Detection of Eating Disorders in Pregnant Women (PREGN'ED)

August 18, 2023 updated by: Centre Hospitalier Henri Laborit

Eating disorders (ED) are insufficiently detected and belatedly or not treated during pregnancy.

There are many screening questionnaires for eating disorders in the literature, but we note the absence of a specific and validated tool for their screening during pregnancy, which would make it possible to differentiate maternal dietary concerns related to pregnancy from symptoms linked to a proven eating disorder.

The main objective of the study is to evaluate which items of the Sick Control One stone Fat Food (SCOFF-F) and Eating disorders examination questionnaire (EDE-Q) questionnaires could be specific to an ED during pregnancy and not related to the simple state of pregnancy, by comparing the answers of pregnant women, for whom the diagnosis of ED has been made, to those of pregnant women without an ED.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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
      • Poitiers, France
        • Recruiting
        • Centre Hospitalier Henri Laborit
        • Contact:
          • Charlotte XAVIER-DAVID, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult pregnant woman
  • Woman with current diagnosed Eating Disorders or without Eating Disorders
  • Having a good command of the French language
  • Having given their consent for their participation in the research

Exclusion Criteria:

  • Underage pregnant woman
  • Woman who does not have a good command of the French language.
  • Woman with past Eating Disorders

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group of pregnant women with eating disorder
Diagnostic test: Administration of the SCOFF-F and EDE-Q questionnaires
The participants will answer to the SCOFF-F and EDE-Q questionnaires as well as socio-demographic questions
Other: Group of pregnant women with no eating disorder
Diagnostic test: Administration of the SCOFF-F and EDE-Q questionnaires
The participants will answer to the SCOFF-F and EDE-Q questionnaires as well as socio-demographic questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific Eating Disorders items in pregnant women
Time Frame: 36 months
A discriminant factor analysis will be used to study whether there are elements that can distinguish women with an Eating Disorders from those who do not have one during pregnancy.
36 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Henri Laborit

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)

June 30, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A00529-36

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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