Study Stopped
The project was to be led by midwives but the director of the school of midwives opposed it at the last moment...
Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa
BodyBabe2
2 other identifiers
observational
N/A
0 countries
N/A
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
Started Jun 2022
Typical duration for all trials
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
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedOctober 19, 2022
February 1, 2022
3 years
February 9, 2022
October 17, 2022
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
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
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