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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Eating Disorders
• Intervention / Treatment: Other: Program (Systematic Minimal Early Intervention for Eating Disorders)

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 Type: Interventional
• Enrollment (Estimated): 215
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: OUIZA Mme MANSEUR, PROJECT MANAGER; Phone Number: +33 1 45 65 84 01.45.65.61.65; Email: ouiza.manseur@ghu-paris.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • GHU Paris Psychiatrie et Neurosciences
    • Contact: Philibert DURIEZ, MD, PhD; Phone Number: +3345658345; Email: p.duriez@ghu-paris.fr
    • Contact: Marion DELOULAY; Phone Number: 01 45 65 83 43; Email: m.deloulay@ghu-paris.fr
    • Principal Investigator: Marion DELOULAY, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	end of the 10-month

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Principal Investigator: MARION Mme DELOULAY, Nurse, Hôpital Sainte-Anne

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Anorexia Nervosa, Bulimia Nervosa
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa
• Other Study ID Numbers: D24-P028; 2025-A00104-45 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be used exclusively for the analyses planned in the protocol and will not be shared outside the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No