Fear Conditioning Paradigm in Obesity
GenAllertOB
Implicit Reactions to Threats in Individuals With Obesity: Primary Evidence From Fear Conditioning Paradigm
1 other identifier
observational
48
1 country
1
Brief Summary
Fear processing in obesity and specifically the ability to i) learn and remember threatening stimuli, and ii) implicitly (i.e., unconsciously) and explicitly (consciously) discriminate them from neutral ones, will be investigated in affected individuals through the fear-conditioning paradigm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2022
CompletedFirst Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2024
CompletedAugust 27, 2025
August 1, 2025
1.6 years
February 22, 2023
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SCRs)
The event-related skin conductance responses (SCRs) in the case of the CS will be measured. This will represent the implicit index.
Baseline
Secondary Outcomes (1)
Recognition %
baseline
Study Arms (2)
Cases
Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30).
Controls
Not-hospitalized participants with a healthy weight
Interventions
It is a 2-day paradigm. Participants will undergo an auditory fear conditioning task in 3 phases: (1) pre-conditioning habituation, (2) unconditioned stimulus (US) calibration, where USs will be delivered to set the individual stimulation intensity threshold, and (3) fear conditioning, in which participants will be exposed to the conditioned stimulus (CS) associated with the US with an 80% pairing rate. 24 hours later, the (1) implicit recognition of the CS and novel stimuli (NSs), and the (2) explicit recognition, through an alternative forced-choice task will be assessed. Also, (3) the perceptual discrimination (among the CS and NSs) will be tested. Event-related skin conductance responses (SCRs) will be collected as an implicit index of defensive fear responses, while the accuracy in detecting and discriminating the CS from NSs as the explicit index. Psychological questionnaires about anxiety symptoms will be also administered.
Eligibility Criteria
Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital.
You may qualify if:
- Right-handed
- diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).
You may not qualify if:
- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
Piancavallo, VCO, 28824, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 22, 2023
First Posted
March 14, 2023
Study Start
June 7, 2022
Primary Completion
January 10, 2024
Study Completion
January 10, 2024
Last Updated
August 27, 2025
Record last verified: 2025-08