Anorexia NervosaAMDPNCT04037215
Exploration of the Mechanisms of Vulnerability of Anorexia Nervosa at an Early Age : Study of the Cognitive Treatment of Food Stimuli and Body Image
A study testing STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE in people with Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2019to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Robert Debré
Paris, 75019
Clarke Julia, PHD, julia.clarke@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE
- Keywords
- eye tracking, cognitive processing
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive processing
cognitive processing in front of 20 images of food and silhouettes of variable weight
Measured: one day
Secondary outcomes (3)
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
Measured: one day
body mass index
severity of symptomatology of the eating disorder
Measured: one day
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start19 Nov 2019
- Primary completion19 Dec 2022 (estimated)
- Study completion19 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarke Julia, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037215
- Sponsor's protocol ID
- K170607J
- Acronym
- AMDP
- Status last verified
- Oct 2021
- First submitted
- 26 Jul 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04037215
- Acronym / sponsor ID
- AMDP / K170607J
- Conditions
- Anorexia Nervosa
- Keywords
- eye tracking, cognitive processing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 19 Dec 2022 (estimated)
- Study completion
- 19 Dec 2022 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE | Other | Other: STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGEIn 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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,
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGEDescribe 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. | Other | COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE |
Primary outcome
cognitive processing
Time frame: one day
cognitive processing in front of 20 images of food and silhouettes of variable weight
3 secondary outcomes
fixing a region of interest
Time frame: one day
body mass index
Time frame: one day
total score on the Morgan and Russell scale
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarke Julia, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STUDY OF THE COGNITIVE TREATMENT OF DIETARY STIMULI AND BODY IMAGE in people with Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clarke Julia, PhD (01 40 03 22 96, julia.clarke@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive processing (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.