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)
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|ClinicalTrials.gov Identifier: NCT04037215|
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Other: STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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|
|Estimated Study Start Date :||September 10, 2019|
|Estimated Primary Completion Date :||May 10, 2021|
|Estimated Study Completion Date :||May 10, 2021|
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:
- cognitive processing [ Time Frame: one day ]cognitive processing in front of 20 images of food and silhouettes of variable weight
- 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
- body mass index [ Time Frame: one day ]severity of symptomatology of the eating disorder
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037215
|Contact: Clarke Julia, PHD||01 40 03 22 firstname.lastname@example.org|
|Hôpital Robert Debré||Not yet recruiting|
|Paris, France, 75019|
|Contact: Clarke Julia, PHD email@example.com|