Anorexia NervosaEVHANNCT00910169
Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM)
An observational study of Anorexia Nervosa, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
The objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. The primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up… Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- inpatient treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Oct 2012
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients hospitalisied in 11 tertiary centers for eating disorders in france
Who may be able to join
- All patients who accept participation between 8 and 50 years old, consecutively hospitalized for a DSM IV diagnosis of Anorexia Nervosa in one of the departments participating in this research by necessity of physical condition (BMI < 15, rapid weight loss) or psychological condition
- Parents of participating patients still living with their parents who accept participation
Who cannot join
- Refusal of research
- Patients who do not speak French
- Patients with a related somatic illness (diabetes, Crohn's disease, metabolic illness)
- Patients not covered by social security health insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.
The objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. The primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up, even after adjustment for confounding factors (age, length of illness, number of previous hospitalizations, clinical state at intake).
Read the detailed description
This study will evaluate global, psychiatric, somatic and psychosocial outcome for inpatients with anorexia nervosa through three evaluations (intake, discharge and one-year follow-up). The study will also consider five types of in-patient treatment in a naturalistic setting (i.e., patients will not be assigned to different treatment conditions; rather, we will study inpatient care as it exists today). The five treatment modalities to be studied are:
- Discharge weight objectives.
- The practice of a separation period.
- The use of clear nutritional and dietary objectives (cognitive/behavioural).
- The intensity of family involvement in treatment.
- Stabilisation phase before ending inpatient treatment.
- Conditions
- Anorexia Nervosa
- Being tested
- inpatient treatment
- Keywords
- Anorexia nervosa, treatment, inpatient, efficacy, outcome
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient treatmentOther
Also called naturalistic treatment
Hospitalisation modalities are described but are naturalistic
| Study group | Role | What they receive |
|---|---|---|
| inpatient treatment | naturalistic treatment no modification: observational study Receives: Other: inpatient treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morgan and Russell score
Measured: one year follow-up
Secondary outcomes (9)
Nutritional status
Measured: one year follow-up
Eating disorders symptoms and diagnosis
Measured: one year follow-up
Psychiatric symptoms and disorders
Measured: one year follow-up
Cognitive functioning
Measured: one year follow-up
Somatic symptoms and complications
Measured: one year follow-up
Social adjustment
Measured: one year follow-up
Quality of life
Measured: one year follow-up
Family relationships
Measured: one year follow-up
Re-hospitalization
Measured: one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, National Research Agency, France, National Health Insurance Fund, Fondation de la Mutuelle Générale de l'Education Nationale, Fondation de France
- Investigators
- Godart Nathalie, PhD, Principal investigator, INSERM and Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910169
- Sponsor's protocol ID
- Eudract: 2007 -A01110-53
- Other IDs
- ANR-0-JC0719-6328, PHRC AOM 06 020
- Acronym
- EVHAN
- Status last verified
- May 2009
- First submitted
- 26 May 2009
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Duclos J, Piva G, Riquin E, Lalanne C, Meilleur D, Blondin S; EVHAN Group; Cook-Darzens S, Godart N. Caregivers in anorexia nervosa: is grief underlying parental burden? Eat Weight Disord. 2023 Feb 20;28(1):16. doi: 10.1007/s40519-023-01530-x.
PubMed 36807834
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.
- ClinicalTrials.gov ID
- NCT00910169
- Acronym / sponsor ID
- EVHAN / Eudract: 2007 -A01110-53
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, treatment, inpatient, efficacy, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, National Research Agency, France, National Health Insurance Fund, Fondation de la Mutuelle Générale de l'Education Nationale, Fondation de France
- Study start
- Mar 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 29 May 2009 (estimated)
- 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.
The objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. The primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up, even after adjustment for confounding factors (age, length of illness, number of previous hospitalizations, clinical state at intake).
Detailed description
This study will evaluate global, psychiatric, somatic and psychosocial outcome for inpatients with anorexia nervosa through three evaluations (intake, discharge and one-year follow-up). The study will also consider five types of in-patient treatment in a naturalistic setting (i.e., patients will not be assigned to different treatment conditions; rather, we will study inpatient care as it exists today). The five treatment modalities to be studied are:
- Discharge weight objectives.
- The practice of a separation period.
- The use of clear nutritional and dietary objectives (cognitive/behavioural).
- The intensity of family involvement in treatment.
- Stabilisation phase before ending inpatient treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inpatient treatment | – | Other: inpatient treatmentnaturalistic treatment no modification: observational study |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients hospitalisied in 11 tertiary centers for eating disorders in france
Key inclusion criteria (2 listed)
- All patients who accept participation between 8 and 50 years old, consecutively hospitalized for a DSM IV diagnosis of Anorexia Nervosa in one of the departments participating in this research by necessity of physical condition (BMI < 15, rapid weight loss) or psychological condition
- Parents of participating patients still living with their parents who accept participation
Key exclusion criteria (4 listed)
- Refusal of research
- Patients who do not speak French
- Patients with a related somatic illness (diabetes, Crohn's disease, metabolic illness)
- Patients not covered by social security health insurance
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 |
|---|---|---|
| inpatient treatmentAlso: naturalistic treatmentHospitalisation modalities are described but are naturalistic | Other | inpatient treatment |
Primary outcome
Morgan and Russell score
Time frame: one year follow-up
9 secondary outcomes
Nutritional status
Time frame: one year follow-up
Eating disorders symptoms and diagnosis
Time frame: one year follow-up
Psychiatric symptoms and disorders
Time frame: one year follow-up
Cognitive functioning
Time frame: one year follow-up
Somatic symptoms and complications
Time frame: one year follow-up
Social adjustment
Time frame: one year follow-up
Quality of life
Time frame: one year follow-up
Family relationships
Time frame: one year follow-up
Re-hospitalization
Time frame: one year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Derived from this study: PubMed 36807834Duclos J, Piva G, Riquin E, Lalanne C, Meilleur D, Blondin S; EVHAN Group; Cook-Darzens S, Godart N. Caregivers in anorexia nervosa: is grief underlying parental burden? Eat Weight Disord. 2023 Feb 20;28(1):16. doi: 10.1007/s40519-023-01530-x.
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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.
Godart Nathalie, PhD principal investigator
INSERM and Institut Mutualiste Montsouris
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 Institut Mutualiste Montsouris 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 2 inclusion and 4 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 7 Aug 2012. 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?
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?
Morgan and Russell score (time frame: one year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00910169, which also lists 1 linked publication.
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 7 Aug 2012.