Exploration of the Mechanisms of Vulnerability of Anorexia Nervosa at an Early Age : Study of the Cognitive Treatment of Food Stimuli and Body Image
AMDP
1 other identifier
interventional
90
1 country
1
Brief Summary
In order to explore the cognitive treatment of patients with early onset anorexia nervosa (AM) in front of images of silhouettes and food, we will use the eye-tracking method. While we hypothesize a judgment disorder in these patients, the exploration of implicit cognitive treatment without desirability bias is essential. Eye-tracking is a method of recording the eye path that provides qualitative and quantitative information on the visual exploration of subjects. The visual pathway depends on how the subject's attention is directed to a given stimulus, but also on certain cognitive traits (e.g., excessive attention to details) or symptoms (e.g., avoidance of caloric food images or attraction to thin images). It is therefore a non-invasive exploration tool, which provides information on how patients look at food images and silhouettes. This project will describe the cognitive treatment of dietary stimuli and body image in young patients with early onset AM. It could identify a biomarker of AM in the pediatric population and improve the diagnosis of the disease. A better diagnosis of AM in patients under 15 years of age is essential and will improve medical care and develop personalized medicine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedStudy Start
First participant enrolled
November 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2022
CompletedOctober 18, 2021
October 1, 2021
3.1 years
July 26, 2019
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cognitive processing
cognitive processing in front of 20 images of food and silhouettes of variable weight
one day
Secondary Outcomes (3)
fixing a region of interest
one day
body mass index
one day
total score on the Morgan and Russell scale
one day
Study Arms (1)
COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE
OTHERIn order to explore the cognitive treatment of patients with early onset anorexia nervosa in front of images of silhouettes and food, it is currently used in the child psychiatry department of the Robert Debré Hospital, the eye-tracking method. Eye tracking is a non-invasive and painless method of recording the path of vision on images presented on a computer screen. In order to understand the specificities of the eye path in sick patients, we will compare the data with those of controls without eating disorders.
Interventions
Describe the cognitive treatment of patients with early onset anorexia nervosa in response to specific stimuli of the disorder (eating and body images), compared to age- and sex-matched control subjects: * children controls not achieved with normal BMI; * children with unbalanced insulin-dependent type 1 diabetes, therefore subject to a strict diet that requires good nutritional knowledge and no weight judgment disorders.
Eligibility Criteria
You may qualify if:
- Patients with anorexia nervosa.
- Age 8 to 14 years,
- Early AM diagnosis (AM DSM-5 criteria, and presence of primary amenorrhea at diagnosis for girls),
- Follow-up in the Child Psychiatry Department of the Robert Debré Hospital,
- Affiliation to a social security system,
- Authorization of the holder(s) of parental authority and acceptance of the child to participate in this research.
- Witnesses from the general population:
- Age 8 to 14 years,
- Normal Height-weight development defined by: Weight, Height, BMI between 10° and 90° percentile for age and sex, without changing the growth curve.
- Authorization of the holder(s) of parental authority and acceptance of the child to participate in this research
- Witnesses with type 1 diabetes:
- Age 8 to 14 years,
- Type 1 diabetes for more than a year,
- Follow-up in the endocrinology department of the Robert Debré Hospital,
- Normal height-weight development defined by: Weight, Height, BMI between 10° and 90° percentile for age and sex, without changing the growth curve.
- +2 more criteria
You may not qualify if:
- Patients with AM.
- Other Axis I disorder (Kiddie SAS)
- Existence of a severe neurosensory disorder
- Existence of a neurological disorder
- other eating disorders(DSM-5)
- Diabetes type 1
- Witnesses :
- Any Axis I psychiatric disorder
- Existence of an intellectual deficit
- Existence of a severe neurosensory disorder
- Existence of a neurological disorder
- Long-term drug treatment (other than insulin for controls with type 1 diabetes)
- Type 1 diabetes (for controls in the general population)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Robert Debré
Paris, 75019, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clarke Julia, PhD
APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2019
First Posted
July 30, 2019
Study Start
November 19, 2019
Primary Completion
December 19, 2022
Study Completion
December 19, 2022
Last Updated
October 18, 2021
Record last verified: 2021-10