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WithdrawnNCT05246696BodyBabe2Updated Oct 19, 2022

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

An observational study in Anorexia Nervosa and Eating Disorders, sponsored by University Hospital, Clermont-Ferrand. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-19.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Why this study was withdrawn
The project was to be led by midwives but the director of the school of midwives opposed it at the last moment...
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
0
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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)
02

Conditions studied

  • Anorexia Nervosa
  • Eating Disorders

Keywords

  • mother anorexia nervosa
  • body perception
  • post-partum
  • baby body
03

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

Browse Anorexia studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient group

    Other: BodyBabe questionnaire

Interventions

  • OtherBodyBabe questionnaire

    assessment of young mothers' perceptions using self-questionnaires

06

What researchers measure

Primary outcomes

  1. evaluate the internal and external validity of the BodyBabe questionnaire

    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

    Time frame: day1, day 15, day 270

Secondary outcomes

  1. impact of the history of anorexia nervosa or severity on the questionnaires' scores

    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.

    Time frame: day1, day 15, day 270

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05246696
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Feb 18, 2022
Start date
Jun 2022 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Oct 19, 2022

Study contacts

Michèle Villemeyre-Plane
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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