Eating DisordersAGIS-TCANCT07411807
Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment.
A study testing Program (Systematic Minimal Early Intervention for Eating Disorders) in people with Eating Disorders, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Eating disorders (EDs) are complex psychiatric conditions-such as anorexia nervosa and bulimia nervosa-often emerging in young adulthood and associated with high morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Program (Systematic Minimal Early Intervention for Eating Disorders)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteFrance
- Study dates
- 29 Dec 2025to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual who has submitted a request for care to the CMME for an eating disorder (anorexia nervosa or bulimia)
- Adult (18 years or older) Resident of the Île-de-France region
Who cannot join
- Body mass index (BMI) greater than 30 kg/m²: these patients will be directed, from the first telephone contact, to structures or care networks that can offer appropriate treatment.
- Poor understanding of the French language
- Sensory impairment significantly affecting telephone communication
- Patient currently receiving care at a specialized eating disorder facility at the time of the call
- Patient not consenting to participate in the study
- Subject under legal protection measures (guardianship or curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
OUIZA Mme MANSEUR, PROJECT MANAGER contact
France1 site, 1 recruiting
- Recruiting
GHU Paris Psychiatrie et Neurosciences
Paris, 75014
Philibert DURIEZ, MD, PhD, +3345658345, p.duriez@ghu-paris.fr
Marion DELOULAY, 01 45 65 83 43, m.deloulay@ghu-paris.fr
About this study
Official title: Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment: A Monocentric Pilot Study.
Eating disorders (EDs) are complex psychiatric conditions-such as anorexia nervosa and bulimia nervosa-often emerging in young adulthood and associated with high morbidity and mortality. Despite their severity, access to specialized care remains difficult, delayed by shame, stigma, and a lack of insight among patients, as well as long waiting times and limited specialized resources.
The AGIS-TCA pilot study aims to evaluate the effectiveness of a systematic minimal early intervention designed to reduce the number of patients lost to follow-up between their request for specialized care and the actual start of treatment.
Read more
This monocentric, low-risk interventional study will be conducted at the Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences. The intervention includes three early, structured telephone calls and five online support group sessions offered during the waiting period for care.
The main objective is to determine whether this proactive approach decreases attrition rates ("lost to follow-up") compared with a historical cohort. Secondary objectives include assessing the acceptability of early phone contact, adherence to support groups, and describing the clinical and sociodemographic profiles of patients requesting care or lost to follow-up.
The expected benefit is to facilitate timely access to care for vulnerable patients, prevent symptom worsening, and strengthen engagement in treatment pathways. Risks and constraints are minimal, as participation involves only remote interactions without any invasive procedures.
Read the detailed description
Eating disorders (EDs) such as anorexia nervosa and bulimia nervosa are severe psychiatric illnesses characterized by pathological eating behaviors and body-weight control strategies that significantly affect physical and mental health. These disorders typically emerge around age 18 and affect up to 2 million people in France. Despite the recognized importance of early treatment, many patients experience delays in accessing specialized care due to structural barriers (long waiting times, lack of resources) and individual factors (shame, denial, and poor insight into the illness).
At the Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences, approximately 20-25% of patients who request specialized care for an eating disorder are lost to follow-up before starting treatment. These individuals often fail to complete their application or do not attend the initial evaluation. The AGIS-TCA (Action Globale d'Intervention Systématique - Troubles du Comportement Alimentaire) study addresses this critical period between the request for care and the beginning of treatment.
The study tests the effectiveness and acceptability of a minimal, systematic, early intervention that supports patients during this waiting phase. The intervention consists of:
Three structured telephone calls (AT1, AT2, AT3) conducted at approximately day 7, day 45, and day 90 after the validation of the care request. These calls aim to maintain contact, provide information, assess needs, and strengthen motivation.
Five online support and education group sessions, each lasting 60 minutes and held biweekly, led by a multidisciplinary team (specialized nurse, physician, dietitian, psychologist, psychomotor therapist, and peer support worker). Topics include medical aspects of EDs, body image, emotions, dietetics, and relationships with relatives.
