NCT04037215

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

3.1 years

First QC Date

July 26, 2019

Last Update Submit

October 15, 2021

Conditions

Keywords

eye trackingcognitive processing

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

OTHER

In 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.

Other: STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE

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.

COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Clarke Julia, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clarke Julia, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All assessments in patients with AM are performed as part of routine care and do not require additional monitoring modalities added by research. For controls, phenotypic exploration will require a consultation with clinical examination including the search for psychiatric comorbidities and the completion of standardized questionnaires, exploration of the neuropsychological profile (with eye tracking, overall cognitive exploration, executive functions, social cognition and self-esteem). Test results will not be returned except for screening requiring specific management. The information will then be returned to the child's parents by the investigating doctor, who will be responsible for organizing specific care whenever it is necessary.
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

Locations