ClinicalTrials.gg
RecruitingNCT07411807AGIS-TCAUpdated Feb 17, 2026

Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment.

An interventional study of Program (Systematic Minimal Early Intervention for Eating Disorders) in Eating Disorders, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
215
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 49 studies in Feeding and Eating Disorders with a site in France — 11 open to participants now, 14 under way, none of them phase 3. Feeding and Eating Disorders · France.

Planned enrollment
4th of 20
215 · median 76
Started
2025
with 7 others
No phase
17 of 49
4 open now
Primary completion
2027-04
later than 10 of 13 live
Registered
47th of 49
by date

Among the 49 studies in Feeding and Eating Disorders with a site in France, this one is the 4th largest by planned enrollment of the 20 interventional ones that give a count, is one of 8 that started in 2025, is one of 17 with no phase, reaches primary completion later than 10 of the 13 other live ones, and was the 47th registered.

Feeding and Eating Disorders

645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.

Browse Feeding and Eating Disorders studies →

Open to participants now

11 of the 49 studies in Feeding and Eating Disorders with a site in France are open now. Recruiting first, the newest first:

5 more — sign in →

All 11 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 100 Feeding and Eating Disorders studies recruiting now, 31 (31%) set no upper age limit and 67 (67%) stop at 75 or younger; 45 take children under 18; 20 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 49 studies in Feeding and Eating Disorders with a site in France, or all of them as a file.
02

Study 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. 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.

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.

03

Conditions studied

  • Eating Disorders

Keywords

  • Anorexia Nervosa, Bulimia Nervosa
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • (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)

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
215 participants (estimated)

Study arms

  • Experimental
    AGIS-TCA Intervention Group

    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.

    Other: Program (Systematic Minimal Early Intervention for Eating Disorders)

  • No intervention
    Historical Comparison Group

    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.

Interventions

  • OtherProgram (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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 months

Secondary outcomes

  1. 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.

    Time frame: At the end of the 3-month

  2. 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.

    Time frame: first 7 days

  3. 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.

    Time frame: the 6-month

  4. 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.

    Time frame: end of the 10-month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — The data will be used exclusively for the analyses planned in the protocol and will not be shared outside the study investigators.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Apr 2027, 16 months after the start.

Of 269 non-industry interventional studies with no phase under Feeding and Eating Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 16 months is below that.

Counting every sponsor, half of 274 studies reached it within 28 months; a quarter within 14 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2026
First posted
Feb 17, 2026
StartActual
Dec 29, 2025
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Feb 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07411807
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Dec 29, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Feb 17, 2026

Study contacts

OUIZA Mme MANSEUR, PROJECT MANAGER
Contact
ouiza.manseur@ghu-paris.fr
01.45.65.61.65 ext. +33 1 45 65 84
MARION Mme DELOULAY, Nurse
principal investigator · Hôpital Sainte-Anne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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