This proactive "outreach" approach is compared to a historical control cohort from the previous year, managed under standard procedures (no systematic follow-up during the waiting period).
The primary endpoint is the rate of patients lost to follow-up (patients who requested care but did not attend evaluation or start treatment within 10 months).
Secondary endpoints include:
Participation rate in support groups.
Acceptance rate of early telephone contact.
Sociodemographic and clinical characterization of patients requesting care and those lost to follow-up.
The study is monocentric, non-randomized, and involves minimal risk. It includes 215 adult participants living in the Île-de-France region who have requested care for anorexia or bulimia at the CMME.
Expected benefits include improved engagement in care, reduced loss to follow-up, and earlier access to specialized treatment. The intervention is non-invasive, free of physical constraints, and participation or withdrawal has no impact on future access to care.
If effective and acceptable, the results of this pilot study could support the implementation of similar early intervention programs across other specialized eating disorder centers and form the basis for a multicenter study assessing long-term clinical outcomes and cost-effectiveness.
- Conditions
- Eating Disorders
- Being tested
- Program (Systematic Minimal Early Intervention for Eating Disorders)
- Keywords
- Anorexia Nervosa, Bulimia Nervosa
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program (Systematic Minimal Early Intervention for Eating Disorders)Other
The AGIS-TCA intervention consists of a structured early proactive support program designed to maintain patient engagement during the waiting period before specialized treatment for eating disorders
| Study group | Role | What they receive |
|---|---|---|
| AGIS-TCA Intervention Group | Experimental | Participants will receive a systematic minimal early intervention designed to maintain engagement during the waiting period before specialized treatment for an eating disorder.
The intervention includes:
Three structured telephone calls (AT1, AT2, AT3) at approximately day 7, day 45, and day 90 after validation of the care request. These calls aim to provide information, emotional support, and risk prevention guidance, and to maintain motivation for treatment.
Five online support group sessions (60 minutes each, every two weeks) led by a multidisciplinary team (specialized nurse, physician, dietitian, psychologist, psychomotor therapist, and peer support worker).
Duration: 3 months per participant. Number of Participants: 215 adults. Study Site: Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences. Receives: Other: Program (Systematic Minimal Early Intervention for Eating Disorders) |
| Historical Comparison Group | No intervention | A historical cohort of patients who requested specialized care for an eating disorder during the previous year (01/11/2024-31/10/2025), before implementation of the AGIS-TCA program. These patients received standard care procedures, which involved no systematic contact during the waiting period between their request for treatment and the start of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Patients Lost to Follow-Up
The primary outcome is the difference in the rate of patients lost to follow-up between the intervention group (AGIS-TCA program) and a historical control cohort.
A patient is considered lost to follow-up if they have submitted a valid request for specialized care (excluding cases of reorientation) but have not attended the evaluation days at the Eating Disorders Expert Center (CMME) or completed their intake process within 10 months of their initial request.
Measured: 7 months
Secondary outcomes (4)
Adherence to Online Support Groups
Adherence will be measured by comparing the number of participants offered the support group sessions with the number of participants who attend at least one 60-minute online session. This indicator reflects engagement and feasibility of the AGIS-TCA program's group component.
Measured: At the end of the 3-month
Acceptability of Early Telephone Contact
Acceptability will be measured by the proportion of eligible patients successfully reached during the first telephone contact (AT1) compared with the total number of patients invited. It evaluates the practicality and acceptance of proactive outreach by patients awaiting care.
Measured: first 7 days
Clinical and Sociodemographic Profile of Patients Requesting Specialized Care
Characterization of all patients requesting specialized care for eating disorders, based on collected data: age, sex, socioeconomic background, presumed diagnosis, and illness duration. This will provide a descriptive overview of the population accessing the service.
