disordered Eating Behaviors
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.
Published trials that share one or more normalized conditions with this study.
NCT07437976
Body Weight, Nutrition Disorders
Research Triangle Park, North Carolina, United States
View Trial DetailsNCT07478653
Body Weight, Dental Care for Children
Lexington, Kentucky, United States
View Trial DetailsNCT05713799
Body Weight, Glucose Metabolism Disorders
Bethesda, Maryland, United States
View Trial DetailsNCT07388537
Body Weight, Diabetes
Bethesda, Maryland, United States
View Trial Details