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)

October 15, 2021 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Monocentric, prospective cohort, case-control type study. The population concerned is composed of patients with early onset anorexia nervosa (AM) and control subjects (two groups).

The objectives of this study are to:

Describe the cognitive treatment of early-onset AM patients with specific stimuli of the disorder (eating and body images) compared to age- and sex-matched control subjects:

  • children controls not achieved with normal body mass index(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.

Describe the links between cognitive treatment and clinical phenotype in patients with early onset AM, in particular severity of eating behaviour trouble symptomatology (TCA), psychiatric and somatic comorbidities, neuropsychological profile.

30 patients with early-onset AM. Two groups of control subjects (matched for age and gender): 30 subjects from the general population with a normal Body Mass Index (BMI) and 30 subjects with chronic somatic pathology (type 1 diabetes) without weight variation (good knowledge of dietary caloric values without impaired judgment about the caloric value of foods and representation of the body image of self and others) A total of 90 participantsPatients and controls without eating disorders will be recruited at Robert Debré Hospital, after signature of the authorization by the holder(s) of parental authority present at the time of hospitalization All patients treated in the department benefit from extensive phenotypic exploration, carried out in routine care.

For controls, phenotypic exploration will require a half-day evaluation.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.
  • No clear imbalance with HbA1c <8.5%.
  • Authorization of the holder(s) of parental authority and acceptance of the child to participate in this research

Exclusion Criteria:

  • Patients with AM.
  • Existence of an intellectual deficit (IQ <70). The patient will not be able to have a new IQ test within one year of inclusion.
  • 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)

Psychometric test taken in the year before inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive processing
Time Frame: one day
cognitive processing in front of 20 images of food and silhouettes of variable weight
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fixing a region of interest
Time Frame: one day
Variables on Eye Tracking ,presence or not of a fixation of a region of interest is defined as a stabilized look at an area of 30 pixels radius for at least 100ms
one day
body mass index
Time Frame: one day
severity of symptomatology of the eating disorder
one day
total score on the Morgan and Russell scale
Time Frame: one day
severity of symptomatology of the eating disorder. Morgan and Russell's (or Global Outcome Assessment Scale), MRS (Morgan and Hayward 1988). Morgan and Russell scales are used to assess the main aspects of anorexia nervosa
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Clarke Julia, PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2019

Primary Completion (ANTICIPATED)

December 19, 2022

Study Completion (ANTICIPATED)

December 19, 2022

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (ACTUAL)

July 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K170607J

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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