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

NCT06855251 | Recruiting

• 1 other identifier: 21C404
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Body Representation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Visual detection accuracy

  At the moment of the experiment

Study Arms (2)

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

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

Interventions

The crossmodal dual-task BEHAVIORAL

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.

Cases; Controls

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Federica Scarpina, PhD

  IRCCS Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Scarpina, PhD

CONTACT

+39032351; f.scarpina@auxologico.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: April 1, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

IT (1)