跳至主要内容
临床试验/NCT04037215
NCT04037215Unknown不适用

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

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年11月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
cognitive processing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

cognitive processing

时间窗: one day

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

次要结局

  • body mass index(one day)
  • fixing a region of interest(one day)
  • total score on the Morgan and Russell scale(one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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