Anorexia NervosaEVA-FAMNCT06218472
Assessment of the Impact of Early Treatment for Anorexia Nervosa in a Day Hospital on Food Symptomatology, the Outcome of Young Patients, and the Family Experience
An observational study of Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
During the management of chronic illnesses, the day hospital (DH) serves as a brief and effective alternative to traditional hospitalization, offering access to multidisciplinary care. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Day Hospital Treatment, Multidisciplinary follow-up "as usual" within the service and Conduct semi-structured qualitative interviews
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2024to Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will include patients of any gender aged 12 to 18 years and their parents, seen in consultation for anorexia nervosa at the pedopsychiatric unit of the Cochin Hospital, Paris, France.
Who may be able to join
- Adolescents in the age range of 12-18 years and their parents,
- First-time consultation at the MDA for anorexia nervosa (according to DSM-5) evolving for less than 12 months,
- Adolescents with clinical characteristics suitable for DH care.
Who cannot join
- Parents and/or children who do not speak French or cannot read or write,
- Patients who have been followed by an eating disorder specialist in the past 12 months (at the MDA or elsewhere) or previously hospitalized for anorexia nervosa,
- Patients who have undergone family therapy in the past,
- Patients with BMI less than 13 kg/m2 for those under 14 years old, or less than 14 kg/m2 for those over 14 years old at the initial assessment,
- Patients with a major psychiatric comorbidity or a metabolic condition interfering with eating or its regulation,
- Patients and families in a crisis situation requiring immediate hospitalization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Maison de Solenn Maison des Adolescents, Cochin Hospital
Paris, IDF, 75014
Corinne BLANCHET, MD, PhD, corinne.blanchet@aphp.fr
Thomas DIOT, MD, thomas.diot@aphp.fr
About this study
During the management of chronic illnesses, the day hospital (DH) serves as a brief and effective alternative to traditional hospitalization, offering access to multidisciplinary care. Indeed, patients can benefit from a range of therapeutic tools provided by a multidisciplinary care team while remaining in their living environment. Numerous structures exist for the management of eating disorders, but primarily for severe cases, often following hospitalization, before transitioning to outpatient care. There is no alternative for the initial management of these patients.
The DH for the evaluation and early intervention in recent forms of anorexia nervosa at Maison de Solenn serves as a rapid entry point to specialized care. It allows for a thorough assessment and sustained management of eating disorders. Our hypothesis is that a multidisciplinary, intensive, and early intervention for patients with anorexia nervosa and their families in a day hospital would improve the short, medium, and long-term prognosis of the disease compared to conventional multidisciplinary outpatient care. It would also enhance the family's experience of this pathology and their coping skills.
Read the detailed description
The patients recruited will come from the active consultation file of the inclusion center (spontaneous consultations, referrals from healthcare professionals, etc.), whether they have had an initial consultation or not. All patients admitted to day hospital during the study period who meet the inclusion criteria will be considered. A first evaluation consultation for mental anorexia will be conducted for all patients, including a somatic and psychological assessment, as well as a consultation with a dietitian. If eligible, the patient and their family will be offered participation in day hospital (for the next session or the following one, depending on availability). In case of refusal, regardless of the reason (parents' availability, excessive distance from home, lack of motivation, etc.), patients will receive regular care in outpatient consultations. For the qualitative study, parents participating in day hospital for their adolescent will be offered inclusion in this research protocol.
The inclusion of young patients will take place over two calendar years (24 consecutive months) for the characterization of the active file. The study will continue for 5 years after the inclusion of the last patient in the study to investigate the outcome. In total, data collection for this research will last a maximum of 84 months (24 months of recruitment and a 5-year follow-up).
Visit 1 - Inclusion: collection of non-oppositions, initial clinical evaluation, then proposal to participate in the day hospital program:
- In case of refusal or impossibility of the day hospital program: multidisciplinary follow-up "as usual" at the consultation center (outpatient group).
- In case of acceptance of the day hospital program (day hospital group): scheduling of 10 to 12 sessions over 12 weeks during a program session, followed by a new evaluation at the end of the program. Outpatient follow-up thereafter.
Outpatient follow-up consists of appointments with the psychiatrist, pediatrician, and dietitian, on average, every month.
Follow-up visits:
- Day hospital group only - at approximately 12 weeks: Visit 1bis: clinical evaluation at the end of the program + semi-structured interviews with parents
- Visit 2 - at 6 months: evaluations, with a search for clinical events + semi-structured interview with patients (either at V2 or V3)
- Visit 3 - at 12 months: evaluations, with a search for clinical events + semi-structured interview with patients (either at V2 or V3)
End of research visit:
- Visit 4 - at 5 years: evaluations, with a search for clinical events
Visits V2, V3, and V4 can be conducted by phone. Visit V4, not necessarily planned as part of the adolescent's follow-up, may be added to care if necessary. It can be conducted by phone, depending on the adolescent's choice.
For participants who have taken part in the day hospital program or outpatient follow-up before the implementation of this protocol and who meet the inclusion criteria, the information sheet will be provided to them during a consultation by an investigator, and non-opposition will be obtained at the next consultation. In case of agreement to participate, data from already conducted visits will be collected retrospectively, and patients will then be contacted for the yet-to-be-performed assessment visits at 6 months (if applicable), 1 year (if applicable), and 5 years.
- Conditions
- Anorexia Nervosa
- Being tested
- Day Hospital Treatment, Multidisciplinary follow-up "as usual" within the service, Conduct semi-structured qualitative interviews
- Keywords
- Anorexia nervosa, Family-based treatment, Day hospital, Early intervention, Parental experience
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day Hospital TreatmentOther
Also called Family based treatment
Scheduling of 12 half-day sessions per week, alternating between sessions with only the patients or involving the entire family. Close medical monitoring and multidisciplinary interventions during sessions (pediatrician, psychiatrist, dietitian, recovered former patients...).
Multidisciplinary follow-up "as usual" within the serviceOther
Multidisciplinary follow-up "as usual" within the service
Conduct semi-structured qualitative interviewsOther
Conduct semi-structured qualitative interviews
| Study group | Role | What they receive |
|---|---|---|
| Day hospital patient | Acceptance of the DH program (DH group): scheduling of 10 to 12 sessions over 12 weeks during a program session, followed by a reassessment at the end of the program. Outpatient follow-up thereafter. Receives: Other: Day Hospital Treatment | |
| Outpatient | Refusal or inability to participate in the DH program: multidisciplinary follow-up "as usual" within the service (outpatient group). Receives: Other: Multidisciplinary follow-up "as usual" within the service | |
| Parents | Not described Receives: Other: Conduct semi-structured qualitative interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of one or more clinical events
Occurrence of one or more clinical events indicative of the progression of this disease (hospitalization, emergency room visits, major decompensation) at 1 year.
Evaluate the impact of early intervention in DH on the clinical progression of the disease compared to the usual outpatient care.
Measured: 1 year after inclusion
Secondary outcomes (6)
Occurrence of one or more clinical events
Occurrence of one or more clinical events indicative of the progression of this disease (hospitalization, emergency room visits, major decompensation) at 5 years in both care groups.
Evaluate the long-term impact of early intervention in DH on the clinical progression of the disease, compared to the usual outpatient care.
Measured: 5 years after inclusion
Conduct semi-structured qualitative interviews
Conduct semi-structured qualitative interviews with parents after participation in the DH program.
Explore the experience and perspectives of families participating in a new day hospital care program for adolescents with recent anorexia nervosa.
Measured: After DH termination = 12 weeks after inclusion
Satisfaction questionnaire CSQ-8 (Consumer satisfaction questionnaire)
Satisfaction questionnaire at the end of DH care. Assess the satisfaction level of the patient and their parents regarding DH care.
The range of possible scores is 8-32; (32 = higher satisfaction = better outcome, 8 = lower satisfaction)
Measured: After DH termination = 12 weeks after inclusion
Clinical characteristics collection
Initial clinical characteristics at the time of inclusion. Determine predictive factors for the outcome at the end of the intervention and in the long term.
