NCT07411807

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Dec 2025Apr 2027

Study Start

First participant enrolled

December 29, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Keywords

Anorexia Nervosa, Bulimia Nervosa

Outcome Measures

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.

    7 months

Secondary Outcomes (4)

  • Adherence to Online Support Groups

    At the end of the 3-month

  • Acceptability of Early Telephone Contact

    first 7 days

  • Clinical and Sociodemographic Profile of Patients Requesting Specialized Care

    the 6-month

  • Clinical and Sociodemographic Profile of Patients Lost to Follow-Up

    end of the 10-month

Study Arms (2)

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.

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.

Interventions

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

AGIS-TCA Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHU Paris Psychiatrie et Neurosciences

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • MARION Mme DELOULAY, Nurse

    Hôpital Sainte-Anne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

OUIZA Mme MANSEUR, PROJECT MANAGER

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

December 29, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations