Study Stopped
low recruitment rate
Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa
BodyBabe
2 other identifiers
observational
12
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
1 active site
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
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
January 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2021
CompletedSeptember 5, 2021
August 1, 2021
1.5 years
January 15, 2020
August 31, 2021
Conditions
Keywords
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
Interventions
assessment of young mothers' perceptions using self-questionnaires
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michèle Villemeyre-Plane
University Hospital, Clermont-Ferrand
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