Measured: Inclusion
Socio-demographic characteristics collection
Initial socio-demographic characteristics at the time of inclusion. Determine predictive factors for the outcome at the end of the intervention and in the long term.
Measured: Inclusion
Semi-structured interviews (DH program group)
Semi-structured interviews 6 to 12 months after their discharge from day hospital (visit 2 or 3 - DH program group), to assess the impact on the evolution of symptomatology of the experience lived by adolescents in the care within the framework of this early management system for anorexia nervosa (HDJ group).
Measured: From 6 to 12 months after the end of day hospital (visit 2 or 3 - DH program group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start19 Feb 2024
- Primary completionFeb 2028 (estimated)
- Study completionApr 2032 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218472
- Sponsor's protocol ID
- APHP231594
- Other IDs
- 2023-A02047-38
- Acronym
- EVA-FAM
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Early Treatment for Anorexia Nervosa in a Day Hospital on Food Symptomatology, the Outcome of Young Patients, and the Family Experience
- ClinicalTrials.gov ID
- NCT06218472
- Acronym / sponsor ID
- EVA-FAM / APHP231594
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Family-based treatment, Day hospital, Early intervention, Parental experience
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 23 Jan 2024 (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.
During the management of chronic illnesses, the day hospital (DH) serves as a brief and effective alternative to traditional hospitalization, offering access to multidisciplinary care. Indeed, patients can benefit from a range of therapeutic tools provided by a multidisciplinary care team while remaining in their living environment. Numerous structures exist for the management of eating disorders, but primarily for severe cases, often following hospitalization, before transitioning to outpatient care. There is no alternative for the initial management of these patients.
The DH for the evaluation and early intervention in recent forms of anorexia nervosa at Maison de Solenn serves as a rapid entry point to specialized care. It allows for a thorough assessment and sustained management of eating disorders. Our hypothesis is that a multidisciplinary, intensive, and early intervention for patients with anorexia nervosa and their families in a day hospital would improve the short, medium, and long-term prognosis of the disease compared to conventional multidisciplinary outpatient care. It would also enhance the family's experience of this pathology and their coping skills.
Detailed description
The patients recruited will come from the active consultation file of the inclusion center (spontaneous consultations, referrals from healthcare professionals, etc.), whether they have had an initial consultation or not. All patients admitted to day hospital during the study period who meet the inclusion criteria will be considered. A first evaluation consultation for mental anorexia will be conducted for all patients, including a somatic and psychological assessment, as well as a consultation with a dietitian. If eligible, the patient and their family will be offered participation in day hospital (for the next session or the following one, depending on availability). In case of refusal, regardless of the reason (parents' availability, excessive distance from home, lack of motivation, etc.), patients will receive regular care in outpatient consultations. For the qualitative study, parents participating in day hospital for their adolescent will be offered inclusion in this research protocol.
The inclusion of young patients will take place over two calendar years (24 consecutive months) for the characterization of the active file. The study will continue for 5 years after the inclusion of the last patient in the study to investigate the outcome. In total, data collection for this research will last a maximum of 84 months (24 months of recruitment and a 5-year follow-up).
Visit 1 - Inclusion: collection of non-oppositions, initial clinical evaluation, then proposal to participate in the day hospital program:
- In case of refusal or impossibility of the day hospital program: multidisciplinary follow-up "as usual" at the consultation center (outpatient group).
- In case of acceptance of the day hospital program (day hospital group): scheduling of 10 to 12 sessions over 12 weeks during a program session, followed by a new evaluation at the end of the program. Outpatient follow-up thereafter.
Outpatient follow-up consists of appointments with the psychiatrist, pediatrician, and dietitian, on average, every month.
Follow-up visits:
- Day hospital group only - at approximately 12 weeks: Visit 1bis: clinical evaluation at the end of the program + semi-structured interviews with parents
- Visit 2 - at 6 months: evaluations, with a search for clinical events + semi-structured interview with patients (either at V2 or V3)
- Visit 3 - at 12 months: evaluations, with a search for clinical events + semi-structured interview with patients (either at V2 or V3)
End of research visit:
- Visit 4 - at 5 years: evaluations, with a search for clinical events
Visits V2, V3, and V4 can be conducted by phone. Visit V4, not necessarily planned as part of the adolescent's follow-up, may be added to care if necessary. It can be conducted by phone, depending on the adolescent's choice.
For participants who have taken part in the day hospital program or outpatient follow-up before the implementation of this protocol and who meet the inclusion criteria, the information sheet will be provided to them during a consultation by an investigator, and non-opposition will be obtained at the next consultation. In case of agreement to participate, data from already conducted visits will be collected retrospectively, and patients will then be contacted for the yet-to-be-performed assessment visits at 6 months (if applicable), 1 year (if applicable), and 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Day hospital patient | – | Other: Day Hospital TreatmentAcceptance of the DH program (DH group): scheduling of 10 to 12 sessions over 12 weeks during a program session, followed by a reassessment at the end of the program. Outpatient follow-up thereafter. |
| Outpatient | – | Other: Multidisciplinary follow-up "as usual" within the serviceRefusal or inability to participate in the DH program: multidisciplinary follow-up "as usual" within the service (outpatient group). |
| Parents | – | Other: Conduct semi-structured qualitative interviews |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include patients of any gender aged 12 to 18 years and their parents, seen in consultation for anorexia nervosa at the pedopsychiatric unit of the Cochin Hospital, Paris, France.
Key inclusion criteria (3 listed)
- Adolescents in the age range of 12-18 years and their parents,
- First-time consultation at the MDA for anorexia nervosa (according to DSM-5) evolving for less than 12 months,
- Adolescents with clinical characteristics suitable for DH care.
Key exclusion criteria (6 listed)
- Parents and/or children who do not speak French or cannot read or write,
- Patients who have been followed by an eating disorder specialist in the past 12 months (at the MDA or elsewhere) or previously hospitalized for anorexia nervosa,
- Patients who have undergone family therapy in the past,
- Patients with BMI less than 13 kg/m2 for those under 14 years old, or less than 14 kg/m2 for those over 14 years old at the initial assessment,
- Patients with a major psychiatric comorbidity or a metabolic condition interfering with eating or its regulation,
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 |
|---|---|---|
| Day Hospital TreatmentAlso: Family based treatmentScheduling of 12 half-day sessions per week, alternating between sessions with only the patients or involving the entire family. Close medical monitoring and multidisciplinary interventions during sessions (pediatrician, psychiatrist, dietitian, recovered former patients...). | Other | Day hospital patient |
| Multidisciplinary follow-up "as usual" within the serviceMultidisciplinary follow-up "as usual" within the service | Other | Outpatient |
| Conduct semi-structured qualitative interviewsConduct semi-structured qualitative interviews | Other | Parents |
Primary outcome
Occurrence of one or more clinical events
Time frame: 1 year after inclusion
Occurrence of one or more clinical events indicative of the progression of this disease (hospitalization, emergency room visits, major decompensation) at 1 year. Evaluate the impact of early intervention in DH on the clinical progression of the disease compared to the usual outpatient care.
6 secondary outcomes
Occurrence of one or more clinical events
Time frame: 5 years after inclusion
Conduct semi-structured qualitative interviews
Time frame: After DH termination = 12 weeks after inclusion
Satisfaction questionnaire CSQ-8 (Consumer satisfaction questionnaire)
Time frame: After DH termination = 12 weeks after inclusion
Clinical characteristics collection
Time frame: Inclusion
Socio-demographic characteristics collection
Time frame: Inclusion
Semi-structured interviews (DH program group)
Time frame: From 6 to 12 months after the end of day hospital (visit 2 or 3 - DH program group)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne BLANCHET, MD, PhD (00 33 1 58 41 24 24, corinne.blanchet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of one or more clinical events (time frame: 1 year after inclusion). 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 29 Jan 2026.