Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— BodyBabe  

Official title:

Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04233450
• Other study ID #: RNI 2019 VILLEMEYRE-PLANE
• Secondary ID: 2019-A01000-57
• Status: Terminated
• Start date: January 26, 2020
• Est. completion date: July 11, 2021

Study information

• Verified date: August 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 11, 2021
• Est. primary completion date: July 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Other:
• BodyBabe questionnaire
assessment of young mothers' perceptions using self-questionnaires

Locations

Country	Name	City	State
France	Chu Clermont Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a 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	impact of the history of anorexia nervosa or severity on the questionnaires' scores	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