Study of the Effectiveness of a Systematic Minimal Early Intervention on Care Engagement in Adults With Eating Disorders Requesting Specialized Treatment.
AGIS-TCA
2 other identifiers
interventional
215
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
1 active site
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 Start
First participant enrolled
December 29, 2025
CompletedFirst Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
February 17, 2026
February 1, 2026
1.3 years
February 9, 2026
February 9, 2026
Conditions
Keywords
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
EXPERIMENTALParticipants 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 INTERVENTIONA 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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MARION Mme DELOULAY, Nurse
Hôpital Sainte-Anne
Central Study Contacts
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