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临床试验/NCT05246696
NCT05246696撤回不适用

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

University Hospital, Clermont-Ferrand0 个研究点开始时间: 2022年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
evaluate the internal and external validity of the BodyBabe questionnaire

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

evaluate the internal and external validity of the BodyBabe questionnaire

时间窗: 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

次要结局

  • impact of the history of anorexia nervosa or severity on the questionnaires' scores(day1, day 15, day 270)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

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