Efficacy of a Phone-based Relapse Prevention for Anorexia Nervosa After a First Hospitalization (EATLINE)

February 28, 2022 updated by: University Hospital, Lille

Anorexia Nervosa (AN) is a highly challenging disease which consequences are serious. Relapse rate is estimated between 38 and 41% during the year following hospitalization. The efficacy of patients' phone contact procedure on relapse has been assessed and has shown interest in numerous disorders. However, no study has ever used phone contact as a relapse prevention intervention tool in AN.

Objective: To evaluate efficacy of a phone contact procedure to increase body weight at 12 months after a first hospitalization for AN, by comparison to standard medical follow-up. Secondary objectives are to evaluate effect of phone contact procedure on: change in body weight at 6 month, general psychopathology disorder, psychopathology disorder specific to AN, rate of usual follow-up visit, and medico-economic impact.

Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for subject over 15 years old presenting with diagnosis of AN. Patients randomized in EATLINE group will be contacted by phone at 15 days, 1, 2, 4 and 9 months after discharge from hospitalization. Patients in control group will benefit from usual follow-up.

Expected outcomes and perspectives:that there will be a significant decrease in relapse due to phone contact procedure compared to control group. Results would justify additional devices at the end of hospitalization, until development of various connected tools allowing to "stay in contact" with patients in order to optimize the current therapeutic possibilities of AN.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Hénin-Beaumont, France
        • Not yet recruiting
        • Centre Hospitalier General
      • Lille, France
        • Recruiting
        • Hôpital Fontan2, CHU
        • Contact:
        • Principal Investigator:
          • Olivier COTTENCIN, MD, PhD
      • Lille, France
        • Not yet recruiting
        • Hôpital Saint Vincent de Paul, GHICL
      • Loos, France
        • Not yet recruiting
        • Cliniqie Lautreamont
      • Montpellier, France
        • Not yet recruiting
        • CHU de Montpellier
      • Nantes, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject over 15 years of age
  • Diagnosis of AN (restrictive and/or purgative) according to DSM-5 criteria
  • Included after a first inpatient hospitalization in specialized care
  • Providing informed, dated and signed consent (for a minor, consent must be signed by both parents who have parental authority )
  • With medical insurance
  • Can be reached by telephone

Exclusion Criteria:

  • Uncompensated psychiatric pathology
  • Refusal to participate in the study
  • The inability to consent to care (patient or his/her legal representative)
  • Pregnancy
  • Major incapable subject or under guardianship or judicial protection
  • Homelessness
  • No mastery of reading and writing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: control group
Other: Control

After discharge from the first hospitalization:

  • No specific phone calls
  • TAU: outpatient visits (at least monthly consultations) or scheduled hospitalizations
  • 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition
Experimental: eatline group
Other: Eatline

After discharge from a first hospitalization:

Phone calls at 15 days, 1, 2, 4 and 9 months by a trained psychologist. The phone interview will be guided by the same standardized frame, which was developed by a group of experts and tested with a group of patients. The purpose of this intervention is to provide a therapeutic and motivational approach, with positive reinforcement and reassurance.

  • Added to treatment as usual (TAU): outpatient visits (at least monthly consultations) or scheduled hospitalizations
  • 6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in body mass index (BMI)
Time Frame: from discharge of the first hospitalization to 12 months.
from discharge of the first hospitalization to 12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
change in BMI from the first hospitalization
Time Frame: from the first hospitalization to 6 months and at 1 year
from the first hospitalization to 6 months and at 1 year
Mini International Neuropsychiatric Interview (MINI)
Time Frame: at baseline, at 6 months , at 1 year
at baseline, at 6 months , at 1 year
SCID-2 (Structured Clinical Interview for DSM IV Axis II Personality Disorders)
Time Frame: at baseline, at 6 months , at 1 year
at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by EDI (Eating Disorders Inventory)
Time Frame: at baseline, at 6 months , at 1 year
at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed BSQ (Body Shape Questionnaire)
Time Frame: at baseline, at 6 months , at 1 year
at baseline, at 6 months , at 1 year
The level of psychopathology specific to AN assessed by WCS (Weight and Shape Concern Scale)
Time Frame: at baseline, at 6 months , at 1 year
at baseline, at 6 months , at 1 year
Rate of patients lost to follow-up visits
Time Frame: during the one year
during the one year
Rate of patients with at least one re-hospitalization or earlier consultations than expected
Time Frame: during the one year
during the one year
Medico-economic evaluation with the MEDEC questionnaire
Time Frame: at 6 months, at 1 year
at 6 months, at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Olivier Cottencin, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_73
  • 2018-A02536-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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