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

August 31, 2021 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

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)

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

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

Study Locations

      • Clermont-Ferrand, France, 63003
        • CHU Clermont Ferrand

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

adult woman delivering in the CHU Clermont-Ferrand maternity hospital with active or in remission anorexia nervosa diagnosed according to DSM-5 criteria

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient group
assessment of young mothers' perceptions using self-questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the internal and external validity of the BodyBabe questionnaire
Time Frame: day1, day 15, day 270
the internal validity of the questionnaire will be assessed with a factorial analysis. The internal consistency between sub-scales will be evaluated with the Cronbach α coefficient. The Spearman coefficient will be used to evaluate the item-subscale and inter-subscale correlation. The external validity will be estimated with Spearman correlation coefficient between different subscales. The reproducibility will be assessed by "test-request" at an interval of 15 days. Intra-class coefficients will be calculated for each subscale
day1, day 15, day 270

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of the history of anorexia nervosa or severity on the questionnaires' scores
Time Frame: day1, day 15, day 270
the scores will be compared to the state of the disease (active or in remission). Student Tests or ANOVA (non-parametric average comparisons from Mann-Whitney or Kruskal-Wallis for non-gaussian variables) will be implemented.
day1, day 15, day 270

Collaborators and Investigators

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

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)

January 26, 2020

Primary Completion (ACTUAL)

July 11, 2021

Study Completion (ACTUAL)

July 11, 2021

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (ACTUAL)

January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • RNI 2019 VILLEMEYRE-PLANE
  • 2019-A01000-57 (OTHER: 2019-A01000-57)

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.

Clinical Trials on Anorexia Nervosa

Clinical Trials on BodyBabe questionnaire

3
Subscribe