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

NCT ID: NCT06855251

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-03-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

The crossmodal dual-task

Intervention Type: 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.

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.

The crossmodal dual-task

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federica Scarpina, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Auxologico Italiano

Locations

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Federica Scarpina, PhD

Role: CONTACT

f.scarpina@auxologico.it

+39032351 ext. 4353

Facility Contacts

Federica Scarpina, PhD

Role: primary

f.scarpina@auxologico.it

+39032351 ext. 4003

Other Identifiers

21C404

Identifier Type: -

Identifier Source: org_study_id