Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa

NCT ID: NCT04233450

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-26

Study Completion Date

2021-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The BodyBabe studies aims to evaluate the perceptions that young mothers with anorexia nervosa (active or in remission) have of their own body and of the body of their child. The evaluations are carried out with self-assessment questionnaires and silhouette scales at three time points: D0 (during the stay at the maternity hospital), D15 (15 days after delivery) and M9 (9 months after delivery).

The output expected from this study is to validate a questionnaire to help healthcare providers to adapt their care of women with anorexia nervosa during the pregnancy and the post-partum period.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

During the stay at maternity hospital, healthcare providers will identify potential candidates for the study on a daily basis according to the following criteria :

* BMI at the beginning of the pregnancy lower than 18,5 kg/m2 And/or
* History of anorexia nervosa

Tools and methods

The questionnaires used for the self-assessments are the following :

* Two questionnaires that evaluate the body satisfaction

* The Body Shape Questionnaire (BSQ)
* A questionnaire assessing the satisfaction of the mother regarding her baby's body shape (BodyBabe questionnaire).
* Two silhouette scales

* Stunkard scale also called Figure Rating Scale (FRS)5
* Infant Body Figure Drawings
* A questionnaire evaluating the severity of the eating disorders : Eating Attitude Test (EAT)
* A questionnaire detecting depression symptoms during post-partum : Edinburgh Post-natal Depression Scale (EPDS)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorexia Nervosa Eating Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient group

BodyBabe questionnaire

Intervention Type OTHER

assessment of young mothers' perceptions using self-questionnaires

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BodyBabe questionnaire

assessment of young mothers' perceptions using self-questionnaires

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult woman, understanding and reading French, delivering in the CHU (Centre Hospitalier Universitaire) Clermont-Ferrand maternity hospital between 01/15/2020 and 01/14/2021, and with active or in remission anorexia nervosa diagnosed according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)
* able to accept participating to the study
* Affiliated to the national healthcare system

Exclusion Criteria

* delivery before 32 weeks of amenorrhea (significant prematurity and extreme prematurity)
* death in utero or medically-motivated induced termination
* infant death during labour or post-partum
* refusal to participate
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michèle Villemeyre-Plane

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A01000-57

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2019 VILLEMEYRE-PLANE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

rTMS and Body Shape Perception
NCT01717079 TERMINATED NA