NCT05246696

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

October 19, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

February 9, 2022

Last Update Submit

October 17, 2022

Conditions

Keywords

mother anorexia nervosabody perceptionpost-partumbaby body

Outcome Measures

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

    day1, day 15, day 270

Secondary Outcomes (1)

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

    day1, day 15, day 270

Study Arms (1)

Patient group

Other: BodyBabe questionnaire

Interventions

assessment of young mothers' perceptions using self-questionnaires

Patient group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michèle Villemeyre-Plane

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 18, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

October 19, 2022

Record last verified: 2022-02