NCT06298539

Brief Summary

The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound): i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants. Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\'s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

March 1, 2024

Last Update Submit

September 5, 2025

Conditions

Keywords

obesitysensory attenuationinterpersonal difficultiessense of agency

Outcome Measures

Primary Outcomes (1)

  • point of subjective equality (PSE)

    individual PSE in each experimental condition is obtained by fitting observed judgements of loudness, relative to seven possible comparison tones. The PSE represents the tone loudness that participants perceive as loud as the target sound (i.e., the sound intensity which records only 50% of correct judgments "which sounds was louder?")

    day 1

Secondary Outcomes (2)

  • cognitive empathy

    day 1

  • interpersonal pleasure

    day 1

Study Arms (2)

Obesity

BMI \> 30 kg/m2

Healthy weight

BMI range: 19 - 29 kg/m2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with obesity will be recruited at the IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital, Piancavallo, VB, Italia during their rehabilitative treatment. Healthy weight participants will be recruited in the local community and among researchers\' contacts.

You may qualify if:

  • BMI \> 30 kg/m2 (controls)
  • handedness: right

You may not qualify if:

  • history of eating disorders (controls)
  • major psychiatric conditions (e.g., psychosis, personality disorders)
  • developmental disorders (e.g., autism spectrum disorders)
  • neurological or brain injuries disorders
  • motor impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Auxologico Italiano, San Giuseppe Hospital

Piancavallo, VCO, 28824, Italy

Location

Related Publications (2)

  • Scarpina F, Fossataro C, Sebastiano AR, Bruni F, Scacchi M, Mauro A, Garbarini F. Behavioural evidence of altered sensory attenuation in obesity. Q J Exp Psychol (Hove). 2022 Nov;75(11):2064-2072. doi: 10.1177/17470218211065766. Epub 2021 Dec 29.

    PMID: 34825612BACKGROUND
  • Weiss C, Herwig A, Schutz-Bosbach S. The self in social interactions: sensory attenuation of auditory action effects is stronger in interactions with others. PLoS One. 2011;6(7):e22723. doi: 10.1371/journal.pone.0022723. Epub 2011 Jul 27.

    PMID: 21818373BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

March 1, 2023

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

anonymized experimental raw data

Access Criteria
upon reasonable request to the Authors through the repository platform. Log-in on the platform is required.
More information

Locations