Eating DisordersUDJ-TCANCT07648108
Evaluation of a Day Hospital Program for Adolescents and Young Adults With Eating Disorders
A study testing Day Hospital Multidisciplinary Care in people with Eating Disorders and Nervosa Adolescent, run by Fondation Santé des Étudiants de France.
Trial summary
This study aims to evaluate the clinical, psychological, and functional outcomes of adolescents with anorexia nervosa receiving multidisciplinary care in hospital settings. Participants are treated either in a day hospitalization program or in a full-time inpatient program, in accordance with the French national… Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Eating Disorders, Nervosa Adolescent, Adolescent Eating Disorders
- What is being tested?
- Day Hospital Multidisciplinary Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2026to 24 Feb 2027
- Phase
- Interventional
- 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 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents and young adults aged 12 to 22 years
- Diagnosed with an eating disorder
- Referred for admission to the day hospital program between October 2019 and December 2023
- Provided informed consent (and parental consent for minors)
Who cannot join
- Refusal to participate
- Age below 12 years or above 22 years
About this study
Official title: Evaluation of the Contribution of a Specialized Day Hospital for Adolescents and Young Adults With Eating Disorders: Long-Term Clinical Outcomes and Cross-Reported Experiences
This study aims to evaluate the clinical, psychological, and functional outcomes of adolescents with anorexia nervosa receiving multidisciplinary care in hospital settings. Participants are treated either in a day hospitalization program or in a full-time inpatient program, in accordance with the French national guidelines (Haute Autorité de Santé, HAS) for the management of anorexia nervosa.
The study seeks to better understand the evolution of patients' health status over time, including nutritional, psychological, and social dimensions, and to identify factors associated with treatment response. Data will be collected as part of routine clinical care without modification of the standard therapeutic management.
The results of this study may help improve clinical practices and optimize care pathways for adolescents with anorexia nervosa.
- Being tested
- Day Hospital Multidisciplinary Care, Standard Care Outside Day Hospital Program
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day Hospital Multidisciplinary CareOther
Participants admitted to the day hospital receive a multidisciplinary treatment program including psychiatric, medical, nutritional, and psychosocial care, delivered through structured daytime sessions without overnight stay.
Standard Care Outside Day Hospital ProgramOther
Participants not admitted to the day hospital program receive usual care according to standard clinical pathways outside the specialized day hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Day Hospital Program | Other | Participants admitted to a specialized multidisciplinary day hospital program for eating disorders. Receives: Other: Day Hospital Multidisciplinary Care |
| Non-Admitted Participants | Other | Participants who requested admission but were not admitted to the day hospital program. Receives: Other: Standard Care Outside Day Hospital Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
Measured: From admission request to at least 18 months follow-up
Secondary outcomes (7)
Change in eating disorder psychopathology assessed by EDE-Q
Eating disorder psychopathology will be assessed using the Eating Disorder Examination Questionnaire (EDE-Q), a self-report scale ranging from 0 to 6, with higher scores indicating more severe symptoms. The assessment will be performed at admission and discharge.
Measured: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in body image concerns assessed by BSQ
Body image concerns will be assessed using the Body Shape Questionnaire (BSQ), a self-report scale with higher scores indicating greater body dissatisfaction. The assessment will be performed at admission and discharge.
Measured: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in anxiety and depression symptoms assessed by HADS
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS), which includes subscales for anxiety and depression, each ranging from 0 to 21, with higher scores indicating greater symptom severity. The assessment will be performed at admission and discharge.
Measured: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in obsessive-compulsive symptoms assessed by MOCI
Obsessive-compulsive symptoms will be assessed using the Maudsley Obsessive-Compulsive Inventory (MOCI), where higher scores indicate more severe symptoms. The assessment will be performed at admission and discharge.
Measured: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in eating disorder-related quality of life assessed by EDQoL
Quality of life related to eating disorders will be assessed using the Eating Disorders Quality of Life (EDQoL) questionnaire, with higher scores indicating greater impairment. The assessment will be performed at admission and discharge
Measured: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in autistic traits assessed by AQ-10
Autistic traits will be assessed using the Autism Spectrum Quotient (AQ-10), a brief screening tool with higher scores indicating more pronounced autistic traits. The assessment will be performed at admission and discharge
Measured: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in family functioning assessed by FAD-12
Family functioning will be assessed using the Family Assessment Device (FAD-12), with higher scores indicating poorer family functioning. The assessment will be performed at admission and discharge.
