ObesityGenAllertOBNCT05768659
Fear Conditioning Paradigm in Obesity
An observational study of Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fear Conditioning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jun 2022to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Right-handed
- diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).
Who cannot join
- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
Piancavallo, VCO, 28824
About this study
Official title: Implicit Reactions to Threats in Individuals With Obesity: Primary Evidence From Fear Conditioning Paradigm
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.
- Conditions
- Obesity
- Being tested
- Fear Conditioning
- Keywords
- fear conditioning, fear processing, anxiety
- Medical subject headings
- Obesity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear ConditioningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants affected by obesity (the level of body mass index (BMI) higher or equal to 30). Receives: Behavioral: Fear Conditioning | |
| Controls | Not-hospitalized participants with a healthy weight Receives: Behavioral: Fear Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCRs)
The event-related skin conductance responses (SCRs) in the case of the CS will be measured. This will represent the implicit index.
Measured: Baseline
Secondary outcomes (1)
Recognition %
Level of accuracy (in %) in recognizing and discriminating the CS from NS will be computed. This will represent the explicit index.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start7 Jun 2022
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768659
- Sponsor's protocol ID
- 21X101
- Acronym
- GenAllertOB
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implicit Reactions to Threats in Individuals With Obesity: Primary Evidence From Fear Conditioning Paradigm
- ClinicalTrials.gov ID
- NCT05768659
- Acronym / sponsor ID
- GenAllertOB / 21X101
- Conditions
- Obesity
- Keywords
- fear conditioning, fear processing, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Behavioral: Fear ConditioningParticipants affected by obesity (the level of body mass index (BMI) higher or equal to 30). |
| Controls | – | Behavioral: Fear ConditioningNot-hospitalized participants with a healthy weight |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Right-handed
- diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).
Key exclusion criteria (1 listed)
- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear ConditioningIt 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. | Behavioural | Cases, Controls |
Primary outcome
SCRs)
Time frame: Baseline
The event-related skin conductance responses (SCRs) in the case of the CS will be measured. This will represent the implicit index.
1 secondary outcome
Recognition %
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCRs) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.