Anorexia NervosaEATLINENCT04102475
Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
A study testing Eatline in people with Anorexia Nervosa, run by University Hospital, Lille at 6 sites in France.
Trial summary
Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Eatline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 6 sitesFrance
- Study dates
- 18 Mar 2021to 8 Mar 2025
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject over 15 years of age
- Diagnosis of AN (restrictive and/or purgative) according to DSM-5 criteria
- Included after a first inpatient hospitalization in specialized care
- Providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority )
- With medical insurance
- Can be reached by telephone
Who cannot join
- Uncompensated psychiatric pathology
- Refusal to participate in the study
- The inability to consent to care (patient or his/her legal representative)
- Pregnancy
- Major incapable subject or under guardianship or judicial protection
- Homelessness
- No mastery of reading and writing
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier Général
Hénin-Beaumont
Hôpital Fontan2, CHU
Lille
Hôpital Saint Vincent de Paul, GHICL
Lille
Cliniqie Lautreamont
Loos
CHU de Montpellier
Montpellier
Centre Hospitalier Universitaire
Nantes
About this study
Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN.
Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact.
Read more
Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up.
Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.
- Conditions
- Anorexia Nervosa
- Being tested
- Eatline, Control
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EatlineOther
After discharge from a first hospitalization:
Phone calls at 15 days, 1, 2, 4 and 9 months by a trained psychologist. The phone interview will be guided by the same standardized frame, which was developed by a group of experts and tested with a group of patients. The purpose of this intervention is to provide a therapeutic and motivational approach, with positive reinforcement and reassurance.
- Added to treatment as usual (TAU): outpatient visits (at least monthly consultations) or scheduled hospitalizations
- 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition
ControlOther
After discharge from the first hospitalization:
- No specific phone calls
- TAU: outpatient visits (at least monthly consultations) or scheduled hospitalizations
- 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition
| Study group | Role | What they receive |
|---|---|---|
| eatline group | Experimental | Not described Receives: Other: Eatline |
| control group | Sham comparator | Not described Receives: Other: Control |
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 discharge of the first hospitalization to 12 months.
Secondary outcomes (9)
change in BMI from the first hospitalization
Measured: from the first hospitalization to 6 months and at 1 year
Mini International Neuropsychiatric Interview (MINI)
Measured: at baseline, at 6 months , at 1 year
SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)
Measured: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)
Measured: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)
Measured: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)
Measured: at baseline, at 6 months , at 1 year
Rate of patients lost to follow-up visits
Measured: during the one year
Rate of patients with at least one re-hospitalization or earlier consultations than expected
Measured: during the one year
Medico-economic evaluation with the MEDEC questionnaire
Measured: at 6 months, at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start18 Mar 2021
- Primary completion8 Mar 2025
- Study completion8 Mar 2025
Why it stopped: lack of human and financial resources
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 University Hospital, LilleThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Olivier Cottencin, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102475
- Sponsor's protocol ID
- 2017_73
- Other IDs
- 2018-A02536-49
- Acronym
- EATLINE
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2019
- Last updated
- 24 Apr 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization
- ClinicalTrials.gov ID
- NCT04102475
- Acronym / sponsor ID
- EATLINE / 2017_73
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of human and financial resources
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 25 Sep 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.
Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN.
Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact.
Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up.
Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eatline group | Experimental | Other: Eatline |
| control group | Sham comparator | Other: Control |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subject over 15 years of age
- Diagnosis of AN (restrictive and/or purgative) according to DSM-5 criteria
- Included after a first inpatient hospitalization in specialized care
- Providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority )
- With medical insurance
Key exclusion criteria (7 listed)
- Uncompensated psychiatric pathology
- Refusal to participate in the study
- The inability to consent to care (patient or his/her legal representative)
- Pregnancy
- Major incapable subject or under guardianship or judicial protection
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 |
|---|---|---|
| EatlineAfter discharge from a first hospitalization: Phone calls at 15 days, 1, 2, 4 and 9 months by a trained psychologist. The phone interview will be guided by the same standardized frame, which was developed by a group of experts and tested with a group of patients. The purpose of this intervention is to provide a therapeutic and motivational approach, with positive reinforcement and reassurance. * Added to treatment as usual (TAU): outpatient visits (at least monthly consultations) or scheduled hospitalizations * 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition | Other | eatline group |
| ControlAfter discharge from the first hospitalization: * No specific phone calls * TAU: outpatient visits (at least monthly consultations) or scheduled hospitalizations * 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition | Other | control group |
Primary outcome
change in body mass index (BMI)
Time frame: from discharge of the first hospitalization to 12 months.
9 secondary outcomes
change in BMI from the first hospitalization
Time frame: from the first hospitalization to 6 months and at 1 year
Mini International Neuropsychiatric Interview (MINI)
Time frame: at baseline, at 6 months , at 1 year
SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)
Time frame: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)
Time frame: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)
Time frame: at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)
Time frame: at baseline, at 6 months , at 1 year
Rate of patients lost to follow-up visits
Time frame: during the one year
Rate of patients with at least one re-hospitalization or earlier consultations than expected
Time frame: during the one year
Medico-economic evaluation with the MEDEC questionnaire
Time frame: at 6 months, at 1 year
Results and safety
The study was stopped early (reason given: lack of human and financial resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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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.
Olivier Cottencin, MD,PhD principal investigator
University Hospital, Lille
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eatline in people with Anorexia Nervosa, run by University Hospital, Lille at 6 sites 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: lack of human and financial resources). 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?
change in body mass index (BMI) (time frame: from discharge of the first hospitalization to 12 months.). 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 24 Apr 2026.