SENSing Inner BodiLy State: Understanding the Role of Interoception in obEsity (SENSIBLE)

Successfully perceiving the flow of interoceptive cues and integrating them with exteroceptive information are fundamental aspects of countering the body's inherent instability and guaranteeing homeostatic regulation. This process deeply affects cognitive/emotional functioning and general health. Recently, it has been suggested that an important signature underpinning obesity might be an interoceptive dysfunction in perceiving internal body signals and/or integrating them with information from the external environment. There is evidence that interoceptive deficits correlate with Body Mass Index (BMI), but it is still largely unclear how different measures and facets of interoception are related to high BMI and eating behaviour. Within this framework, it is mandatory to understand the role of interoception in obesity at perceptual, cognitive, and emotional levels. One open issue regards the relationships between interoceptive signals and the reactivity to external food cues.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Body Representation
• Intervention / Treatment: Behavioral: The crossmodal dual-task

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Federica Scarpina, PhD; Phone Number: 4353 +39032351; Email: f.scarpina@auxologico.it

Study Locations

• Italy
  • VCO
    • Piancavallo, VCO, Italy, 28824
      • Recruiting
      • IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
      • Contact: Federica Scarpina, PhD; Phone Number: 4003 +39032351; Email: f.scarpina@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants with obesity were consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).

Description

Inclusion Criteria:

• Right-handed individuals diagnosed with obesity
• In rehabilitative treatment at the Istituto Auxologico

Exclusion Criteria:

• Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Right-handed women diagnosed with obesity are consecutively recruited during their rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders are exclusion criteria.	Behavioral: The crossmodal dual-task; Two main sensory tasks performed together: 1. the visual task, in which participants are requested to monitor visual stimuli presented on a computer screen and to detect the "deviant" target" as soon as possible. The target changes across blocks: in half of the trials, participants will have to respond to food stimuli presented together with irrelevant non-food stimuli (food target condition); in the other half conditions, participants will have to respond to non-food stimuli presented together with irrelevant food stimuli (non-food target condition). For each participant, we will collect the Reaction Time in milliseconds only for the valid responses, and the level of Accuracy in percentage. 2) The interoceptive task, in which participants are requested to monitor their heartbeat presented through headphones and registered through pulse oximetry. Participants will judge the level of asynchrony between their heartbeat and the auditory cue.
Controls; Age-matched, right-handed, healthy women (i.e., with no history of eating disorders) are recruited outside the hospital through personal contacts of the researchers and word-of-mouth.	Behavioral: The crossmodal dual-task; Two main sensory tasks performed together: 1. the visual task, in which participants are requested to monitor visual stimuli presented on a computer screen and to detect the "deviant" target" as soon as possible. The target changes across blocks: in half of the trials, participants will have to respond to food stimuli presented together with irrelevant non-food stimuli (food target condition); in the other half conditions, participants will have to respond to non-food stimuli presented together with irrelevant food stimuli (non-food target condition). For each participant, we will collect the Reaction Time in milliseconds only for the valid responses, and the level of Accuracy in percentage. 2) The interoceptive task, in which participants are requested to monitor their heartbeat presented through headphones and registered through pulse oximetry. Participants will judge the level of asynchrony between their heartbeat and the auditory cue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual detection velocity	Reaction Time in milliseconds only for the valid responses in the visual task	At the moment of the experiment
Interoceptive judgement	Individual's judgement from 0 (no synchronicity) to 100 (maximum synchronicity) between between the auditory stimulus and own heartbeat in the heartbeat detection task	At the moment of the experiment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual detection accuracy	Percentage of the correct answers in the "No-Go" trials in the visual task.	At the moment of the experiment

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Principal Investigator: Federica Scarpina, PhD, IRCCS Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 21C404

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No