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Inhibitory Capabilities Among Women With Eating Disorders

Primary Purpose

Food Response, Food Stop, Food Response-inhibition

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Stop signal food task
Sponsored by
Hebrew University of Jerusalem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Food Response

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of restrained eaters
  • Adults ages 18-40

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hebrew university of Jerusalem

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Food response

Food stop

Food response-inhibition

Arm Description

Outcomes

Primary Outcome Measures

Main outcome
The participants will increase food consumption,decrease food-related anxiety and affect implicit attitudes towards palatable foods

Secondary Outcome Measures

Full Information

First Posted
May 26, 2021
Last Updated
March 1, 2023
Sponsor
Hebrew University of Jerusalem
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1. Study Identification

Unique Protocol Identification Number
NCT05553574
Brief Title
Inhibitory Capabilities Among Women With Eating Disorders
Official Title
Inhibitory Capabilities Among Women With Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Response, Food Stop, Food Response-inhibition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Food response
Arm Type
Experimental
Arm Title
Food stop
Arm Type
Experimental
Arm Title
Food response-inhibition
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Stop signal food task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Main outcome
Description
The participants will increase food consumption,decrease food-related anxiety and affect implicit attitudes towards palatable foods
Time Frame
one hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of restrained eaters Adults ages 18-40 Exclusion Criteria: 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.
Facility Information:
Facility Name
Hebrew university of Jerusalem
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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Inhibitory Capabilities Among Women With Eating Disorders

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