search
Back to results

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)

Primary Purpose

Anorexia Nervosa

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa focused on measuring eye tracking, cognitive processing

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Robert DebréRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE

Arm Description

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.

Outcomes

Primary Outcome Measures

cognitive processing
cognitive processing in front of 20 images of food and silhouettes of variable weight

Secondary Outcome Measures

fixing a region of interest
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
body mass index
severity of symptomatology of the eating disorder
total score on the Morgan and Russell scale
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

Full Information

First Posted
July 26, 2019
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
search

1. Study Identification

Unique Protocol Identification Number
NCT04037215
Brief Title
Exploration of the Mechanisms of Vulnerability of Anorexia Nervosa at an Early Age : Study of the Cognitive Treatment of Food Stimuli and Body Image
Acronym
AMDP
Official Title
Exploration of the Mechanisms of Vulnerability of Anorexia Nervosa at an Early Age : Study of the Cognitive Treatment of Food Stimuli and Body Image
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
December 19, 2022 (Anticipated)
Study Completion Date
December 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
eye tracking, cognitive processing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE
Intervention Description
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.
Primary Outcome Measure Information:
Title
cognitive processing
Description
cognitive processing in front of 20 images of food and silhouettes of variable weight
Time Frame
one day
Secondary Outcome Measure Information:
Title
fixing a region of interest
Description
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
Time Frame
one day
Title
body mass index
Description
severity of symptomatology of the eating disorder
Time Frame
one day
Title
total score on the Morgan and Russell scale
Description
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
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarke Julia, PhD
Phone
01 40 03 22 96
Email
julia.clarke@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarke Julia, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarke Julia, PHD
Email
julia.clarke@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Exploration of the Mechanisms of Vulnerability of Anorexia Nervosa at an Early Age : Study of the Cognitive Treatment of Food Stimuli and Body Image

We'll reach out to this number within 24 hrs