Anorexia NervosaBodyBabeNCT04233450
Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa
An observational study of Anorexia Nervosa and Eating Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anorexia Nervosa, Eating Disorders
- What is being tested?
- BodyBabe questionnaire
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2020to 11 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Anorexia Nervosa, Eating Disorders
- Being tested
- BodyBabe questionnaire
- Keywords
- mother anorexia nervosa, body perception, post-partum, baby body
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyBabe questionnaireOther
assessment of young mothers' perceptions using self-questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Not described Receives: Other: BodyBabe questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day1, day 15, day 270
Secondary outcomes (1)
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.
Measured: day1, day 15, day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start26 Jan 2020
- Primary completion11 Jul 2021
- Study completion11 Jul 2021
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle Villemeyre-Plane, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233450
- Sponsor's protocol ID
- RNI 2019 VILLEMEYRE-PLANE
- Other IDs
- 2019-A01000-57
- Acronym
- BodyBabe
- Status last verified
- Aug 2021
- First submitted
- 15 Jan 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions of Their Own Body and of the Body of Their Child Among Young Mothers With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04233450
- Acronym / sponsor ID
- BodyBabe / RNI 2019 VILLEMEYRE-PLANE
- Conditions
- Anorexia Nervosa, Eating Disorders
- Keywords
- mother anorexia nervosa, body perception, post-partum, baby body
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 26 Jan 2020 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: BodyBabe questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BodyBabe questionnaireassessment of young mothers' perceptions using self-questionnaires | Other | Patient group |
Primary outcome
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
1 secondary outcome
impact of the history of anorexia nervosa or severity on the questionnaires' scores
Time frame: day1, day 15, day 270
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michèle Villemeyre-Plane principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Eating Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the internal and external validity of the BodyBabe questionnaire (time frame: day1, day 15, day 270). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.