Measured: the 6-month
Clinical and Sociodemographic Profile of Patients Lost to Follow-Up
Characterization of patients identified as lost to follow-up, using the same variables (age, sex, socioeconomic background, presumed diagnosis, illness duration) to identify potential predictors of disengagement from care.
Measured: end of the 10-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start29 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 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.
- More trials run by Centre Hospitalier St AnneThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARION Mme DELOULAY, Nurse, Principal investigator, Hôpital Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411807
- Sponsor's protocol ID
- D24-P028
- Other IDs
- 2025-A00104-45
- Acronym
- AGIS-TCA
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be used exclusively for the analyses planned in the protocol and will not be shared outside the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment: A Monocentric Pilot Study.
- ClinicalTrials.gov ID
- NCT07411807
- Acronym / sponsor ID
- AGIS-TCA / D24-P028
- Conditions
- Eating Disorders
- Keywords
- Anorexia Nervosa, Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Feb 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.
Eating disorders (EDs) are complex psychiatric conditions-such as anorexia nervosa and bulimia nervosa-often emerging in young adulthood and associated with high morbidity and mortality. Despite their severity, access to specialized care remains difficult, delayed by shame, stigma, and a lack of insight among patients, as well as long waiting times and limited specialized resources.
The AGIS-TCA pilot study aims to evaluate the effectiveness of a systematic minimal early intervention designed to reduce the number of patients lost to follow-up between their request for specialized care and the actual start of treatment.
This monocentric, low-risk interventional study will be conducted at the Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences. The intervention includes three early, structured telephone calls and five online support group sessions offered during the waiting period for care.
The main objective is to determine whether this proactive approach decreases attrition rates ("lost to follow-up") compared with a historical cohort. Secondary objectives include assessing the acceptability of early phone contact, adherence to support groups, and describing the clinical and sociodemographic profiles of patients requesting care or lost to follow-up.
The expected benefit is to facilitate timely access to care for vulnerable patients, prevent symptom worsening, and strengthen engagement in treatment pathways. Risks and constraints are minimal, as participation involves only remote interactions without any invasive procedures.
Detailed description
Eating disorders (EDs) such as anorexia nervosa and bulimia nervosa are severe psychiatric illnesses characterized by pathological eating behaviors and body-weight control strategies that significantly affect physical and mental health. These disorders typically emerge around age 18 and affect up to 2 million people in France. Despite the recognized importance of early treatment, many patients experience delays in accessing specialized care due to structural barriers (long waiting times, lack of resources) and individual factors (shame, denial, and poor insight into the illness).
At the Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences, approximately 20-25% of patients who request specialized care for an eating disorder are lost to follow-up before starting treatment. These individuals often fail to complete their application or do not attend the initial evaluation. The AGIS-TCA (Action Globale d'Intervention Systématique - Troubles du Comportement Alimentaire) study addresses this critical period between the request for care and the beginning of treatment.
The study tests the effectiveness and acceptability of a minimal, systematic, early intervention that supports patients during this waiting phase. The intervention consists of:
Three structured telephone calls (AT1, AT2, AT3) conducted at approximately day 7, day 45, and day 90 after the validation of the care request. These calls aim to maintain contact, provide information, assess needs, and strengthen motivation.
Five online support and education group sessions, each lasting 60 minutes and held biweekly, led by a multidisciplinary team (specialized nurse, physician, dietitian, psychologist, psychomotor therapist, and peer support worker). Topics include medical aspects of EDs, body image, emotions, dietetics, and relationships with relatives.
This proactive "outreach" approach is compared to a historical control cohort from the previous year, managed under standard procedures (no systematic follow-up during the waiting period).
The primary endpoint is the rate of patients lost to follow-up (patients who requested care but did not attend evaluation or start treatment within 10 months).
Secondary endpoints include:
Participation rate in support groups.
Acceptance rate of early telephone contact.
Sociodemographic and clinical characterization of patients requesting care and those lost to follow-up.