Measured: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start25 May 2026 (estimated)
- Primary completion24 Feb 2027 (estimated)
- Study completion24 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to groups based on admission status to a specialized day hospital program for eating disorders. This is a non-randomized quasi-experimental study comparing individuals admitted to the program and those not admitted, with outcomes assessed over time.
- Masking
- None (open label)
- Enrolment
- 307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Santé des Étudiants de France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648108
- Sponsor's protocol ID
- 2024-A02535-42
- Acronym
- UDJ-TCA
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 15 Jun 2026
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contribution of a Specialized Day Hospital for Adolescents and Young Adults With Eating Disorders: Long-Term Clinical Outcomes and Cross-Reported Experiences
- ClinicalTrials.gov ID
- NCT07648108
- Acronym / sponsor ID
- UDJ-TCA / 2024-A02535-42
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 307 participants (estimated)
- Lead sponsor
- Fondation Santé des Étudiants de FranceUniversity, hospital or other
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Feb 2027 (estimated)
- First posted
- 15 Jun 2026 (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.
This study aims to evaluate the clinical, psychological, and functional outcomes of adolescents with anorexia nervosa receiving multidisciplinary care in hospital settings. Participants are treated either in a day hospitalization program or in a full-time inpatient program, in accordance with the French national guidelines (Haute Autorité de Santé, HAS) for the management of anorexia nervosa.
The study seeks to better understand the evolution of patients' health status over time, including nutritional, psychological, and social dimensions, and to identify factors associated with treatment response. Data will be collected as part of routine clinical care without modification of the standard therapeutic management.
The results of this study may help improve clinical practices and optimize care pathways for adolescents with anorexia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to groups based on admission status to a specialized day hospital program for eating disorders. This is a non-randomized quasi-experimental study comparing individuals admitted to the program and those not admitted, with outcomes assessed over time.
| Arm | Type | Receives |
|---|---|---|
| Day Hospital Program | Other | Other: Day Hospital Multidisciplinary CareParticipants admitted to a specialized multidisciplinary day hospital program for eating disorders. |
| Non-Admitted Participants | Other | Other: Standard Care Outside Day Hospital ProgramParticipants who requested admission but were not admitted to the day hospital program. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents and young adults aged 12 to 22 years
- Diagnosed with an eating disorder
- Referred for admission to the day hospital program between October 2019 and December 2023
- Provided informed consent (and parental consent for minors)
Key exclusion criteria (2 listed)
- Refusal to participate
- Age below 12 years or above 22 years
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 Multidisciplinary CareParticipants admitted to the day hospital receive a multidisciplinary treatment program including psychiatric, medical, nutritional, and psychosocial care, delivered through structured daytime sessions without overnight stay. | Other | Day Hospital Program |
| Standard Care Outside Day Hospital ProgramParticipants not admitted to the day hospital program receive usual care according to standard clinical pathways outside the specialized day hospital setting. | Other | Non-Admitted Participants |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: From admission request to at least 18 months follow-up
7 secondary outcomes
Change in eating disorder psychopathology assessed by EDE-Q
Time frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in body image concerns assessed by BSQ
Time frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in anxiety and depression symptoms assessed by HADS
Time frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in obsessive-compulsive symptoms assessed by MOCI
Time frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in eating disorder-related quality of life assessed by EDQoL
Time frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in autistic traits assessed by AQ-10
Time frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
Change in family functioning assessed by FAD-12
Time frame: Baseline (at admission), discharge (end of hospitalization), and follow-up at least 18 months after admission
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 15 Jun 2026.
Related trials for Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Recruiting
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Bulimia Nervosa, Feeding and Eating Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Day Hospital Multidisciplinary Care in people with Eating Disorders and Nervosa Adolescent, run by Fondation Santé des Étudiants de 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: From admission request to at least 18 months follow-up). 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 15 Jun 2026.