NCT04233450

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

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Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

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

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

January 26, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

January 15, 2020

Last Update Submit

August 31, 2021

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

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

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

Study Design

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

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

January 26, 2020

Primary Completion

July 11, 2021

Study Completion

July 11, 2021

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations