- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04233450
Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa (BodyBabe)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Clermont-Ferrand, France, 63003
- CHU Clermont Ferrand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient group
|
assessment of young mothers' perceptions using self-questionnaires
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate the internal and external validity of the BodyBabe questionnaire
Time Frame: day1, day 15, day 270
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
impact of the history of anorexia nervosa or severity on the questionnaires' scores
Time Frame: day1, day 15, day 270
|
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.
|
day1, day 15, day 270
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2019 VILLEMEYRE-PLANE
- 2019-A01000-57 (OTHER: 2019-A01000-57)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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