The study is monocentric, non-randomized, and involves minimal risk. It includes 215 adult participants living in the Île-de-France region who have requested care for anorexia or bulimia at the CMME.
Expected benefits include improved engagement in care, reduced loss to follow-up, and earlier access to specialized treatment. The intervention is non-invasive, free of physical constraints, and participation or withdrawal has no impact on future access to care.
If effective and acceptable, the results of this pilot study could support the implementation of similar early intervention programs across other specialized eating disorder centers and form the basis for a multicenter study assessing long-term clinical outcomes and cost-effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGIS-TCA Intervention Group | Experimental | Other: Program (Systematic Minimal Early Intervention for Eating Disorders)Participants will receive a systematic minimal early intervention designed to maintain engagement during the waiting period before specialized treatment for an eating disorder. The intervention includes: Three structured telephone calls (AT1, AT2, AT3) at approximately day 7, day 45, and day 90 after validation of the care request. These calls aim to provide information, emotional support, and risk prevention guidance, and to maintain motivation for treatment. Five online support group sessions (60 minutes each, every two weeks) led by a multidisciplinary team (specialized nurse, physician, dietitian, psychologist, psychomotor therapist, and peer support worker). Duration: 3 months per participant. Number of Participants: 215 adults. Study Site: Clinique des Maladies Mentales et de l'Encéphale (CMME), GHU Paris Psychiatrie \& Neurosciences. |
| Historical Comparison Group | No intervention | –A historical cohort of patients who requested specialized care for an eating disorder during the previous year (01/11/2024-31/10/2025), before implementation of the AGIS-TCA program. These patients received standard care procedures, which involved no systematic contact during the waiting period between their request for treatment and the start of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individual who has submitted a request for care to the CMME for an eating disorder (anorexia nervosa or bulimia)
- Adult (18 years or older) Resident of the Île-de-France region
Key exclusion criteria (6 listed)
- Body mass index (BMI) greater than 30 kg/m²: these patients will be directed, from the first telephone contact, to structures or care networks that can offer appropriate treatment.
- Poor understanding of the French language
- Sensory impairment significantly affecting telephone communication
- Patient currently receiving care at a specialized eating disorder facility at the time of the call
- Patient not consenting to participate in the study
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 |
|---|---|---|
| Program (Systematic Minimal Early Intervention for Eating Disorders)The AGIS-TCA intervention consists of a structured early proactive support program designed to maintain patient engagement during the waiting period before specialized treatment for eating disorders | Other | AGIS-TCA Intervention Group |
Primary outcome
Rate of Patients Lost to Follow-Up
Time frame: 7 months
The primary outcome is the difference in the rate of patients lost to follow-up between the intervention group (AGIS-TCA program) and a historical control cohort. A patient is considered lost to follow-up if they have submitted a valid request for specialized care (excluding cases of reorientation) but have not attended the evaluation days at the Eating Disorders Expert Center (CMME) or completed their intake process within 10 months of their initial request.
4 secondary outcomes
Adherence to Online Support Groups
Time frame: At the end of the 3-month
Acceptability of Early Telephone Contact
Time frame: first 7 days
Clinical and Sociodemographic Profile of Patients Requesting Specialized Care
Time frame: the 6-month
Clinical and Sociodemographic Profile of Patients Lost to Follow-Up
Time frame: end of the 10-month
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided. The data will be used exclusively for the analyses planned in the protocol and will not be shared outside the study investigators.
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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.
OUIZA Mme MANSEUR, PROJECT MANAGER contact
MARION Mme DELOULAY, Nurse principal investigator
Hôpital Sainte-Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program (Systematic Minimal Early Intervention for Eating Disorders) in people with Eating Disorders, run by Centre Hospitalier St Anne 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 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 17 Feb 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 OUIZA Mme MANSEUR, PROJECT MANAGER (01.45.65.61.65 ext. +33 1 45 65 84, ouiza.manseur@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Patients Lost to Follow-Up (time frame: 7 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 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.