Food ResponseNCT05553574
Inhibitory Capabilities Among Women With Eating Disorders
A study testing Stop signal food task in people with Food Response and Food Stop, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial summary
The goal of the study is to increase the flexible behavior toward food via inhibition training among restrained eaters. The expectation is that the train will increase food consumption, decrease food-related anxiety and affect implicit attitudes towards palatable foods Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food Response, Food Stop, Food Response-inhibition
- What is being tested?
- Stop signal food task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Mar 2021to 30 Dec 2023
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of restrained eaters
- Adults ages 18-40
Who cannot join
- Current history or diagnosis of the following according to the criteria of the DSM-5:
- Schizophrenia, schizoaffective disorder, hallucinations, unspecified psychotic disorder (NOS), a mental disorder due to acquired head injury, bipolar disorder, mental disorder as a result of organic development.
- Abuse or addiction to drugs and alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to increase the flexible behavior toward food via inhibition training among restrained eaters. The expectation is that the train will increase food consumption, decrease food-related anxiety and affect implicit attitudes towards palatable foods
- Conditions
- Food Response, Food Stop, Food Response-inhibition
- Being tested
- Stop signal food task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop signal food taskBehavioural
The participants need to classify pictures of food and not food. They were asked to hold their response if they see a white frame around the picture.
| Study group | Role | What they receive |
|---|---|---|
| Food response | Experimental | Not described Receives: Behavioral: Stop signal food task |
| Food stop | Experimental | Not described Receives: Behavioral: Stop signal food task |
| Food response-inhibition | Experimental | Not described Receives: Behavioral: Stop signal food task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome
The participants will increase food consumption,decrease food-related anxiety and affect implicit attitudes towards palatable foods
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start8 Mar 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food ResponseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shir Berebbi, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553574
- Sponsor's protocol ID
- SB1
- Status last verified
- Mar 2023
- First submitted
- 26 May 2021
- Last updated
- 2 Mar 2023
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibitory Capabilities Among Women With Eating Disorders
- ClinicalTrials.gov ID
- NCT05553574
- Acronym / sponsor ID
- SB1
- Conditions
- Food Response, Food Stop, Food Response-inhibition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Sep 2022 (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.
The goal of the study is to increase the flexible behavior toward food via inhibition training among restrained eaters. The expectation is that the train will increase food consumption, decrease food-related anxiety and affect implicit attitudes towards palatable foods
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Food response | Experimental | Behavioral: Stop signal food task |
| Food stop | Experimental | Behavioral: Stop signal food task |
| Food response-inhibition | Experimental | Behavioral: Stop signal food task |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of restrained eaters
- Adults ages 18-40
Key exclusion criteria (3 listed)
- Current history or diagnosis of the following according to the criteria of the DSM-5:
- Schizophrenia, schizoaffective disorder, hallucinations, unspecified psychotic disorder (NOS), a mental disorder due to acquired head injury, bipolar disorder, mental disorder as a result of organic development.
- Abuse or addiction to drugs and alcohol.
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 |
|---|---|---|
| Stop signal food taskThe participants need to classify pictures of food and not food. They were asked to hold their response if they see a white frame around the picture. | Behavioural | Food response, Food response-inhibition, Food stop |
Primary outcome
Main outcome
Time frame: one hour
The participants will increase food consumption,decrease food-related anxiety and affect implicit attitudes towards palatable foods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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?
A study testing Stop signal food task in people with Food Response and Food Stop, run by Hebrew University of Jerusalem at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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 Israel. 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?
Results are not available in the source record.
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?
Main outcome (time frame: one hour). 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 2 Mar 2023.